Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
NCT ID: NCT03580213
Last Updated: 2023-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2018-04-05
2023-05-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Hand therapy MCPJ affected
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.
Hand therapy MCPJ affected
Prevention of oedema, treatment of scar, splinting to maintain or improve extension, exercises, activity of daily living as exercise. Instructions, demonstration and advices.
Hand therapy PIPJ 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.
Hand therapy PIPJ affected
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.
Control group MCPJ affected
40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected.
No treatment after the collagenase injection and extension treatment.
No interventions assigned to this group
Control group PIPJ affected
40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected.
No treatment after the collagenase injection and extension treatment.
No interventions assigned to this group
Interventions
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Hand therapy MCPJ affected
Prevention of oedema, treatment of scar, splinting to maintain or improve extension, exercises, activity of daily living as exercise. Instructions, demonstration and advices.
Hand therapy PIPJ affected
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Terese Aglen
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Locations
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Haukeland University Hospital
Bergen, , Norway
Countries
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References
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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.
Other Identifiers
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2017/613
Identifier Type: -
Identifier Source: org_study_id
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