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1 CRITICALLY APPRAISED PAPER (CAP) Prosser, R., Hancock, M. J., Nicholson, L., Merry, C., Thorley, F., & Wheen, D. (2014). Rigid versus semi-rigid orthotic use following TMC arthroplasty: A randomized controlled trial. Journal of Hand Therapy, 27, CLINICAL BOTTOM LINE Orthotic intervention is a vital component of intervention after trapeziometacarpal (TMC) arthroplasty. Immobilization immediately after a TMC arthroplasty is essential to allow for proper healing. In this study, for the first 2 weeks after the operation, complete immobilization was achieved with a plaster back slab. The study investigated whether a custom-fabricated semirigid orthosis that allowed for limited wrist and thumb movement from Weeks 2 12 after the operation would be as effective as a rigid orthosis, which does not allow movement. The study concluded that there was no difference in results between the semirigid orthotic intervention and the rigid orthotic intervention 1 year after operation. On the basis of the results, either orthosis can be recommended, depending on other factors, such as cost and the patient s comfort and preference. Limitations of the study include a smaller sample size than required and the lack of a post hoc power analysis. Also, the researchers did not measure participants adherence to the orthotic schedule and home exercise program. Further research with a larger sample size and compliance measurement is recommended. RESEARCH OBJECTIVE(S) List study objectives. Determine whether a semirigid orthosis was at least as effective as a standard rigid orthosis after TMC arthroplasty on self-reported short- and medium-term outcome measures of pain, range, strength, and function DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Researchers screened consecutive patients who presented at three hand surgery practices for TMC arthroplasty. The hand surgery practices were located in Australia. 1

2 Inclusion Criteria Patients had TMC osteoarthritis and were scheduled to have one of two surgery techniques, either trapeziectomy with ligament reconstruction tendon interposition (LRTI) or simple trapeziectomy. Exclusion Criteria Patients were excluded if they had rheumatoid arthritis or if surgery would require other orthotic intervention because of other digit or wrist problems. SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 56 #/% Male 11/20% #/% Female 45/80% Ethnicity NR Disease/disability diagnosis Osteoarthritis INTERVENTION(S) AND CONTROL GROUPS Group 1: Rigid forearm thumb opponens orthosis and an active exercise program Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? 10 to 14 days after the operation, the rigid orthotic intervention began. The rigid orthosis was made from 2.4 mm thermoplastic extending from the radial aspect of the Digit I proximal phalanx to the distal two-thirds of the forearm. The patient s wrist was positioned in 30 degrees of extension, and the thumb was in a palmar abducted position. All participants, regardless of group allocation, received the same exercise program. 27 participants were included in the rigid orthotic intervention. Hand therapy took place at the hand clinic, and exercises were also performed at home. No information was provided as to who delivered hand therapy. Rigid orthotic intervention was to be worn 24 hr/day for 2 6 weeks after the operation and only taken off for exercises. The exercise program was to be completed at home four times per day. Participants had therapy visits once per week for the first 4 weeks and every other week for the remaining 6 weeks. 12 weeks total Weeks 1 2 postoperative: dorsal plaster back slab Weeks 2 6 postoperative: rigid orthosis Weeks 2 12 postoperative: exercise program 2

3 Group 2: Semirigid orthotic intervention and an active exercise program Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? 10 to 14 days after the operation, the semirigid orthotic intervention began. The semirigid orthosis included neoprene and a bonded thermoplastic piece. The neoprene extended from the Digit I interphalangeal joint to the distal two-thirds of the forearm. The thermoplastic piece was positioned on the radial aspect of Digit I, extending from the midproximal phalanx to just below the wrist. The semirigid orthosis allowed for 60 70% of wrist flexion and extension, 5 25 degrees of metacarpophalangeal (MCP) flexion, and degrees of TMC palmar abduction and opposition. All participants, regardless of group allocation, received the same exercise program. 28 participants were included in the semirigid orthotic intervention. Hand therapy took place at the hand clinic, and exercises were also performed at home. No information was provided as to who delivered hand therapy. How often? Semirigid orthotic intervention was to be worn 24 hr/day for 2 6 weeks after the operation and only taken off for exercises. The exercise program was to be completed at home four times per day. Participants had therapy visits once per week for the first 4 weeks and every other week for the remaining 6 weeks. For how long? Intervention Biases Contamination: NR 12 weeks total Weeks 1 2 postoperative: dorsal plaster back slab Weeks 2 6 postoperative: semirigid orthosis Weeks 2 12 postoperative: exercise program Comment: The study did not report adherence to the orthotic intervention or the home exercise program. Cointervention: Comment: Both groups received an exercise intervention program in addition to the orthotic intervention. Timing: NO Comment: 3

