Effect of orthoses in hand osteoarthritis

ISRCTN	ISRCTN40357804
DOI	https://doi.org/10.1186/ISRCTN40357804
Protocol serial number	N/A
Sponsor	Diakonhjemmet Hospital (Norway)
Funders	National Resource Centre for Rehabilitation in Rheumatology (Norway), Norwegian Association of Occupational Therapists (Norsk Ergoterapeutforbund [NETF]) (Norway)

Submission date: 03/11/2008
Registration date: 11/12/2008
Last edited: 27/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ingvild Kjeken
Scientific

Diakonhjemmet Hospital
Boks 23 Vinderen
Oslo
0319
Norway

Phone	+47 22 45 48 45
Email	ingvild.kjeken@diakonsyk.no

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of prefabricated orthoses for persons with osteoarthritis of the carpometacarpal joint: a randomised controlled trial
Study acronym	HandOAorthoses
Study objectives	Primary question: Is the use of prefabricated orthoses combined with hand exercises more effective to relieve pain and improve hand function in persons with osteoarthritis in the carpometacarpal (CMC1) joint, than hand exercises alone? Secondary question: Is the use of prefabricated orthoses combined with hand exercises more effective to increase hand strength in persons with osteoarthritis in the CMC1 joint, than hand exercises alone?
Ethics approval(s)	Ethical Committee for Medical Research, 24/09/2008, ref: 413-08-00056, and the Norwegian Data Inspectorate
Health condition(s) or problem(s) studied	Osteoarthritis of the carpometacarpal joint
Intervention	Provision of orthoses: Participants in group 1 are provided with a prefabricated orthosis, aimed at giving support to the CMC1 joint. Participants with an adduction contracture are offered a custom-made orthosis to wear routinely at night. Hand exercises: All participants (group 1 and group 2) are instructed in four basic hand exercises, aimed at improving or maintaining joint mobility, joint stability and hand strength. They are given a leaflet with descriptions and pictures of the exercises, and instructed to perform the exercises twice a day. Patients in group 2 will be offered orthoses at two months follow-up.
Intervention type	Other
Primary outcome measure(s)	Assessed at baseline and after two months: 1. Hand pain measured on visual analogue scales 2. Function in performance of daily activities, measured by the MAP-hand
Key secondary outcome measure(s)	Assessed at baseline and after two months: 1. Hand strength, measured with the Grippit 2. Hand function, measured with the pain, stiffness and function subscales of the Australian/Canadian hand osteoarthritis measure (AUSCAN) 3. Abduction of the thumb, measured with Gripsizer 4. Patient-acceptable symptoms, measured with the Patient Acceptable Symptom State (PASS) 5. General function, measured with the Modified Health Questionnaire (MHAQ) 6. Quality of life, European Quality of Life questionnaire (EuroQoL EQ-5D) 7. Self-efficacy in relation to pain, measured with the Arthritis Self Efficacy Pain Subscale Assessed after two months only: 8. Costs 9. Participants' experiences with prefabricated orthoses and hand exercises (structured interview with participants in group 1)
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Aged from 18 to 75 years, either sex 2. Hand osteoarthritis 3. Pain in the carpometacarpal joint 4. Ability to communicate in Norwegian
Key exclusion criteria	1. Cognitive impairment or mental disease 2. Past surgery of the thumb 3. Impaired hand function due to other diseases 4. Steroid injections within the last month
Date of first enrolment	15/11/2008
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Norway

Study participating centre

Diakonhjemmet Hospital

Oslo
0319
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes