Effect of orthoses in hand osteoarthritis
| ISRCTN | ISRCTN40357804 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40357804 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Diakonhjemmet Hospital
Boks 23 Vinderen
Oslo
0319
Norway
| Phone | +47 22 45 48 45 |
|---|---|
| ingvild.kjeken@diakonsyk.no |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 |
| Secondary outcome measures | 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) |
| Overall study start date | 15/11/2008 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
0319
Norway
Sponsor information
Diakonhjemmet Hospital (Norway)
Hospital/treatment centre
Hospital/treatment centre
Boks 23 Vinderen
Oslo
0319
Norway
| Phone | +47 22 45 15 00 |
|---|---|
| firmapost@diakonsyk.no | |
| Website | http://www.diakonsyk.no |
"ROR" |
https://ror.org/02jvh3a15 |
Funders
Funder type
Research organisation
National Resource Centre for Rehabilitation in Rheumatology (Norway)
No information available
Norwegian Association of Occupational Therapists (Norsk Ergoterapeutforbund [NETF]) (Norway)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
