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Redefining Rehabilitation




            0300
Carpal Tunnel Syndrome (CTS)
       Medicare Splints



        Product Specifications
                 And
    Technical Recommendation Note

                   From



    MGRM Medicare Limited, Hyderabad
      201, II Floor, Block A, Kushal Towers
       Khairatabad, Hyderabad – 500 004.
             Andhra Pradesh. INDIA
  Ph: +91 40 2339 6784 Fax: +91 40 6666 8551
PRODUCT SPECIFICATIONS
                                CTS MEDICARE SPLINTS


INTENDED USE
CTS MEDICARE SPLINTS ARE USED TO PROVIDE SUPPORT TO THE WRIST
JOINT IN ORDER TO PREVENT HYPER-FLEXION MOVEMENTS OR REDUCE
PAINFUL JOINT MOVEMENTS DURING DAY-TIME WORKS WHILE PROVIDING
COMPLETE REST TO THE CTS-AFFECTED WRIST JOINT IN NEUTRAL
POSITION DURING SLEEP HOURS.


                THE TYPES AND SIZES OF CTS MEDICARE SPLINTS
S.  PRODUCT PRODUCT                       SIZES         UNIT Made of Materials
No. CODE    NAME                                        Qty
1   0302    Carpal Tunnel                 Universal     1 Pc Al Splint, Elastic Band
            Splint
2   0303    Solar Splint                  S, M, L, XL   1 Pc     Nylon Loop, Elastic Band
3   0304    Lunar Splint                  Universal     1 Pc     Al Splint, Polyester PUF

INDICATIONS FOR USE:

   •   To reduce the incidence of carpal tunnel syndrome among
       Computer Staff, Hand Drillers, Carpenters, etc.
   •   Wrist Pain and Numbness (Carpal Tunnel Syndrome)
   •   Post-Operative Wrist Joint Rehabilitation


COLORS AVAILABLE:

Beige (Skin Color) and Navy Blue


CAUTION

Indications for use are suggestive in nature.
For specific use, medical advice is recommended.

WASHING INSTRUCTIONS

Hand-Wash using cold water and mild soap
Do not brush hard. Do not squeeze. No Machine-Wash
Air-dry in shade
0302 Carpal Tunnel Splint




   •   Made of Skin-Friendly, Polyester Fabric Laminated PUF, Special Aluminum Alloy
       Splint and 3” width Polyester Elastic Tape

   •   Easy product application using Nylon Hook and Loop Straps

   •   Designed for use on either Right or Left Hand

   •   Available in Universal Size for Adults

Indications for use

      Management of Carpal Tunnel Syndrome (CTS) by minimizing compression on the
       Median Nerve due to Hyper-Flexion movements of the Wrist.

      Prevention of CTS occurrence by reducing Repetitive Stress to the Wrist due to Hyper-
       Flexion.


Fitting Instructions

      Insert thumb of the affected hand into the loop provided. With the fabric laminated foam
       side of the pad touching the hand, wrap the elastic band over the wrist joint.

      Position the foam pad over the middle of the dorsal side of wrist and use nylon hook and
       loop closure to fix the splint.
0303 Solar Splint




      Made of Elastic wrap with buckle and hook/loop strap closure enable easy product
       application and comfortable fit.

      Unique, adjustable NYLON loop covered with a soft flexible PVC tube for middle
       finger in order to control Volar Flexion movement of the wrist.

      Versatile Design allows self application.

      Designed for use on either Right or Left Hand


Indications for use

      Day-time wrist splinting for Carpal Tunnel (CT) Syndrome patients
       as a part of comprehensive treatment program

      Prevention of CT Syndrome occurrence.


Fitting Instructions

      To form tubular opening, insert the nylon hook end of the elastic band into the buckle.
       Then, insert the affected hand into this opening and the middle finger into the loop
       provided.

      Pull the nylon hook on to the nylon loop for comfortable fit.

Size Chart: Measure circumference of the affected wrist joint.
Size Label                    Small          Medium          Large          X-Large
Inches        5-6             6-7            7-8             8-9            9 - 10
0304 Lunar Splint




      Made of Skin-Friendly, Polyester Fabric Laminated PUF and special, light-weight
       Al Alloy splint to provide dorsal support with extraordinary comfort during sleep.

      This Night-Time Splinting limits involuntary hyper-flexion of the affected wrist
       splint during sleep or rest.

      Nylon hook & loop closures through buckles enable easy product application and
       proper fit.

      Designed to fit either left or right hand.

      Available in Universal Size for Adults



Indications for use

      Wrist Splinting for Carpal Tunnel (CT) Syndrome patients as a part of comprehensive
       treatment program during Rest or Night-time.



Fitting Instructions

      Insert nylon hook and loop straps into the corresponding plastic buckles.
   Insert the affected hand into the product by keeping the padded splint on backside
       (dorsal) of the hand. Tighten the straps of nylon hook and loop for secured and
       comfortable fit.



                       TECHNICAL RECOMMENDATION NOTE


Introduction

Carpal Tunnel Syndrome is a painful progressive condition caused by compression of the
Median Nerve in the Wrist (Carpal Tunnel).

If you have been suffering from tingling or numbness in your hand and wrist for several months,
you are probably suffering from CTS.




About Carpal Tunnel Syndrome (CTS)

Carpal tunnel syndrome (CTS) is a condition brought on by swelling and pressure inside a
“tunnel” made up of bones (carpal bones) and a ligament (transverse carpal ligament) in your
wrist. Several tendons and the median nerve pass through the carpal tunnel. It is the
compression of the median nerve that causes the symptoms of CTS.

Symptoms of Carpal Tunnel Syndrome (CTS)
      Pain, frequent tingling, or numbness in the fingers that can sometimes disturb sleep
      Cramping in the hand or wrist
      Feeling of fingers being swollen, although there is no swelling
      Weakness, with difficulty making a fist or squeezing objects in the hand
   Symptoms of CTS may be variable and are often felt in the thumb, index, middle, and
       part of the ring finger.




                                        Area Supplied by
                                        the Median Nerve




                                  Transverse Carpal Ligament
                                                                        Carpal Tunnel
                                 Tendons and Tendon Sheaths


                             Median Nerve




                                                            CROSS SECTION




Risks for Carpal Tunnel Syndrome (CTS)

People who type, work in manufacturing, use vibrating machinery, play sports involving hand
movements, knit, or do any kind of repetitive motion involving the hand may be at risk of
developing CTS. However, sometimes there is no definite cause, and there are many other risk
factors, including
• Arthritis or fracture near the wrist
• Injury of the wrist causing swelling in the carpal tunnel
• Pregnancy
• Diabetes
• Thyroid disease, particularly an underactive thyroid

Treatment for Carpal Tunnel Syndrome (CTS)

Treatment usually begins with a wrist splint to be worn mainly at night. Anti-inflammatory drugs
can help relieve pain and numbness.

Your doctor may also recommend a corticosteroid shot to help reduce swelling.

It may be important to modify your workplace to ensure that your wrist stays in the neutral
position (wrist joint straight, not down) while you perform your job.

If your CTS symptoms are severe or do not improve using the above treatments,

Your doctor might recommend carpal tunnel release surgery to release pressure on the median
nerve. This surgery is usually performed through an incision in the wrist or palm. It may take
several months for strength in the hand and wrist to return to normal.

Unfortunately, CTS may not go away completely after surgery in some cases.



CTS - Prevention is Better than Cure

Because many factors can contribute to carpal tunnel syndrome, there is no single mode of
prevention. Treating any underlying medical condition is certainly important. Simple common
sense may help minimize some risk factors predisposing a person to work-related CTS or other
cumulative trauma disorders. A patient can learn how to adjust the work area, handle tools, or
perform tasks in ways that put less stress on the hands and wrists. Proper posture and exercise
programs to strengthen the fingers, hands, wrists, forearms, shoulders, and neck may help
prevent CTS.

Corporate Efforts

Many companies are now taking action to help prevent repetitive stress injuries. In a major
survey, 84% reported that they were modifying equipment, tasks, and processes. Nearly 85%
were analyzing their workstations and jobs, and 79% were buying new equipment. It should be
stressed, however, that there has been no evidence that any of these methods can provide
complete protection against CTS. The optimal corporate approach, if possible, is to reallocate
workers suffering from repetitive stress injuries to other jobs.

Preventing CTS in Keyboard Workers
Altering the way a person performs repetitive activities may help prevent inflammation in the
hand and wrist. Most of the interventions described below have been found to reduce repetitive
motion problems in the muscles and tendons of the hand and arm. They may reduce the
incidence of carpal tunnel syndrome, although there is no definite proof of this effect.

Replacing old tools with ergonomically designed new ones can be very helpful.

Rest Periods and Avoiding Repetition. Anyone who does repetitive tasks should begin with a
short warm-up period, take frequent breaks, and avoid overexertion of the hand and finger
muscles whenever possible. Employers should be urged to vary the tasks and work content of
their employees.

Taking multiple "micro-breaks" (about 3 minutes each) reduces strain and discomfort without
decreasing productivity. Such breaks may include the following:

   •   Shaking or stretching the limbs
   •   Leaning back in the chair
   •   Squeezing the shoulder blades together.
   •   Taking deep breaths

Good Posture. Good posture is extremely important in preventing carpal tunnel syndrome,
particularly for typists and computer users.

   •   The worker should sit with the spine against the back of the chair with the shoulders
       relaxed.
   •   The elbows should rest along the sides of the body, with wrists straight.
   •   The feet should be firmly on the floor or on a footrest.
   •   Typing materials should be at eye level so that the neck does not bend over the work.
   •   Keeping the neck flexible and head upright maintains circulation and nerve function to
       the arms and hands. One method for finding the correct head position is the "pigeon"
       movement. Keeping the chin level, glide the head slowly and gently forward and
       backward in small movements, avoiding neck discomfort.

Good Office Furniture. Poorly designed office furniture is a major contributor to bad posture.
Chairs should be adjustable for height, with a supportive backrest. Custom-designed chairs,
made for people who do not fit in standard chairs, can be expensive. However, the costs are often
offset by the savings in medical expenses that follow injuries related to bad posture.

Keyboard and Mouse Tips: Anyone using a keyboard and mouse has some options that may
help protect the hands.

   •   The tension of the keys should be adjusted so they can be depressed without excessive
       force.
   •   The hands and wrists should remain in a relaxed position to avoid excessive force on the
       keyboard.
•   A 2003 study suggested that mouse-use poses a higher risk than keyboard use. Replacing
    the mouse with a trackball device and the standard keyboard with a jointed-type keyboard
    are helpful substitutions.
•   Wrist rests, which fit under most keyboards, can help keep the wrists and fingers in a
    comfortable position.
•   Some people recommend keeping the computer mouse as close to the keyboard and the
    user's body as possible, to reduce shoulder muscle movement.
•   The mouse should be held lightly, with the wrist and forearm relaxed. New mouse
    supports are also available that relieve stress on the hand and support the wrist.
•   Some people cut their mouse pads in half to reduce movement.
What Medical Research says about Wearing Splints
                        To Prevent or Reduce the Risk of CTS
                                         and
                        for Post-Surgical Rehabilitation Care



Comparison of splinting, splinting plus local steroid
injection and open carpal tunnel release outcomes in
idiopathic carpal tunnel syndrome.
Ucan H, Yagci I, Yilmaz L, Yagmurlu F, Keskin D, Bodur H.

Rheumatol Int. 2006 Nov;27(1):45-51. Epub 2006 Jul 27.

Department of Physical Medicine and Rehabilitation, Ankara Numune Education and Research
Hospital, Ankara, Turkey.

