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

Primary Purpose

Dupuytren Disease of Palm and Finger, With Contracture

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hand therapy MCPJ affected
Hand therapy PIPJ affected
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dupuytren Disease of Palm and Finger, With Contracture focused on measuring Occupational Therapy, Physical Therapy, Hand Therapy, ADL, COPM, URAM, ROM, Hand exercise, Scar, Oedema, Splint, Orthosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Hand therapy MCPJ affected

Hand therapy PIPJ affected

Control group MCPJ affected

Control group PIPJ affected

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Change in grip force from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Jamar dynamometer

Full Information

First Posted
April 10, 2018
Last Updated
September 21, 2023
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03580213
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
May 3, 2023 (Actual)
Study Completion Date
May 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand therapy MCPJ affected
Arm Type
Experimental
Arm Description
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.
Arm Title
Hand therapy PIPJ affected
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group MCPJ affected
Arm Type
No Intervention
Arm Description
40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment.
Arm Title
Control group PIPJ affected
Arm Type
No Intervention
Arm Description
40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment.
Intervention Type
Other
Intervention Name(s)
Hand therapy MCPJ affected
Intervention Description
Prevention of oedema, treatment of scar, splinting to maintain or improve extension, exercises, activity of daily living as exercise. Instructions, demonstration and advices.
Intervention Type
Other
Intervention Name(s)
Hand therapy PIPJ affected
Intervention Description
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.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM) change from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Description
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.
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
Change on Range of motion (ROM) from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Description
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
Title
Change on Visual Analogue Scale of pain (VAS) from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Description
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
Title
Change in grip force from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Description
Jamar dynamometer
Time Frame
Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Other Pre-specified Outcome Measures:
Title
Change in sensitivity to cold from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Description
yes/no
Time Frame
Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Title
Change in sick-leave status from baseline to 6 weeks, from baseline to 4 months and to 1 year.
Description
yes/no
Time Frame
Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Title
Patient liability
Description
Did the patient do as the protocol for therapy instructed? yes/no
Time Frame
Measured at 1 year from baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terese Aglen
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31455312
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.
Results Reference
derived

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

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