CRITICALLY APPRAISED PAPER (CAP)

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1 1 CRITICALLY APPRAISED PAPER (CAP) FOCUSED QUESTION For patients with De Quervain's tenosynovitis, how does kinesiotaping compare with a thumb spica splint on reducing pain and increasing strength? Jongprasitkul, H., Suputtitada, A., Kitisomprayoonkul, W., & Pintawinruj, K. (2011). Elastic bandage versus neoprene thumb stabilizer splint in acute De Quervain s tenosynovitis. Asian Biomedicine, 5, CLINICAL BOTTOM LINE: The use of an elastic bandage and a brace produced similar results in reducing pain and increasing strength in subjects with acute De Quervain s tenosynovitis. No differences were seen favoring one intervention over the other; however, this is a limitation of this study. This study was not powered adequately, and the potential of a type II error exists. In other words, it is possible there was a difference between the two interventions, but it was not reflected in this study due to an inadequate sample size. Participants were primarily women in their late 40s and early 50s who were diagnosed with acute De Quervain s tendonitis. Through a randomized controlled trial, patients were divided into two s: one received neoprene thumb spica braces and the other wrapped their thumbs using a specific technique with elastic bandages. The intervention was worn for at least 6 hours a day for a duration of 2 weeks. Both s showed similar gains in pain reduction and strength. Subjects were found to be more satisfied using a neoprene thumb brace than an elastic bandage. This study showed that the elastic bandage can be substituted for the neoprene thumb brace for patients with acute De Quervain s tenosynovitis, especially when cost of the brace is a concern. RESEARCH OBJECTIVE(S) List study objectives. The objective of this study was to compare the effectiveness of an elastic bandage versus a neoprene thumb brace in participants with acute De Quervain s tenosynovitis. DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial Limitations (appropriateness of study design):

2 Was the study design type appropriate for the knowledge level about this topic? Circle yes or no, and if no, explain. YES/NO Treatment of De Quervain s tenosynovitis often includes a thumb stabilizer brace. Splinting is recommended as an effective treatment to reduce or prevent friction of the thumb tendons with movement further exacerbating pain and swelling (Ilyas et al., 2007). The authors of this reviewed study wished to compare a second intervention (elastic bandage) to the use of a thumb stabilizer brace; therefore, a randomized controlled trial of two s with two interventions was appropriate. SAMPLE SELECTION How were subjects selected to participate? Please describe. Participants were recruited from a convenience sample from a hospital. Inclusion Criteria Inclusion criteria included: 1. Over 18 years of age 2. Diagnosis of De Quervain s tenosynovitis 3. Positive Finklestein s test. Exclusion Criteria Participants were excluded for the following conditions: 1. Orthopedic disease of the wrist and hand (rheumatoid arthritis) 2. Osteoarthritis and other types of arthritis 3. Having received steroid injection for De Quervain s tenosynovitis within 3 months. SAMPLE CHARACTERISTICS N = 40 % Dropouts 0 #/ (%) Male 3 (7.5%) #/ (%) Female 37 (92.5%) Ethnicity Not stated Disease/disability diagnosis Acute De Quervain s tenosynovitis Check appropriate : <20/study 20 50/study /study /study /study INTERVENTION(S) AND CONTROL GROUPS Add s if necessary 2

3 Group 1 Brief Description Elastic bandage that was wrapped around the palm twice and then to bind the base of thumb twice, then across the back of the hand, finishing around the wrist twice. Setting Who Delivered? Frequency? Duration? Group 2 Presumed clinical setting, not specified Patient applied Worn at least 6 hours a day 2 weeks Brief Description Neoprene thumb stabilizer splint, prefabricated Setting Who Delivered? Frequency? Duration? Presumed clinical setting, not specified Patient applied Worn at least 6 hours a day 2 weeks Intervention Biases: Circle yes or no and explain, if needed. Contamination YES/NO No contamination of intervention was identified; both s received alternative treatments. Co-intervention Timing YES/NO The researchers indicated that the participants did not receive any antiinflammatory medication or analgesics during this study to minimize cointervention bias. YES/NO The intervention lasted over a short duration time, which may have contributed to the results. The duration of the effectiveness of braces or application of elastic bandage has not been demonstrated. In addition, the frequency of bracing or bandaging could have been anywhere from 6 24 hours a day, as the study s specification was only at least 6 hours a day. The length of time the brace or bandage was used could have influenced the results positively or negatively. Site YES/NO The site appears consistent for all participants. Use of different therapists to provide intervention 3

4 YES/NO It is possible that different application techniques by different patients or clinicians could have influenced the effectiveness of the elastic bandage. In addition, concerns for safety may have arisen if the person wrapped the bandage too tightly. MEASURES AND OUTCOMES Complete for each relevant measure when answering the evidence-based question: Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/nr [not reported]), and how frequently the measure was used. VAS (visual analog scale), a self-report tool for usual pain, worst pain, and pain relief was used pre and post intervention, the end of the first and second weeks. The VAS is a measurement of pain intensity. No psychometric property information was noted in this particular study, but the VAS is a reliable and valid tool as noted by Anandkumar (2013). The patient is asked to indicate pain on a 10 cm line, with 0 being no pain and 10 being the worst imaginable pain. The length of the line is measured and reported in centimeters. Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/nr [not reported]), and how frequently the measure was used. Pinch strength: The Jamar Hydraulic pinch strength gauge was employed for lateral and palmar pinches before and after intervention and the end of the first and second weeks. No information was provided for psychometric properties of this test in this article, but Mathiowetz, Weber, Volland, and Kashman (1984) reported high reliability for pinch strength testing. Name of measure, what outcome was measured, whether the measure is reliable and valid (as reported in article yes/no/nr [not reported]), and how frequently the measure was used. A patient satisfaction scale was completed before and after intervention and at the end of the first and second weeks. No additional information is provided for this outcome measurement including the psychometric properties. Measurement Biases Were the evaluators blind to treatment status? Circle yes or no, and if no, explain. YES/NO The participants were blindly assessed according to the study. Recall or memory bias. Circle yes or no, and if yes, explain. YES/NO There was potential for recall bias with the participant recalling the score provided on both the VAS and satisfaction questionnaires. RESULTS List results of outcomes relevant to answering the focused question 4