                                         Abstract

The objective of this study was to compare the short- and long-term efficacies of splinting (S),
splinting plus local steroid injection (SLSI), and open carpal tunnel release (OCTR) in mild or
moderate idiopathic carpal tunnel syndrome (CTS). Patients with mild or moderate idiopathic
CTS who experienced symptoms for over 6 months were included in the study. The patients
were evaluated for the baseline and the third and sixth month scores after treatment. Follow-up
criteria were ENMG parameters, Boston Questionnaire, and patient satisfaction. Fifty-seven
hands completed the study. Twenty-three hands had been splinted for 3 months. Twenty-three
hands were given a single steroid injection and splinted for 3 months, and 11 hands were
operated. In the first 3 months, all treatment methods provided significant improvements in both
clinical and EMG parameters in which OCTR had better outcomes on median sensorial nerve
velocity at palm wrist segment. In the second 3 months, while the clinical and EMG parameters
began to deteriorate in S and SLSI group, OCTR group continued to improve, and BQ functional
capacity score of OCTR group was statistically better than that in conservative methods (P =
0.03). S and SLSI treatments improved clinical and EMG parameters comparable to OCTR in
short term. However, these beneficial effects were transient in the sixth month follow-up and
OCTR was superior to conservative treatments.

PMID: 16871409 [PubMed - indexed for MEDLINE]
Effects of wrist splinting for Carpal Tunnel syndrome
and motor nerve conduction measurements
Nobuta S, Sato K, Nakagawa T, Hatori M, Itoi E.

Ups J Med Sci. 2008;113(2):181-92.

Department of Orthopaedic Surgery, Tohoku Rosai Hospital, Sendai, Miyagi 981-8563 Japan.
nobutays@jc5.so-net.ne.jp

                                         Abstract

BACKGROUND: Carpal tunnel syndrome (CTS) is one of the most common disease among the
entrapment neuropathies. Wrist splinting has been conventionally used for the CTS treatment.
The purposes of this study were to assess the efficacy of wrist splinting for CTS, and to evaluate
the value of the motor nerve conduction measurement as a prognostic indicator for CTS.

METHODS: Two hundred and fourteen hands with CTS were treated by wrist splinting, and
reviewed after a mean follow up of seven months. Severity of symptoms were minimal lesions in
177 hands, intermediate lesions in 33 hands, and severe lesions in four hands. Motor nerve
conduction measurement was performed in all cases before and after treatment, and distal latency
(DL) and amplitude on compound muscle action potential (CMAP) from the abductor pollicis
brevis (APB) muscle were analyzed.

RESULTS: According to Kelly's grading of outcome, results were excellent in 41 hands, good
in 110 hands, fair in 45 hands, and poor in 18 hands. Excellent or good results were obtained in
131 hands (74 percent) with minimal lesions, 20 hands (61 percent) with intermediate lesions,
and in no cases with severe lesions. The ratio of excellent or good results was 79 percent in
patients in whom DL of pre-treatment APB-CMAP was less than 8 milliseconds (ms), and 62
percent in patients whose DL was 8 ms or more, which showed a significant difference. In nine
hands whose pre-treatment APB-CMAP was unrecordable, the results were good in one hand,
fair in five, and poor in three.

CONCLUSIONS: Wrist splinting is most effective in cases of minimal or intermediate lesions
with DL of APB-CMAP less than 8 ms. If relief of symptoms is not obtained after five months of
treatment by splinting, that would be the limit of splinting. Surgical release is recommended for
cases with severe lesions and with unrecordable APB-CMAP.

PMID: 18509812 [PubMed - indexed for MEDLINE]
Neutral wrist splinting in carpal tunnel syndrome:
a comparison of night-only versus full-time wear
instructions.
Walker WC, Metzler M, Cifu DX, Swartz Z.

Arch Phys Med Rehabil. 2000 Apr;81(4):424-9.

Department of Physical Medicine and Rehabilitation, Medical College of Virginia at Virginia
Commonwealth University, Richmond, USA.

Abstract

OBJECTIVE: To compare the effects of night-only to full-time splint wear instructions on
symptoms, function, and impairment in carpal tunnel syndrome (CTS).

DESIGN: Randomized clinical trial with 6-week follow-up.

SETTING: Veterans Administration Medical Center, outpatient clinic.

SUBJECTS: Outpatients with untreated CTS were consecutively recruited from our electro
diagnostics lab. Twenty-one patients (30 hands) were enrolled, and 17 patients (24 hands)
completed the study.

INTERVENTIONS: Thermoplastic, custom-molded, neutral wrist splints with subjects
receiving either full-time or night-only wear instructions.

OUTCOME MEASURES: Symptoms and functional deficits were measured by Levine's self-
administered questionnaire, and physiologic impairment was measured by median nerve sensory
and motor distal latency. COMPLIANCE AND CROSSOVER: Almost all (92%) of the
combined sample reported frequent splint use, but their adherence to specific wearing
instructions was limited. A majority (73%) of the full-time group reported splint wear less than
one half of waking hours, and some (23%) of the night-only group reported occasional daytime
wear. Despite this tendency for treatment crossover, the two treatment groups differed in daytime
wear as intended (chi2 analysis, p = .004).

RESULTS: The combined sample improved in three of four outcome measures: sensory distal
latency (mean = .28msec, standard deviation [SD] = .37, p = .004), symptom severity (mean = .
64, SD = .46, p = .0001), and functional deficits (mean = .49, SD = .51, p = .0001). Severity of
CTS was a factor only in sensory distal latency improvement (more improvement in severe
CTS). Subjects receiving full-time wear instructions showed superior distal latency
improvement, both motor (.35 vs -.07msec, p = .04) and sensory (.46 vs . 13msec, p = .05) when
compared with subjects receiving night-only wear instructions.
CONCLUSIONS: This study provides added scientific evidence to support the efficacy of
neutral wrist splints in CTS and suggests that physiologic improvement is best with full-time
splint wear instructions.

PMID: 10768530 [PubMed - indexed for MEDLINE]




Prevalence of carpal tunnel syndrome
in pregnant women.
Ablove RH, Ablove TS.

WMJ. 2009 Jul;108(4):194-6.

