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Goodwin efetividade da fisio supervisionada num período prec

  1. 1. Research Report Effectiveness of Supervised Physical Therapy in the Early Period After Arthroscopic Partial Meniscectomy Background and Purpose. Controversy exists about the effectiveness of physical therapy after arthroscopic partial meniscectomy. This ran- domized controlled trial evaluated the effectiveness of supervised physical therapy with a home program versus a home program alone. Subjects. Eighty-four patients (86% males; overall mean age 39 years, SD 9, range 21–58; female mean age 39 years, SD 9, range 24 – 58; male mean age 40, SD 9, range 21–58) who underwent an uncomplicated arthroscopic partial meniscectomy participated. Meth- ods. Subjects were randomly assigned to either a group who received 6 weeks of supervised physical therapy with a home program or a group who received only a home program. Blinded test sessions were conducted 5 and 50 days after surgery. Outcome measures were: (1) Hughston Clinic questionnaire, (2) Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and EuroQol EQ-5D (EQ- 5D) questionnaires, (3) number of days to return to work after surgery divided by the Factor Occupational Rating System score, (4) kinematic analysis of knee function during level walking and stair use, and (5) horizontal and vertical hops. Results. No differences between groups were found for any of the outcomes measured. Discussion and Conclusion. The results indicate that the supervised physical therapy used in this study is not beneficial for patients in the early period after uncomplicated arthroscopic partial meniscectomy. [Goodwin PC, Mor- rissey MC, Omar RZ, et al. Effectiveness of supervised physical therapy in the early period after arthroscopic partial meniscectomy. Phys Ther. 2003;83:520 –535.] Key Words: Arthroscopy, Home program, Randomized controlled trial, Therapeutic exercise. Peter C Goodwin, Matthew C Morrissey, Rumana Z Omar, Michael Brown, Kathleen Southall, Thomas B McAuliffe 520 Physical Therapy . Volume 83 . Number 6 . June 2003
  2. 2. M eniscal injuries are reported to be the most (ROM), and they may have increased joint laxity and common injury sustained by athletes, but osteoarthritis in the long term.2– 6 sports injuries account for only 30% of all meniscal lesions.1 In the United Kingdom, Supervised rehabilitation after surgery has been advo-medical management for a torn or damaged meniscus cated and studied as part of short- and long-termusually consists of arthroscopic partial resection, fol- follow-up after arthroscopic partial meniscectomy.7–9lowed by a 2- to 6-week outpatient follow-up by the Durand et al10 compared 17 patients who had under-surgical team. Follow-up is used to detect postoperative gone arthroscopic partial meniscectomy with 22knee complications and to assess the eradication of matched male subjects without known knee pathologypresurgical symptoms and the progression of recovery of during walking and ascending and descending stairs.the knee toward its premordid level. Although meniscec- Eight weeks after their surgery, 18% of the patientstomy appears to be effective, patients who have had an experienced pain at rest, 10% still had knee effusions,arthroscopic partial meniscectomy often initially experi- and 41% showed restricted knee flexion. Differencesence knee swelling, pain, and loss of range of motion were found between the intervention group and thePC Goodwin, MCSP, is a doctoral student, Centre for Applied Biomedical Research, GKT School of Biomedical Sciences, King’s College London,London, United Kingdom.MC Morrissey, PT, ScD, is Lecturer, Centre for Applied Biomedical Research, GKT School of Biomedical Sciences, King’s College London,Shepherd’s House, Guy’s Campus, London SE1 1UL, United Kingdom ( Address all correspondence to Dr Morrissey.RZ Omar, PhD, is Senior Lecturer, Department of Statistical Sciences, University College London.M Brown, MCSP, is Senior I Physiotherapist, Forest Healthcare Trust, London, United Kingdom.K Southall, MCSP, is Physiotherapy Manager, Holly House Hospital, Buckhurst Hill, Essex, United Kingdom.TB McAuliffe, FRCS, is Orthopaedic Consultant, Forest Healthcare Trust.Mr Goodwin, Dr Morrissey, Dr Omar, Mr Brown, and Ms Southall provided concept/idea/research design. Mr Goodwin, Dr Morrissey, Mr Brown,and Ms Southall provided writing. Mr Goodwin, Dr Morrissey, Mr Brown, and Ms Southall provided data collection. Mr Goodwin, Dr Morrissey,and Dr Omar provided data analysis and fund procurement. Mr Goodwin and Dr Morrissey provided project management. Mr McAuliffe providedsubjects. Ms Southall provided facilities/equipment, and Mr Brown and Ms Southall provided institutional liaisons. The authors thank orthopedicsurgeons Matthew Barry, Thomas Bucknill, Mustafa El-Zebdeh, David Goodier, John Ireland, John B King, Kin C Kong, Mandeep Lamba,Benigmus E Okafor, and Vairavippillai Siva and physical therapists Jane Dredge, Salu Fellows, Jo Jones, Maria Klarneta, Philippa Knight, and DylanMorrissey for their support of this study.This study was approved by the ethics committees of the University of East London and the East London and City Health Authority (ELCHA).This study was supported by a grant from the National Health Service Executive, London Regional Office, Responsive Funding Programme andan Educational Award from the Hospital Savings Association.This article was submitted December 27, 2001, and was accepted November 22, 2002.Physical Therapy . Volume 83 . Number 6 . June 2003 Goodwin et al . 521
  3. 3. control group in terms of single ipsilateral-to- The deficits in knee extensor work, function, and othercontralateral limb-support ratio (95% for the interven- variables occurring after partial meniscectomy indicatetion group, 100% for the control group) during gait and that exercise programs may be useful for these patients.the time taken to complete 2 steps (X 1,478 millisec- Several randomized controlled trials have examined theonds [SD 192] for the intervention group, X 1,318 benefits of exercise after this type of surgery. Using themilliseconds [SD 121] for the control group) and Noyes Knee Rating Questionnaire preoperatively and 7,cadence (X 82 steps/min [SD 11] for the intervention 14, and 42 days postoperatively, Birch et al15 comparedgroup, X 92 steps/min [SD 8] for the control group) 120 patients who were randomly assigned to 1 of 3during stair descent, which continued up to 8 weeks groups: a group who received physical therapy (X 3after surgery. These patients were described by Durand treatment sessions), a group who received nonsteroidalet al as not managed with supervised physical therapy. anti-inflammatory drugs, and a control group. SubjectsDurand et al, however, referred to evidence by Moffet in the group who received physical therapy were seenet al11 showing that physical therapy consisting of a during the afternoon after surgery and were allowed tohome exercise program combined with 9 supervised return home when they were able to do straight legtreatments (including electrotherapy, ice, and compres- raises, demonstrate the home exercise program, andsion followed by isometric and isokinetic exercises and walk fully weight bearing with minimal discomfort. Sub-bicycle ergometry) promotes faster recovery from the jects were then treated daily until they reached fulldeficits found in their study. functional recovery. Content of the home or supervised therapy program was not detailed. No differences inA knee extensor strengthening program was suggested knee function scores were found among the Moffet et al,12 who reported that decreased muscleactivity caused a decrease in knee extensor work (work Knee extensor work and a knee function questionnairewas measured during maximal voluntary isokinetic con- were used in a randomized controlled trial by Moffet ettractions). They contended that deficits of more than al11 in which subjects who participated in 9 physical25% 3 weeks after surgery may be used to estimate stair therapy sessions and a home exercise program (n 15)ascent performance. In the study by Moffet et al, the were compared with a control group who received onlypostoperative work deficit of the operated lower extrem- general advice (n 16). The home program consisted ofity was established as a percentage of the knee extensor 2 main sections, one for the first week and the second forwork of the contralateral lower extremity in 31 male the second and third weeks postoperatively. Exercisessubjects. Patients with a work deficit of less than 25% consisted of ankle movements, knee mobility exercises,ascended the stairs normally, and those with deficits isometric contractions of the quadriceps femoris mus-greater than 25% showed the greatest changes. cles, and straight leg raises. A booklet was issued on the progressive use of crutches, ice therapy, and limb eleva-Matthews and St-Pierre13 advocated use of a supervised tion. The second section consisted of progression ofisokinetic knee exercise program in the first 3 months exercises with 0.45-kg (1-lb) weight increments andafter surgery. Twenty-two patients were measured before isotonic quadriceps femoris muscle contractions. Thesurgery and at 2-week intervals up to 12 weeks after supervised therapy program was initiated on average 2.3surgery. With a home exercise program that did not days after surgery and consisted of 2 phases. In the firstinvolve resistance exercises, quadriceps femoris muscle week postoperatively, the initial phase concentrated ontorque (measured at 60°, 120°, 180°, and 240°/s) reducing knee pain and effusion, regaining knee mobil-returned to preoperative levels at between 4 and 6 weeks ity, and strengthening the knee flexors and extensorsafter surgery, but did not reach that of the uninjured using isometric exercises at 30 and 60 degrees of kneelower extremity even at 12 weeks after surgery. flexion. The second phase began about 10 days after surgery. It included isokinetic exercises using a Cybex IIRoos et al14 used the Knee Injury and Osteoarthritis dynamometer* at 60°, 120°, and 200°/s through fullOutcome Score, the Medical Outcomes Study 36-Item knee ROM and bicycle ergometry starting at 5 minutesShort-Form Health Survey (SF-36) questionnaire, and per session and increasing up to 30 minutes per session.the Lysholm Knee Scoring Scale to measure knee func- Knee extensor work at 30°/s improved after surgery intion and quality of life in 74 patients compared with the intervention group compared with the controlreference scores from the general population and pre- group. Knee extensor work at 180°/s decreased in bothoperative data. Although improvements from preopera- groups after surgery, but to a greater degree in thetive values were seen, postoperative values also showed control group. No differences were found between the 2that disability and handicap remained compared with groups with regard to function as measured with thethe general population even up to 14.4 weeks after Lysholm * Cybex, 2100 Smithtown Ave, Ronkonkoma, NY 11779.522 . Goodwin et al Physical Therapy . Volume 83 . Number 6 . June 2003
