1. PMR
BUZZ
Volume 4, Issue 3, October 2022
Contributors:
• Dr. Ravi Gaur, Associate Professor,
Department of PMR, AIIMS, Jodhpur.
• Dr. Navin BP, Assistant Professor,
Department of Neurorehabilitation,
NIMHANS, Bengaluru.
• Dr. Mahima Agrawal, Assistant Professor,
Department of PMR, JLN Medical
College, Ajmer.
• Dr. Harleen Uppal, Associate Professor,
Dept. of PMR, AIIMS, Nagpur.
• Dr. Vinay Goyal, Associate Professor,
Dept. of PMR, AIIPMR, Mumbai.
Editor & Contributor:
• Dr. Mrinal Joshi, Director & Professor
(PMR), Rehabilitation Research Centre,
SMS Medical College, Jaipur.
2. Randomized controlled trial of suprascapular nerve blocks for subacute
adhesive capsulitis.
Schiltz M, Beeckmans N, Gillard B, De Baere T, Hatem SM. Randomized controlled trial of suprascapular nerve blocks for subacute
adhesive capsulitis.
Eur J phys rehabil Med 2022; 58: 630-7. European Journal of Physical and Rehabilitation Medicine
Background
Shoulder pain and loss of function remain a therapeutic
challenge in adhesive capsulitis. Suprascapular nerve
blocks, a common treatment in adhesive capsulitis, are
considered a safe and effective method for the
resolution of pain and restoration of shoulder range of
motion (ROM). To our knowledge, no data are
available on the use of suprascapular nerve blocks in
adhesive capsulitis in the subacute phase.
Aim
The aim of this study was to compare the efficacy of
ultrasound-guided suprascapular nerve blocks versus
saline injections for treating adhesive capsulitis in the
subacute phase.
Design
Randomized double-blinded controlled trial; level of
evidence 2.
Setting
out-patient consultation of physical and rehabilitation
Medicine in a general hospital.
Population
Thirty-five patients with subacute adhesive capsulitis.
Methods
Patients were randomly allocated to receive either 3
successive (1-week interval) ultrasound-guided
suprascapular nerve blocks with ropivacaine 5 ml 2
mg/ml (intervention group) or ultrasound-guided
injections of 5 ml sterile saline solution (nacl 0.9%)
(control group), at the floor of the suprascapular fossa.
Primary outcome was shoulder function assessed by
the Constant-Murley Score. Secondary outcomes were
shoulder roM and shoulder pain intensity. assessments
were performed before each injection and 4 weeks
after the last injection.
Results
A significant increase of Constant-Murley Score
(P<0.001), increase of shoulder ROM (all directions:
P<0.011) and decrease of pain (P<0.001), were
observed over time in both study groups. However, no
significant differences were observed between the
intervention and the control group.
Conclusions
three successive suprascapular nerve blocks did not
provide a better outcome than saline injections on
shoulder function, ROM, and pain in subacute adhesive
capsulitis. These negative findings warrant some
considerations on the natural history of adhesive
capsulitis, as well as timing, type, and placebo effects of
injections.
1
3. 2
Effects of Intra-articular Coinjections of Hyaluronic Acid and Hypertonic
Dextrose on Knee Osteoarthritis: A Prospective, Randomized, Double-
Blind Trial.
Hsieh RL, Lee WC. Effects of Intra-articular Coinjections of Hyaluronic Acid and Hypertonic Dextrose on Knee Osteoarthritis:
A Prospective, Randomized, Double-Blind Trial.
Arch Phys Med Rehabil 2022; 103(8): 1505-14.
Objective
To determine whether intra-articular coinjection with
hypertonic dextrose improves the outcome of
hyaluronic acid (HA) prolotherapy for knee
osteoarthritis (OA).
Design
Prospective, randomized, double-blind trial.
Setting
Medical center in Taiwan.
Participants
In total, 104 participants who fulfilled the American
College of Rheumatology clinical and radiographic
criteria for knee OA with a Kellgren-Lawrence score of
2 or 3 were recruited (N=104).
Interventions
The participants were blocked randomized to the
treatment (HA and hypertonic dextrose) or control
(HA and normal saline) group. Ultrasound-guided knee
intra-articular injections were administered once a
week for 3 weeks.