5 Include statistical significance where appropriate (p<0.05) Include effect size if reported. Outcome data: Comparison of pain level by VAS, lateral and palmar pinch strength before and after using the neoprene thumb stabilizer splint Variables Mean ± SD Week 0 Week 1 Week 2 p value VAS (100 mm) ± ± ± < Lateral pinch strength (lbs) 8.90 ± ± ± 2.48 < Palmar pinch strength (lbs) 3.07 ± ± ± 1.36 < Comparison of pain level by VAS, lateral and palmar pinch strength before and after using elastic bandage for 0, 1 and 2 weeks. Week 0 Week 1 Week 2 p value VAS (100 mm) ± ± ± < Lateral pinch strength (lbs) 9.40 ± ± ± 3.58 < Palmar pinch strength (lbs) 3.63 ± ± ± 1.41 <

6 1. Descriptive statistics were used to clarify the participant characteristics. The means (+/ standard deviations) for each based on age, gender, and duration of symptoms were recorded. 2. Comparison of VAS, lateral pinch strength, and palmar pinch strength over time within each was calculated with statistical significance of p < These data were compared using the Friedman test. The Friedman test is a nonparametric test and strong alternative to the ANOVA. It is used for repeated measurements in comparison of three or more treatments with one independent variable (Portney & Watkins, 2009). 3. Comparison of the VAS, lateral pinch strength, and palmar pinch strength over time between the two s was completed with the Mann-Whitney U test with statistical level of significance 95% and 99%. The Mann-Whitney U test is a nonparametric test for comparing two separate s (Portney, & Watkins, 2009). The resulting p-values were not statistically significant between the two s for the VAS, lateral pinch, and palmar pinch strength measurements. VAS: Week 1 p = 0.551; week 2 p = Lateral pinch strength: Week 1 p = 0.715; week 2 p = Palmar pinch strength: Week 1 p = 0.151; week 2 p = Comparison of the patient satisfaction score between the two s was statistically significant: p=0.013 with the patients preferring the neoprene brace over the elastic bandaging. The effect size was not included in this study. The effect size would have been important to help identify the power or to determine the sample size needed to minimize the possibility of making a type II error st 2nd 3rd 4th East West North East West North Was this study adequately powered (large enough to show a difference)? Circle yes or no, and if no, explain. YES/NO This study did not report that a power analysis was completed. This is potentially a major limitation to this study as the results showed no difference. The possibility of a type II error or stating there is no difference when there may indeed be a difference is possible. By determining the power in the planning of this study, the researchers could have determined the sample size needed to detect a difference of significance for an effect size and thus minimized the likelihood of making a type II error (Portney &Watkins, 2009). 6

7 Were appropriate analytic methods used? Circle yes or no, and if no, explain. YES/NO The statistical tests selected for this study were the Friedman and Mann- Whitney U tests, which are non-parametric tests. These tests were appropriate given the non-homogenous and small test s. The Friedman test was selected because of the need to compare three treatment values in succession, and then the Mann-Whitney U test compared the results between the two s (Portney & Watkins, 2009). Were statistics appropriately reported (in written or table format)? Circle yes or no, and if no, explain. YES/NO All data for this study were clearly reported in table form with summary of findings documented in written format. CONCLUSIONS State the authors conclusions that are applicable to answering the evidence-based question. For patients with acute De Quervain s tenosynovitis, this study demonstrated that a neoprene thumb brace could be replaced with the use of an elastic bandage with a savings in cost. Pain and strength measurements were affected equally with use of an elastic bandage and a thumb brace. The reader must consider the limitations of the study, including that the results were not strong enough to demonstrate a significant difference between the two interventions, there was no control offered, and the duration of treatment was only 2 weeks. This study also revealed that patients were more satisfied with the use of the brace over the elastic bandage, which may be due to convenience of the brace. Other limitations found were in the consistency of bandage application, including the person applying, and technique, including tightness and the ease of application, which may influence the participant s compliance. It is suggested that patients understand the advantages and disadvantages of using an elastic bandage over a brace. As demonstrated in this study, it is worth considering alternative materials in the treatment of De Quervain s tenosynovitis that may provide similar support in reducing pain and increasing strength. An elastic bandage provided equivalent results compared to the thumb spica. This work is based on the evidence-based literature review completed by Sharon Montgomery, OTR/L, CHT, and Mary Jane Mulcahey, PhD, OTR/L, Faculty Advisor, Thomas Jefferson University. CAP Worksheet adapted from: Critical Review Form Quantitative Studies Law, M., Stewart, D., Pollack, N., Letts, L., Bosch, J., & Westmorland, M., 1998, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: 7