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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02528630
Other study ID # CEP UNIFESP
Secondary ID
Status Completed
Phase Phase 4
First received August 17, 2015
Last updated February 19, 2017
Start date October 2013
Est. completion date October 2015

Study information

Verified date February 2017
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Progressive resistance strength training program
Patients undergo to strength training for intrinsic muscles of the hand twice a week, during 12 weeks.
Joint protection and energy conservation advice
A session regarding joint protection and energy conservation for hands was done before randomization.

Locations

Country Name City State
Brazil Universidade Federal de Sao Paulo Sao Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Pain Measured by a numerical pain scale Baseline, after 6 and 12 weeks
Secondary Change in hand function measured by AUSCAN Baseline, after 6 and 12 weeks
Secondary Change in Patient satisfaction with treatment Measured by a Likert scale 6 and 12 weeks
Secondary Change in grip strength Measured by a Grip Hydraulic Hand Dynamometer Baseline, after 6 and 12 weeks
Secondary Change in hand function Measured by COCHIN questionnaires Baseline, after 6 and 12 weeks
Secondary Change in pinch stength Measured by pinch gauge dynamometer Baseline, after 6 and 12 weeks
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