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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

Tracking Information
First Submitted Date  ICMJE April 10, 2018
First Posted Date  ICMJE July 9, 2018
Last Update Posted Date July 9, 2018
Actual Study Start Date  ICMJE April 5, 2018
Estimated Primary Completion Date April 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 6, 2018)
  • 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
  • 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
  • Patient liability [ Time Frame: Measured at 1 year from baseline ]
    Did the patient do as the protocol for therapy instructed? yes/no
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
Official Title  ICMJE Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dupuytren Disease of Palm and Finger, With Contracture
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Hand therapy MCPJ affected
  • 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.

    Intervention: Other: Hand therapy PIPJ affected
  • 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2018)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 3, 2024
Estimated Primary Completion Date April 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Terese Aglen +47 55975460 terese.aglen@helse-bergen.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03580213
Other Study ID Numbers  ICMJE 2017/613
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Terese Aglen Haukeland University Hospital
PRS Account Haukeland University Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP