NCT02528630

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

August 17, 2015

Last Update Submit

February 19, 2017

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change in Pain

    Measured by a numerical pain scale

    Baseline, after 6 and 12 weeks

Secondary Outcomes (5)

  • Change in hand function

    Baseline, after 6 and 12 weeks

  • Change in Patient satisfaction with treatment

    6 and 12 weeks

  • Change in grip strength

    Baseline, after 6 and 12 weeks

  • Change in hand function

    Baseline, after 6 and 12 weeks

  • Change in pinch stength

    Baseline, after 6 and 12 weeks

Study Arms (2)

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.

Other: Progressive resistance strength training programOther: Joint protection and energy conservation advice

Control group

ACTIVE COMPARATOR

Performed a session regarding joint protection and energy conservation

Other: Joint protection and energy conservation advice

Interventions

Progressive resistance strength training programOTHER

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

Exercise group
Joint protection and energy conservation adviceOTHER

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

Control groupExercise group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023900, Brazil

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 19, 2015

Study Start

October 1, 2013

Primary Completion

January 1, 2015

Study Completion

October 1, 2015

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

BR(1)