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Study of Effectiveness of Hand Exercises to Treat Symptoms of Hand Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
The Arthritis Research Institute of America
ClinicalTrials.gov Identifier:
NCT00375947
First received: September 11, 2006
Last updated: August 22, 2007
Last verified: August 2007
History of Changes
  Purpose

Participants in this study will do hand exercises once per day for 16 weeks. The purpose of the study is to determine if hand exercises designed to improve range of movement and strength are an effective way to decrease functional limitations for people with hand osteoarthritis. The study will also attempt to determine if pain and stiffness are improved, and if hand strength and dexterity are improved.


Condition Intervention
Osteoarthritis
 Other: Hand Exercise
Other: sham hand cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Efficacy of a Home-Based Hand Range-of-Motion and Strength Training Exercise Program for Improvement of Hand Function in Older Adults With Hand Osteoarthritis: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Arthritis Research Institute of America:

Primary Outcome Measures:
  • Australian-Canadian Osteoarthritis Index (AUSCAN)hand disability score at 16 weeks of exercise

Secondary Outcome Measures:
  • AUSCAN hand pain score at 16 weeks of exercise
  • AUSCAN hand stiffness score at 16 weeks of exercise
  • Maximal and average grip strength at 16 weeks of exercise
  • Maximal and average key pinch strength at 16 weeks of exercise
  • Maximal and average 3-point pinch strength at 16 weeks of exercise
  • Purdue Peg Board dexterity scores at 16 weeks of exercise

Estimated Enrollment: 65
Study Start Date: November 2005
Study Completion Date: April 2007
Arms Assigned Interventions
Experimental: 1
Home-based hand exercise program
 Other: Hand Exercise
Placebo Comparator: 2
Sham hand cream
 Other: sham hand cream
placebo intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women
  • Ages 50 years and older
  • Reside within Tampa Bay Region, Florida
  • Presence of symptomatic OA as determined by the AUSCAN Index. Specifically, a hand function score of > 225 mm for the AUSCAN VA-subscale
  • Presence of radiographic hand OA, as defined by grades 2, or higher, per the Kellgren and Lawrence scale in one or more joints.

Exclusion Criteria:

  • Concomitant rheumatic disease (e.g., rheumatoid arthritis, gout, lupus, fibromyalgia)
  • Current hand or wrist injury (e.g., carpal tunnel syndrome, palmer tenosynovitis, fracture, sprain)
  • Use of an assistive device such as a cane or crutch
  • Has hand surgery scheduled within the 48 weeks following the start of the study
  • Prior hand surgery requiring joint replacement or other instrumentation in the hands
  • Received any intra-articular injection (hyaluronic acid, corticosteroid, or joint lavage) during the 3 months preceding the study
  • Currently participating in another conflicting research study
  • Currently using a therapeutic hand cream or practicing a hand exercise routine
  • Unwilling to sign an informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375947

Locations
United States, Florida
The Arthritis Research Institute of America
Clearwater, Florida, United States, 33755
Sponsors and Collaborators
The Arthritis Research Institute of America
Investigators
Principal Investigator: Matthew W Rogers, MS The Arthritis Research Institute of America
Study Director: Frances V Wilder, PhD The Arthritis Research Institute of America
  More Information

Additional Information:
ARIA web site  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00375947     History of Changes
Other Study ID Numbers: ARIA-0001
Study First Received: September 11, 2006
Last Updated: August 22, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by The Arthritis Research Institute of America:
exercise
hand disability
arthritis
AUSCAN

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013