  4. 4. Jokl et al16 compared 30 patients assigned to either a score of 28/100 (no sports possible), whereas the inter-group who received a home exercise program or a group vention group improved from a score of 30 to a score ofwho received physical therapy (X 13.5 treatment ses- 48 (activities equal to running, cycling, and swimmingsions). The home exercise program included quadriceps 1–3 times per month). Subjects who received physicalfemoris muscle setting and 3 sets of 10 straight leg raises therapy also made greater improvements over the treat-without weights on the first postoperative day. Once ment period as compared with subjects in the controlsubjects were able to weight bear without crutches, knee group on the single-leg vertical hop test (11.4 cm versusROM exercises were started from 45 degrees to full 1.5 cm, respectively) and the horizontal hop testextension as well as hamstring muscle curls and hip (56.5 cm versus 7.4 cm, respectively).adduction and abduction exercise in a supine position.After 2 days of exercising without weights, subjects began We believe that small samples,11,15–17 lack of doubleisotonic exercises with a weight boot adding 0.45-kg blinding11,15–17 and standardization,15,17 and method-increments per day or as tolerated. Low-impact sports ological weaknesses15 limit the conclusions that can be(eg, slow jogging) were encouraged once 11.34 kg drawn from these randomized controlled trials, in which(25 lb) was achieved in the knee extension exercises, and the results seem to be contradictory.18 In these studies,full athletic activity was allowed once 20.41 kg (45 lb) was outcome measures often consisted of small changes inachieved. The supervised regimen began 5 days postop- knee extensor torque and activity without consideringeratively and included whirlpool, instruction on knee outcomes such as quality of life, something that RoosROM exercises, electrical stimulation of the quadriceps et al14 contended should be part of any assessmentfemoris muscles, quadriceps femoris muscle setting, following arthroscopic partial meniscectomy. The pur-straight leg raises, and hip extension exercises. Compres- pose of our study was to assess the benefits of written andsion dressings were used when a knee effusion was verbal advice plus an intensive course of physical therapyjudged present. Hamstring muscle curls, leg presses, consisting of an early period to decrease pain andquadriceps femoris muscle extension exercises, and bicy- swelling and to increase joint ROM, a middle period tocle ergometry were introduced, with intensity and dura- increase muscle force and joint position sense, and a latetion of exercises progressed as quickly as were tolerated. period focused on advanced exercises compared withWhirlpool was continued as long as knee ROM was treatment consisting of written and verbal advice alonelimited, and electrical stimulation was continued until in the early period after arthroscopic partial meniscec-the subjects were judged to have good muscle tone tomy. Our goal was to include outcome measures ofduring a quadriceps femoris muscle set. importance to patients such as lower-extremity function and quality of life and sufficient numbers of subjects toKnee function was assessed using a questionnaire, time allow generalizable results. Our hypothesis was that thetaken to return to work, and knee extensor torque group who received supervised physical therapy would(measured at 60°, 120°, and 180°/s with an isokinetic exhibit greater improvements in knee function anddynamometer). No differences were detected at 2, 4, and quality of life during the early period after partial8 weeks postoperatively for the questionnaire and the meniscectomy than the group who did not receive thisother outcome measures. Vervest et al17 compared a who received standard written and verbal postop-erative advice with a group who received physical ther- Materials and Methodsapy. The standard written and verbal advice was aimed atrecovery of activities of daily living, but its content was Subjectsnot described. Subjects in the intervention group Prior to data collection, a sample size estimation wasreceived 9 exercise sessions of 30 minutes’ duration over calculated in order to formulate a sample size target fora 3-week period according to a dynamic protocol super- the study. This calculation was based on existing data10vised by the authors. The advice given to the control and rather than on guesses as to effect size. The calculationintervention groups was not described in any further also was based on an outcome measure that would bedetail. Ten patients in each group were tested 7, 14, 21, considered important. These 2 criteria led to our use ofand 28 days after surgery. From an array of outcome the length of time from surgery to return to work as anmeasures (height of one-leg vertical hop, distance of outcome measure. Due to the high variability in thisone-leg horizontal hop, Tegner scale score, Lysholm outcome,10 a large effect size (10 days) was used forquestionnaire score, Sports Activity Rating Scale, Factor sample size calculation. To detect an average differenceOccupational Rating Scale (FORS), satisfaction with of 10 days between the 2 groups with a .05 level oftreatment, and function and pain) the intervention significance and 90% power and assuming a standardgroup did better than the control group on the Sports deviation of 19 led to a target sample size of 152 subjects.Activity Rating Scale. Over 4 weeks, the subjects in the For ethical reasons, however, an interim analysis wascontrol group had not improved their sports activity carried out at the halfway point of data collection (ie, toPhysical Therapy . Volume 83 . Number 6 . June 2003 Goodwin et al . 523
  5. 5. Figure.Flow diagram of subject progress through a randomized controlled trial of physical therapist-supervised intervention versus no intervention other thanwritten instructions in the early period following arthroscopic partial meniscectomy.avoid patients receiving extended physical therapist Subjects were identified from patients recovering fromintervention if it was of no benefit to them or to withhold knee arthroscopic partial meniscectomy at 4 Nationaltreatment if treatment was appearing effective). Results Health Service (NHS) hospitals and 3 private hospitals infrom the interim analysis led to termination of data the East London area over an 18-month period. Twelvecollection prior to reaching this target sample size. orthopedic surgeons referred their patients for the524 . Goodwin et al Physical Therapy . Volume 83 . Number 6 . June 2003
  6. 6. Table 1.Baseline Characteristics for the Control and Intervention Groups Control Group Intervention Group Variable N X SD Range N X SD Range Age (y) 41 41 9 23 to 58 45 38 8 21 to 58 Height (cm) 41 174 9 157 to 192 45 176 7 157 to 192 Mass (kg) 41 84 16 54 to 123 45 80 13 57 to 110 Sex 35 male, 6 female 39 male, 6 female No. of days absent from work prior to surgery 40 2 2 1 to 7 40 64 268 0 to 1,600 Duration of injury (y) 39 2.4 5.0 0.5 d to 25.7 y 45 1.7 2.6 0.5 d to 14.2 y Period from surgery to pretest measurement (d) 41 6 3 2 to 10 45 5 2 2 to 9 Passive knee flexion (difference between injured and uninjured knees) (°) 41 39 19 5 to 93 45 44 27 0 to 110 Suprapatellar knee girth (difference between injured and uninjured knees) (cm) 41 1.3 1.2 1.0 to 4.0 45 1.4 1.0 1.5 to 3.5 Injured side Left 13, right 28 Left 22, right 23 Meniscus involved Medial 30 Medial 34 Lateral 9 Lateral 10 Medial and lateral 1 Medial and lateral 1 Not reported 1study. Subjects were deemed suitable for inclusion if they and control groups) balanced among the treatmentwere between 18 and 60 years of age and underwent an sites.uncomplicated arthroscopic partial meniscectomy. Sub-jects were excluded if they had any concurrent injuries The subject characteristics are presented in Table 1. Theto their contralateral lower extremity that required groups were very similar for all characteristics. Themedical attention, if they had any neurological disorders number of days absent from work prior to surgeryaffecting their lower extremities, or if they were expect- contained an outlying value of 1,600 days in the inter-ing surgery within 6 months following their arthroscopy. vention group, but no difference was found between thePrior to the surgery in the private hospitals and within intervention and control groups, either with or withoutthe first 48 hours following surgery in the NHS hospitals, this value.approximately 250 suitable subjects were approached byone of the authors (PCG) and were given a written and Testingverbal explanation of the study and invited to volunteer The target date for the pretest measurement was 4 daysfor participation. One hundred patients agreed to take after meniscectomy. We believed this target date waspart and signed an informed consent form prior to study realistic in terms of contacting patients and arrangingparticipation. Fourteen patients did not return for appointments. This target date also was practical becausefollow-up testing, leaving 86 subjects for the final the compression bandage prescribed by all the surgeonsanalysis. postoperatively remained on the knee for a minimum of 48 hours after surgery. During the first session, informedAfter initial testing, subjects were assigned to 1 of 2 written consent was obtained. The following tests andgroups—a group who received physical therapy from a measures also were administered: Hughston Clinic kneestandardized protocol 3 times a week for 6 weeks (inter- self-assessment questionnaire,19 self-assessed quality ofvention group) and a group who did not receive physical life using the SF-3620 and EuroQol EQ-5D (EQ-5D)21therapy (control group)— using block randomization questionnaires, passive knee flexion and extensionstratified by treatment site (Figure). Block randomiza- ROM, and knee circumference and kinematic analysis oftion was used to keep a balance in the number of knee function during level walking and stair use. Twosubjects in each group throughout the study. Blocks of 4 examiners who were blinded to group assignment wereand 6 subjects were used in a random order so that involved in each test, with at least one examiner being arandomization was not predictable. Stratified random- physical therapist.ization was done for each of the potential treatment sitesin an effort to keep the number of subjects (interventionPhysical Therapy . Volume 83 . Number 6 . June 2003 Goodwin et al . 525
  7. 7. Passive knee flexion and extension and knee circumfer- assessing the validity of data for the questionnaire whereence were considered representative of measurements there were fewer than 18 responses because, in ourused in the clinic and included in order to determine study, the minimum number of responses was 20. Thedifferences between the 2 groups at baseline only. Bio- final score was calculated by aggregating the scores ofmechanical measures of kinematics of the knee while the questions answered and converting to a percentagewalking and ascending and descending stairs were of a maximum possible score for the questions answered.included as a sensitive measure of knee angle during An uninjured knee would have a score of 0%.simple functional tasks. Self-assessed knee function gavea patient perspective on knee performance during activ- The SF-36 is a widely used measure of health-relatedities of daily living. Use of quality-of-life measures, we quality of life. It has been found satisfactory in terms ofbelieve, allowed us to obtain an extra dimension for ease of use and acceptability to patients,22 and there isanalysis. Such generic outcomes included anxiety and evidence of construct validity and convergent validitydepression as well as emotional health and vitality and compared with the Western Ontario and McMasterhave the potential of being able to measure the side University Osteoarthritis Index (WOMAC).22 Foreffects or complications of treatment.22 Quality-of-life patients with knee osteoarthritis and rheumatoid arthri-scores also can be combined with cost data to enable tis, the SF-36 was found to be more responsive to changeeconomic evaluation of health care.21 We believed that than a condition-specific measure (ie, WOMAC).22 It hasthese outcomes represented important clinical and been used in studies in which health-related quality ofpatient-orientated problems and would be helpful in life was assessed in patients with knee problems26 and indetecting differences between the 2 groups. patients with partial meniscectomy.14 