Dupuytren ContractureNCT03982719
Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols in Patients With Dupuytren's Disease
A study testing Brief protocol and Intense protocol in people with Dupuytren Contracture, run by Véronique Flamand at 1 site in Canada.
Trial summary
Dupuytren's disease can cause physical impairments that lead to reduced functional performance in personal care, work-related and leisure activities. The prevalence of Dupuytren's disease increases with age. A meta-analysis completed in 2014 by Lanting and al. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Dupuytren Contracture
- What is being tested?
- Brief protocol and Intense protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2019to Dec 2020
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To present Dupuytren's contracture to one or two digits of the same hand and at an important stage of Dupuytren's Disease before the surgery (PIP contracture of 45 degrees or more)
- Having had a fasciectomy to treat Dupuytren's Disease with per-op PIP contracture of 30 degrees or less.
Who cannot join
- Recurrence of Dupuytren's Disease
- To have or have had a complex regional pain syndrome
- To present a health condition that could affect cognitive functions (dementia, neuro-cognitive disorders)
- To have a diagnosis of diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols Differing in Intensity and Implementation of Modalities in Patients With Dupuytren's Disease
Dupuytren's disease can cause physical impairments that lead to reduced functional performance in personal care, work-related and leisure activities. The prevalence of Dupuytren's disease increases with age. A meta-analysis completed in 2014 by Lanting and al. estimated the its prevalence in western countries at 12% among people aged 55 years and over and at 29% among individuals aged 75 and over. The fasciectomy is the most current surgical procedure to reduce the flexion contracture occurring in this disease. Studies confirm the relevance of post-operative rehabilitation after fasciectomy. This rehabilitation is usually conducted by hand therapists who are mostly occupational therapists. However, the required duration and frequency of interventions and exercises for the post-op rehabilitation are not clearly described in the literature. In fact, the guidelines that are currently available recommend a total duration between 16 and 75 hours, which is highly variable. Also, the need to include supervised exercises by the occupational therapist is not specified. The main goal of this study is to compare two post-fasciectomy rehabilitation protocols to determine the influence of protocols intensity on motor and functional outcomes in people with Dupuytren's disease. The hypothesis is that the protocol involving a higher intensity will lead to better motor and functional improvements. The secondary goal of this study is to explore the link between the total time that the person has done the recommended exercises (combination of supervised exercises and the home program) and motor/functional recovery. The hypothesis is that the relationship between the amount of time and the motor/functional improvements will not be linear, but will either be logarithmic toward a plateau of recovery.
A randomized controlled trial will be realized. 40 participants will be randomly assigned to one of the two rehabilitation protocols. Each participant will be evaluated at four times (initial evaluation, final evaluation and 2 follow-up evaluations). Data on motor and functional recovery will be collected.
Read the detailed description
Dupuytren's disease can cause physical impairments that lead to reduced functional performance in personal care, work-related and leisure activities. The prevalence of Dupuytren's disease increases with age. A meta-analysis completed in 2014 by Lanting and al. estimated the its prevalence in western countries at 12% among people aged 55 years and over and at 29% among individuals aged 75 and over. The fasciectomy is the most current surgical procedure to reduce the flexion contracture occurring in this disease. Studies confirm the relevance of post-operative rehabilitation after fasciectomy. This rehabilitation is usually conducted by hand therapists who are mostly occupational therapists. However, the required duration and frequency of interventions and exercises for the post-op rehabilitation are not clearly described in the literature. In fact, the guidelines that are currently available recommend a total duration between 16 and 75 hours, which is highly variable. Also, the need to include supervised exercises by the occupational therapist is not specified. The main goal of this study is to compare two post-fasciectomy rehabilitation protocols to determine the influence of protocols intensity on motor and functional outcomes in people with Dupuytren's disease. The hypothesis is that the protocol involving a higher intensity will lead to better motor and functional improvements. The secondary goal of this study is to explore the link between the total time that the person has done the recommended exercises (combination of supervised exercises and the home program) and motor/functional recovery. The hypothesis is that the relationship between the amount of time and the motor/functional improvements will not be linear, but will either be logarithmic towards a plateau of recovery.
A randomized controlled trial will be realized. 40 participants will be randomly assigned to one of the two rehabilitation protocols. Each participant will be evaluated at four times (initial evaluation, final evaluation and 2 follow-up evaluations). The independent variable of this study is the intensity of the rehabilitation protocol (BRIEF or INTENSE). The primary dependent variable is the functional abilities to perform activities of daily living. The secondary dependent variables are the following : digits range of motion, pain, grip and pinch strengths, as well as tactile sensibility.
The BRIEF PROTOCOL consists of 4 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 4 weeks and 8 weeks post-fasciectomy. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. Finally, an extension splint that must be worn at night until the third month after surgery will be made at the first session. The INTENSE PROTOCOL consists of 6 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks after surgery. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. An extension splint that must be worn at night until the third month after surgery will be made at the first session. Also, exercises will be performed by the patient under the supervision of the occupational therapist (supervised exercises) in each session except the first one at 0-3 days after surgery.
Statistical analyses will take into account the moderate size of our sample (n=40) and the independence of the two groups. Descriptive statistics and Shapiro-Wilk test will be used to evaluate if variables follow the normal distribution. If the normal distribution is confirmed, repeated measure ANOVA will be used to compare the 2 groups. If not, Mann-Whitney test will be used (non-parametric test). Pearson correlation coefficient (parametric) or Spearman correlation coefficient (non-parametric) will be used to analyze the relationships between variables (secondary aim of the study).
- Conditions
- Dupuytren Contracture
- Being tested
- Brief protocol, Intense protocol
- Keywords
- Dupuytren's disease, rehabilitation, fasciectomy, hand therapy
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief protocolOther
This protocol consists of 4 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 4 weeks and 8 weeks post-fasciectomy. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. The occupational therapist will make an extension splint that should be worn at night for the 3 months following surgery.
Intense protocolOther
This protocol consists of 6 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks after surgery. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. The occupational therapist will make an extension splint that should be worn at night for the 3 months following surgery. Also, exercises will be performed by the patient under the supervision of the occupational therapist (supervised exercises) in each session except the first one at 0-3 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Brief protocol | Experimental | 4 intervention sessions with the occupational therapist of 30 minutes duration. Receives: Other: Brief protocol |
| Intense Protocol | Active comparator | 6 intervention sessions with the occupational therapist of 60 minutes duration. Receives: Other: Intense protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from first evaluation on the Michigan Hand Questionnaire at 2, 3 and 6 months
Patient-reported questionnaire that evaluates function and quality of life in patients with hand disorders. There are 37 items divided into 6 subscales (1)overall hand function, (2)activities of daily living, (3)pain, (4)work performance, (5)aesthetics and (6)patient's satisfaction with hand function). (Total score between 0-100, rating scale from 1 to 5)
Measured: 0-3 days, 2 months, 3 months and 6 months after surgery
Change from first evaluation on the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure at 2, 3 and 6 months
Patient-reported questionnaire that evaluates 11 items on symptoms and functional impairments related to musculoskeletal disorders of the upper limb. (Total score between 0-100, rating scale from 1 to 5)
Measured: 0-3 days, 2 months, 3 months and 6 months after surgery
Change from first evaluation on the Sollerman Test at 2, 3 and 6 months
A standardized hand function assessment based on seven of the eight most common hand grips that consists of 20 activities of daily living. (Total score between 0-80, rating scale 0 to 4).
Measured: 2 months and 6 months after surgery
Secondary outcomes (5)
Range of motion assessed by Rolyan digital goniometer
Range of motion of the affected digits assessed by Rolyan digital goniometer (data scope -30° to 120°, accuracy of 2°)
Measured: 0-3 days, 2 months, 3 months and 6 months after surgery
Pain measured using the Visual Analogue Scale
Responders specify their level of pain by indicating a position along a continuous line between two end-points. One end (corresponding to score 0) represents the absence of pain, and the other end (corresponding to score 100) represents the worst pain that the person can imagine. (Thus the minimum score is 0, and the maximum score is 100. There are no sub-scales. 0 represents the absence of pain, and higher values represent more pain.)
