CRITICALLY APPRAISED PAPER (CAP)

Transcription

1 CRITICALLY APPRAISED PAPER (CAP) Svens, B., Ames, E., Burford, K., & Caplash, Y. (2015). Relative active motion programs following extensor tendon repair: A pilot study using a prospective cohort and evaluating outcomes following orthotic interventions. Journal of Hand Therapy, 28(1), CLINICAL BOTTOM LINE: Early active mobilization has become the preferred approach for treating extensor tendon repairs, compared with static immobilization, because it achieves earlier recovery of finger motion and allows earlier return to work and daily activities. In 2005, a study by Howell, Merrit, and Robinson introduced a novel approach for early active mobilization called the immediate controlled active mobilization approach. This approach used orthotic intervention for 7 weeks, with a wrist orthosis with the wrist placed in extension and a separate yoke component for the fingers to limit full flexion. The retrospective study by Howell et al. found favorable results with this protocol, but no studies have been performed with a prospective cohort. A primary aim of this prospective cohort study was to compare these findings with the results previously published by Howell et al. (2005). The secondary purpose of this study was to prospectively examine the effects of an immediate controlled active mobilization program on patients range of motion (ROM), strength, and function by comparing two immediate mobilization protocols. For patients with simple extensor tendon repairs in Zones IV, V, or VI, early mobilization that used an immediate relative active motion (IRAM) program achieved good results for ROM, grip strength, and function. An immediate relative active motion program that used a shorter duration of orthotic intervention seemed to facilitate earlier return of function and might allow for an earlier return to work. Future studies are needed to examine outcomes among relative active motion programs within the immediate postoperative timeframe and should include larger samples with randomized allocation to increase the validity and generalizability of the results. RESEARCH OBJECTIVE(S) List study objectives. Compare these findings with the results previously published by Howell et al. (2005), as well as to prospectively examine the effects of an immediate controlled active mobilization program on patients ROM, strength, and function by comparing two immediate mobilization protocols 1

2 DESIGN TYPE AND LEVEL OF EVIDENCE: Level II: Prospective cohort; nonrandomized controlled trial with repeated measurements SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Patients were recruited from two urban, public hospitals in Australia. Patients at the Royal Adelaide Hospital received an IRAM program with orthotic intervention for 5 weeks, and those recruited at Flinders Medical Center received a modified immediate relative active motion (miram) program with orthotic intervention for 4 weeks. Patients were asked to participate with written consent when they presented for postoperative care in the respective center s occupational therapy department. Inclusion Criteria Patients who were older than 18 years and had 80% 100% lacerations of extensor tendons in Zone IV, V, or VI Exclusion Criteria Patients who presented with lacerations to all four extensor digitorum communis (EDC) tendons (p. 13) or laceration of the EDC of three adjacent fingers (pp ) or had other complex injuries to the skin or underlying tissues; patients who did not speak English or who were not willing to participate SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 63 #/ (%) Male 54/(86%) #/ (%) Female 9/(14%) Ethnicity NR Disease/disability diagnosis Extensor tendon repairs in Zones IV, V, or VI Of the 63 participants, 30 (48%) presented with injuries in their dominant hand. Thirty-one (49%) worked in light-work or pension roles, and 32 (51%) worked in manual- or heavylabor roles. Forty-five (71%) lived in a metropolitan area, and 18 (29%) lived in the country or interstate area. Out of the total sample, 7 participants (11%) had sustained a compensable injury. Mechanisms of injury included glass (n = 24, 38%), tool or machinery (n = 25, 40%), metal (n = 11, 17%), and other (n = 3, 5%). Location of injury included home 2

3 INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: IRAM group Brief description of the intervention (n = 49, 78%), work (n = 12, 19%), and other (n = 2, 3%). The IRAM group was immobilized for 5 weeks in an orthosis. The protocol was as follows: Days 1 21: Wrist orthosis extension plus a yoke orthosis with affected digit in greater extension than adjacent digits Avoid use of the hand in activities of daily living (ADLs) Orthosis worn at all times Education about tendon healing and strength of repair Active composite finger flexion and extension, 5 10 repetitions every hour Days 22 35: Days 36 42: Wean orthosis over a period of 7 days, continue yoke at all times Initially, exercises performed with wrist relaxed. When no active extensor lag, composite wrist and finger flexion and wrist and finger extension During active use of hand, both orthoses worn When wrist moved freely, light use of hand without wrist orthosis Wrist orthosis discarded. Yoke orthosis or buddy strap could be worn during activity and discarded when full composite wrist and finger motion was achieved, at the latest Day 42. Continue ROM exercises as required Grip-strengthening exercises Return to driving at 6 weeks Weeks 7 11: Return to light duties at work Gradual return to heavy duties at work 3

