Contact information
Type
Scientific
Primary contact
Dr Ingvild Kjeken
ORCID ID
Contact details
Diakonhjemmet Hospital
Boks 23 Vinderen
Oslo
0319
Norway
+47 22 45 48 45
ingvild.kjeken@diakonsyk.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of prefabricated orthoses for persons with osteoarthritis of the carpometacarpal joint: a randomised controlled trial
Acronym
HandOAorthoses
Study hypothesis
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
Ethical Committee for Medical Research, 24/09/2008, ref: 413-08-00056, and the Norwegian Data Inspectorate
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
15/11/2008
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
15/11/2008
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Norway
Trial participating centre
Diakonhjemmet Hospital
Oslo
0319
Norway
Sponsor information
Organisation
Diakonhjemmet Hospital (Norway)
Sponsor details
Boks 23 Vinderen
Oslo
0319
Norway
+47 22 45 15 00
firmapost@diakonsyk.no
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
National Resource Centre for Rehabilitation in Rheumatology (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Norwegian Association of Occupational Therapists (Norsk Ergoterapeutforbund [NETF]) (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24215554
Publication citations
-
Results
Hermann M, Nilsen T, Eriksen CS, Slatkowsky-Christensen B, Haugen IK, Kjeken I, Effects of a soft prefabricated thumb orthosis in carpometacarpal osteoarthritis., Scand J Occup Ther, 2014, 21, 1, 31-39, doi: 10.3109/11038128.2013.851735.