- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02528630
Progressive Strength in Hand Osteoarthritis
Effectiveness of a Progressive Resistance Strength Program on Hand Osteoarthritis: a Randomized Controlled Trial
Background: Hand osteoarthritis (OA) is highly prevalent, affecting 55-70% of the population over 55 years with an age-related progressive increase. The OA of interphalangeal (IF) and carpometacarpal joints may have varying degrees of deformity associated with pain, decreased of grip and pinch strength, decreased range of motion and functional impairment. Systematic reviews and meta-analyzes have shown the beneficial effect of exercise for lower limb OA, however for hand OA exercise is still used based on recommendations based on clinical experience and low quality studies, not allowing a conclusion about the effects of exercise in pain, function and strength in hand OA patients.
Objective: assess the effectiveness of progressive resistance strength training program on pain, function and strength in hand OA patients.
Methods: diagnostic of hand OA according to American College of Rheumatology of at least 1year, age over 50 years, both genders, pain in IF joints between 3-8 cm on a 10-cm numerical pain scale (NPS). Sixty patients who meet the eligibility criteria were randomized into exercise group (EG) and control group (CG). Both groups performed a session regarding joint protection and energy conservation before randomization. The EG performed a progressive resistance strength training program for intrinsic muscles of the hand for 12 weeks. The outcome measures were NPS; Australian/Canadian (AUSCAN) Hand Osteoarthritis Index and Cochin Hand Functional Scale for hand function; grip and pinch strengthening using the Hydraulic Hand Dynamometer and a pinch gauge dynamometer and satisfaction with the treatment using a Likert scale. A blinded evaluator performed the evaluations at baseline, 6 and 12 weeks after treatment baseline.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil, 04023900
- Universidade Federal de Sao Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnostic of hand OA according to american college of rheumatology of at least 1year;
- age over 50 years;
- both genders;
- pain in interphalangeal joints between 3-8 cm on a 10-cm numerical pain scale
Exclusion Criteria:
- other joint disease in hands;
- other rheumatic systemic disease;
- surgery in hands or writs;
- exercise or joint injection in hands in the previous 3 months;
- disability to perform the exercises.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
Performed a session regarding joint protection and energy conservation and a progressive resistance strength training program for intrinsic muscles of the hand for 12 weeks.
|
Patients undergo to strength training for intrinsic muscles of the hand twice a week, during 12 weeks.
A session regarding joint protection and energy conservation for hands was done before randomization.
|
|
Active Comparator: Control group
Performed a session regarding joint protection and energy conservation
|
A session regarding joint protection and energy conservation for hands was done before randomization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain
Time Frame: Baseline, after 6 and 12 weeks
|
Measured by a numerical pain scale
|
Baseline, after 6 and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in hand function
Time Frame: Baseline, after 6 and 12 weeks
|
measured by AUSCAN
|
Baseline, after 6 and 12 weeks
|
|
Change in Patient satisfaction with treatment
Time Frame: 6 and 12 weeks
|
Measured by a Likert scale
|
6 and 12 weeks
|
|
Change in grip strength
Time Frame: Baseline, after 6 and 12 weeks
|
Measured by a Grip Hydraulic Hand Dynamometer
|
Baseline, after 6 and 12 weeks
|
|
Change in hand function
Time Frame: Baseline, after 6 and 12 weeks
|
Measured by COCHIN questionnaires
|
Baseline, after 6 and 12 weeks
|
|
Change in pinch stength
Time Frame: Baseline, after 6 and 12 weeks
|
Measured by pinch gauge dynamometer
|
Baseline, after 6 and 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP UNIFESP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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