4 Week 12: Return to heavy work Return to contact sports How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Group 2: miram group Brief description of the intervention 45 The occupational therapy department at the Royal Adelaide Hospital Occupational therapists at the Royal Adelaide Hospital NR NR The miram program was of shorter duration, with 4 weeks of immobilization, compared with 5 weeks for the IRAM program. Participants in the miram program with repairs distal to the juncturae tendinae for Zones IV or V used a less-restrictive yoke orthosis with no wrist immobilization, compared with all other participants, who used a wrist orthosis and a yoke orthosis. Days 1 21: Yoke orthosis only (if repair distal to juncturae tendinae for Zones IV and V) For all other repairs, wrist orthosis extension plus a yoke orthosis with affected digit in greater extension than adjacent digits Commence light-duty ADLs in orthosis Return to light-duty work as able in orthosis Orthosis worn at all times Education about tendon healing and strength of repair Active composite finger flexion and extension, 5 10 repetitions every hour Days 22 28: Repairs distal to juncturae tendinae: continue yoke wear at all times All other repairs: wean orthosis over a period of 7 days, continue yoke at all times Initially, exercises performed with wrist relaxed. When no active extensor lag, composite wrist and finger flexion and wrist and finger extension During active use of hand, both orthoses worn When wrist moved freely, light use of hand without wrist orthosis 4

5 Days Day 36: When no active extensor lag, removal of yoke (or wrist and yoke) orthosis Continue composite wrist and finger flexion and extension Continue graded grip-strengthening exercises Graded return to normal activities, sports, and heavy work activities. Return to driving on medical advice. No restrictions Continue ROM exercises as required Continue grip-strengthening exercises as required How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? 18 The occupational therapy department at Flinders Medical Center Occupational therapists at Flinders Medical Center NR NR Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: YES NO X NR Comment: Contamination was avoided, because groups received treatment at two locations, with no crossover between groups. Co-intervention: YES NO NR Timing: YES NR Comment: Cointervention was not avoided, because patients received concomitant treatment for edema, scar, nerve, and hand function, as required. Comment: The effect of timing on the results is not discussed. If treatment effects are studied over a short duration, there may not be sufficient time to see a difference between groups (Law & MacDermid, 2008). This study was of long enough duration to see a difference between groups early on; however, long-term follow-up at 6 months or a year might have provided additional findings. Site: YES Comment: It is possible that differences in the two treatment centers might 5

6 NR have affected outcomes, but details regarding any differences between the treatment environments are not provided. Use of different therapists to provide intervention: YES NR Comment: Performance bias occurs when care is provided differently between treatment groups and can be reduced when the treatment providers are blinded (Portney & Watkins, 2009). Performance bias might have affected this study because of the differences in treatment between therapists at the two centers. Therapists were not blind to treatment groups. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of Wrist and finger ROM measure used: What outcome was measured? Finger ROM was categorized according to two methods. Total active motion (TAM) was calculated as the sum of total flexion minus extension across all joints in a digit and compared with the contralateral side. Criteria defined by Kleinert and Verdan (1983) were used to categorize TAM outcomes (excellent = 100% contralateral finger; good = >75% contralateral finger; fair = >50% contralateral finger; poor = <50% contralateral finger). Criteria defined by Miller (1942) were used to rate outcomes for composite extension (excellent = no lag; good = 5 10 lag; fair = lag; poor = >45 lag) and for composite active flexion (excellent = no lag; good = 20 lag; fair = lag; poor = >45 lag). There is no discussion of the reliability or validity of these outcome criteria. reliable? valid? When is the measure used? Measure 2: Name/type of Wrist ROM was reported in degrees and also as a percentage of the motion of the unaffected wrist. ROM measurements for the digits and wrist were performed according to a uniform method with baseline goniometers; however, the reliability of this technique is not discussed. In particular, a report of interrater reliability is missing, which is needed to address the potential for varied measuring techniques between therapists (Law and MacDermid, 2008). YES NR YES NR At baseline, 4 weeks, 6 weeks, and 8 weeks postoperatively Grip strength 6

7 measure used: What outcome was measured? reliable? valid? When is the measure used? Measure 3: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Measure 4: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? A Jamar dynamometer was used to assess grip. The dynamometers were calibrated before the study and every 6 months after its initiation. When the researchers measured grip, the patient was seated in a chair with the elbow flexed to 90 and the dynamometer set to Level 2. There is no discussion of the reliability of this assessment method. YES NR YES NR At 6 weeks and 8 weeks postoperatively Function, as per the Patient Evaluation Measure (PEM) Part 2 of the PEM was used to evaluate patients perceptions of pain and disability due to their injured hand. This tool includes 11 items rating hand pain and activity restrictions on a scale from 1 (normal function/no pain) to 7 (significant limitation/high-level pain). This measure has been shown to be valid and reliable for a variety of hand conditions (Dias, Rajan, & Thompson, 2008), although it has not been studied specifically for patients with extensor tendon repairs. YES NR YES NR At baseline, 6 weeks, and 12 weeks postoperatively Return to work and number of therapy visits Average number of therapy visits and average time to return to work were reported as means. YES NR YES NR At 8 weeks postoperatively Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. YES NO X Comment: Because of the use of multiple sites, blinding of the evaluators was not possible. 7

8 NR Recall or memory bias. Check yes, no, or NR, and if yes, explain. YES NR Others (list and explain): Comment: Recall or memory bias can occur when participants have difficulty recalling past events when completing a self-report outcome measure (Law & MacDermid, 2008). Recall bias might have affected patients self-report on the functional outcome measure (PEM) used in this study; however, this is not addressed. Random allocation and concealment of allocation are necessary for reducing the risk of selection bias in a study (Portney & Watkins, 2009). Selection bias might have affected the results of this study, because participants were drawn from a convenience sample at two facilities and were not randomly allocated to groups. RESULTS List key findings based on study objectives Include statistical significance where appropriate (p<0.05) Include effect size if reported Data for TAM and grip strength were normally distributed and reported in terms of means and standard deviations. Mixed-effect models were used to analyze the changes in outcomes over time for TAM, wrist ROM, grip strength, and PEM scores. Results for number of treatments and return to work were analyzed with paired t tests. All outcomes improved over time, but the miram group generally had better outcomes on the initial 4-week assessment. Analysis showed that the interaction between time (weeks) and the group (miram vs. IRAM) was not significant for TAM, wrist ROM, grip strength, or PEM scores (p.06). In both programs, a significant time effect was found for TAM, wrist ROM, grip strength, and PEM scores (p.0001). TAM was significantly greater at both Week 6 and Week 8 compared with Week 4 (p.0001), and Week 8 outcomes were greater than at Week 4 (p =.0005). Wrist ROM was greater at Weeks 6 and 8 compared with Week 4 (p.0001). Wrist ROM showed no significant change between Weeks 6 and 8 (p =.17); however, grip strength increased significantly in this timeframe (p.0001). PEM scores were significantly better (i.e., lower) at Weeks 6 and 8 compared with baseline, and these scores improved significantly from Week 6 to Week 12 (p.0001). No significant difference was seen between the IRAM and miram groups for any of the outcomes, independent of time (p.09). Participants in the IRAM group attended 82% of scheduled therapy visits, versus 73% in the miram group. The mean number of therapy visits attended was significantly higher in the IRAM group (p =.013). Participants in the miram group returned to work more quickly. Average return to work for this group was significant for full-duty work (p =.012) but not for modifiedduty work (p =.424). Results for ROM and grip strength were compared with those in Howell et al. s (2005) 8

