CRITICALLY APPRAISED PAPER (CAP) FOCUSED QUESTION

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1 CRITICALLY APPRAISED PAPER (CAP) FOCUSED QUESTION The use of an othosis has been shown to decrease symptoms in carpal tunnel syndrome, but which type of orthosis (cock up or lumbrical) with which type of stretches (lumbrical or general hand) shows the most improvement in function and the greatest decrease in symptoms? Baker, N. A., Moehling, K. K., Rubinstein, E. N., Wollstein, R., Gustafson, N. P., & Baratz, M. (2012). The comparative effectiveness of combined lumbrical muscle splints and stretches on symptoms and function in carpal tunnel syndrome. Archives of Physical Medicine and Rehabilitation, 93, CLINICAL BOTTOM LINE: This study compared two different orthoses designs,cock-up orthosis and lumbrical orthosis, with two different stretches, general hand stretches or lumbrical stretches, to determine which combination was most effective in decreasing symptoms, improving function, and postponing possible surgery. This study examined the statistical significance of the different variables and the clinically important change on three outcome measurers: (1) Carpal Tunnel Questionnaire Symptom (CTQ Symptom), (2) Carpal Tunnel Questionnaire Function (CTQ Function) and the (3) Disabilities of the Arm, Shoulder and Hand (DASH). The results indicate that at 4, 12 and 24 weeks after beginning treatment, all groups had a significant difference from baseline. Analysis of the interaction effect among orthosis, stretch, or a combination of both showed no difference between groups, except at 12 weeks for othosis with stretch. Ad hoc testing indicated that the cock-up orthosis with the lumbrical stretches and lumbrical orthosis with general exercise demonstrated significant improvement in CTQ Function, and lumbrical orthosis with general exercise demonstrated significant improvement for the DASH. All groups demonstrated a significant decrease in symptoms when considering clinically important change, but at 24 weeks, only the cock-up orthosis with lumbrical stretches also demonstrated a significant improvement with function (CTQ Function). Use of any othosis with stretches have been shown to decrease symptoms, but the combination of a prefabricated cock-up orthosis with the lumbrical stretch appeared to result in the greatest decrease of symptoms and a significant increase in function for those with mild-to-moderate carpal tunnel symptoms. Several other observations were made from this study. The most improvement in function was seen at 24 weeks; therefore, conservative treatment should be given for at least 3 months to determine its full effects. Function can continue to improve even after symptoms stabilize. More studies to validate these finding will be needed in order to make this a recommendation for best practice. 1

2 RESEARCH OBJECTIVE(S) List study objectives. To determine which treatment decreased symptoms and improved function after 4, 12, and 24 weeks of treatment: lumbrical orthosis or cock-up orthosis, lumbrical stretches or general hand stretches, or a combination of these. To determine which treatment had the greatest clinically important change. To determine which treatment resulted in fewer surgeries at 24 weeks after treatment. DESIGN TYPE AND LEVEL OF EVIDENCE: Design type: Randomized clinical trial (RCT) Level of evidence: Level 1 After baseline assessments the subjects were randomly assigned to 1 of 4 groups and given different orthosis and stretching instructions. At 4 weeks, a blinded assessor reassessed all subjects. Assessments at 12 and 24 weeks after treatment were done by mail. Limitations (appropriateness of study design): Was the study design type appropriate for the knowledge level about this topic? Circle yes or no, and if no, explain. YES/NO Yes, the design is appropriate. An (RCT) such as this gives more power to the assertion that one type of orthosis with one type of stretching is more effective than another. Allocation of health resource goes to treatment with the best evidence. SAMPLE SELECTION How were subjects selected to participate? Please describe. Two hand and upper-extremity surgeons screened and recruited patients for inclusion into the study, and flyers in hand therapy clinics and automatic telephone messages identified selfreferred volunteers. Inclusion Criteria Inclusion criteria includes adults age 18 years or older with mild or moderate clinical symptoms of carpal tunnel syndrome (CTS), 2-point discrimination sensation at 5 mm or less for and willing to comply with all aspects of the study. Exclusion Criteria Exclusion criteria included subjects with; medical conditions such as pregnancy or diabetes, thenar muscle atrophy, prior surgery for CTS, severe symptoms indicating surgery is needed, peripheral polyneuropathy and addition compression neuropathy in the same extremity. 2

