Clinical trial NCT03580213: Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
Official title: Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dupuytren Disease of Palm and Finger, With Contracture
Keywords: Occupational Therapy
Physical Therapy
Hand Therapy
ADL
COPM
URAM
ROM
Hand exercise
Scar
Oedema
Splint
Orthosis
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM) change from baseline to 6 weeks, from baseline to 4 months and to 1 year.
timeFrame: change from baseline to 6 weeks, baseline to 4 months and to 1 year.
Secondary outcomes:
measure: Change on Unité Rhumatoloique des Affections de la Main (URAM) scale results from baseline to 6 weeks, from baseline to 4 months and to 1 year.
timeFrame: Change from Baseline to 6 weeks, from baseline to 4 months and to 1 year
measure: Change on Range of motion (ROM) from baseline to 6 weeks, from baseline to 4 months and to 1 year.
timeFrame: Change from Baseline to 6 weeks, from baseline to 4 months and to 1 year
measure: Change on Visual Analogue Scale of pain (VAS) from baseline to 6 weeks, from baseline to 4 months and to 1 year.
timeFrame: Change from Baseline to 6 weeksfrom baseline to 4 months and to 1 year
measure: Change in grip force from baseline to 6 weeks, from baseline to 4 months and to 1 year.
timeFrame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Other outcomes:
measure: Change in sensitivity to cold from baseline to 6 weeks, from baseline to 4 months and to 1 year.
timeFrame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
measure: Change in sick-leave status from baseline to 6 weeks, from baseline to 4 months and to 1 year.
timeFrame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
measure: Patient liability
timeFrame: Measured at 1 year from baseline
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Terese Aglen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aglen T, Matre KH, Lind C, Selles RW, Assmus J, Taule T. Hand therapy or not following collagenase treatment for Dupuytren's contracture? Protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2019 Aug 28;20(1):387. doi: 10.1186/s12891-019-2712-z.