The Hand Osteoarthritis Exercise Trial

Hand Osteoarthritis Clinical Trial

Official title:

Osteoarthritis Care in Primary Health: Hand Exercises and Telephone Counselling for Hand OA - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245842
• Other study ID #: 100286_1
• Status: Completed
• Phase: N/A
• First received: November 19, 2010
• Last updated: October 27, 2013
• Start date: January 2011
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: The National Committees for Research Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of a hand exercise intervention on function and osteoarthritis symptoms in persons with hand osteoarthritis .

Description:

Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population. The disease may have large influences on an individual's function, health related quality of life and participation in the society. In recently published clinical guidelines for management, non-pharmacological approaches are considered as core treatments.

Several studies have demonstrated that exercise may reduce pain and improve function in persons with knee OA, and a similar effect is suggested for hip OA. Regarding effect of exercises in hand OA, available research results are limited, and randomised controlled trials (RCT) of good quality are needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• The American College of Rheumatology (ACR) classification criteria for clinical hand osteoarthritis

• FIHOA = 5 at pre-baseline

• The persons must have a telephone

Exclusion Criteria:

• Persons with cognitive dysfunction

• Persons who do not understand Norwegian language

• Persons with inflammatory rheumatic diseases (e.g. rheumatoid arthritis, ankylosing spondylitis) or cancer

• Persons that have recently experienced severe trauma

• Persons that have recently gone through OA surgery or other major surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

Other:
• Hand exercise program
Hand exercise program three times/week for 12 weeks. In total four group sessions, otherwise home based. Weekly telephone calls from experienced physiotherapist/occupational therapist addressing adjustments of the exercise program and encouragement of program adherence.

Locations

Country	Name	City	State
Norway	Physiotherapy and Occupational Therapy Service Centre	Ullensaker Municipality	Jessheim

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The functional index for hand osteoarthritis (FIHOA)		6 months	No
Primary	Patient specific function scale (PSFS)		6 months	No
Secondary	Hand joint pain (Numeric rating scale, 0-10)		6 months	No
Secondary	Hand joint stiffness (Numeric rating scale, 0-10)		6 months	No
Secondary	Fatigue (numeric rating scale, 0-10)		6 months	No
Secondary	Patient global assessment of disease activity (Numeric rating scale, 0-10)		6 months	No
Secondary	Exercise self-efficacy		6 months	No
Secondary	Health related quality of life (15D)		6 months	No
Secondary	Self-reported work ability and sick leave		6 months	No
Secondary	Self-reported health care utilisation		6 months	No
Secondary	Grip strength (JAMAR)		6 months	No
Secondary	Grip size		6 months	No
Secondary	Hand functioning (The Moberg Pick Up Test)		6 months	No
Secondary	Global assessment of change of hand problem		6 months	No