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

Diakonhjemmet Hospital
Boks 23 Vinderen
Oslo
0319
Norway

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffect of prefabricated orthoses for persons with osteoarthritis of the carpometacarpal joint: a randomised controlled trial
Study acronymHandOAorthoses
Study objectivesPrimary 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) studiedOsteoarthritis of the carpometacarpal joint
InterventionProvision 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 typeOther
Primary outcome measureAssessed 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 measuresAssessed 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 date15/11/2008
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. 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 criteria1. 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 enrolment15/11/2008
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Norway

Study participating centre

Diakonhjemmet Hospital
Oslo
0319
Norway

Sponsor information

Diakonhjemmet Hospital (Norway)
Hospital/treatment centre

Boks 23 Vinderen
Oslo
0319
Norway

Phone +47 22 45 15 00
Email firmapost@diakonsyk.no
Website http://www.diakonsyk.no
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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