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Dupuytren's contracture: nightly splinting after fasciectomy or dermo-fasciectomy
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March 2014
Dupuytren's contracture: nightly splinting after fasciectomy or dermo-fasciectomy
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
Night-time splinting after fasciectomy or dermo-fasciectomy for Dupuytren's contracture: a pragmatic, multi-centre, randomised controlled trial
BMC Musculoskelet Disord. 2011 Jun 21;12:136. doi: 10.1186/1471-2474-12-136Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
154 patients with Dupuytren's disease were randomized to receive hand therapy either with or without nightly splinting for 6 months following fasciectomy or dermofasciectomy, in order to determine if splinting provided a beneficial effect to patients 1 year postoperatively. Patients were primarily assessed with the Disabilities of the Arm, Hand, and Shoulder questionnaire, and secondarily through total active flexion, total active extension, and patient satisfaction. The results of the study reflected no significant differences between the primary outcome or any of the secondary outcomes, and that there was no beneficial effect of nightly splinting combined with hand therapy.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
Action Medical Research Charity
Conflicts:
None disclosed
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
3/4
Randomization
2/4
Outcome Measurements
3/4
Inclusion / Exclusion
2/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
Dupuytren's disease is commonly treated with fasciectomy or dermofasciectomy. The most appropriate postoperative rehabilitation protocol following these procedures remains controversial. The use of thermoplastic extension splints is advocated by some authors, whereas others have reported negative results with the use of splinting following surgery. Therefore, this study aimed to evaluate the effect of static night splinting in addition to hand therapy compared to hand therapy alone.
What was the principal research question?
Did combined static night splinting with hand therapy following fasciectomy for Dupuytren's disease improve patient-reported function and disability, active range of motion of the digits, patient satisfaction and recurrence rate of contracture compared to hand therapy alone, measured over 1 year postoperatively?
Study Characteristics
-
Population:
154 patients with Dupuytren's disease of one or more digits, requiring surgical intervention (fasciectomy or dermofasciectomy (surgeon preference)). (n=146 completed follow-up)
Intervention:
Splinting group: 77 patients received a custom-made thermoplastic splint, which they were instructed to wear nightly for 6 months following surgery. Splints were designed for static maximal extension of metacarpophalangeal joint (MCPJ) and/or proximal interphalangeal joint (PIPJ), without adding tension to the wound. Splint diaries were given to monitor adherence to treatment. Patients also underwent non-standardized hand therapy postoperatively. (n=71 completed follow-up)
Comparison:
No Splinting group: 77 patients were allocated to not receive splinting following surgery, and receive hand therapy alone. However, it was deemed unethical to withhold splinting if patients in this group developed contracture which did not respond to hand therapy, therefore a priori criteria were developed for 'per protocol' deviations. Criteria for receiving splinting was a net loss in range of motion of 15 degrees or more at the PIPJ or 20 degrees or more at the MCPJ of the operated finger(s) from 1st to 2nd hand therapy session (usually a week apart; onset and frequency of hand therapy sessions was unclear, however). (n=75 completed follow-up)
Outcomes:
Primary outcome assessment was patient-report function and disability using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcomes included active range of motion of the MCPJ, PIPJ, and distal interphalangeal joint (DIPJ), assessed with a Rolyan finger goniometer, and summed for total active flexion (TAF) and extension (TAE). Patient satisfaction was also assessed on a scale from 0-10.
Methods:
Open-RCT, Pragmatic, Mulitcentre
Time:
12 months. Follow-up of primary and secondary outcomes was conducted at 3, 6, and 12 months postoperatively, with the exception of patient satisfaction, which was assessed at 6 and 12 months.
What were the important findings?
- A total of 21 patients of the non-splint group received splinting, 8 of which were protocol violations: One patient received splinting by mistake prior to randomization and 7 patients were given splinting at first hand therapy session due to surgeon request. 13 patients developed contractures between first and second hand therapy sessions fitting the per protocol deviation criteria (all at PIPJ).
- Intention to treat analysis of 12-month outcome assessment of splint group versus no splint group indicated no significant differences in DASH score (Mean 7.0 vs 6.0, Adjusted difference 0.66 (95%CI -2.79 to 4.11), p=0.703), total active flexion (223.8 degrees vs 227.3 degrees, -2.02 (-7.89 to 3.85), p=0.493), total active extension (-32.9 degrees vs -29.6 degrees, 5.11 (-2.23 to 12.55), p=0.172) and patient satisfaction (8.5 vs 8.9, -0.35 (-1.04 to 0.34), p=0.315). Non-significant difference between groups was also reflected in 3 and 6 month assessments.
- A per-protocol analysis was also performed due to the number of per protocol deviations, as well as to account for patients with adherence to treatment <50% in first 3 months. No statistically significant differences in primary and secondary outcomes were found between groups in 3-, 6- and 12-month assessment of the per-protocol analysis.
- Adherence to splint wear in the first 3 months of treatment was 74.6% (SD 29.4%) of nights. 12 patients failed to meet the adherence criterion (>50% of nights for first 3 months).
What should I remember most?
The addition of nightly static splinting to hand therapy in the first 6 months following fasciectomy or dermofascietomy did not significantly improve patient-reported function/disability, range of motion of operated digits, or patient satisfaction compared to hand therapy alone in patients suffering from Dupuytren's disease.
How will this affect the care of my patients?
The findings of this study suggest that there is no additional benefit to routine nightly splinting in functional and satisfaction outcomes following surgical treatment of Dupuytren's disease; however, patients who develop postoperative contracture, especially in the early postoperative period, should still be treated with splinting.
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