3 SAMPLE CHARACTERISTICS N = 103 % Dropouts 17% #/ (%) Male 29/ (28.2%) #/ (%) Female 74/ (71.8%) Ethnicity White 93/ (91.2%) Black 7/ (6.9%) Asian 1/ (1%) Non-Hispanic 97/ (100%) Disease/disability diagnosis Symptom duration 3 months 14/ (14.3%) 3 months to 1 year 29/ (29.6%) 1 year 55/ (56.1%) Check appropriate group: <20/study group 20 50/study group /study group / study group /study group INTERVENTION(S) AND CONTROL GROUPS Add groups, if necessary. Group 1 Brief Description Lumbrical orthosis with lumbrical stretches. Setting Who Delivered? Frequency? Assessments completed at a hand therapy clinic and the intervention completed at home. Hand therapist did baseline assessment, orthosis fabrication and fit, and patient education and instruction in stretches. Participants wore orthosis nightly and performed stretches 6 times daily. They completed a daily self-report tracking for adherence and the hours orthosis was worn. Duration? Participants wore orthosis nightly with daily stretches for 4 weeks. At 4 weeks, they were reassessed. Participants were instructed to continue both the stretches and orthosis wearing if helpful. Follow-up assessments at 12 and 24 weeks were completed by mail. Group 2 Brief Description Lumbrical orthotic with general hand stretches. Setting Who Delivered? Assessments completed at a hand therapy clinic and the intervention completed at home. Hand therapist did baseline assessment, orthosis fabrication and fit, and patient education and instruction in stretches. 3

4 Frequency? Participants wore orthosis nightly and performed stretches 6 times daily. They completed a daily self-report tracking for adherence and the hours orthosis was worn. Duration? Participants wore orthosis nightly with daily stretches for 4 weeks. At 4 weeks, they were reassessed. Participants were instructed to continue both the stretches and orthosis wearing if helpful. Follow-up assessments at 12 and 24 weeks were completed by mail. Group 3 Brief Description Cock-up orthosis with lumbrical stretches. Setting Who Delivered? Frequency? Assessments completed at a hand therapy clinic and the intervention completed at home. Hand therapist did baseline assessment, orthosis fabrication and fit, and patient education and instruction in stretches. Participants wore orthosis nightly and performed stretches 6 times daily. They completed a daily self-report tracking for adherence and the hours orthosis was worn. Duration? Participants wore orthosis nightly with daily stretches for 4 weeks. At 4 weeks, they were reassessed. Participants were instructed to continue both the stretches and orthosis wearing if helpful. Follow-up assessments at 12 and 24 weeks were completed by mail. Group 4 Brief Description Cock-up orthosis with general hand stretches. Setting Who Delivered? Frequency? Assessments completed at a hand therapy clinic and the intervention completed at home. Hand therapist did baseline assessment, orthosis fabrication and fit, and patient education and instruction in stretches. Subjects wore orthosis nightly and performed stretches 6 times daily. They completed a daily self-report tracking for adherence and the hours orthosis was worn. Duration? Participants wore orthosis nightly with daily stretches for 4 weeks. At 4 weeks, they were reassessed. Participants were instructed to continue both the stretches and orthosis wearing, if helpful. Follow-up assessments at 12 and 24 weeks were completed by mail. Intervention Biases: Circle yes or no and explain, if needed. Contamination YES/NO After 4 weeks of the study, participants did not have to continue orthosis 4

5 Co-intervention Timing wearing or stretches and could have other interventions. However, because some groups did not improve, it appeared that there was no contamination. YESNO There is no obvious co-intervention bias, but the authors did not report whether they checked for the use of oral anti-inflammatories or other exercise regimens. YES/NO This study had a 12- and 24-week follow-up period to determine long-term effects of the use of orthosis and stretching. Site YES/NO All groups completed the majority of their intervention at home. Use of different therapists to provide intervention YES/NO The same therapist provided the orthotics and stretching instruction. 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. CTQ Symptom and the CTQ Function have been shown to be reliable and valid and are disease-specific to CTS (Leite, Jerosch-Herold, & Song, 2006; Levine et al., 1993;). The total score can be used, as can the scores of the two subtests of CTQ Symptoms and CTQ Function. CTQ Symptom is an 11-item symptoms severity scale and the CTQ Function contains 8 items on functional status. Both use a 5-point Likert scale in which the mean is calculated. The measures were administered at baseline, 4 weeks, 12 weeks and 24 weeks. This assessment also has an established minimal important change, a decrease of 0.16 points (Amirfeyz, Pentlow, Foote, & Leslie, 2009). 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. The DASH is reported as reliable, responsive, and valid. Gay, Amadio, and Johnson (2003) also found the DASH has good construct and internal validity (intraclass correlation coefficient =.92, Pearson correlation coefficient =.92). Gay et al. compared the DASH to the CTQ to evaluate the CTS population and found high sensitivity and a high correlation, especially with function (Spearman Correlation Coefficients =.91). The DASH is a 30 item self-report that uses a 5-point Likert scale. This was administered at baseline, 4 weeks, 12 weeks, and 24 weeks after treatment began. The authors choose a decrease of 20.9 points to indicate clinically important change (Amirfey et al. 2009). It should be noted that according to Gummesson, Atroshi, and Ekdahl (2003), the minimal important change has been calculated 10 points. 5

6 Measurement Biases Were the evaluators blind to treatment status? Circle yes or no, and if no, explain. YES/NO The baseline measurements were taken prior to allocation to groups. The assessor at the 4-week time frame was blinded to group allocation. The assessment at 12 and 24 weeks was self-report done by mail. Recall or memory bias. Circle yes or no, and if yes, explain. YES/NO There does not appear to be memory or recall biases with any of these three outcome measures. Others (list and explain): RESULTS List results of outcomes relevant to answering the focused question. Include statistical significance where appropriate (p < 0.05). Include effect size, if reported. Analysis of the 4 groups using ANOVA and chi square found the groups were not significantly different at baseline or at 4 weeks (expect for educational level). Comparing each group from baseline, the results indicate that at 4, 12 and 24 weeks, found all groups were significantly improved when measuring the effect of time at p <.001. Analysis of the orthoses, the stretches or the orthoses and stretches found no interaction effect except at 12 weeks. They found a difference with othoses with stretch. Ad hoc analysis using pairwise comparison of the differences in the scores were used to determine which combination had the largest effect. It found that the cock-up orthosis with the lumbrical stretches and lumbrical orthosis with general exercise demonstrated significant improvement for the CTQ-Function and lumbrical orthosis with general exercise demonstrated significant improvement for the DASH. The authors were interested in determining which orthosis, stretch or orthosis and stretch combination had the most significant clinically important change. They thought that by analyzing clinical important change they could determine the clinical effectiveness of the treatment. They used published values and analyzed the mean differences between groups using chi square. They found at 4 weeks, all groups improved 66% in symptoms and 34% in function with no difference between groups. At 12 weeks, all groups improved 68% in symptoms and 37% in function with no difference between groups. At 24 weeks all groups improved to 72 % in symptoms but cock up orthoses and lumbrical stretches improved to 65% in function and all other groups average was 32%. This indicated that clinically, cockup orthosis with lumbrical stretches results in greater improvement in function and a decrease in symptoms. A chi square analysis of adherence at 4, 12 or 24 weeks and percentage of subjects going to surgery indicate no difference among the 4 groups. 6

7 Was this study adequately powered (large enough to show a difference)? Circle yes or no, and if no, explain. YES/NO The power analysis they completed suggested 25 participants per group; 4 groups would require 100 participants. The investigators over-recruited, as they anticipated dropouts for various reasons. They completed a flow sheet to show missing data, the reason for the dropout, and the number of participants in each group at each follow-up period. Were appropriate analytic methods used? Circle yes or no, and if no, explain. YES/NO To ensure groups were similar for demographics, ANOVA analysis with continuous data and chi square with categorical data was used at baseline and at 4 weeks. Three-way ANOVA with orthoses, stretches, and orthoses with stretches and time was completed to see if one factor had greater effect. If a factor did have an effect, post hoc analysis was completed to determine which group had the largest change for that factor using pair-wise analysis. Chi square analysis was used on categorical data, such as demographics, clinical important change, adherence, and participants who underwent surgery, which seem appropriate (Portney & Watkins, 2009). Were statistics appropriately reported (in written or table format)? Circle yes or no, and if no, explain. YES/NO The statistics were shown in tables and graphs and could be easily understood. CONCLUSIONS State the authors conclusions that are applicable to answering the evidence-based question. This study suggests that a cock-up or a lumbrical orthosis and stretching are effective treatment to reduce symptoms and influence surgery rates for mild-to-moderate CTS, short term (4 or 12 weeks). However, at 24 weeks, a cock-up orthotic with lumbrical stretches is most effective in decreasing symptoms, influencing surgery rates and improving function. Additional studies supporting this finding are needed before this can be defined as best practice. Amirfeyz, R., Pentlow, A., Foote, J., & Leslie, I. (2009). Assessing the clinical significance of change scores following carpal tunnel surgery. International Orthopaedics, 33, Gay, R. E., Amadio, P. C., & Johnson, J. C. (2003). Comparative responsiveness of the disabilities of the arm, shoulder, and hand, the carpal tunnel questionnaire, and the SF 36 to clinical change after carpal tunnel release. Journal of Hand Surgery, 28, Gummesson, C., Atroshi, I., & Ekdahl, C. (2003). The Disabilities of the Arm, Shoulder and Hand (DASH) outcome questionnaire: longitudinal construct validity and measuring selfrated health change after surgery. BMC Musculoskeletal Disorders, 4,

8 Leite, J. C., Jerosch-Herold, C., & Song, F. (2006). A systematic review of the psychometric properties of the Boston Carpal Tunnel Questionnaire. BMC Musculoskeletal Disorders, 7(1), 78. Levine, D. W., Simmons, B. P., Koris, M. J., Daltroy, L. H., Hohl, G. G., Fossel, A. H., & Katz, J. N. (1993). A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. Journal of Bone and Joint surgery- American Volume, 75, Portney, L. G., & Watkins, M. P. (2009). Foundations of clinical research: Applications to practice. Upper Saddle River, NJ: Pearson/Prentice Hall. This work is based on the evidence-based literature review completed by Mariann E Moran, OTD, OTR, CHT. 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: 8