CRITICALLY APPRAISED PAPER (CAP)

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1 CRITICALLY APPRAISED PAPER (CAP) Rocchi, L., Merolli, A., Morini, A., Monteleone, G., & Foti, C. (2014). A modified spica-splint in postoperative early-motion management of skier's thumb lesion: A randomized clinical trial. European Journal of Physical and Rehabilitation Medicine, 50(1), CLINICAL BOTTOM LINE: Although both splints tested provided the patients with the same outcomes at 12 months, a modified spica splint (which allows metacarpophalangeal [MCP] joint flexion and extension) seemed to improve the patient s pain, function, and range of motion (ROM) earlier than a classic hand-based splint. However, no tests of statistical significance were run, so it is unclear whether the differences were real and not due to chance. In theory, the apparent early improvements from the modified spica-splint should allow clients to return to their typical occupations (after splint removal) faster and more comfortably than with a classic splint. Both splints were said to have improved joint stability in patients; however, no numerical data were reported. If a client presents with skier s thumb, the information in this article suggests that a modified spica-splint should be fabricated. RESEARCH OBJECTIVE(S) List study objectives. Assess the efficacy of a postoperative hand-based splint for the thumb that allows immediate postoperative movement. The article compares two splints to see which is better in the categories of pain, function, stability, ROM, pinch strength, time lost from work, and amount of physiotherapy in patients with skier s thumb. DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized clinical trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Thirty patients were chosen between February 2009 and April All were surgically treated by the same hand surgeon for the same injury. 1

2 Inclusion Criteria Acute complete tear of the ulnar collateral ligament (UCL) of the thumb (no solid endpoint at the valgus stress, more than 30 stressed radial deviation, and more than 20 difference from the uninjured side), and an x-ray Exclusion Criteria Partial suspected tear of the UCL of the thumb; associated injuries of the skin, tendons, nerves, or vessels; or bone fractures SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 30 #/ (%) Male 24 (80%) #/ (%) Female 6 (20%) Ethnicity Not reported, but the study took place in a hospital in Italy Disease/disability diagnosis Skier s (or gamekeeper s) thumb lesion (complete tear of the UCL) INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: Control classic splint group Brief description of the intervention How many participants in the group? A classic hand-based spica splint made of thermoplastic material was used to immobilize participants thumb after surgery. The splint positioned the carpometacarpal in slight abduction and the MCP in slight flexion to minimize movement and pinch to optimize surgical repair. It left the wrist and interphalangeal joint free. Consequently, the splint completely immobilized the MCP joint of the thumb. A Velcro strap was used proximally across the wrist. Patients in both groups were instructed to perform active flexion and extension exercises of the thumb while still in the splint; pinching small objects was encouraged. Patients were prohibited from removing their splint and engaging in heavy loading. The splints were worn full time for 4 weeks after surgery. At 15 days post-op, the surgeon removed the splints to remove the skin suture; the splints were then reapplied. At 1 month post-op, the splints were discontinued. Then, sessions of active assisted rehabilitation were provided by a hand physiotherapist (edema and scar treatment, active and passive thumb MCP joint mobilization, thenar eminence massage, and Theraputty exercises for grip strength). 15 2

3 Where did the intervention take place? Who Delivered? Orthopedics and Hand Surgery Unit of the Catholic University School of Medicine in Rome, Italy Surgeon and hand physiotherapist How often? The splints were worn continuously; they were removed once at 15 days for skin suture removal and then reapplied. The frequency of exercises was not reported. For how long? Group 2: Intervention modified splint group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? The splints were worn full-time for 4 weeks. The classic splint group received an average of 15 physiotherapy sessions. The duration of all other exercises was not reported. The splints in the modified splint group were made with the same material and used the same technique as those in the classic splint group, but they did not immobilize the proximal phalanx. On the palmar and dorsal side of the thumb, the splints were open. The radial and ulnar sides were fabricated with double-reinforced plastic walls to permit flexion and extension of the thumb MCP joint while preventing lateral deviation. A Velcro strap was used proximally across the wrist. Patients in both groups were instructed to perform active flexion and extension exercises of the thumb while still in the splint; pinching small objects was encouraged. Patients were prohibited from removing their splint and engaging in heavy loading. The splints were worn full time for 4 weeks after surgery. At 15 days post-op, the surgeon removed the splints to remove the skin suture; the splints were then reapplied. At 1 month post-op, the splints were discontinued. Then, sessions of active assisted rehabilitation were provided by a hand physiotherapist (edema and scar treatment, active and passive thumb MCP joint mobilization, thenar eminence massage, and Theraputty exercises for grip strength). 15 Orthopedics and Hand Surgery Unit of the Catholic University School of Medicine in Rome, Italy Surgeon and hand physiotherapist How often? The splints were worn continuously; they were removed once at 15 days for skin suture removal and then reapplied. The frequency of exercises was not reported. For how long? The splints were worn full-time for 4 weeks. The modified splint group received an average of four physiotherapy sessions. The duration of all other exercises was not reported. 3

4 Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: Comment: The classic splint group and the modified splint group received two different interventions. The control group was designated as such because its participants wore the typical, widely used, classic hand-based spica splint for skier s thumb. Co-intervention: NR Timing: Comment: The article does not state whether the patients partook in other forms of treatment (e.g., medication for pain relief) during the study. Comment: The mean age of the patients was 39 years, which suggests that maturation had already occurred and thus could not affect treatment outcomes. Moreover, both splints were worn for the standard amount of time in treating a skier s thumb lesion, followed by physiotherapy sessions. Site: Comment: The site of both the intervention and the control was the same. After the splints were fabricated and applied, the participants wore the splints in their home for the duration of the study. Use of different therapists to provide intervention: NR Comment: The same hand physiotherapist provided rehabilitation sessions for both of the groups after the splint removal at 1 month. However, the article does not specify who or how many therapists administered and fabricated the splints and gave directions describing the home exercise program. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Goniometer Thumb MCP active flexion; the results were compared with the uninjured hand NR 4

5 Measure 2: Measure 3: Measure 4 NR A goniometer was used to measure thumb MCP flexion active range of motion (AROM) preoperatively and at 1 month post-op (splint removal), 2 months post-op, 6 months post-op, and 12 months post-op. Preston Pinchometer Tip pinch strength, measured in kilograms; the results were compared with the uninjured hand YES NR NR A Preston Pinchometer was used to measure tip pinch strength preoperatively and at 1 month post-op (splint removal), 2 months post-op, 6 months post-op, and 12 months post-op. Visual Analogue Scale from 0 to 10 Pain was measured, then compared with the uninjured hand. NR NR The Visual Analogue Scale was used to assess pain preoperatively and at 1 month post-op (splint removal), 2 months post-op, 6 months post-op, and 12 months post-op. Dreiser s Functional Hand Index Thumb function was measured from 0 (complete hand function without difficulty) to 30 (no function). The results were compared with the uninjured hand. NR NR This measure was used preoperatively and at 1 month post-op (splint removal), 2 months post-op, 6 months post-op, and 12 months post-op. 5

6 Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. YES Comment: The evaluators were two doctors who were blinded to group assignment. The patients were told not to disclose any information to the evaluators about which splint they used or to which group they had been assigned. Recall or memory bias. Check yes, no, or NR, and if yes, explain. Others (list and explain): N/R Comment: No outcome measures were used in this study that required the participants to recall past events. RESULTS List key findings based on study objectives Include statistical significance where appropriate (p < 0.05) Include effect size if reported No tests of statistical significance were performed, so it is unclear whether any of the below differences are real or a chance occurrence. ROM and function seemed to be better at 1, 2, and 6 months in the modified splint group; the values became similar to the classic splint group at the 12-month mark. Pain seemed to be markedly decreased in the modified splint group at 2 months, whereas at 6 months the values started to become comparable between groups. There was no difference in pinch strength between groups. There was an average of 48 days lost from work in the classic splint group, compared with 36 days in the modified splint group. The classic splint group also received an average of 15 active assisted physiotherapy sessions, whereas the modified splint group, on average, received 4. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. NR Comment: Thirty people took part in this study; there were no tests of statistical significance. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. Comment: No tests of statistical significance were performed. 6

7 Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. Comment: No tests of statistical significance were performed. A section of numerical data involving stability of the thumb MCP joint seems to be missing. Was the percent/number of subjects/participants who dropped out of the study reported? YES Limitations: What are the overall study limitations? No tests of statistical significance were performed. Some data are missing; the authors mentioned that they evaluated joint stability with valgus-stress tests but did not report the data. CONCLUSIONS State the authors conclusions related to the research objectives. The authors concluded that surgical repair of skier s thumb lesion, partnered with the instant restoration of active thumb MCP ROM and protected by a modified spica splint, is safe and effective. Moreover, it permits a faster return to hand-related activities when compared with a classic, traditional hand-based spica splint for skier s thumb. The authors noted that the sample size was small, but the study may be useful for surgeons and therapists who frequently deal with skier s thumb injuries. This work is based on the evidence-based literature review completed by Carly Larson, MOTS, and Michael Borst, OTD, OTR, CHT, Faculty Advisor, Concordia University Wisconsin. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: 7