NCT00375947

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 23, 2007

Status Verified

August 1, 2007

First QC Date

September 11, 2006

Last Update Submit

August 22, 2007

Conditions

Keywords

exercisehand disabilityarthritisAUSCAN

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Home-based hand exercise program

Other: Hand Exercise

2

PLACEBO COMPARATOR

Sham hand cream

Other: sham hand cream

Interventions

placebo intervention

2

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Arthritis Research Institute of America

Clearwater, Florida, 33755, United States

Location

Related Links

MeSH Terms

Conditions

OsteoarthritisMotor ActivityArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Matthew W Rogers, MS

    The Arthritis Research Institute of America

    PRINCIPAL INVESTIGATOR
  • Frances V Wilder, PhD

    The Arthritis Research Institute of America

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 13, 2006

Study Start

November 1, 2005

Study Completion

April 1, 2007

Last Updated

August 23, 2007

Record last verified: 2007-08

Locations