Main Outcome Measures
The primary outcomes were performance-based
physical function measures (regular and fastest walking
speed, stair climbing time, and chair rising time), and the
secondary outcomes were the Western Ontario and
McMaster Universities Osteoarthritis Index
(WOMAC) and Knee Injury and Osteoarthritis
Outcome Score (KOOS). The outcome measures
were assessed before the injections and at 1 week and
1, 3, and 6 months after the injections. The data were
analyzed through repeated-measures analysis of
covariance.
Results
Significant intergroup difference-in-differences favoring
the treatment group were observed for improvements
in stair climbing time (-1.6; 95% confidence interval, -
8.56 to 4.16; P=.38) and WOMAC physical function (-
21.2; 95% confidence interval, -126.05 to 103.83; P
=.045) at 6 months. The group×time interaction effects
favored the treatment group for regular (P=.001) and
fastest walking speed (P=.001) and chair rising time
(P=.038); WOMAC stiffness (P < .001) and physical
function (P = .003); and KOOS for pain (P = .035), other
symptoms (P=.022), and quality of life (P=.012).
Conclusions
Compared with HA plus normal saline coinjections, HA
plus dextrose coinjections resulted in more significant
improvements in stair climbing time and physical
function at 6 months, effectively decreased pain, and
improved physical function and physical functional
performance from 1 week to 6 months. HA plus
dextrose coinjections could be a suitable adjuvant
therapy for patients with knee OA.
4. 3
Preventive treatment with alendronate of loss of bone mineral density in
acute traumatic spinal cord injury. Randomized controlled clinical trial.
Fernández Dorado, M.T., Díaz Merino, M., García Marco, D. et al. Preventive treatment with alendronate of loss of bone mineral
density in acute traumatic spinal cord injury. Randomized controlled clinical trial.
Spinal Cord 2022; 60: 687–693.
Study design
Randomized controlled clinical trial of two parallel
groups.
Objectives
Analyse the efficacy of primary prevention with
alendronate on the loss of bone mass which occurs
during the first year of traumatic SCI, measured by
double-energy X-ray bone densitometry (DXA).
Setting
National Hospital for Paraplegics (HNP), Toledo, Spain.
Methods
We included 52 people admitted to the HNP with
traumatic SCI Grade A and B on the ASIA Impairment
Scale and less than 8 weeks of progression, which were
randomized to one of the two treatment groups. Both
groups received calcifediol and a calcium-enriched diet
for 52 weeks. Only one group was administered
alendronate 70 mg weekly. The dose of alendronate
was adjusted according to changes in serum b-CTX.
Results
52 Participants were randomized. Of the 26 assigned to
each group, 4 patients were lost in the alendronate
group and 3 in the control group. The random
distribution of women was asymmetrical, so we
analysed the effect of treatment on men. In the total left
hip, the mean (SD) decrease in bone mass was -22.791%
(10.768) in the control group compared to the mean
(SD) decrease of -2.693% (6.283) in the same location
in the alendronate group (p < 0.0001). No patient
presented related adverse events.
Conclusion
Alendronate administered for one year in the first 8
weeks after traumatic SCI decreases bone loss in the
hip in men. This treatment is well tolerated.
5. 4
The Impact of Spasticity and Contractures on Dependency and Outcomes
from Rehabilitation.
1
Stephen Ashford , Barbara Singer, Hilary Rose1, Lynne Turner‐Stokes
J Int Soc Phys Rehabil Med 2022;5:97-104.
Background
Acquired brain injury (ABI) can result in severe physical
impairment causing difficulty with moving which, if not
actively managed, can lead to contracture and
deformity. Delayed access to rehabilitation may result
in more contracture, with potential to increase
duration of rehabilitation, cost and therapy time
required.
Objective
Describe the amount of therapy input for patients
undergoing specialist in-patient rehabilitation following
ABI, the differences in the type of therapy received by
people with and without contracture and/or spasticity,
and the impacts on functional outcomes including care
needs and cost of care.
Materials and Methods
A cohort analysis of prospectively collected data from
426 patients with ABI in a UK tertiary inpatient
rehabilitation program. The Neurological impairment
Scale (NIS) was used to identify the presence of
spasticity or contracture. The Northwick Park Therapy
Dependency Assessment (NPTDA) was used to
calculate the therapy hours and type of treatment
provided to people with and without spasticity and/or
contracture. Outcomes (change in function and
independence) were compared including the UK
Functional Assessment Measure (UK FIM+FAM).