University of Wisconsin School of Medicine and Public Health, Department of Orthopedics and
Rehabilitation, Madison, Wis, USA. ablove@orthorehab.wisc.edu



                                          Abstract


Carpal tunnel syndrome (CTS) is a frequent complication of pregnancy, with a prevalence
reported as high as 62%. The most typical symptoms are numbness and tingling in the thumb,
index finger, middle finger, and radial half of the ring finger. Other common manifestations
include burning dysesthetic wrist pain, as well as the loss of grip strength and dexterity. Proximal
radiation along the volar forearm, medial arm, and shoulder, while not as common, is not
unusual. Symptoms are often worse at night and can be exacerbated by forceful activity and
extreme wrist positions. It can be diagnosed to a high degree of specificity via history and
physical examination. Median nerve function is impaired in virtually all pregnant women during
the third trimester, even in the absence of symptoms. Treatment is symptomatic and usually
consists of activity modification, splinting, edema control, and, if necessary, steroid injections.
While most women experience symptomatic improvement following delivery, a significant
percentage may still have some complaints up to at least 3 years post-partum and continue to
wear splints. A high level of vigilance should be maintained in the management of these patients.

PMID: 19753825 [PubMed - indexed for MEDLINE]
Systematic Reviews of Treatments for CTS


Carpal Tunnel Syndrome Part I:
Effectiveness of Non-Surgical Treatments - A
Systematic Review.
Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, van Middelkoop M, Koes BW.

Arch Phys Med Rehabil. 2010 Jul; 91 (7):981-1004.

Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.
b.huisstede@erasmusmc.nl

                                          Abstract
OBJECTIVE: To review literature systematically concerning effectiveness of nonsurgical
interventions for treating carpal tunnel syndrome (CTS).

DATA SOURCES: The Cochrane Library, PubMed, EMBASE, CINAHL, and PEDro were
searched for relevant systematic reviews and randomized controlled trials (RCTs).

STUDY SELECTION: Two reviewers independently applied the inclusion criteria to select
potential studies.

DATA EXTRACTION: Two reviewers independently extracted the data and assessed the
methodologic quality.

DATA SYNTHESIS: A best-evidence synthesis was performed to summarize the results of the
included studies. Two reviews and 20 RCTs were included. Strong and moderate evidence was
found for the effectiveness of oral steroids, steroid injections, ultrasound, electromagnetic field
therapy, nocturnal splinting, and the use of ergonomic keyboards compared with a standard
keyboard, and traditional cupping versus heat pads in the short term. Also, moderate evidence
was found for ultrasound in the midterm. With the exception of oral and steroid injections, no
long-term results were reported for any of these treatments. No evidence was found for the
effectiveness of oral steroids in long term. Moreover, although higher doses of steroid injections
seem to be more effective in the midterm, the benefits of steroids injections were not maintained
in the long term. For all other nonsurgical interventions studied, only limited or no evidence was
found.
CONCLUSIONS: The reviewed evidence supports that a number of nonsurgical interventions
benefit CTS in the short term, but there is sparse evidence on the midterm and long-term
effectiveness of these interventions. Therefore, future studies should concentrate not only on
short-term but also on midterm and long-term results.

Copyright 2010 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All
rights reserved.

PMID: 20599038 [PubMed - indexed for MEDLINE]




Carpal Tunnel Syndrome Part II:
Effectiveness of Surgical Treatments
- A Systematic Review.
Huisstede BM, Randsdorp MS, Coert JH, Glerum S, van Middelkoop M, Koes BW.

Arch Phys Med Rehabil. 2010 Jul;91(7):1005-24.

Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands.
b.huisstede@erasmusmc.nl

                                          Abstract
OBJECTIVE: To present an evidence-based overview of the effectiveness of surgical and
postsurgical interventions to treat carpal tunnel syndrome (CTS).

DATA SOURCES: The Cochrane Library, PubMed, EMBASE, CINAHL, and PEDro were
searched for relevant systematic reviews and randomized controlled trials (RCTs).

STUDY SELECTION: Two reviewers independently applied the inclusion criteria to select
potential studies.

DATA EXTRACTION: Two reviewers independently extracted the data and assessed the
methodologic quality.

DATA SYNTHESIS: A best-evidence synthesis was performed to summarize the results of the
included studies. Two reviews and 25 RCTs were included. Moderate evidence was found in
favor of surgical treatment compared with splinting or anti-inflammatory drugs plus hand
therapy in the midterm and long term, and for the effectiveness of corticosteroid irrigation of the
median nerve before skin closure as additive to carpal tunnel release in the short term. Limited
evidence was found in favor of a double-incision technique compared with the standard incision
technique. Also, limited evidence was found in favor of a mini-open technique assisted by a
Knifelight instrument compared with a standard open release at 19 months of follow-up.
However, in the short term and at 30 months of follow-up, no significant differences were found
between the mini-open technique assisted by a Knifelight instrument compared with a standard
open release. Many studies compared different surgical interventions, but no evidence was found
in favor of any one of them. No RCTs explored the optimal timing strategy for surgery. No
evidence was found for the efficacy of various presurgical or postsurgical treatment programs,
including splinting.

CONCLUSIONS: Surgical treatment seems to be more effective than splinting or anti-
inflammatory drugs plus hand therapy in the midterm and long term to treat CTS. However,
there is no unequivocal evidence that suggests one surgical treatment is more effective than the
other. More research is needed to study conservative to surgical treatment in which also should
be taken into account the optimal timing of surgery. Future research should also concentrate on
optimal pre-surgical and post-surgical treatment programs.

Copyright 2010 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All
rights reserved.

PMID: 20599039 [PubMed - indexed for MEDLINE]



                  Why MGRM Medicare CTS Splints?

Product Quality are of International Standards

"CE" Certified
which consisting of ISO 14971, EN1441 & EN980 and conforms to the
requirements of "Medical Devices Directive 93/42/EEC" (for Europe market).

Registered with FDA (Food and Drug Administration) of the USA (for US
Market)

Quality of Company-wide Processes for Design, Development, Manufacturing
and Marketing are being Assured by the ISO
Standards – IS0 9001:2008 and ISO 13485:2003.