Measured: 0-3 days, 2 months, 3 months and 6 months after surgery
Grip strength
JAMAR dynamometer (data scope 0-80 kg, accuracy of 2 kg)
Measured: 2 months, 3 months and 6 months after surgery
Pinch strength
B\&L pinch gauge (data scope 0-30 pounds, accuracy of 1 pound)
Measured: 2 months, 3 months and 6 months after surgery
Tactile sensibility
Semmes-Weinstein monofilaments
Measured: 2 months, 3 months and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study startJun 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Dupuytren ContractureStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Véronique Flamand
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale
- Responsible party
- Sponsor-investigator, Véronique Flamand, Laval University
- Investigators
- Veronique Flamand, PhD, Principal investigator, Center for Interdisciplinary Research in Rehabilitation and Social Integration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982719
- Sponsor's protocol ID
- Dupuytren2019-4462
- Status last verified
- Jun 2019
- First submitted
- 7 Jun 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ball C, Pratt AL, Nanchahal J. Optimal functional outcome measures for assessing treatment for Dupuytren's disease: a systematic review and recommendations for future practice. BMC Musculoskelet Disord. 2013 Apr 10;14:131. doi: 10.1186/1471-2474-14-131.
PubMed 23575442Bayat A, McGrouther DA. Management of Dupuytren's disease--clear advice for an elusive condition. Ann R Coll Surg Engl. 2006 Jan;88(1):3-8. doi: 10.1308/003588406X83104.
PubMed 16460628Bell-Krotoski JA, Fess EE, Figarola JH, Hiltz D. Threshold detection and Semmes-Weinstein monofilaments. J Hand Ther. 1995 Apr-Jun;8(2):155-62. doi: 10.1016/s0894-1130(12)80314-0.
PubMed 7550627Budd HR, Larson D, Chojnowski A, Shepstone L. The QuickDASH score: a patient-reported outcome measure for Dupuytren's surgery. J Hand Ther. 2011 Jan-Mar;24(1):15-20; quiz 21. doi: 10.1016/j.jht.2010.08.006. Epub 2010 Nov 24.
PubMed 21106346Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011 May;36(5):936-42. doi: 10.1016/j.jhsa.2011.03.002.
PubMed 21527148Efanov JI, Shine JJ, Darwich R, Besner Morin C, Arsenault J, Harris PG, Danino AM, Izadpanah A. French translation and cross-cultural adaptation of the Michigan Hand Outcomes Questionnaire and the Brief Michigan Hand Outcomes Questionnaire. Hand Surg Rehabil. 2018 Apr;37(2):86-90. doi: 10.1016/j.hansur.2017.12.003. Epub 2018 Jan 17.
PubMed 29373241Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PubMed 4139420Huisstede BMA, Hoogvliet P, Coert JH, Friden J; European HANDGUIDE Group. Dupuytren disease: European hand surgeons, hand therapists, and physical medicine and rehabilitation physicians agree on a multidisciplinary treatment guideline: results from the HANDGUIDE study. Plast Reconstr Surg. 2013 Dec;132(6):964e-976e. doi: 10.1097/01.prs.0000434410.40217.23.
PubMed 24281643Lanting R, Broekstra DC, Werker PMN, van den Heuvel ER. A systematic review and meta-analysis on the prevalence of Dupuytren disease in the general population of Western countries. Plast Reconstr Surg. 2014 Mar;133(3):593-603. doi: 10.1097/01.prs.0000438455.37604.0f.
PubMed 24263394Lewis E, Fors L, Tharion WJ. Interrater and intrarater reliability of finger goniometric measurements. Am J Occup Ther. 2010 Jul-Aug;64(4):555-61. doi: 10.5014/ajot.2010.09028.
PubMed 20825126Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.
PubMed 6715829Melchior H, Vatine JJ, Weiss PL. Is there a relationship between light touch-pressure sensation and functional hand ability? Disabil Rehabil. 2007 Apr 15;29(7):567-75. doi: 10.1080/09638280600902547.
PubMed 17453977Sollerman C, Ejeskar A. Sollerman hand function test. A standardised method and its use in tetraplegic patients. Scand J Plast Reconstr Surg Hand Surg. 1995 Jun;29(2):167-76. doi: 10.3109/02844319509034334.
PubMed 7569815Sweet S, Blackmore S. Surgical and therapy update on the management of Dupuytren's disease. J Hand Ther. 2014 Apr-Jun;27(2):77-83; quiz 84. doi: 10.1016/j.jht.2013.10.006. Epub 2013 Nov 5.
PubMed 24388681Wilburn J, McKenna SP, Perry-Hinsley D, Bayat A. The impact of Dupuytren disease on patient activity and quality of life. J Hand Surg Am. 2013 Jun;38(6):1209-14. doi: 10.1016/j.jhsa.2013.03.036.
PubMed 23707018
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols Differing in Intensity and Implementation of Modalities in Patients With Dupuytren's Disease
- ClinicalTrials.gov ID
- NCT03982719
- Acronym / sponsor ID
- Dupuytren2019-4462
- Conditions
- Dupuytren Contracture
- Keywords
- Dupuytren's disease, rehabilitation, fasciectomy, hand therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Véronique FlamandUniversity, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 11 Jun 2019 (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.
Dupuytren's disease can cause physical impairments that lead to reduced functional performance in personal care, work-related and leisure activities. The prevalence of Dupuytren's disease increases with age. A meta-analysis completed in 2014 by Lanting and al. estimated the its prevalence in western countries at 12% among people aged 55 years and over and at 29% among individuals aged 75 and over. The fasciectomy is the most current surgical procedure to reduce the flexion contracture occurring in this disease. Studies confirm the relevance of post-operative rehabilitation after fasciectomy. This rehabilitation is usually conducted by hand therapists who are mostly occupational therapists. However, the required duration and frequency of interventions and exercises for the post-op rehabilitation are not clearly described in the literature. In fact, the guidelines that are currently available recommend a total duration between 16 and 75 hours, which is highly variable. Also, the need to include supervised exercises by the occupational therapist is not specified. The main goal of this study is to compare two post-fasciectomy rehabilitation protocols to determine the influence of protocols intensity on motor and functional outcomes in people with Dupuytren's disease. The hypothesis is that the protocol involving a higher intensity will lead to better motor and functional improvements. The secondary goal of this study is to explore the link between the total time that the person has done the recommended exercises (combination of supervised exercises and the home program) and motor/functional recovery. The hypothesis is that the relationship between the amount of time and the motor/functional improvements will not be linear, but will either be logarithmic toward a plateau of recovery.
A randomized controlled trial will be realized. 40 participants will be randomly assigned to one of the two rehabilitation protocols. Each participant will be evaluated at four times (initial evaluation, final evaluation and 2 follow-up evaluations). Data on motor and functional recovery will be collected.
Detailed description
Dupuytren's disease can cause physical impairments that lead to reduced functional performance in personal care, work-related and leisure activities. The prevalence of Dupuytren's disease increases with age. A meta-analysis completed in 2014 by Lanting and al. estimated the its prevalence in western countries at 12% among people aged 55 years and over and at 29% among individuals aged 75 and over. The fasciectomy is the most current surgical procedure to reduce the flexion contracture occurring in this disease. Studies confirm the relevance of post-operative rehabilitation after fasciectomy. This rehabilitation is usually conducted by hand therapists who are mostly occupational therapists. However, the required duration and frequency of interventions and exercises for the post-op rehabilitation are not clearly described in the literature. In fact, the guidelines that are currently available recommend a total duration between 16 and 75 hours, which is highly variable. Also, the need to include supervised exercises by the occupational therapist is not specified. The main goal of this study is to compare two post-fasciectomy rehabilitation protocols to determine the influence of protocols intensity on motor and functional outcomes in people with Dupuytren's disease. The hypothesis is that the protocol involving a higher intensity will lead to better motor and functional improvements. The secondary goal of this study is to explore the link between the total time that the person has done the recommended exercises (combination of supervised exercises and the home program) and motor/functional recovery. The hypothesis is that the relationship between the amount of time and the motor/functional improvements will not be linear, but will either be logarithmic towards a plateau of recovery.
A randomized controlled trial will be realized. 40 participants will be randomly assigned to one of the two rehabilitation protocols. Each participant will be evaluated at four times (initial evaluation, final evaluation and 2 follow-up evaluations). The independent variable of this study is the intensity of the rehabilitation protocol (BRIEF or INTENSE). The primary dependent variable is the functional abilities to perform activities of daily living. The secondary dependent variables are the following : digits range of motion, pain, grip and pinch strengths, as well as tactile sensibility.
The BRIEF PROTOCOL consists of 4 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 4 weeks and 8 weeks post-fasciectomy. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. Finally, an extension splint that must be worn at night until the third month after surgery will be made at the first session. The INTENSE PROTOCOL consists of 6 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks after surgery. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. An extension splint that must be worn at night until the third month after surgery will be made at the first session. Also, exercises will be performed by the patient under the supervision of the occupational therapist (supervised exercises) in each session except the first one at 0-3 days after surgery.
Statistical analyses will take into account the moderate size of our sample (n=40) and the independence of the two groups. Descriptive statistics and Shapiro-Wilk test will be used to evaluate if variables follow the normal distribution. If the normal distribution is confirmed, repeated measure ANOVA will be used to compare the 2 groups. If not, Mann-Whitney test will be used (non-parametric test). Pearson correlation coefficient (parametric) or Spearman correlation coefficient (non-parametric) will be used to analyze the relationships between variables (secondary aim of the study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief protocol | Experimental | Other: Brief protocol4 intervention sessions with the occupational therapist of 30 minutes duration. |
| Intense Protocol | Active comparator | Other: Intense protocol6 intervention sessions with the occupational therapist of 60 minutes duration. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To present Dupuytren's contracture to one or two digits of the same hand and at an important stage of Dupuytren's Disease before the surgery (PIP contracture of 45 degrees or more)
- Having had a fasciectomy to treat Dupuytren's Disease with per-op PIP contracture of 30 degrees or less.
Key exclusion criteria (4 listed)
- Recurrence of Dupuytren's Disease
- To have or have had a complex regional pain syndrome
- To present a health condition that could affect cognitive functions (dementia, neuro-cognitive disorders)
- To have a diagnosis of diabetes
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 |
|---|---|---|
| Brief protocolThis protocol consists of 4 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 4 weeks and 8 weeks post-fasciectomy. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. The occupational therapist will make an extension splint that should be worn at night for the 3 months following surgery. | Other | Brief protocol |
| Intense protocolThis protocol consists of 6 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks after surgery. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. The occupational therapist will make an extension splint that should be worn at night for the 3 months following surgery. Also, exercises will be performed by the patient under the supervision of the occupational therapist (supervised exercises) in each session except the first one at 0-3 days after surgery. | Other | Intense Protocol |
Primary outcome
Change from first evaluation on the Michigan Hand Questionnaire at 2, 3 and 6 months
Time frame: 0-3 days, 2 months, 3 months and 6 months after surgery
Patient-reported questionnaire that evaluates function and quality of life in patients with hand disorders. There are 37 items divided into 6 subscales (1)overall hand function, (2)activities of daily living, (3)pain, (4)work performance, (5)aesthetics and (6)patient's satisfaction with hand function). (Total score between 0-100, rating scale from 1 to 5)
Change from first evaluation on the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure at 2, 3 and 6 months
Time frame: 0-3 days, 2 months, 3 months and 6 months after surgery
Patient-reported questionnaire that evaluates 11 items on symptoms and functional impairments related to musculoskeletal disorders of the upper limb. (Total score between 0-100, rating scale from 1 to 5)
Change from first evaluation on the Sollerman Test at 2, 3 and 6 months
Time frame: 2 months and 6 months after surgery
A standardized hand function assessment based on seven of the eight most common hand grips that consists of 20 activities of daily living. (Total score between 0-80, rating scale 0 to 4).
5 secondary outcomes
Range of motion assessed by Rolyan digital goniometer
Time frame: 0-3 days, 2 months, 3 months and 6 months after surgery
Pain measured using the Visual Analogue Scale
Time frame: 0-3 days, 2 months, 3 months and 6 months after surgery
Grip strength
Time frame: 2 months, 3 months and 6 months after surgery
Pinch strength
Time frame: 2 months, 3 months and 6 months after surgery
Tactile sensibility
Time frame: 2 months, 3 months and 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Background: PubMed 23575442Ball C, Pratt AL, Nanchahal J. Optimal functional outcome measures for assessing treatment for Dupuytren's disease: a systematic review and recommendations for future practice. BMC Musculoskelet Disord. 2013 Apr 10;14:131. doi: 10.1186/1471-2474-14-131.
- Background: PubMed 16460628Bayat A, McGrouther DA. Management of Dupuytren's disease--clear advice for an elusive condition. Ann R Coll Surg Engl. 2006 Jan;88(1):3-8. doi: 10.1308/003588406X83104.
- Background: PubMed 7550627Bell-Krotoski JA, Fess EE, Figarola JH, Hiltz D. Threshold detection and Semmes-Weinstein monofilaments. J Hand Ther. 1995 Apr-Jun;8(2):155-62. doi: 10.1016/s0894-1130(12)80314-0.
- Background: PubMed 21106346Budd HR, Larson D, Chojnowski A, Shepstone L. The QuickDASH score: a patient-reported outcome measure for Dupuytren's surgery. J Hand Ther. 2011 Jan-Mar;24(1):15-20; quiz 21. doi: 10.1016/j.jht.2010.08.006. Epub 2010 Nov 24.
- Background: PubMed 21527148Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011 May;36(5):936-42. doi: 10.1016/j.jhsa.2011.03.002.
- Background: PubMed 29373241Efanov JI, Shine JJ, Darwich R, Besner Morin C, Arsenault J, Harris PG, Danino AM, Izadpanah A. French translation and cross-cultural adaptation of the Michigan Hand Outcomes Questionnaire and the Brief Michigan Hand Outcomes Questionnaire. Hand Surg Rehabil. 2018 Apr;37(2):86-90. doi: 10.1016/j.hansur.2017.12.003. Epub 2018 Jan 17.
- Background: PubMed 4139420Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- Background: PubMed 24281643Huisstede BMA, Hoogvliet P, Coert JH, Friden J; European HANDGUIDE Group. Dupuytren disease: European hand surgeons, hand therapists, and physical medicine and rehabilitation physicians agree on a multidisciplinary treatment guideline: results from the HANDGUIDE study. Plast Reconstr Surg. 2013 Dec;132(6):964e-976e. doi: 10.1097/01.prs.0000434410.40217.23.
- Background: PubMed 24263394Lanting R, Broekstra DC, Werker PMN, van den Heuvel ER. A systematic review and meta-analysis on the prevalence of Dupuytren disease in the general population of Western countries. Plast Reconstr Surg. 2014 Mar;133(3):593-603. doi: 10.1097/01.prs.0000438455.37604.0f.
- Background: PubMed 20825126Lewis E, Fors L, Tharion WJ. Interrater and intrarater reliability of finger goniometric measurements. Am J Occup Ther. 2010 Jul-Aug;64(4):555-61. doi: 10.5014/ajot.2010.09028.
- Background: PubMed 6715829Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.
- Background: PubMed 17453977Melchior H, Vatine JJ, Weiss PL. Is there a relationship between light touch-pressure sensation and functional hand ability? Disabil Rehabil. 2007 Apr 15;29(7):567-75. doi: 10.1080/09638280600902547.
- Individual participant dataSharing planned: No
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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
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.
Veronique Flamand, PhD principal investigator
Center for Interdisciplinary Research in Rehabilitation and Social Integration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief protocol and Intense protocol in people with Dupuytren Contracture, run by Véronique Flamand at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Jun 2019. 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 Canada. 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?
Results are not available in the source record.
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?
Change from first evaluation on the Michigan Hand Questionnaire at 2, 3 and 6 months (time frame: 0-3 days, 2 months, 3 months and 6 months after surgery). The study lists 3 primary outcomes in all. 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 NCT03982719, which also lists 15 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 13 Jun 2019.