Clinical trial NCT01245842: The Hand Osteoarthritis Exercise Trial
Official title: Osteoarthritis Care in Primary Health: Hand Exercises and Telephone Counselling for Hand OA - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Osteoarthritis
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2010-11-23
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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 .

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The functional index for hand osteoarthritis (FIHOA)
timeFrame: 6 months
measure: Patient specific function scale (PSFS)
timeFrame: 6 months
Secondary outcomes:
measure: Hand joint pain (Numeric rating scale, 0-10)
timeFrame: 6 months
measure: Hand joint stiffness (Numeric rating scale, 0-10)
timeFrame: 6 months
measure: Fatigue (numeric rating scale, 0-10)
timeFrame: 6 months
measure: Patient global assessment of disease activity (Numeric rating scale, 0-10)
timeFrame: 6 months
measure: Exercise self-efficacy
timeFrame: 6 months
measure: Health related quality of life (15D)
timeFrame: 6 months
measure: Self-reported work ability and sick leave
timeFrame: 6 months
measure: Self-reported health care utilisation
timeFrame: 6 months
measure: Grip strength (JAMAR)
timeFrame: 6 months
measure: Grip size
timeFrame: 6 months
measure: Hand functioning (The Moberg Pick Up Test)
timeFrame: 6 months
measure: Global assessment of change of hand problem
timeFrame: 6 months
Other outcomes:
Locations:
city: Ullensaker Municipality
country: Norway
facility: Physiotherapy and Occupational Therapy Service Centre
state: Jessheim
Study officials:
affiliation: Diakonhjemmet Hospital
name: Nina Østerås, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osteras N, Hagen KB, Grotle M, Sand-Svartrud AL, Mowinckel P, Kjeken I. Limited effects of exercises in people with hand osteoarthritis: results from a randomized controlled trial. Osteoarthritis Cartilage. 2014 Sep;22(9):1224-33. doi: 10.1016/j.joca.2014.06.036. Epub 2014 Jul 5.
citation: Osteras N, Hagen KB, Grotle M, Sand-Svartrud AL, Mowinckel P, Aas E, Kjeken I. Exercise programme with telephone follow-up for people with hand osteoarthritis - protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2014 Mar 14;15:82. doi: 10.1186/1471-2474-15-82.