Results
The Male/Female ratio was 63:37% with a mean age:
44.0(SD 13) years and a mean length of stay in specialist
inpatient rehabilitation: 103 (SD 49) days. Aetiology:
Stroke (63%), Trauma (20%); Hypoxia (7%): Other
(10%). Patients with contractures were significantly
more dependent than those without, both on
admission and discharge. They stayed on average 31
days longer (95%CI 21.1, 40.5) (P=0.001) with an
additional mean episode cost of £25,588 (95%CI
£18.085, 34,043) (P<0.001). Despite this, they made
similar overall functional gains resulting in similar long-
term savings in the cost of ongoing care.
Conclusion
Routine collection of the NPTDA supported
quantification of the impact of spasticity and
contracture on therapy inputs, length of stay, functional
gains, and costs. People with contractures following
ABI require more therapy time in rehabilitation to
achieve similar functional gains, but nevertheless were
cost‐efficient to treat.
6. 5
The preliminary results of physiotherapy scoliosis-specific exercises on
spine joint position sense in adolescent idiopathic scoliosis: A randomized
controlled trial.
Akyurek, Elcin1; Zengin Alpozgen, Ayse2; Akgul, Turgut3. The preliminary results of physiotherapy scoliosis-specific exercises on
spine joint position sense in adolescent idiopathic scoliosis: A randomized controlled trial.
Prosthetics and Orthotics International: October 2022 - Volume 46 - Issue 5 - p 510-517.
Background
It has been observed that there are difficulties in
maintaining spinal harmony in the absence of
proprioceptive information, which has an important
role in achieving postural control in scoliosis. One of
the tests used to evaluate proprioceptive mechanisms
is joint position reproduction.
Objective(s)
The main aim of our study was to investigate the effect
of physiotherapy scoliosis-specific exercise (PSSE) on
spine joint reposition (JR) sense. The second aim was to
determine the effects of PSSE on the angle of trunk
rotation (ATR), posture, and deformity perception in
adolescent idiopathic scoliosis.
Methods
Twenty-nine patients with adolescent idiopathic
scoliosis (mean age 13.79 ± 1.82 years) were randomly
allocated to two groups. “Schroth” exercises were
applied to the PSSE group for 8 weeks (16 sessions).
The control group was placed on the waiting list.
Patients' JR error (dual inclinometer), ATR
(scoliometer), posture parameters (PostureScreen
Mobile, Posterior Trunk Asymmetry Index, and
Anterior Trunk Asymmetry Index), and deformity
perception (Walter Reed Visual Assessment Scale
[WRVAS]) were assessed at the first session and at the
end of 8 weeks.
Results
The initial demographic characteristics, Cobb
(thoracal: 19.41 ± 7.03 degrees; lumbar: 20.76 ± 7.24
degrees) and ATR (thoracal: 5.86 ± 3.98 degrees;
lumbar: 5.66 ± 3.33 degrees) and clinical test
parameters of the groups (JR, posture parameters, and
WRVAS) were similar (P > .05). According to the
findings, thoracal and lumbar JR error values (P < .05),
ATR (P < .001), posture parameters (P < .001), and
WRVAS (P = .048) were significantly improved in the
PSSE group. Besides, when the groups were compared,
a significant difference was found in favor of PSSE
except for the deformity perception (P < .05).
Conclusions
Schroth exercises have a positive contribution for
improving JR sense of the spine, vertebral rotation, and
posture.
7. 6
Functional Resistance Training Improves Thigh Muscle Strength after
ACL Reconstruction: A Randomized Clinical Trial.
PALMIERI-SMITH, RIANN M., BROWN, SCOTT R, WOJTYS, EDWARD, KRISHNAN, CHANDRAMOULI
Medicine & Science in Sports & Exercise: October 2022 - Volume 54 - Issue 10 - p 1729-1737.
Purpose
Quadriceps weakness is common after anterior
cruciate ligament (ACL) reconstruction, resulting in
prolonged disability and increased risk for reinjury and
osteoarthritis. Functional resistance training (FRT)
combines resistance training with task-specific training
and may prove beneficial in restoring quadriceps
strength. The primary purpose of this study was to
determine if a walking-specific FRT program (e.g.,
resisted walking) improves knee strength in individuals
after ACL reconstruction.
Methods
Thirty participants were randomized into one of three
groups: 1) FRT with a customized knee BRACE applied
to the ACL leg, 2) FRT with elastic BAND tethered to
the ankle of the ACL leg, or 3) a TARGET MATCH
condition where no resistance was externally applied.
Participants in all groups received training while walking
on a treadmill 2–3 times per week for 8 wk. Isometric
knee extension and flexion strength were measured
before the start of the intervention, after the
intervention (POST), and 8 wk after intervention
completion (POST-2).
Results
The BRACE group had greater knee extensor strength
compared with the TARGET MATCH group at POST
and POST-2 (P < 0.05). The BRACE group had greater
knee flexor strength than the TARGET MATCH group
at POST and POST-2 (P < 0.05) and the BAND group at
POST (P < 0.05).
Conclusions
FRT applied via a customized knee brace results in
improvements in knee extensor and flexor strength
after ACL reconstruction. FRT is a beneficial adjuvant
to ACL rehabilitation and leads to better strength
compared with standard of care.
8. 7
American and European Guidelines on Disorders of Consciousness:
Ethical Challenges of Implementation.
Farisco, Michele PhD; Salles, Arleen PhD
Journal of Head Trauma Rehabilitation: July/August 2022 - Volume 37 - Issue 4 - p 258-262.
The recently published Guidelines on Disorders of
Consciousness (DoCs) by the European Academy of
Neurology (EAN)1 and by the American Academy of
Neurology (AAN) in collaboration with the American
Congress of Rehabilitation Medicine (ACRM) and the
National Institute on Disability, Independent Living, and
Rehabilitation Research (NIDILRR)2 stand as the most
ambitious international attempts to provide clear and
standardized recommendations to clinicians working
with patients with DoCs. They offer an updated, timely,
and wide-ranging list of recommendations for the
diagnosis, prognosis, and clinical care of affected
patients.
However, while commendable, the guidelines pose a
number of questions, including some related to the
practical implementation of their recommendations.
For example, both documents rightly consider that the
integration of behavioural and instrumental
assessments is the best strategy to improve diagnostic
accuracy and quality of care. Yet, the operationalization
of this recommendation in actual clinical settings,
where the necessary technology, for example,
functional magnetic resonance image (fMRI), might not
be available or convenient to use, remains an open
issue. The potential unavailability of the required
technology or of the necessary expertise for use in
some contexts might undermine the reliability,
practical value, and ethical impact of some
recommendations. These are not minor concerns
because the practical inapplicability of specific
recommendations has clear ethical implications: it
might directly impact patients' well-being, their right to
the best possible care, the communication between
clinicians and family members, and overall shared
decision-making and unintentionally lead to unequal
and unfair treatment of some patients.
In this commentary, we propose a responsibility-
oriented strategy to address some of the practical and
normative barriers to implementation. We begin by
summarizing the main points of the 2 guidelines. Next,
we outline a Distributed Responsibility Model (DRM)
based on a distributed multilevel understanding of
responsibility as a means to better understand and
address barriers to the implementation of the
recommendations. While we do not aim at elaborating
an in-depth analysis of all the relevant factors, we hope
to set the stage for a more inclusive and comprehensive
discussion that involves diverse relevant stakeholders
(i.e., clinicians, researchers, and hospital managers,
among others).
9. 8
The TWIST Tool Predicts When Patients Will Recover Independent
Walking After Stroke: An Observational Study.
Marie-Claire Smith, Alan P Barber, Benjamin J Scrivener, Cathy M Stinear
Neurorehabil Neural Repair. 2022 Jul;36(7):461-471.
Background
The likelihood of regaining independent walking after
stroke influences rehabilitation and hospital discharge
planning.
Objective
This study aimed to develop and internally validate a
tool to predict whether and when a patient will walk
independently in the first 6 months post-stroke.
Methods
Adults with stroke were recruited if they had new
lower limb weakness and were unable to walk
independently. Clinical assessments were completed
one week post-stroke. The primary outcome was time
post-stroke by which independent walking (Functional
Ambulation Category score > 4) was achieved. Cox
hazard regression identified predictors for achieving
independent walking by 4, 6, 9, 16, or 26 weeks post-
stroke. The cut-off and weighting for each predictor
was determined using b-coefficients. Predictors were
assigned a score and summed for a final TWIST score.
The probability of achieving independent walking at
each time point for each TWIST score was calculated.
Results
We included 93 participants (36 women, median age 71
years). Age < 80 years, knee extension strength Medical
Research Council grade > 3/5, and Berg Balance Test <
6, 6 to 15, or > 16/56, predicted independent walking
and were combined to form the TWIST prediction
tool. The TWIST prediction tool was at least 83%
accurate for all time points.
Conclusions
The TWIST tool combines routine bedside tests at one
week post-stroke to accurately predict the probability
of an individual patient achieving independent walking
by 4, 6, 9, 16, or 26 weeks post-stroke. If externally
validated, the TWIST prediction tool may benefit
patients and clinicians by informing rehabilitation
decisions and discharge planning.
10. 9
Validity of the Central Sensitization Inventory compared with traditional
measures of disease severity in fibromyalgia.
Fausto Salaffi, Sonia Farah, Claudia Mariani, Piercarlo Sarzi-Puttini , Marco Di Carlo
Pain Pract. 2022 Sep 13.Online ahead of print.
Objective
The goal of this study was to explore additional
evidence of convergent and discriminant validity of the
Central Sensitization Inventory (CSI) in a large sample
of subjects with fibromyalgia (FM).
Methods
Patients were consecutively enrolled for a cross-
sectional assessment comprehensive of three FM-
specific measures (the revised Fibromyalgia Impact
Questionnaire [FIQR], the modified Fibromyalgia
A s s e s s m e n t S t a t u s [ m o d F A S ] , a n d t h e
Polysymptomatic Distress Scale [PDS]) and of CSI. To
test the convergent validity, the Spearman's rho was
used to measure the degree of correlation between the
variables CSI and the FM-specific measures. To assess
discriminant validity, CSI scores were grouped
according to FIQR disease severity states, and
differences between these groups studied with the
Kruskal-Wallis test. Interpretative cutoffs were
established with the interquartile reconciliation
approach.
Results
The study included 562 FM patients, 199 (35.4%) were
classified as having central sensitization syndrome (CSI
>40). CSI was largely correlated with modFAS (p =
0.580; p < 0.0001), FIQR (p = 0.542; p < 0.0001), and
PDS (p = 0.518; p < 0.0001). The differences between
the CSI scores in accordance with the FIQR were
significant (p < 0.000001). CSI cutoffs proposed for FM:
21 between remission and mild severity, 30 between
mild and moderate severity, 37 between moderate and
severe disease, and 51 between severe and very severe
disease.
Conclusion
The current study successfully showed additional
evidence of the convergent and discriminant validity of
the CSI in FM patients.
11. 10
Ultrasound-guided Genicular Nerve Blockade With Pharmacological
Agents for Chronic Knee Osteoarthritis: A Systematic Review.
Yeow Leng Tan, Edmund Jin Rui Neo, and Tze Chao Wee
Background
Ultrasound-guided (ULSD-g) genicular nerve blocks
(GNB) using pharmacological agents for pain control in
chronic knee osteoarthritis (OA) are gaining in
popularity. There lacks a systematic review to evaluate
the ULSD techniques and pharmacological agents used
during the intervention, and to assess the knee’s
function postintervention.
Objectives
Our study aimed to determine the clinical
characteristics of patients with chronic knee OA
selected for ULSD-g GNB, describe the various ULSD-
g techniques and pharmacological agents used to target
the genicular nerves, and evaluate the primary
outcomes of pain and function.
Study Design
Systematic review.
Methods
We looked at patients with chronic knee OA with
symptoms or disease features of at least 3 months and
the use of ULSD guidance for GNB using either local
anesthetic agents and/or corticosteroids or alcohol.
Two major electronic databases (Medline/PubMed and
EMBASE) were searched from their inception through
August 2021, without language restriction.
After removing duplicates, 2 reviewers independently
reviewed the abstracts of 340 records. Nine of the 10
full texts that were reviewed were selected for
inclusion. A third reviewer was involved in resolving
disagreements.
Two reviewers extracted relevant information
pertaining to study types, patient characteristics,
intervention details, outcome measures, and adverse
effects. This was followed by independent verification
for accuracy.
Results
Data synthesis: Nine studies were included with a total
of 280 patients who had symptoms or disease features
of at least 3 months. The National Institute of Health’s
Study Quality Assessment Tools were used for quality
appraisal, of which 8 studies were at least of fair quality.
All studies involved targeted at least the superior
medial, superior lateral, and inferior medial genicular
nerves. ULSD techniques relied on bony, soft tissue, or
periarterial landmarks; either local anesthetic agents
and/or corticosteroids or alcohol were used in the
injections. Follow-up intervals for pain and functional
assessments were heterogeneous, ranging from one
week to 6 months postprocedure. Sustained
improvements in both pain and knee function were
observed for up to 6 months regardless of the choice of
pharmacological agents. Minimal adverse effects were
reported.
Limitations
Meta-analysis was not performed due to heterogeneity
of study designs, ULSD techniques, pharmacological
agents used, and dosages administered. Only one study
targeted additional genicular nerves; conclusions
regarding the therapeutic blockade of these nerves
could not be made.
Conclusions
There is fair evidence to at least target the superior
medial genicular nerve, inferior medial genicular nerve,
and Inferior medial genicular nerve using local
anesthetics, corticosteroids, or alcohol to reduce pain
and to improve knee function in patients with chronic
knee OA under ULSD guidance. The procedure is safe
but more research is needed to determine the optimal
interventional approach.
12. 11
Validity and reliability of Turkish transcultural adaptation of the
Prosthetic Limb Users Survey of Mobility.
Sevgin Yosmaoglu, Gul Yazicioglu, Yasin Demir, Koray Aydemir, Hayri Baran Yosmaoglu
Prosthet Orthot Int. 2022 Aug 25.Online ahead of print.
Background
Amputee-specific, self-assessment mobility scales are
essential to evaluate mobility in lower-limb amputees.
Objectives
To evaluate the validity and reliability of a Turkish
translation and adaptation of the Prosthetic Limb Users
Survey of Mobility.
Study design
This is a validation study.
Methods
Turkish translation of the Prosthetic Limb Users Survey
of Mobility (PLUS-M-T) from its original was performed
following the rules of intercultural adaptation and
translation methods. The PLUS-M-T and its 12-item
short form were applied to '100 induviduals with limb
loss twice in 3-day intervals. The structural validity
analysis was determined by calculating the correlation
with the Amputee Mobility Scale, which is a valid,
reliable scale for assessing the functional level in
amputees. The Cronbach alpha coefficient was
calculated to analyze the internal consistency. The
interclass correlation coefficient (ICC) and Spearman
correlation coefficient (r) were calculated, and the test-
retest reliability was determined.
Results
A positive, high correlation was found between the first
application and its repetition of both PLUS-M-T (ICC =
0.85, r = 0.94, P < 0.001) and 12-item short form (ICC =
0.92, r = 0.93, P < 0.001). The internal consistency was
high for both PLUS-M-T (Cronbach alpha = 0.94) and
12-item short form (Cronbach alpha = 0.91). A
positive, high correlation was found between the
scores obtained from the Amputee Mobility Scale and
PLUS-M-T (r = 0.84, P < 0.001) and 12 question short
form (r = 0.77, P < 0.001).
Conclusion
Turkish translation of the PLUS-M questionnaire is a
valid and reliable scale for assessing the mobility of
individuals who have undergone lower-extremity
amputation using a prosthesis.
14. Supports patients initiatives programs
In Cerebral Palsy,
In Spasticity,
Abridged Prescribing Information (BACLOF)
Active Ingredient: each tablet of BACLOF contains: baclofen 10, 25 mg, BACLOF liquid contains baclofen 5mg/5ml, 100 ml bottle. Indication: treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant
pain, clonus, and muscular rigidity. Dosage: Tablets: Initiate with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. The maximum dosage is 80 mg daily (20 mg four times a day). When
discontinuing, reduce the dosage slowly. Liquid: adults: One 5ml spoonful (5mg) 3 times a day for 3 days; Two 5ml spoonfuls (10mg) 3 times a day for 3 days; Three 5ml spoonfuls (15mg) 3 times a day for 3 days; Four 5ml spoonfuls (20mg) 3 times a day for 3
days.Elderly:Smalldosesshouldbeusedatthe start oftreatment, the dosebeing titrated graduallyagainst the response,under carefulsupervision.Paediatric population(0to<18years):Adosageof0.75-2mg/kg bodyweight shouldbeused.In children over
ten years of age, however a maximum daily dosage of 2.5mg/kg body weight may be given. Treatment is usually started with half a 5ml spoonful (2.5mg) given 4 times daily. The recommended daily dosages for maintenance therapy are as: 12 months – 2
years: Two to four 5ml spoonfuls (10-20mg), 2 years – 6 years: Four to six 5ml spoonfuls (20-30mg); 6 years – 10 years: Six to twelve 5ml spoonfuls (30-60mg). Contraindications: hypersensitivity to baclofen or any component of this product. Warning and
precautions: Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen is discontinued. Neonatal withdrawal symptoms can occur; gradually reduce the dosage and
discontinue baclofen before delivery. Baclofen can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system
effects of baclofen may be additive to those of alcohol and other CNS depressants. Baclofen can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with
these condition. Pregnancy & Lactation: Pregnancy: Based on animal data, may cause fetal harm. At recommended oral doses, baclofen is present in human milk. There are no human data on the effects of baclofen on milk production and on breastfed infant.
