An interventional study of Hand therapy MCPJ affected and Hand therapy PIPJ affected in Dupuytren Disease of Palm and Finger, With Contracture, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Treatment
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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.
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.
78 studies on the registry are indexed under Dupuytren Contracture; 18 are open to participants now.
This study's enrollment of 72 is close to the median of 72 across 57 interventional studies indexed under Dupuytren Contracture.
Browse Dupuytren Contracture studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
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.
Other: Hand therapy MCPJ affected
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.
Other: Hand therapy PIPJ affected
40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment.
40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment.
Prevention of oedema, treatment of scar, splinting to maintain or improve extension, exercises, activity of daily living as exercise. Instructions, demonstration and advices.
Prevention of oedema, treatment of scar, splinting to maintain or improve extension, exercises, activity of daily living as exercise. Instructions, demonstration and advices. Possible additional splint and exercises specifically for the PIPJ extension.
Canadian Occupational Performance Measure (COPM) change from baseline to 6 weeks, from baseline to 4 months and to 1 year.
An individualized, client-centred outcome measure. COPM is an evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living, over time.
Time frame: change from baseline to 6 weeks, baseline to 4 months and to 1 year.
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.
URAM, the Norwegian translation will be used. The scale evaluates the patients ability to perform 9 specific daily activities, which the patient are asked to score. The values are 6 ranges of difficulty: from no difficulties with doing the activity (score 0) to impossible to do (score 5). The possible total score ranges from 0 to 45, where 45 is the worse case.
Time frame: Change from Baseline to 6 weeks, from baseline to 4 months and to 1 year
Change on Range of motion (ROM) from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Each affected joint will be measured for movement in extension and flexion with a goniometer.
Time frame: Change from Baseline to 6 weeks, from baseline to 4 months and to 1 year
Change on Visual Analogue Scale of pain (VAS) from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Visual analogue scale of pain. The patient scores from 0-10cm how much pain they have had the last week. No pain is scored 0 and worse pain is 10.
Time frame: Change from Baseline to 6 weeksfrom baseline to 4 months and to 1 year
Change in grip force from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Jamar dynamometer
Time frame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Change in sensitivity to cold from baseline to 6 weeks, from baseline to 4 months and to 1 year.
yes/no
Time frame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Change in sick-leave status from baseline to 6 weeks, from baseline to 4 months and to 1 year.
yes/no
Time frame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Patient liability
Did the patient do as the protocol for therapy instructed? yes/no
Time frame: Measured at 1 year from baseline
Plan to share: No
Ran from Apr 2018 to primary completion in May 2023, 60 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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