4 Site: NR Comment: The researchers did not report the nature of the hand clinics that were involved in the study. Use of different therapists to provide intervention: Comment: Four hand surgeons were involved in the study. The number of hand therapists who carried out the intervention was not specified. The training and expertise of the hand therapists was also not specified. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy. Measure 1 Name/type of Patient Rated Wrist and Hand Evaluation (PRWHE) measure used What outcome is Pain and disability (function level) Measure 2 Name/type of measure used What outcome is Measure 3 Name/type of measure used What outcome is Minnesota Hand Questionnaire Overall hand function, activities of daily living, pain, work performance, aesthetics, patient satisfaction with hand function NR Active range of motion assessment with goniometer, according to American Society of Hand Therapists guidelines TMC palmar abduction and Digit I MCP extension and hyperextension NR 4

5 Measure 4 Name/type of measure used: What outcome is NR Three-point pinch grip with B&L pinch gauge with the arm positions by the side, elbow in 90 degrees flexion, and wrist in 40 degrees extension Pinch strength Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Comment: The assessor was blinded to group allocation; however, the researchers did not explain how blinding occurred. Was there recall or memory bias? Check yes, no, or NR, and if yes, explain. Comment: The PRWHE is a patient-rated questionnaire. RESULTS List key findings based on study objectives. Include statistical significance where appropriate (p <.05). Include effect size if reported. The minimal clinically important difference in PRWRE score was set at a 15-point difference. At the 3-month and 1-year follow-ups, no statistically significant difference was found between groups. Additionally, no clinically important difference existed between groups for PRWHE total at the 3-month (1.0, 95% confidence interval [ 11.8, 13.8]) and 1-year follow-ups (0.5, 95% confidence interval [ 11.5, 12.4]), nor was a difference found for the subscales of pain and function. Because the confidence interval indicated a true difference between groups of less than or equal to 12.4, any difference that might exist is clinically unimportant (i.e., less than the 15-point minimum for a clinically important difference). Thus, we can be 95% certain that any difference that might exist is clinically unimportant. Three months after the operation, for PRWHE total (pain and function), between-groups p =.879; for TMC palmar abduction, between-groups p =.298; for MCP extension, between-groups p =.203; and for three-point pinch grip, between-groups p =.364. One year after the operation, for PRWHE total (pain and function), between-groups p =.937; for TMC palmar abduction, between-groups p =.581; for 5

6 MCP extension, between-groups p =.422; and for three-point pinch grip, between-groups p =.358. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. NO Comment: The researchers stated that 28 participants were required per group to provide 80% power to detect a 15-point difference on the PRWHE. The rigid orthotic group only had 27 participants because of dropouts. Power was not reevaluated after the study was completed. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. Comment: Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. Comment: Was the percentage or number of participants who dropped out of the study reported? Limitations What are the overall study limitations? Because 53 of the 56 participants had a trapeziectomy with LRTI technique, the results of the study are most generalizable to patients who have had LRTI. The study did not have enough participants who underwent the simple trapeziectomy to perform a post hoc subgroup analysis to determine whether the results were the same for both procedures. Although four surgeons were involved in the study, the researchers intention was to compare patients from different surgeons, and there were not enough participants from each surgeon to make a meaningful comparison. CONCLUSIONS State the authors conclusions related to the research objectives. This study showed that no clinically important difference existed between the standard rigid orthosis and semirigid orthosis for the outcomes of pain, range, strength, and function of the hand after TMC arthroplasty. The study concluded that the semirigid orthotic intervention was no better or worse than the rigid orthotic intervention on patients who had undergone TMC arthroplasty. 6

7 This work is based on the evidence-based literature review completed by Jennifer Genteman, MOTS, and Michael J. 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

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