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

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ClinicalTrials.gov Identifier: NCT03580213
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

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.

Condition or disease Intervention/treatment Phase
Dupuytren Disease of Palm and Finger, With Contracture Other: Hand therapy MCPJ affected Other: Hand therapy PIPJ affected Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : April 3, 2021
Estimated Study Completion Date : April 3, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Other: 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.

Experimental: 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.

Other: 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.

No Intervention: 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 Intervention: 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.




Primary Outcome Measures :
  1. Canadian Occupational Performance Measure (COPM) change from baseline to 6 weeks, from baseline to 4 months and to 1 year. [ Time Frame: change from baseline to 6 weeks, 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.


Secondary Outcome Measures :
  1. 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. [ Time Frame: Change 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.

  2. Change on Range of motion (ROM) from baseline to 6 weeks, from baseline to 4 months and to 1 year. [ Time Frame: Change 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.

  3. Change on Visual Analogue Scale of pain (VAS) from baseline to 6 weeks, from baseline to 4 months and to 1 year. [ Time Frame: Change from Baseline to 6 weeksfrom 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.

  4. Change in grip force from baseline to 6 weeks, from baseline to 4 months and to 1 year. [ Time Frame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year ]
    Jamar dynamometer


Other Outcome Measures:
  1. Change in sensitivity to cold from baseline to 6 weeks, from baseline to 4 months and to 1 year. [ Time Frame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year ]
    yes/no

  2. Change in sick-leave status from baseline to 6 weeks, from baseline to 4 months and to 1 year. [ Time Frame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year ]
    yes/no

  3. Patient liability [ Time Frame: Measured at 1 year from baseline ]
    Did the patient do as the protocol for therapy instructed? yes/no



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580213


Contacts
Contact: Terese Aglen +47 55975460 terese.aglen@helse-bergen.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Terese Aglen Haukeland University Hospital

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03580213     History of Changes
Other Study ID Numbers: 2017/613
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haukeland University Hospital:
Occupational Therapy
Physical Therapy
Hand Therapy
ADL
COPM
URAM
ROM
Hand exercise
Scar
Oedema
Splint
Orthosis

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases