Hand OsteoarthritisPhase 4NCT02528630
Progressive Strength in Hand Osteoarthritis
A Phase 4 study testing Progressive resistance strength training program and Joint protection and energy conservation advice in people with Hand Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Progressive resistance strength training program and Joint protection and energy conservation advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hand Osteoarthritis
- Being tested
- Progressive resistance strength training program, Joint protection and energy conservation advice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance strength training programOther
Patients undergo to strength training for intrinsic muscles of the hand twice a week, during 12 weeks.
Joint protection and energy conservation adviceOther
A session regarding joint protection and energy conservation for hands was done before randomization.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Other: Progressive resistance strength training program; Other: Joint protection and energy conservation advice |
| Control group | Active comparator | Performed a session regarding joint protection and energy conservation Receives: Other: Joint protection and energy conservation advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Measured by a numerical pain scale
Measured: Baseline, after 6 and 12 weeks
Secondary outcomes (5)
Change in hand function
measured by AUSCAN
Measured: Baseline, after 6 and 12 weeks
Change in Patient satisfaction with treatment
Measured by a Likert scale
Measured: 6 and 12 weeks
Change in grip strength
Measured by a Grip Hydraulic Hand Dynamometer
Measured: Baseline, after 6 and 12 weeks
Change in hand function
Measured by COCHIN questionnaires
Measured: Baseline, after 6 and 12 weeks
Change in pinch stength
Measured by pinch gauge dynamometer
Measured: Baseline, after 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Nery, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528630
- Sponsor's protocol ID
- CEP UNIFESP
- Status last verified
- Feb 2017
- First submitted
- 17 Aug 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Progressive Resistance Strength Program on Hand Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02528630
- Acronym / sponsor ID
- CEP UNIFESP
- Conditions
- Hand Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Progressive resistance strength training program, Other: Joint protection and energy conservation advicePerformed a session regarding joint protection and energy conservation and a progressive resistance strength training program for intrinsic muscles of the hand for 12 weeks. |
| Control group | Active comparator | Other: Joint protection and energy conservation advicePerformed a session regarding joint protection and energy conservation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Progressive resistance strength training programPatients undergo to strength training for intrinsic muscles of the hand twice a week, during 12 weeks. | Other | Exercise group |
| Joint protection and energy conservation adviceA session regarding joint protection and energy conservation for hands was done before randomization. | Other | Control group, Exercise group |
Primary outcome
Change in Pain
Time frame: Baseline, after 6 and 12 weeks
Measured by a numerical pain scale
5 secondary outcomes
Change in hand function
Time frame: Baseline, after 6 and 12 weeks
Change in Patient satisfaction with treatment
Time frame: 6 and 12 weeks
Change in grip strength
Time frame: Baseline, after 6 and 12 weeks
Change in hand function
Time frame: Baseline, after 6 and 12 weeks
Change in pinch stength
Time frame: Baseline, after 6 and 12 weeks
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 23 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progressive resistance strength training program and Joint protection and energy conservation advice in people with Hand Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 5 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 23 Feb 2017. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Pain (time frame: Baseline, after 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.