9 study. The percentage of patients who achieved good or excellent finger extension ROM according to Miller s (1942) criteria in the current study was not as good as in Howell et al. s study (75% in the current study vs. 96% in Howell et al. s study); however, the percentage of patients who achieved good or excellent composite flexion was similar between studies (87% vs. 93%, respectively). Grip strength was similar between studies. Return to work was significantly faster in the study by Howell et al. (M = 2.6 weeks, no distinction between modified and full-duty work), compared with the current study (M = 3.7 weeks for modified work, n = 31; M = 6.2 weeks for full-duty work, n = 26). The mean number of therapy visits was greater in Howell et al. s study (M = 8.1) compared with the current study (M = 4.8). The miram and IRAM groups achieved similar long-term outcomes that were not statistically different for ROM, grip strength, and PEM scores. The miram group, however, exhibited earlier gains in ROM at 4 weeks postoperatively and returned to work significantly faster than the IRAM group. This suggests that the shorter duration of immobilization and less-restrictive orthosis may facilitate earlier recovery of motion, although future studies are needed to investigate these gains earlier than 4 weeks postoperatively. Compared with results previously reported for an IRAM program by Howell et al. (2005), patients achieved less total extension but similar composite flexion and grip strength. One of the reasons for this difference might have been that Howell et al. reported outcomes at discharge, which ranged from 3 20 weeks, with an average of 7 weeks, whereas the current study reports outcomes at 8 weeks postoperatively. Patients in Howell et al. s study returned to work more quickly, on average, than in the current study, although patients in the current study returned to work more quickly than the mean of 46 days reported by Sylaidis, Youatt, and Logan (1997). Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. YES NO NR Comment: Power calculations for sample size were performed for Type I and Type II errors, with a 30% dropout rate. Final sample size based on this calculation was 45 participants for each group. The study did not achieve this sample size, given that 63 total participants were recruited. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. YES Comment: NR Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. YES Comment: Was the percent/number of subjects/participants who dropped out of the study reported? YES 9

10 Limitations: What are the overall study limitations? The main limitations of this study were lack of randomization and high rate of attrition. The study did not meet the sample size identified in its power calculation and had a high loss to follow-up (21%, 25%, 30%, and 44% for the PEM only at 4, 6, 8, and 12 weeks, respectively), which introduces the likelihood of Type I and II errors (Portney & Watkins, 2009). CONCLUSIONS State the authors conclusions related to the research objectives. The outcomes of this study for patients treated with an IRAM program were similar to those previously reported in the literature and beneficial for treating clients with Zone IV, V, and VI repairs. There were no significant differences in outcomes between groups for ROM, grip strength, or function (measured by the PEM) at 8 12 weeks postoperatively. The miram program had the advantage of shorter duration, less-restrictive orthosis wear, fewer therapy visits, and a faster return to work, although further studies are needed to evaluate outcomes earlier than 4 weeks postoperatively. Despite the limitations of nonrandomization and high rate of attrition, this study contributes a useful comparison of early mobilization protocols using an immediate controlled active motion approach and provides evidence in favor of a shorter period of immobilization to promote patients earlier return to ADLs and work activities. Future studies using a larger sample size and randomized allocation are needed to increase the validity and generalizability of these results. References Dias, J. J., Rajan, R. A., & Thompson, J. R. (2008). Which questionnaire is best? The reliability, validity and ease of use of the Patient Evaluation Measure, the Disabilities of the Arm, Shoulder and Hand and the Michigan Hand Outcome Measure. Journal of Hand Surgery European Volume, 33(1), 9e17. Howell, J. W., Merrit, W. H., & Robinson, S. J. (2005). Intermediate controlled active motion following zone 4 7 extensor tendon repair. Journal of Hand Therapy, 18(2), Kleinert, H. E., & Verdan, C. (1983). Report of the Committee on Tendon Injuries. Journal of Hand Surgery, 8, Law, M. C., & MacDermid, J. (2008). Evidence-based rehabilitation: A guide to practice (2nd ed.). Thorofare, NJ: Slack. Miller, H. (1942). Repair of severed tendons of the hand and wrist: Statistical analysis of 300 cases. Surgery, Gynecology & Obstetrics, 75, Portney, L. G., & Watkins, M. P. (2009). Foundations of clinical research: Applications to practice (3rd ed.). Upper Saddle River, NJ: Pearson/Prentice Hall. Sylaidis, P., Youatt, M., & Logan, A. (1997). Early active mobilisation for extensor tendon injuries, the Norwich regime. Journal of Hand Surgery, 22,

11 This work is based on the evidence-based literature review completed by Annalisa Synnestvedt, MS, OTR/L, and Maryjane Mulcahey, PhD, OTR/L, faculty advisor, Thomas Jefferson University. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. 11