Dupuytren DiseaseKOSMYNCT07907146
Kinesitherapy Plus Osteopathy After Surgery for Dupuytren Disease
A study testing Physiotherapy in people with Dupuytren Disease, run by Clinique Bizet at 1 site in France.
Trial summary
This randomized, double-blind clinical trial evaluates whether adding targeted osteopathy to physiotherapy improves recovery after open surgery for Dupuytren disease. Patients who have undergone their first open fasciectomy for Dupuytren disease will be randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Disease
- What is being tested?
- Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Ability to provide informed consent
- Adults operated for Dupuytren disease, stages 2-3, excluding PIP deformity >90°
- First open fasciectomy
- No participation in another clinical trial
- Affiliation with social security
- Acceptance of questionnaires
- Acceptance of 12-week follow-up
Who cannot join
- Minor
- Previous intervention on the same hand
- Associated hand conditions: symptomatic finger osteoarthritis, other major hand pathologies, significant neuropathies
- History of poor wound healing Diabetes
- Central or peripheral neurological diseases affecting the hand
- Protected adult under curatorship or guardianship
- Refusal to participate
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Clinique Bizet
Paris, 75116
benkessou BOUCHRA, 0764486016, b.benkessou@hexagone-sante-paris.fr
About this study
Official title: Randomized Double-Blind Trial Evaluating the Combination of Kinesitherapy and Osteopathy in the Postoperative Management of Dupuytren Disease
This randomized, double-blind clinical trial evaluates whether adding targeted osteopathy to physiotherapy improves recovery after open surgery for Dupuytren disease.
Patients who have undergone their first open fasciectomy for Dupuytren disease will be randomly assigned to one of two groups. Both groups will receive physiotherapy. One group will additionally receive a targeted osteopathy session, while the other group will receive a sham osteopathy session.
Read more
The main objective is to evaluate recovery of extension of the metacarpophalangeal joint of the operated finger. Secondary outcomes include hand function, extension of the proximal and distal interphalangeal joints, grip strength, scar vascularization, quality of life, scar adherence, and postoperative pain.
The study will include 50 adult patients. Participants will be followed for 12 weeks, with assessments at 1, 4, 8, and 12 weeks after the start of treatment.
Read the detailed description
Dupuytren disease is a chronic fibroproliferative condition of the hand characterized by progressive fibrosis of the palmar aponeurosis, which can lead to nodules, fibrous cords, digital retractions, and contractures. These deformities may impair hand function and daily activities and may affect quality of life.
For advanced stages of the disease, open fasciectomy is a surgical treatment. Although surgery generally allows recovery of finger extension, postoperative recovery may be prolonged and may be associated with persistent inflammation, scar adhesions, altered tissue gliding, and temporary reductions in mobility and strength.
The purpose of this pilot randomized controlled trial is to evaluate the potential benefit of adding osteopathy to conventional postoperative physiotherapy following open fasciectomy for Dupuytren disease. According to the study protocol, the benefits of osteopathy in this specific postoperative context have not previously been evaluated in a prospective randomized controlled trial.
After eligibility has been confirmed and informed consent has been obtained, participants will be randomly assigned to one of two groups. Both groups will receive physiotherapy as part of postoperative care. The experimental group will receive a targeted osteopathy session, while the control group will receive a sham osteopathy session. Physiotherapy and osteopathy sessions are planned to take place on the same day when possible. A gentle night extension splint will be applied on postoperative day 8 according to the usual protocol.
The primary outcome is recovery of extension of the metacarpophalangeal joint of the operated finger, assessed by goniometry at 1, 4, 8, and 12 weeks after the start of treatment.
Secondary outcomes include hand function assessed using the Unité Rhumatologique des Affections de la Main (URAM) score; extension of the proximal and distal interphalangeal joints assessed by goniometry; grip strength assessed using a hand dynamometer; scar vascularization assessed using an infrared camera (FLIR ONE Pro); hand-related quality of life assessed using the Brief Michigan Hand Outcomes Questionnaire (Brief MHQ); scar adherence assessed using an adhesiometer; and postoperative pain assessed using the Visual Analog Scale (VAS). These outcomes will be assessed at 1, 4, 8, and 12 weeks after the start of treatment.
The planned sample size is 50 participants. The planned inclusion period is 15 months, with a 3-month follow-up for each participant and a total planned study duration of 18 months.