The SF-36 consists of 36 questions relating to 8 dimensions of health. AnThe Hughston Clinic questionnaire was used to evaluate algorithm has been produced allowing mapping ofthe subjects’ self-assessment of their knee condition.19 results from this questionnaire onto a new SF-6D ques-This questionnaire consists of 28 questions in which the tionnaire for the construction of a preference-basedsubject is asked to respond by placing a mark on a 10-cm single index of health status.27 The result is a score fromvisual analog scale (VAS). This questionnaire was chosen 0 to 1.0, where 1.0 equates to perfect health. We chose tobecause: (1) it includes a continuous measure as analyze quality of life using the SF-36 in the single indexopposed to an ordinal system23; (2) it can be used to form because: (1) it produces a single index allowingcharacterize most forms of knee function (from simpler, easier analysis, (2) it possibly has increased sensitivityless stressful tasks such as turning over in bed to more over other single index measures of quality of life due tocomplex and relatively stressful tasks such as pivoting the richness and sensitivity of the original SF-36,28 andwhile running); (3) it provides a measure of pain, (3) it has been suggested that any greater sensitivityswelling, and other complaints common in, and impor- would be most likely in people with mild to moderatetant to, patients with injured knees; (4) patients find it health problems and in those expected to experienceeasy to understand and complete relative to other ques- comparatively small changes, or where small differencestionnaires19; (5) it is sensitive to clinically meaningful are expected between interventions such as in the sub-change;24 and (6) its reliability and construct and con- jects in our study.28tent validity for patients with knee injuries have beenexhibited.24,25 The EQ-5D is a generic instrument for describing and evaluating health-related quality of life. It was designedIn scoring the VAS, where the subject’s mark bisected to be used for economic analysis (cost-utility analysis)the horizontal line connecting 2 descriptors reflecting representing the cost per quality-adjusted life yearwhat was measured, the distance to the nearest 0.5 cm (QALY) of a technology and to complement otherwas measured from the left end of the scale. When values health-related quality-of-life measures such as thewere between 0.0 and 0.5, they were always rounded up. SF-36.21 The EQ-5D has been used with patients withRounding was done in this fashion to ensure consistency rheumatoid arthritis affecting their knees,29 and there isamong examiners of the data. No attempt was made to evidence that it has moderate construct validity (Spear-determine the location of the knee pain that led to a man rho .71) and reliability (intraclass correlationsubject’s responses. Ten of the 28 questions had 2 coefficient .70) when used with patients (N 82) withalternative marking options. For questions in which the osteoarthritis affecting their knees.30 Brazier and col-subject responded by marking the box for “not leagues22 suggested that it should be used for patientsattempted because of my knee injury,” a value of 10 was following knee surgery; however, it has not been vali-given. For questions in which the subject responded by dated for use with patients following arthroscopic partialmarking the box for “not attempted because of other meniscectomy. We included the EQ-5D in our studyreasons besides my knee injury,” the question was because it has been used with patients who have kneedeleted from the analysis. We did not have a policy for problems and because it, in our opinion, is widely526 . Goodwin et al Physical Therapy . Volume 83 . Number 6 . June 2003
  8. 8. accepted as an easy-to-use tool for measuring the relative were not assessed prior to this study. Neither interratercost-effectiveness of an intervention. Our original intent nor intrarater reliability of marker placement over ana-in this study was to assess the cost-effectiveness of the 2 tomical areas was assessed. Reflective markers wereinterventions in terms of cost per QALY gained. placed over the greater trochanter, the middle of the lateral joint line of the knee, the lateral malleolus, andLimits of passive knee motion were measured with the the base of the fifth metatarsal to produce an animatedsubjects lying supine and using a manual goniometer as stick figure from which sagittal-plane knee angles wereroutinely used in the clinics where our subjects were calculated. For each subject, mean knee angle curvesseen. The knee was passively flexed as far as the joint during stance phase (heel-strike to toe-off) were calcu-would allow or according to a subject’s tolerance of pain. lated from 3 trials of each task. Subjects walked along anThe goniometer was aligned with the greater trochanter 8-m walkway and ascended and descended a staircase inand lateral malleolus while the knee angle was recorded. bare feet and at their own pace. The staircase consistedPassive knee extension was measured with the subject of 4 standardized steps with a tread length of 28.5 cmpositioned supine with a block placed under the sub- and a rise height of 18 cm.ject’s heel to allow for hyperextension or used to supportthe thigh if extension was limited. Goniometer align- The Hughston Clinic questionnaire also was completedment was the same as for the flexion test. Passive ROM 3 weeks after surgery. This was done for 2 reasons. First,testing was included as a baseline characteristic for for subjects in the intervention group, knee extensorcomparing the control and intervention groups prior to resistance exercise weight at 3 weeks after surgery wasintervention. Knee ROM was measured by 1 of 2 quali- determined relative to their Hughston Clinic question-fied clinicians. Intrarater reliability analysis of measure- naire scores. These values were then compared at eachments of