Progressive Strength in Hand Osteoarthritis

NCT ID: NCT02528630

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hand Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Progressive resistance strength training program

Intervention Type OTHER

Patients undergo to strength training for intrinsic muscles of the hand twice a week, during 12 weeks.

Joint protection and energy conservation advice

Intervention Type OTHER

A session regarding joint protection and energy conservation for hands was done before randomization.

Control group

Performed a session regarding joint protection and energy conservation

Group Type ACTIVE_COMPARATOR

Joint protection and energy conservation advice

Intervention Type OTHER

A session regarding joint protection and energy conservation for hands was done before randomization.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Progressive resistance strength training program

Patients undergo to strength training for intrinsic muscles of the hand twice a week, during 12 weeks.

Intervention Type OTHER

Joint protection and energy conservation advice

A session regarding joint protection and energy conservation for hands was done before randomization.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michele Nery

Master Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEP UNIFESP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Balneotherapy in Hand Osteoarthritis
NCT06702514 NOT_YET_RECRUITING NA