- Conditions
- Dupuytren Disease
- Being tested
- Physiotherapy, Sham Osteopathy
- Keywords
- Dupuytren disease, Osteopathy, Physiotherapy
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
Physiotherapy
Sham OsteopathyBehavioural
Sham osteopathy
| Study group | Role | What they receive |
|---|---|---|
| Group A - Physiotherapy + Targeted Osteopathy | Experimental | Participants receive physiotherapy combined with targeted osteopathy. Receives: Behavioral: Physiotherapy |
| Group B - Physiotherapy + Sham Osteopathy | Sham comparator | Participants receive physiotherapy combined with sham osteopathy. Receives: Behavioral: Sham Osteopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCP joint extension
Goniometric measurement of metacarpophalangeal (MCP) joint extension
Measured: 1, 4, 8, and 12 weeks after treatment start
Secondary outcomes (7)
URAM score
Assessment of hand function using the Unité Rhumatologique des Affections de la Main (URAM) score.
Measured: 1, 4, 8, and 12 weeks after treatment start
PIP and DIP joint extension
Goniometric measurement of proximal and distal interphalangeal joint extension.
Measured: 1, 4, 8, and 12 weeks after treatment start
Grip strength
Measurement of grip strength using a hand dynamometer.
Measured: 1, 4, 8, and 12 weeks after treatment start
Scar vascularization
Assessment of scar vascularization using a FLIR ONE Pro infrared camera.
Measured: 1, 4, 8, and 12 weeks after treatment start
Brief Michigan Hand Questionnaire (Brief MHQ) score
Assessment of quality of life using the Brief Michigan Hand Questionnaire (Brief MHQ).
Measured: 1, 4, 8, and 12 weeks after treatment start
Scar adherence
Assessment of scar adherence using an adhesiometer.
Measured: 1, 4, 8, and 12 weeks after treatment start
Postoperative pain
Assessment of pain using a visual analog scale (VAS).
Measured: 1, 4, 8, and 12 weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion28 Sep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dupuytren DiseaseStudies of the same condition, open and under way.
- 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
- Model description
- Randomized, double-blind, two-group parallel study comparing targeted osteopathy with sham osteopathy, both combined with physiotherapy.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907146
- Sponsor's protocol ID
- HSP_Bizet_2026/01
- Other IDs
- 2026-A00258-43
- Acronym
- KOSMY
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karbowiak M, Holme T, Khan K, Mohan A. Dupuytren's disease. BMJ. 2021 Jun 4;373:n1308. doi: 10.1136/bmj.n1308. No abstract available.
PubMed 34088710Ruettermann M, Hermann RM, Khatib-Chahidi K, Werker PMN. Dupuytren's Disease-Etiology and Treatment. Dtsch Arztebl Int. 2021 Nov 19;118(46):781-788. doi: 10.3238/arztebl.m2021.0325.
PubMed 34702442
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Trial Evaluating the Combination of Kinesitherapy and Osteopathy in the Postoperative Management of Dupuytren Disease
- ClinicalTrials.gov ID
- NCT07907146
- Acronym / sponsor ID
- KOSMY / HSP_Bizet_2026/01
- Conditions
- Dupuytren Disease
- Keywords
- Dupuytren disease, Osteopathy, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Oct 2026 (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 randomized, double-blind clinical trial evaluates whether adding targeted osteopathy to physiotherapy improves recovery after open surgery for Dupuytren disease.
Patients who have undergone their first open fasciectomy for Dupuytren disease will be randomly assigned to one of two groups. Both groups will receive physiotherapy. One group will additionally receive a targeted osteopathy session, while the other group will receive a sham osteopathy session.
The main objective is to evaluate recovery of extension of the metacarpophalangeal joint of the operated finger. Secondary outcomes include hand function, extension of the proximal and distal interphalangeal joints, grip strength, scar vascularization, quality of life, scar adherence, and postoperative pain.
The study will include 50 adult patients. Participants will be followed for 12 weeks, with assessments at 1, 4, 8, and 12 weeks after the start of treatment.
Detailed description
Dupuytren disease is a chronic fibroproliferative condition of the hand characterized by progressive fibrosis of the palmar aponeurosis, which can lead to nodules, fibrous cords, digital retractions, and contractures. These deformities may impair hand function and daily activities and may affect quality of life.
For advanced stages of the disease, open fasciectomy is a surgical treatment. Although surgery generally allows recovery of finger extension, postoperative recovery may be prolonged and may be associated with persistent inflammation, scar adhesions, altered tissue gliding, and temporary reductions in mobility and strength.
The purpose of this pilot randomized controlled trial is to evaluate the potential benefit of adding osteopathy to conventional postoperative physiotherapy following open fasciectomy for Dupuytren disease. According to the study protocol, the benefits of osteopathy in this specific postoperative context have not previously been evaluated in a prospective randomized controlled trial.
