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

This study has been completed.

Sponsored by: The Arthritis Research Institute of America
Information provided by: The Arthritis Research Institute of America
ClinicalTrials.gov Identifier: NCT00375947
  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

MedlinePlus related topics:   Exercise and Physical Fitness    Osteoarthritis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study
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

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
1: Experimental
Home-based hand exercise program
Other: Hand Exercise
2: Placebo Comparator
Sham hand cream
Other: sham hand cream
placebo intervention

Show detailed description  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

ARIA web site  This link exits the ClinicalTrials.gov site
 

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

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

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 21, 2008




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