Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?

Haukeland University Hospital

Status: Completed

Conditions: Dupuytren Disease of Palm and Finger, With Contracture

Treatments: Other: Hand therapy PIPJ affected; Other: Hand therapy MCPJ affected

Study type: Interventional

Funder types: Other

Identifiers

NCT03580213

2017/613

Details and patient eligibility

About

This study evaluates if hand therapy have an impact on the patients' preformance of and satisfaction with everyday activities or not following collagenase injection treatment for Dupuytren's contracture. Differences on this between patients with contracted proximal interphalangeal joint(s) and patients with affected metacarpophalangeal joint(s) only, will also be investigated. Two equal sized groups will either receive hand therapy or no treatment following the injection and extension procedure.

Full description

Today it varies if patients with collagenase treated Dupuytren's contracture (DC) are referred to hand therapy or not. No studies are found looking at the effect of therapy following collagenase treatment compared to no therapy.

The main purpose of the study is to find if hand therapy improves patients' performance of and satisfaction with everyday activities or not, one year after collagenase treatment for DC. Differences on this between patients with contracted proximal interphalangeal joint(s) (PIPJ) and patients with affected metacarpophalangeal joint(s) (MCPJ) only, will also be investigated.

A Norwegian randomised controlled trial will be conducted with two parallel intervention groups in a pre-test - post-test design. Hand therapy includes oedema control, scar management, night-time splinting, movement exercises and use of everyday activities as therapy. Additional individualised therapy will be provided if needed. Test times are right before, straight after, six weeks, four months and one year after collagenase treatment. Sample size needed is 160 participants. Appropriate methods of statistical analysis will be used.

Discussion Research on DC is challenging as the clinical picture is heterogeneous, no cure exists and no agreement on who should receive collagenase treatment. Hand therapy in the study will be individualised and not equal for every patient.

Enrollment: 72 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients treated with collagenase injection and extension procedure for Dupuytren's contracture

Exclusion criteria

• earlier injury or treatment for Dupuytren's contracture in the same finger
• patients not capable of following a therapy program
• before randomisation: infection or an allergic reaction to the drug or Complex regional pain syndrome arising
• earlier participation in the same study makes the participant not eligible to be included once more when treated in the other hand.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups

Hand therapy MCPJ affected

Experimental group

Description:

40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected, receiving hand therapy after collagenase injection and extension treatment. Hand therapy: edema control, wound and scar treatment, splinting, exercises for hand, exercise through activities of daily living.

Treatment:

Other: Hand therapy MCPJ affected

Hand therapy PIPJ affected

Experimental group

Description:

40 participants With Dupuytren's contracture with the proximal interphalangeal joint involved, receiving hand therapy after collagenase injection and extension treatment. Hand therapy: edema control, wound and scar treatment, splinting, exercises for hand, exercise through activities of daily living. Possible additional splint and exercises specifically for the PIPJ extension.

Treatment:

Other: Hand therapy PIPJ affected

Control group MCPJ affected

No Intervention group

Description:

40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment.

Control group PIPJ affected

No Intervention group

Description:

40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment.