Hand therapy or not following collagenase treatment for Dupuytren's contracture? Protocol for a randomised controlled trial

Abstract

Background: Dupuytren's contracture (DC) is a fibrotic hand condition in which one or more fingers develop progressive flexion deformities. Quality of life is diminished due to disabling limitations in performing everyday activities. For DC patients treated with collagenase, referral for subsequent hand therapy is inconsistent. It is unknown whether subsequent hand therapy is beneficial compared to no therapy. The purpose of this study is to determine whether hand therapy improves DC patients' performance of and satisfaction with performing everyday activities one year after collagenase treatment.

Methods: We will conduct a randomised controlled trial with two treatment groups (hand therapy vs. control) of DC patients who have received collagenase treatment. DC patients with contracted metacarpophalangeal joint(s) (MCPJ) (hand therapy, n = 40; control, n = 40) and those with proximal interphalangeal joint(s) (PIPJ) involvement (hand therapy, n = 40; control, n = 40) comprise two subgroups, and we will study if the treatment effect will be different between both groups (n = 160). Patients with a previous injury or treatment for DC in the treatment finger are excluded. Hand therapy includes oedema and scar management, splinting, movement exercises, and practice of everyday activities. The main outcome variable is patients' performance of and satisfaction with performing everyday activities, as assessed with the Canadian Occupational Performance Measure. Secondary outcomes are DC-specific activity problems, as assessed with the Unité Rhumatologique des Affections de la Main scale, and active/passive flexion/extension of treated joints and grip force using standard measuring tools, and self-reported pain level. Demographic and clinical variables, degree of scarring, cold hypersensitivity, number of occupational sick-leave days are collected. Self-reported global impression of change will be used to assess patient satisfaction with change in hand function. Assessments are done pre-injection and 6 weeks, 4 months, and 1 year later. Standard univariate and multivariate statistical analyses will be used to evaluate group differences.

Discussion: This study aims to assess whether hand therapy is beneficial for activity-related, biomechanical, and clinical outcomes in DC patients after collagenase treatment. The results will provide an objective basis for determining whether hand therapy should be conducted after collagenase treatment.

Trial registration: This study has been registered at ClinicalTrials.gov as NCT03580213 (April 5, 2018).

Keywords: ADL; Activity; COPM; Hand exercise; Occupational therapy; Orthosis; Physical therapy; ROM; Splint; URAM.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1

Flow chart illustrating the selection, allocation, intervention, and assessment schedule of patients with Dupuytren’s contracture.a Reasons for receiving hand therapy after allocation to the control group are developing CRPS or an infection. This will be noted and considered in the analysis

Fig. 2

Make a fist

Fig. 3

Stretch out the fingers

Fig. 4

Night splint volar side

Fig. 5

Night splint dorsal side

Fig. 6

Finger gutter splint, volar side

Fig. 7

Finger gutter splint, dorsal side

Fig. 8

Finger three-point splint volar side

Fig. 9

Finger three-point splint dorsal side

Fig. 10

Isolated exercise for DIPJ

Fig. 11

Isolated exercise for PIPJ

Fig. 12

Isolated exercise for MCPJ

Fig. 13

Extension of the PIPJ and DIPJ with the MCPJ blocked in flexion