After eligibility has been confirmed and informed consent has been obtained, participants will be randomly assigned to one of two groups. Both groups will receive physiotherapy as part of postoperative care. The experimental group will receive a targeted osteopathy session, while the control group will receive a sham osteopathy session. Physiotherapy and osteopathy sessions are planned to take place on the same day when possible. A gentle night extension splint will be applied on postoperative day 8 according to the usual protocol.
The primary outcome is recovery of extension of the metacarpophalangeal joint of the operated finger, assessed by goniometry at 1, 4, 8, and 12 weeks after the start of treatment.
Secondary outcomes include hand function assessed using the Unité Rhumatologique des Affections de la Main (URAM) score; extension of the proximal and distal interphalangeal joints assessed by goniometry; grip strength assessed using a hand dynamometer; scar vascularization assessed using an infrared camera (FLIR ONE Pro); hand-related quality of life assessed using the Brief Michigan Hand Outcomes Questionnaire (Brief MHQ); scar adherence assessed using an adhesiometer; and postoperative pain assessed using the Visual Analog Scale (VAS). These outcomes will be assessed at 1, 4, 8, and 12 weeks after the start of treatment.
The planned sample size is 50 participants. The planned inclusion period is 15 months, with a 3-month follow-up for each participant and a total planned study duration of 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, two-group parallel study comparing targeted osteopathy with sham osteopathy, both combined with physiotherapy.
| Arm | Type | Receives |
|---|---|---|
| Group A - Physiotherapy + Targeted Osteopathy | Experimental | Behavioral: PhysiotherapyParticipants receive physiotherapy combined with targeted osteopathy. |
| Group B - Physiotherapy + Sham Osteopathy | Sham comparator | Behavioral: Sham OsteopathyParticipants receive physiotherapy combined with sham osteopathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Ability to provide informed consent
- Adults operated for Dupuytren disease, stages 2-3, excluding PIP deformity >90°
- First open fasciectomy
- No participation in another clinical trial
Key exclusion criteria (8 listed)
- Minor
- Previous intervention on the same hand
- Associated hand conditions: symptomatic finger osteoarthritis, other major hand pathologies, significant neuropathies
- History of poor wound healing Diabetes
- Central or peripheral neurological diseases affecting the 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 |
|---|---|---|
| PhysiotherapyPhysiotherapy | Behavioural | Group A - Physiotherapy + Targeted Osteopathy |
| Sham OsteopathySham osteopathy | Behavioural | Group B - Physiotherapy + Sham Osteopathy |
Primary outcome
MCP joint extension
Time frame: 1, 4, 8, and 12 weeks after treatment start
Goniometric measurement of metacarpophalangeal (MCP) joint extension
7 secondary outcomes
URAM score
Time frame: 1, 4, 8, and 12 weeks after treatment start
PIP and DIP joint extension
Time frame: 1, 4, 8, and 12 weeks after treatment start
Grip strength
Time frame: 1, 4, 8, and 12 weeks after treatment start
Scar vascularization
Time frame: 1, 4, 8, and 12 weeks after treatment start
Brief Michigan Hand Questionnaire (Brief MHQ) score
Time frame: 1, 4, 8, and 12 weeks after treatment start
Scar adherence
Time frame: 1, 4, 8, and 12 weeks after treatment start
Postoperative pain
Time frame: 1, 4, 8, and 12 weeks after treatment start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 34088710Karbowiak M, Holme T, Khan K, Mohan A. Dupuytren's disease. BMJ. 2021 Jun 4;373:n1308. doi: 10.1136/bmj.n1308. No abstract available.
- Background: PubMed 34702442Ruettermann M, Hermann RM, Khatib-Chahidi K, Werker PMN. Dupuytren's Disease-Etiology and Treatment. Dtsch Arztebl Int. 2021 Nov 19;118(46):781-788. doi: 10.3238/arztebl.m2021.0325.
- Individual participant dataSharing planned: No
Related trials for Dupuytren Disease
Not yet recruitingPhase 3
DEPART Study at Yale
Dupuytren's Contracture
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
Recruiting
Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
Dupuytren Contracture
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
Active, not recruiting
Skin Involvement in Dupuytren Surgical Treatment Outcome
Dupuytren Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Dupuytren Disease, run by Clinique Bizet at 1 site in France.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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 France. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline LECLERCQ, Dr (0033140693525, caroline1leclercq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCP joint extension (time frame: 1, 4, 8, and 12 weeks after treatment start). 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 NCT07907146, which also lists 2 linked publications.
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 30 Oct 2026.