A clinical trial of tension and compression orthoses for Dupuytren contractures.

STUDY DESIGN

Randomized clinical trial on 2 patient groups with Dupuytren's disease.

INTRODUCTION

Despite an unpredictable outcome, surgery remains an important treatment for Dupuytren's disease. Orthotic devices are a controversial noninvasive treatment method to influence the myofibroblasts in the nodules.

PURPOSE OF THE STUDY

To detect how much improvement 2 types of orthotic device (tension and compression) as only treatment intervention can provide on a Dupuytren's contracture. Is a compression orthosis better than a tension orthosis?

METHODS

Thirty patients with measurable flexion contractures of the fingers were identified. Both primary and recurrence cases were included. Patients were randomized in 2 groups of 15 patients. One group had a standard tension orthosis (Levame), the other group a newly designed silicon compression orthotic device. Patients were instructed to wear the orthotic devices 20 hours a day during 3 months. Data were collected at first visit and after 3 months of orthotic treatment. Primary outcomes were active extension deficit of each joint and total active extension (TAE) of the digit. Secondary outcome was patient satisfaction. Visual Analog Scale (VAS) score of function and esthetics (0-10 points) were recorded at the start and after 3 months.

RESULTS

Flexion contracture was reduced at least 5 degrees in all patients. After 3 months, TAE was significantly reduced in both groups (both P < .001).The mean change in TAE was 32.36° in the tension group and 46.47° in the compression group. Although reduction of TAE deficit was bigger in the compression group, this difference was not statistically significant (P = .39). VAS scale of esthetics and functionality was significantly increased in both treatment groups. The functional VAS scale after 3 months was 11% higher in the compression group than in the tension group (P = .03). A major complication of a tension orthotic is skin ulcers.

DISCUSSION

Too much tension may cause myofibroblast stimulation and disease progression, whereas continuous limited tension can improve flexion contractures. The idea of a compression device is based on the treatment concept of hypertrophic burn scars.

CONCLUSION

Tension and compression orthotic devices can be used as a nonoperative treatment of Dupuytren's disease in both early proliferative untreated hands and aggressive postsurgery recurrence. Although there is no statistically significant difference, compression orthoses appear to be more effective and are better tolerated. Nevertheless, adjustment of orthotic design and research on long-term results are needed.

LEVEL OF EVIDENCE

I (Randomized controlled trial, Therapeutic study).