Environmental and Occupational Health & Safety Management are being
Planned, Implemented, Monitored and Controlled by the ISO Standards – ISO
14001:2004 and OHSAS 18001:2007.
Redefining Rehabilitation




“Search and research are the essence of mankind. The resultant
awareness leads to an individual’s physical, psychological, social and
spiritual evolution. Extensive scientific and medical research has
proved that the concept of rehabilitation is not limited to physical
rehabilitation. Ultimate rehabilitation for the human race is one that
can recognize and simultaneously encompass all the above elements
that make an individual, a complete personality. “
                                                   Dr . K. V. R. Mur thy
                                                     Founder MGRM




                  MGRM Medicare Limited
             201, II Floor, Block A, Kushal Towers
              Khairatabad, Hyderabad – 500 004.
                   Andhra Pradesh. INDIA
         Ph: +91 40 2339 6784 Fax: +91 40 6666 8551
                            www.mgrm.com
                          mgrm.hyd@mgrm.com

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Redefining Rehabilitation for CTS Patients

  • 1. Redefining Rehabilitation 0300 Carpal Tunnel Syndrome (CTS) Medicare Splints Product Specifications And Technical Recommendation Note From MGRM Medicare Limited, Hyderabad 201, II Floor, Block A, Kushal Towers Khairatabad, Hyderabad – 500 004. Andhra Pradesh. INDIA Ph: +91 40 2339 6784 Fax: +91 40 6666 8551
  • 2. PRODUCT SPECIFICATIONS CTS MEDICARE SPLINTS INTENDED USE CTS MEDICARE SPLINTS ARE USED TO PROVIDE SUPPORT TO THE WRIST JOINT IN ORDER TO PREVENT HYPER-FLEXION MOVEMENTS OR REDUCE PAINFUL JOINT MOVEMENTS DURING DAY-TIME WORKS WHILE PROVIDING COMPLETE REST TO THE CTS-AFFECTED WRIST JOINT IN NEUTRAL POSITION DURING SLEEP HOURS. THE TYPES AND SIZES OF CTS MEDICARE SPLINTS S. PRODUCT PRODUCT SIZES UNIT Made of Materials No. CODE NAME Qty 1 0302 Carpal Tunnel Universal 1 Pc Al Splint, Elastic Band Splint 2 0303 Solar Splint S, M, L, XL 1 Pc Nylon Loop, Elastic Band 3 0304 Lunar Splint Universal 1 Pc Al Splint, Polyester PUF INDICATIONS FOR USE: • To reduce the incidence of carpal tunnel syndrome among Computer Staff, Hand Drillers, Carpenters, etc. • Wrist Pain and Numbness (Carpal Tunnel Syndrome) • Post-Operative Wrist Joint Rehabilitation COLORS AVAILABLE: Beige (Skin Color) and Navy Blue CAUTION Indications for use are suggestive in nature. For specific use, medical advice is recommended. WASHING INSTRUCTIONS Hand-Wash using cold water and mild soap Do not brush hard. Do not squeeze. No Machine-Wash Air-dry in shade
  • 3. 0302 Carpal Tunnel Splint • Made of Skin-Friendly, Polyester Fabric Laminated PUF, Special Aluminum Alloy Splint and 3” width Polyester Elastic Tape • Easy product application using Nylon Hook and Loop Straps • Designed for use on either Right or Left Hand • Available in Universal Size for Adults Indications for use  Management of Carpal Tunnel Syndrome (CTS) by minimizing compression on the Median Nerve due to Hyper-Flexion movements of the Wrist.  Prevention of CTS occurrence by reducing Repetitive Stress to the Wrist due to Hyper- Flexion. Fitting Instructions  Insert thumb of the affected hand into the loop provided. With the fabric laminated foam side of the pad touching the hand, wrap the elastic band over the wrist joint.  Position the foam pad over the middle of the dorsal side of wrist and use nylon hook and loop closure to fix the splint.
  • 4. 0303 Solar Splint  Made of Elastic wrap with buckle and hook/loop strap closure enable easy product application and comfortable fit.  Unique, adjustable NYLON loop covered with a soft flexible PVC tube for middle finger in order to control Volar Flexion movement of the wrist.  Versatile Design allows self application.  Designed for use on either Right or Left Hand Indications for use  Day-time wrist splinting for Carpal Tunnel (CT) Syndrome patients as a part of comprehensive treatment program  Prevention of CT Syndrome occurrence. Fitting Instructions  To form tubular opening, insert the nylon hook end of the elastic band into the buckle. Then, insert the affected hand into this opening and the middle finger into the loop provided.  Pull the nylon hook on to the nylon loop for comfortable fit. Size Chart: Measure circumference of the affected wrist joint.
  • 5. Size Label Small Medium Large X-Large Inches 5-6 6-7 7-8 8-9 9 - 10 0304 Lunar Splint  Made of Skin-Friendly, Polyester Fabric Laminated PUF and special, light-weight Al Alloy splint to provide dorsal support with extraordinary comfort during sleep.  This Night-Time Splinting limits involuntary hyper-flexion of the affected wrist splint during sleep or rest.  Nylon hook & loop closures through buckles enable easy product application and proper fit.  Designed to fit either left or right hand.  Available in Universal Size for Adults Indications for use  Wrist Splinting for Carpal Tunnel (CT) Syndrome patients as a part of comprehensive treatment program during Rest or Night-time. Fitting Instructions  Insert nylon hook and loop straps into the corresponding plastic buckles.
  • 6. Insert the affected hand into the product by keeping the padded splint on backside (dorsal) of the hand. Tighten the straps of nylon hook and loop for secured and comfortable fit. TECHNICAL RECOMMENDATION NOTE Introduction Carpal Tunnel Syndrome is a painful progressive condition caused by compression of the Median Nerve in the Wrist (Carpal Tunnel). If you have been suffering from tingling or numbness in your hand and wrist for several months, you are probably suffering from CTS. About Carpal Tunnel Syndrome (CTS) Carpal tunnel syndrome (CTS) is a condition brought on by swelling and pressure inside a “tunnel” made up of bones (carpal bones) and a ligament (transverse carpal ligament) in your wrist. Several tendons and the median nerve pass through the carpal tunnel. It is the compression of the median nerve that causes the symptoms of CTS. Symptoms of Carpal Tunnel Syndrome (CTS)  Pain, frequent tingling, or numbness in the fingers that can sometimes disturb sleep  Cramping in the hand or wrist  Feeling of fingers being swollen, although there is no swelling  Weakness, with difficulty making a fist or squeezing objects in the hand
  • 7. Symptoms of CTS may be variable and are often felt in the thumb, index, middle, and part of the ring finger. Area Supplied by the Median Nerve Transverse Carpal Ligament Carpal Tunnel Tendons and Tendon Sheaths Median Nerve CROSS SECTION Risks for Carpal Tunnel Syndrome (CTS) People who type, work in manufacturing, use vibrating machinery, play sports involving hand movements, knit, or do any kind of repetitive motion involving the hand may be at risk of developing CTS. However, sometimes there is no definite cause, and there are many other risk factors, including
  • 8. • Arthritis or fracture near the wrist • Injury of the wrist causing swelling in the carpal tunnel • Pregnancy • Diabetes • Thyroid disease, particularly an underactive thyroid Treatment for Carpal Tunnel Syndrome (CTS) Treatment usually begins with a wrist splint to be worn mainly at night. Anti-inflammatory drugs can help relieve pain and numbness. Your doctor may also recommend a corticosteroid shot to help reduce swelling. It may be important to modify your workplace to ensure that your wrist stays in the neutral position (wrist joint straight, not down) while you perform your job. If your CTS symptoms are severe or do not improve using the above treatments, Your doctor might recommend carpal tunnel release surgery to release pressure on the median nerve. This surgery is usually performed through an incision in the wrist or palm. It may take several months for strength in the hand and wrist to return to normal. Unfortunately, CTS may not go away completely after surgery in some cases. CTS - Prevention is Better than Cure Because many factors can contribute to carpal tunnel syndrome, there is no single mode of prevention. Treating any underlying medical condition is certainly important. Simple common sense may help minimize some risk factors predisposing a person to work-related CTS or other cumulative trauma disorders. A patient can learn how to adjust the work area, handle tools, or perform tasks in ways that put less stress on the hands and wrists. Proper posture and exercise programs to strengthen the fingers, hands, wrists, forearms, shoulders, and neck may help prevent CTS. Corporate Efforts Many companies are now taking action to help prevent repetitive stress injuries. In a major survey, 84% reported that they were modifying equipment, tasks, and processes. Nearly 85% were analyzing their workstations and jobs, and 79% were buying new equipment. It should be stressed, however, that there has been no evidence that any of these methods can provide complete protection against CTS. The optimal corporate approach, if possible, is to reallocate workers suffering from repetitive stress injuries to other jobs. Preventing CTS in Keyboard Workers
  • 9. Altering the way a person performs repetitive activities may help prevent inflammation in the hand and wrist. Most of the interventions described below have been found to reduce repetitive motion problems in the muscles and tendons of the hand and arm. They may reduce the incidence of carpal tunnel syndrome, although there is no definite proof of this effect. Replacing old tools with ergonomically designed new ones can be very helpful. Rest Periods and Avoiding Repetition. Anyone who does repetitive tasks should begin with a short warm-up period, take frequent breaks, and avoid overexertion of the hand and finger muscles whenever possible. Employers should be urged to vary the tasks and work content of their employees. Taking multiple "micro-breaks" (about 3 minutes each) reduces strain and discomfort without decreasing productivity. Such breaks may include the following: • Shaking or stretching the limbs • Leaning back in the chair • Squeezing the shoulder blades together. • Taking deep breaths Good Posture. Good posture is extremely important in preventing carpal tunnel syndrome, particularly for typists and computer users. • The worker should sit with the spine against the back of the chair with the shoulders relaxed. • The elbows should rest along the sides of the body, with wrists straight. • The feet should be firmly on the floor or on a footrest. • Typing materials should be at eye level so that the neck does not bend over the work. • Keeping the neck flexible and head upright maintains circulation and nerve function to the arms and hands. One method for finding the correct head position is the "pigeon" movement. Keeping the chin level, glide the head slowly and gently forward and backward in small movements, avoiding neck discomfort. Good Office Furniture. Poorly designed office furniture is a major contributor to bad posture. Chairs should be adjustable for height, with a supportive backrest. Custom-designed chairs, made for people who do not fit in standard chairs, can be expensive. However, the costs are often offset by the savings in medical expenses that follow injuries related to bad posture. Keyboard and Mouse Tips: Anyone using a keyboard and mouse has some options that may help protect the hands. • The tension of the keys should be adjusted so they can be depressed without excessive force. • The hands and wrists should remain in a relaxed position to avoid excessive force on the keyboard.
  • 10. A 2003 study suggested that mouse-use poses a higher risk than keyboard use. Replacing the mouse with a trackball device and the standard keyboard with a jointed-type keyboard are helpful substitutions. • Wrist rests, which fit under most keyboards, can help keep the wrists and fingers in a comfortable position. • Some people recommend keeping the computer mouse as close to the keyboard and the user's body as possible, to reduce shoulder muscle movement. • The mouse should be held lightly, with the wrist and forearm relaxed. New mouse supports are also available that relieve stress on the hand and support the wrist. • Some people cut their mouse pads in half to reduce movement.
  • 11.
  • 12. What Medical Research says about Wearing Splints To Prevent or Reduce the Risk of CTS and for Post-Surgical Rehabilitation Care Comparison of splinting, splinting plus local steroid injection and open carpal tunnel release outcomes in idiopathic carpal tunnel syndrome. Ucan H, Yagci I, Yilmaz L, Yagmurlu F, Keskin D, Bodur H. Rheumatol Int. 2006 Nov;27(1):45-51. Epub 2006 Jul 27. Department of Physical Medicine and Rehabilitation, Ankara Numune Education and Research Hospital, Ankara, Turkey. Abstract The objective of this study was to compare the short- and long-term efficacies of splinting (S), splinting plus local steroid injection (SLSI), and open carpal tunnel release (OCTR) in mild or moderate idiopathic carpal tunnel syndrome (CTS). Patients with mild or moderate idiopathic CTS who experienced symptoms for over 6 months were included in the study. The patients were evaluated for the baseline and the third and sixth month scores after treatment. Follow-up criteria were ENMG parameters, Boston Questionnaire, and patient satisfaction. Fifty-seven hands completed the study. Twenty-three hands had been splinted for 3 months. Twenty-three hands were given a single steroid injection and splinted for 3 months, and 11 hands were operated. In the first 3 months, all treatment methods provided significant improvements in both clinical and EMG parameters in which OCTR had better outcomes on median sensorial nerve velocity at palm wrist segment. In the second 3 months, while the clinical and EMG parameters began to deteriorate in S and SLSI group, OCTR group continued to improve, and BQ functional capacity score of OCTR group was statistically better than that in conservative methods (P = 0.03). S and SLSI treatments improved clinical and EMG parameters comparable to OCTR in short term. However, these beneficial effects were transient in the sixth month follow-up and OCTR was superior to conservative treatments. PMID: 16871409 [PubMed - indexed for MEDLINE]
  • 13. Effects of wrist splinting for Carpal Tunnel syndrome and motor nerve conduction measurements Nobuta S, Sato K, Nakagawa T, Hatori M, Itoi E. Ups J Med Sci. 2008;113(2):181-92. Department of Orthopaedic Surgery, Tohoku Rosai Hospital, Sendai, Miyagi 981-8563 Japan. nobutays@jc5.so-net.ne.jp Abstract BACKGROUND: Carpal tunnel syndrome (CTS) is one of the most common disease among the entrapment neuropathies. Wrist splinting has been conventionally used for the CTS treatment. The purposes of this study were to assess the efficacy of wrist splinting for CTS, and to evaluate the value of the motor nerve conduction measurement as a prognostic indicator for CTS. METHODS: Two hundred and fourteen hands with CTS were treated by wrist splinting, and reviewed after a mean follow up of seven months. Severity of symptoms were minimal lesions in 177 hands, intermediate lesions in 33 hands, and severe lesions in four hands. Motor nerve conduction measurement was performed in all cases before and after treatment, and distal latency (DL) and amplitude on compound muscle action potential (CMAP) from the abductor pollicis brevis (APB) muscle were analyzed. RESULTS: According to Kelly's grading of outcome, results were excellent in 41 hands, good in 110 hands, fair in 45 hands, and poor in 18 hands. Excellent or good results were obtained in 131 hands (74 percent) with minimal lesions, 20 hands (61 percent) with intermediate lesions, and in no cases with severe lesions. The ratio of excellent or good results was 79 percent in patients in whom DL of pre-treatment APB-CMAP was less than 8 milliseconds (ms), and 62 percent in patients whose DL was 8 ms or more, which showed a significant difference. In nine hands whose pre-treatment APB-CMAP was unrecordable, the results were good in one hand, fair in five, and poor in three. CONCLUSIONS: Wrist splinting is most effective in cases of minimal or intermediate lesions with DL of APB-CMAP less than 8 ms. If relief of symptoms is not obtained after five months of treatment by splinting, that would be the limit of splinting. Surgical release is recommended for cases with severe lesions and with unrecordable APB-CMAP. PMID: 18509812 [PubMed - indexed for MEDLINE]
  • 14. Neutral wrist splinting in carpal tunnel syndrome: a comparison of night-only versus full-time wear instructions. Walker WC, Metzler M, Cifu DX, Swartz Z. Arch Phys Med Rehabil. 2000 Apr;81(4):424-9. Department of Physical Medicine and Rehabilitation, Medical College of Virginia at Virginia Commonwealth University, Richmond, USA. Abstract OBJECTIVE: To compare the effects of night-only to full-time splint wear instructions on symptoms, function, and impairment in carpal tunnel syndrome (CTS). DESIGN: Randomized clinical trial with 6-week follow-up. SETTING: Veterans Administration Medical Center, outpatient clinic. SUBJECTS: Outpatients with untreated CTS were consecutively recruited from our electro diagnostics lab. Twenty-one patients (30 hands) were enrolled, and 17 patients (24 hands) completed the study. INTERVENTIONS: Thermoplastic, custom-molded, neutral wrist splints with subjects receiving either full-time or night-only wear instructions. OUTCOME MEASURES: Symptoms and functional deficits were measured by Levine's self- administered questionnaire, and physiologic impairment was measured by median nerve sensory and motor distal latency. COMPLIANCE AND CROSSOVER: Almost all (92%) of the combined sample reported frequent splint use, but their adherence to specific wearing instructions was limited. A majority (73%) of the full-time group reported splint wear less than one half of waking hours, and some (23%) of the night-only group reported occasional daytime wear. Despite this tendency for treatment crossover, the two treatment groups differed in daytime wear as intended (chi2 analysis, p = .004). RESULTS: The combined sample improved in three of four outcome measures: sensory distal latency (mean = .28msec, standard deviation [SD] = .37, p = .004), symptom severity (mean = . 64, SD = .46, p = .0001), and functional deficits (mean = .49, SD = .51, p = .0001). Severity of CTS was a factor only in sensory distal latency improvement (more improvement in severe CTS). Subjects receiving full-time wear instructions showed superior distal latency improvement, both motor (.35 vs -.07msec, p = .04) and sensory (.46 vs . 13msec, p = .05) when compared with subjects receiving night-only wear instructions.
  • 15. CONCLUSIONS: This study provides added scientific evidence to support the efficacy of neutral wrist splints in CTS and suggests that physiologic improvement is best with full-time splint wear instructions. PMID: 10768530 [PubMed - indexed for MEDLINE] Prevalence of carpal tunnel syndrome in pregnant women. Ablove RH, Ablove TS. WMJ. 2009 Jul;108(4):194-6. University of Wisconsin School of Medicine and Public Health, Department of Orthopedics and Rehabilitation, Madison, Wis, USA. ablove@orthorehab.wisc.edu Abstract Carpal tunnel syndrome (CTS) is a frequent complication of pregnancy, with a prevalence reported as high as 62%. The most typical symptoms are numbness and tingling in the thumb, index finger, middle finger, and radial half of the ring finger. Other common manifestations include burning dysesthetic wrist pain, as well as the loss of grip strength and dexterity. Proximal radiation along the volar forearm, medial arm, and shoulder, while not as common, is not unusual. Symptoms are often worse at night and can be exacerbated by forceful activity and extreme wrist positions. It can be diagnosed to a high degree of specificity via history and physical examination. Median nerve function is impaired in virtually all pregnant women during the third trimester, even in the absence of symptoms. Treatment is symptomatic and usually consists of activity modification, splinting, edema control, and, if necessary, steroid injections. While most women experience symptomatic improvement following delivery, a significant percentage may still have some complaints up to at least 3 years post-partum and continue to wear splints. A high level of vigilance should be maintained in the management of these patients. PMID: 19753825 [PubMed - indexed for MEDLINE]
  • 16. Systematic Reviews of Treatments for CTS Carpal Tunnel Syndrome Part I: Effectiveness of Non-Surgical Treatments - A Systematic Review. Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, van Middelkoop M, Koes BW. Arch Phys Med Rehabil. 2010 Jul; 91 (7):981-1004. Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands. b.huisstede@erasmusmc.nl Abstract OBJECTIVE: To review literature systematically concerning effectiveness of nonsurgical interventions for treating carpal tunnel syndrome (CTS). DATA SOURCES: The Cochrane Library, PubMed, EMBASE, CINAHL, and PEDro were searched for relevant systematic reviews and randomized controlled trials (RCTs). STUDY SELECTION: Two reviewers independently applied the inclusion criteria to select potential studies. DATA EXTRACTION: Two reviewers independently extracted the data and assessed the methodologic quality. DATA SYNTHESIS: A best-evidence synthesis was performed to summarize the results of the included studies. Two reviews and 20 RCTs were included. Strong and moderate evidence was found for the effectiveness of oral steroids, steroid injections, ultrasound, electromagnetic field therapy, nocturnal splinting, and the use of ergonomic keyboards compared with a standard keyboard, and traditional cupping versus heat pads in the short term. Also, moderate evidence was found for ultrasound in the midterm. With the exception of oral and steroid injections, no long-term results were reported for any of these treatments. No evidence was found for the effectiveness of oral steroids in long term. Moreover, although higher doses of steroid injections seem to be more effective in the midterm, the benefits of steroids injections were not maintained in the long term. For all other nonsurgical interventions studied, only limited or no evidence was found.
  • 17. CONCLUSIONS: The reviewed evidence supports that a number of nonsurgical interventions benefit CTS in the short term, but there is sparse evidence on the midterm and long-term effectiveness of these interventions. Therefore, future studies should concentrate not only on short-term but also on midterm and long-term results. Copyright 2010 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved. PMID: 20599038 [PubMed - indexed for MEDLINE] Carpal Tunnel Syndrome Part II: Effectiveness of Surgical Treatments - A Systematic Review. Huisstede BM, Randsdorp MS, Coert JH, Glerum S, van Middelkoop M, Koes BW. Arch Phys Med Rehabil. 2010 Jul;91(7):1005-24. Department of General Practice, Erasmus Medical Center, Rotterdam, The Netherlands. b.huisstede@erasmusmc.nl Abstract OBJECTIVE: To present an evidence-based overview of the effectiveness of surgical and postsurgical interventions to treat carpal tunnel syndrome (CTS). DATA SOURCES: The Cochrane Library, PubMed, EMBASE, CINAHL, and PEDro were searched for relevant systematic reviews and randomized controlled trials (RCTs). STUDY SELECTION: Two reviewers independently applied the inclusion criteria to select potential studies. DATA EXTRACTION: Two reviewers independently extracted the data and assessed the methodologic quality. DATA SYNTHESIS: A best-evidence synthesis was performed to summarize the results of the included studies. Two reviews and 25 RCTs were included. Moderate evidence was found in favor of surgical treatment compared with splinting or anti-inflammatory drugs plus hand therapy in the midterm and long term, and for the effectiveness of corticosteroid irrigation of the median nerve before skin closure as additive to carpal tunnel release in the short term. Limited evidence was found in favor of a double-incision technique compared with the standard incision
  • 18. technique. Also, limited evidence was found in favor of a mini-open technique assisted by a Knifelight instrument compared with a standard open release at 19 months of follow-up. However, in the short term and at 30 months of follow-up, no significant differences were found between the mini-open technique assisted by a Knifelight instrument compared with a standard open release. Many studies compared different surgical interventions, but no evidence was found in favor of any one of them. No RCTs explored the optimal timing strategy for surgery. No evidence was found for the efficacy of various presurgical or postsurgical treatment programs, including splinting. CONCLUSIONS: Surgical treatment seems to be more effective than splinting or anti- inflammatory drugs plus hand therapy in the midterm and long term to treat CTS. However, there is no unequivocal evidence that suggests one surgical treatment is more effective than the other. More research is needed to study conservative to surgical treatment in which also should be taken into account the optimal timing of surgery. Future research should also concentrate on optimal pre-surgical and post-surgical treatment programs. Copyright 2010 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved. PMID: 20599039 [PubMed - indexed for MEDLINE] Why MGRM Medicare CTS Splints? Product Quality are of International Standards "CE" Certified which consisting of ISO 14971, EN1441 & EN980 and conforms to the requirements of "Medical Devices Directive 93/42/EEC" (for Europe market). Registered with FDA (Food and Drug Administration) of the USA (for US Market) Quality of Company-wide Processes for Design, Development, Manufacturing and Marketing are being Assured by the ISO Standards – IS0 9001:2008 and ISO 13485:2003. Environmental and Occupational Health & Safety Management are being Planned, Implemented, Monitored and Controlled by the ISO Standards – ISO 14001:2004 and OHSAS 18001:2007.
  • 19. Redefining Rehabilitation “Search and research are the essence of mankind. The resultant awareness leads to an individual’s physical, psychological, social and spiritual evolution. Extensive scientific and medical research has proved that the concept of rehabilitation is not limited to physical rehabilitation. Ultimate rehabilitation for the human race is one that can recognize and simultaneously encompass all the above elements that make an individual, a complete personality. “ Dr . K. V. R. Mur thy Founder MGRM MGRM Medicare Limited 201, II Floor, Block A, Kushal Towers Khairatabad, Hyderabad – 500 004. Andhra Pradesh. INDIA Ph: +91 40 2339 6784 Fax: +91 40 6666 8551 www.mgrm.com mgrm.hyd@mgrm.com