Interaction: CNS depressants like benzodiazepines, antihistamine, antipsychotic, and alcohol etc., may cause increased sedative effects. Morphine (epidural) may cause hypotension and dyspnea. Laboratory Test Interactions may cause false elevation of
AST (aspartate aminotransferase), alkaline phosphatase, or blood glucose. Adverse reactions: most common drowsiness, dizziness, and weakness. Overdose: Symptoms: Patients may present in coma or with progressive drowsiness, lightheadedness,
dizziness, somnolence, accommodation disorders, respiratory depression, seizures, or hypotonia progressing to loss of consciousness. Treatment: includes gastric decontamination, maintaining an adequate airway and respirations. (Prepared on 23rd Feb
2020. It is recommended to refer full prescribing information before prescription. For further medical information, please write to: Intas Pharmaceuticals Ltd., Corporate House, Near Sola Bridge, SG highway, Thaltej, Ahmedabad-380054, Gujarat, India.
productqueries@intaspharma.com.)
Abridged Prescribing Information (BACLOF LIQUID)
Active Ingredient: each tablet of BACLOF contains: baclofen 10, 25 mg, BACLOF liquid contains baclofen 5mg/5ml, 100 ml bottle. Indication: treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant
pain, clonus, and muscular rigidity. Dosage: Tablets: Initiate with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. The maximum dosage is 80 mg daily (20 mg four times a day). When
discontinuing, reduce the dosage slowly. Liquid: adults: One 5ml spoonful (5mg) 3 times a day for 3 days; Two 5ml spoonfuls (10mg) 3 times a day for 3 days; Three 5ml spoonfuls (15mg) 3 times a day for 3 days; Four 5ml spoonfuls (20mg) 3 times a day for 3
days.Elderly:Smalldosesshouldbeusedatthe start oftreatment, the dosebeing titrated graduallyagainst the response,under carefulsupervision.Paediatric population(0to<18years):Adosageof0.75-2mg/kg bodyweight shouldbeused.In children over
ten years of age, however a maximum daily dosage of 2.5mg/kg body weight may be given. Treatment is usually started with half a 5ml spoonful (2.5mg) given 4 times daily. The recommended daily dosages for maintenance therapy are as: 12 months – 2
years: Two to four 5ml spoonfuls (10-20mg), 2 years – 6 years: Four to six 5ml spoonfuls (20-30mg); 6 years – 10 years: Six to twelve 5ml spoonfuls (30-60mg). Contraindications: hypersensitivity to baclofen or any component of this product. Warning and
precautions: Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen is discontinued. Neonatal withdrawal symptoms can occur; gradually reduce the dosage and
discontinue baclofen before delivery. Baclofen can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system
effects of baclofen may be additive to those of alcohol and other CNS depressants. Baclofen can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with
these condition. Pregnancy & Lactation: Pregnancy: Based on animal data, may cause fetal harm. At recommended oral doses, baclofen is present in human milk. There are no human data on the effects of baclofen on milk production and on breastfed infant.
Interaction: CNS depressants like benzodiazepines, antihistamine, antipsychotic, and alcohol etc., may cause increased sedative effects. Morphine (epidural) may cause hypotension and dyspnea. Laboratory Test Interactions may cause false elevation of
AST (aspartate aminotransferase), alkaline phosphatase, or blood glucose. Adverse reactions: most common drowsiness, dizziness, and weakness. Overdose: Symptoms: Patients may present in coma or with progressive drowsiness, lightheadedness,
dizziness, somnolence, accommodation disorders, respiratory depression, seizures, or hypotonia progressing to loss of consciousness. Treatment: includes gastric decontamination, maintaining an adequate airway and respirations. (Prepared on 23rd Feb
2020. It is recommended to refer full prescribing information before prescription. For further medical information, please write to: Intas Pharmaceuticals Ltd., Corporate House, Near Sola Bridge, SG highway, Thaltej, Ahmedabad-380054, Gujarat, India.
productqueries@intaspharma.com.)
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