Dupuytren Disease of Palm and Finger, With ContractureNCT03580213
Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
A study testing Hand therapy MCPJ affected and Hand therapy PIPJ affected in people with Dupuytren Disease of Palm and Finger, With Contracture, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dupuytren Disease of Palm and Finger, With Contracture
- What is being tested?
- Hand therapy MCPJ affected and Hand therapy PIPJ affected
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- 5 Apr 2018to 3 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients treated with collagenase injection and extension procedure for Dupuytren's contracture
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Hand therapy MCPJ affected, Hand therapy PIPJ affected
- Keywords
- Occupational Therapy, Physical Therapy, Hand Therapy, ADL, COPM, URAM, ROM, Hand exercise, Scar, Oedema, Splint, Orthosis
- Medical subject headings
- Dupuytren Contracture, Cicatrix, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand therapy MCPJ affectedOther
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 affectedOther
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 group | Role | What they receive |
|---|---|---|
| Hand therapy MCPJ affected | Experimental | 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. Receives: Other: Hand therapy MCPJ affected |
| Hand therapy PIPJ affected | Experimental | 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. Receives: Other: Hand therapy PIPJ affected |
| Control group MCPJ affected | No intervention | 40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment. |
| Control group PIPJ affected | No intervention | 40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to 6 weeks, baseline to 4 months and to 1 year.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start5 Apr 2018
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dupuytren Disease of Palm and Finger, With ContractureStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terese Aglen, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580213
- Sponsor's protocol ID
- 2017/613
- Status last verified
- Mar 2022
- First submitted
- 10 Apr 2018
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31455312
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
- ClinicalTrials.gov ID
- NCT03580213
- Acronym / sponsor ID
- 2017/613
- Keywords
- Occupational Therapy, Physical Therapy, Hand Therapy, ADL, COPM, URAM, ROM, Hand exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hand therapy MCPJ affected | Experimental | Other: Hand therapy MCPJ affected40 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 PIPJ affected | Experimental | Other: Hand therapy PIPJ affected40 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. |
| Control group MCPJ affected | No intervention | –40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment. |
| Control group PIPJ affected | No intervention | –40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients treated with collagenase injection and extension procedure for Dupuytren's contracture
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand therapy MCPJ affectedPrevention 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 MCPJ affected |
| Hand therapy PIPJ affectedPrevention 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. | Other | Hand therapy PIPJ affected |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 31455312Aglen 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.
- Individual participant dataSharing planned: No
Related trials for Dupuytren Disease of Palm and Finger, With Contracture
RecruitingPhase 1/2
Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
Dupuytren Contracture, Dupuytren Disease of Finger
Recruiting
Effectiveness of Percutaneous Needle Aponeurotomy
Dupuytren Disease of Finger
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terese Aglen principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand therapy MCPJ affected and Hand therapy PIPJ affected in people with Dupuytren Disease of Palm and Finger, With Contracture, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03580213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.