knee ROM taken by the 2 examiners for the of the 3 treatment sites to evaluate whether the thera-uninjured leg in early participants in the study demon- pists were being equally aggressive in their treatment.strated least significant difference (LSD)31 values of 4 For example, we divided the resistance weight used fordegrees (PCG) and 6 degrees (MK) for extension and 6 the knee extensor exercise by the Hughston Clinicdegrees (PCG) and 9 degrees (MK) for flexion. questionnaire scores to estimate how aggressive each therapist was being in his or her treatment. The dataKnee circumference also was measured with the subjects were used to instruct the therapists in order to ensurein the supine position. Each subject’s heel was placed on consistency of treatment aggressiveness. Second, testinga block in full passive extension to standardize the knee at 3 weeks allowed for comparison of the 2 groupsangle. For subjects who were unable to achieve full during the early period of the intervention.passive extension, the knee angle was recorded and theposttest knee circumference measurement was obtained Subjects returned for repeat testing 6 weeks after thein the same position as in the pretest. The uninjured pretest (target date for the pretest was 4 days afterknee was measured in the same position as the injured meniscectomy). New tests administered at the 6-weekknee. Measurements were taken 1 cm above the superior follow-up were the FORS questionnaire34 and single-legborder of the patella because such measurements have vertical35 and horizontal36 hop tests. The single-leg ver-been shown to be more precise and to correlate better tical hop test was done only during the 6-week follow-upwith the quantity of synovial fluid aspirated than mea- because subjects were unable to perform the test duringsurements obtained at the mid-patella level.32 Intrarater the first week after surgery. The FORS questionnairereliability analysis showed LSD values for girth tests for measures the amount of stress the knee encounters inthe 2 examiners (MK and PCG) were 1.22 and 0.58 cm, the workplace.34 In a randomized controlled trial, therespectively. FORS questionnaire was compared with an alternative questionnaire, which used job titles to rate occupationalKnee ROM in the sagittal plane during the stance phase activity. The FORS questionnaire was used to discrimi-of walking and while ascending and descending stairs nate between perceived activity at work according to jobwas measured with the Kinemetrix infrared-based title and actual stress to the knee experienced.34 This3-dimensional (3D) camera system using 3 cameras.† A discrimination allows an added dimension to our under-force platform (model 4020H‡) was used for these standing when we consider the time it takes to return tomeasurements to detect the initiation and termination work following surgery. The FORS questionnaire con-of the stance phase. Although 3D accuracy of the Kine- sists of 7 questions and uses criteria for rating themetrix system has been shown,33 the reliability and frequency, intensity, and duration of various tasks under-validity of the measurements obtained with this system taken in the workplace. The questionnaire is scored between 0 and 60, with 0 representing “no stress on the knee at work” and 60 representing “a very stressful† MIE Medical Research, Leeds, United Kingdom. occupation.” We combined this measurement with the‡ Bertec Corp, 6185 Huntley Rd, Columbus, OH 43229.Physical Therapy . Volume 83 . Number 6 . June 2003 Goodwin et al . 527
  9. 9. number of days taken to return to work and expressed it exercises, straight leg raises, hip flexion movements in aas a ratio in order to weight the days taken to return to supine position, and knee flexion and circular hipwork according to the stressfulness of the subject’s work movements in a long-sitting position were done 4 timeson the knee. per day until the subject’s orthopedic review at 6 weeks postoperatively. Subjects in the control group receivedSubjects performed the single-leg horizontal and vertical no other care during the intervention period.hop tests, with the vertical hop test being done lastbecause we considered it the most strenuous test and we Subjects assigned to the intervention group were askedwere concerned that it might affect the subjects’ perfor- to attend physical therapy sessions 3 times per week formance in the other tests. We used the single-leg hop tests the 6-week training period of the study. Sessionsbecause they have been found to yield relatively reliable occurred in the outpatient physical therapy departmentsdata36 –39 and representative measurements of knee func- at 1 of 2 NHS hospitals (Mile End Hospital or Whippstion35,36,40 during the postoperative period. Both tests Cross Hospital) or in a private hospital (Holly Housewere performed with bare feet with the test leg landing Hospital) in the East London area.on a sponge mat. For both hop tests, the limb on the sidewithout injury was tested first, and subjects repeated The intervention was devised in collaboration with themaximum-effort jumps until there were 2 consecutive senior therapists (MB and KS) who provided the treat-reductions in distance or height jumped. This method ment. It allowed for progression of the subjects accord-was used based on our belief that no further gains would ing to their level of pain. The therapists asked thebe made through practice and that further reductions subjects to report their pain score (between 0 and 10,would occur due to pain or fatigue. Tests were consid- with 0 being “no pain” and 10 being “the worst pain everered successful if the subject landed on the test leg experienced”) during and following each exercise. Thewithout losing balance. The trial with the maximum exercise was then revised (increased or decreased)distance was used in later analysis. For the purpose of according to whether the subjects’ pain level fell abovethis analysis, only the more strenuous single-leg vertical or below 3 out of 10, respectively. The 6-week interven-hop test was used. tion consisted of 3 sequential treatment periods of arbitrary duration, each with distinct general goals.Subjects stood with bare feet on a sponge mat in amarked out rectangle to standardize the starting posi- The first treatment period aimed at decreasing pain andtion. The subjects stood at a right angle to the wall and swelling (using ice, ultrasound therapy, and deep fric-reached as high as they could with their feet flat on the tion massage) and increasing joint ROM (using jointfloor. They then marked the wall with the tip of their mobilization). For every subject, an ice pack was appliedchalked middle finger. This mark represented the base- anteriorly to the knee for 15 minutes after every treat-line height. The subjects then hopped as high as they ment session. Ultrasound therapy was used only overcould, re-marking the wall at the highest point of the arthroscopy scar sites and only if the tissues could not bejump. The distance between the baseline height and the made more mobile by friction massage such that ROMhighest chalk mark was considered the maximum height was increased, thus reducing pain. If pulsed ultrasoundjumped. therapy was used, it was at a standardized 3 MHz for 1 to 2 minutes/10 cm2 at an intensity of 0.5 W/cm2 andTraining recorded each session.41 Deep transverse friction mas-All subjects received a standardized written home exer- sage was performed over the scar sites for 5 minutes oncise program and advice sheet while they were in the all subjects during the first session. Subsequent treat-hospital. The sheet format was an amalgamation of ments were recorded and ceased when there was noadvice provided by the hospitals involved in the study palpable restriction of the scar tissue. Maitland tech-and agreed on by the principal investigator (MCM) and niques42 for assessment of patellofemoral and tibiofemo-the clinicians involved. The advice and exercises were ral mobility were performed on all subjects during theexplained by a physical therapist prior to each subject’s first session. Patellofemoral assessments includeddischarge home. The sheet included information about caudad, cephalad, medial, lateral, and combinedthe surgery and the recovery period and basic home motions of the patella. Tibiofemoral assessmentsexercises for the knee. Subjects were instructed to man- included anterior, posterior, medial, lateral, and rota-age their pain and swelling with rest, elevation of the tional movements of the tibia in relation to the femur.limb, and application of crushed ice or a packet of Treatment grades of I to IV in doses of 3 30 secondsfrozen vegetables to the knee for 15 minutes, 4 times per were performed as needed based on the Ten repetitions of the exercises were done hourly Treatment was continued and recorded until pain-free,for the first 3 days. Then static and inner-range (0°-45° of full ROM was achieved or until the 18th treatment,knee flexion) quadriceps femoris muscle strengthening whichever occurred sooner.528 . Goodwin et al Physical Therapy . Volume 83 . Number 6 . June 2003
  10. 10. The second treatment period aimed at increasing mus- Hughston Clinic questionnaire score scale is 0 to 100, with 0 being the score for a normal knee. Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) single index score scale is 0 to 1.0, with 1.0 being 0.48–1.28cle force and joint position sense (calf raises; step-ups; 0.7–8.3 Range 0.27–1 0.06–1 32–58specific hip abductor, adductor, and extensor exercises; 1–76knee flexor and extensor exercises; bicycle ergometry;and mini-trampette and wobbleboard work). Cycle 6 Wk Postsurgery 18.4 0.12 0.21 0.19ergometry for 10 minutes against minimum resistance at 1.8 SD 670 revolutions per minute was started as soon as a subjecthad sufficient knee flexion to complete one revolution 27.7 0.75 0.75 0.88 1.5of the pedal, with a pain score of 3/10. Cycling was 49 Xcontinued in subsequent treatments, and resistance was 44 43 42 38 41 41increased as long as pain remained 3/10. All strength- Nening exercises began when the minimum ROM needed 0.38–0.89 0.05–1.00to perform the exercise was reached. Strengthening Rangebegan with 3 sets of 10 repetitions against gravity, 28–96 20–54progressing in subsequent sessions to ankle weights and NT NT the score for normal health. EQ-5D score scale is 0 to 1.0, with 1.0 being the score for normal health. FORS Factor Occupational Rating System, NT not tested.then hamstring muscle curls or knee extension machine Intervention Groupexercises as long as pain levels remained 3/10. Calf 14.8 0.12 0.22 SD NT NTraises were initiated bilaterally and progressed to unilat- 6eral exercises, and step-ups on a 29.2-cm-high (11.5-in- 58.5 0.68 0.56high) bench were performed in 3 sets of 10 repetitions. Baseline NT NT 42 XAs soon as the subject could stand on the injured lowerextremity with pain of 3/10, wobbleboard and mini- NT NT 45 45 43 36 Ntrampette exercises were initiated. Exercises progressed Measurements of Outcomes Taken at Baseline and 6 Weeks After Surgery for the Control and Intervention Groupsafrom unsupported standing on both lower extremities 0.51–0.96 0.39–1.05with eyes open to single-leg standing with eyes closed to Range 0.62–1 39–61 4–78unsupported single-leg standing while the subject was 0–1throwing and catching a ball. 6 Wk Postsurgery 16.7 0.10 0.12 0.18 1.5The third treatment period focused on more advanced SD 5exercises such as lateral and Z hops. Both exercises werebegun bilaterally, progressing to single-leg hops in 3 sets 24.8 0.76 0.81 0.82 1.4 51of 10 repetitions. Lateral hops consisted of hops on Xeither side of parallel lines initially marked 30 cm apart 40 40 40 34 36 38 Nand then 50 cm apart. Z hops were done between 4equidistant points marked 40 cm apart, and they were 0.51–0.88 0.19–0.76begun when the subjects were able to hop on their Range 11–99 21–54injured lower extremity 10 times with pain of 3/10. NT NTThe physical therapist recorded the status of treatmenton a standardized form for each patient visit. 0.10 0.20 17.3 SDData Analysis NT NT 8 Control GroupInitially, we prepared an analysis plan identifying the 6 0.69 0.54study outcome variables and the subject characteristics 59.1 Baseline NT NT 40(Tabs. 1 and 2), which could influence the outcomes. XFollowing the analysis plan, we used normal plots and NT NT 41 41 40 30Shapiro-Francia tests of normality to assess normal dis- Ntributional assumptions for each variable required by Maximum-minimum knee anglecommonly used statistical methods such as t-test and Injured/uninjured limb vertical Hughston Clinic questionnaire No. of days taken to return to during stair ascent stance work after surgery/FORSlinear regression analyses.43 We used 2-sample t tests to SF-36 single index scorecompare subject characteristics and pretest measure-ments in the 2 groups. We decided to use regressionanalysis because this method can handle data that arenot normally distributed. Furthermore, regression mod- EQ-5D score jump ratio phase (°) Outcomeels can easily handle multiple confounding variables if Table 2. score scorerequired. In its simplest form, for normally distributeddata, a regression model with one binary predictor and aPhysical Therapy . Volume 83 . Number 6 . June 2003 Goodwin et al . 529
  11. 11. Table 3.Comparison of Pretest and Posttest Outcomes for the 3 Training Sitesa Days Taken to Return to Hughston Clinic EQ-5D Questionnaire Injured/Uninjured Limb Work After Questionnaire Score Score Vertical Jump Height Surgery/FORS Score Site and Test X SD Range X SD Range X SD Range X SD Range HHH pretest 58 14 10–70 0.50 0.25 0.06–0.80 NT NT NT NT NT NT (n 17) (n 16) HHH posttest 28 15 0–59 0.76 0.16 0.29–1.0 0.86 0.21 0.49–1.16 1.25 2.02 0.07–3 (n 17) (n 16) (n 12) (n 15) MEH pretest 59 14 31–83 0.55 0.22 0.06–0.81 NT NT NT NT NT NT (n 17) (n 16) MEH posttest 29 19 3–61 0.66 0.25 0.06–1.0 0.89 0.19 0.55–2 1.75 2.15 0.21–8.26 (n 17) (n 17) (n 17) (n 15) WCH pretest 59 19 40–100 0.64 0.16 0.4–1.0 NT NT NT NT NT NT (n 11) (n 10) WCH posttest 25 22 0–80 0.89 0.12 0.69–1.0 0.87 0.18 0.48–1.13 1.38 1.24 0.17–4.25 (n 11) (n 9) (n 11) (n 10)a HHH Holly House Hospital, MEH Mile End Hospital, WCH Whipps Cross Hospital, NT not tested. Hughston Clinic questionnaire score scale is 0 to 100,with 0 being the score for a normal knee. Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) single index score scale is 0 to 100, with 100 beingthe score for normal health. EQ-5D questionnaire score scale is 0 to 1.0, with 1.0 being the score for normal health. FORS Factor Occupational Rating System,possible range of scores 0 – 60, with 60 being the score for the occupation that is most taxing on the continuous predictor produces the same results as attended by subjects influenced the outcome scores afterthat from an analysis of covariance.43 A linear regression adjustment for differences in baseline scores. Subjects inanalysis was used to examine treatment differences in the intervention group were subgrouped into thosethe 2 groups for each of the 2 normally distributed attending 1 to 6 treatment sessions, those attending 7 tooutcomes: (1) maximum-minimum knee angle during 12 treatment sessions, and those attending 12 treat-stair ascent; and (2) injured and uninjured limb vertical ment sessions. These grouping criteria were based on ajump ratio. Relevant baseline scores were included in the simple division into 3 groups of the 18 sessions, the goalanalysis for maximum-minimum knee angle during stair for the intervention group. A significance level of.05 wasascent to adjust for differences in these measurements. used to assess statistical significance. All analyses wereThe following outcomes were not normally distributed, carried out on an intention-to-treat basis using STATAand we therefore did not use an ordinary linear regres- statistical software (Release 7.0, 2001).§sion for those analyses: Hughston Clinic questionnairescores, SF-36 scores, EQ-5D scores, and the number of Resultsdays off work after surgery adjusted for the FORS Baseline outcome measurements collected for bothquestionnaire scores. We attempted to use mathematical groups included Hughston Clinic questionnaire scores,transformations to satisfy the assumption of normality. SF-36 scores, EQ-5D scores, the difference betweenWe found the best transformations to achieve normality maximum and minimum knee angles during stancefor the Hughston Clinic questionnaire scores, SF-36 phase while ascending stairs, and the difference inscores, and EQ-5D scores were square root and square end-range passive knee flexion angles between injuredtransformations, which would make interpretation of and noninjured limbs (Tab. 2). No differences wereresults difficult. Moreover, no suitable transformation found between the 2 groups in these baselinewas found for the outcome of number of days off questionnaire scores. Therefore, a medianregression analysis, which examines the difference in Before the 2 main study groups were compared, themedians rather than means and does not require the relative effectiveness of the supervised physical therapyassumption of normality, was used for these 3 out- at the different training sites was assessed (Tab. 3). Nocomes.44 The relevant baseline scores were included in differences were noted among the 3 sites. These resultsthe regression analysis for the Hughston Clinic question- indicate that treatment effectiveness was similar amongnaire scores and EQ-5D scores to adjust for baseline the 3 sites. The components of the intervention aredifferences.The regression analyses as described were also used todetermine whether the number of treatment sessions § Stata Corp, College Station, TX 77840.530 . Goodwin et al Physical Therapy . Volume 83 . Number 6 . June 2003