Condition category
Musculoskeletal Diseases
Date applied
03/11/2008
Date assigned
11/12/2008
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.diakonsyk.no

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

  1. 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.

Additional files

Editorial Notes