Condition category
Musculoskeletal Diseases
Date applied
04/10/2006
Date assigned
15/11/2006
Last edited
28/08/2012
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 Margreth Grotle

ORCID ID

Contact details

National Resource Center for Rehabilitation in Rheumatology
Diakonhjemmet Hospital
P.O.Box 23
Vinderen
Oslo
0319
Norway
+47 22 45 48 47
margreth.grotle@medisin.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

OsteoArthritis (OA) is a term used to describe both the degenerative disease of synovial joints with its accompanying radiographic signs, and the clinical syndrome of pain, stiffness and restricted movement of the joints. OA is the commonest cause of chronic pain in older people, and the most frequent reason for activity limitations in this age-group. OA of the knee and hip have the greatest impact on individuals, but OA in hand is also commonly affected. With an increasing proportion of older people in the population, OA assumes a growing public health problem.

The aims of this trial are:
1. Patients with OsteoArthritis (OA) in hip, knee, hand and/or generalised OA who enter a multidisciplinary outpatient clinic, providing a brief group education intervention and individual consultations according to their needs, will be more satisfied with the health service and their health status than patients who receive individual consultation(s) in a traditional individual outpatient clinic.
2. We expect no clinically significant difference in pain and disability between patients who enter a multidisciplinary outpatient clinic and patients who enter a traditional individual outpatient clinic.
3. Patients with OA in hip, knee, hand and/or generalised OA who receive a telephone follow-up interview will be more satisfied with the health service and their health status than patients who receive follow-up 'as usual' (patients contact the clinic when necessary).
4. Patients with OA in hip, knee, hand and/or generalised OA who receive both the multidisciplinary outpatient clinic intervention and a telephone follow-up interview will have a significant effect on patient satisfaction, pain and disability when compared to patients who enter a traditional individual outpatient clinic with follow-up 'as usual'.
5. On the longer term, a multidisciplinary outpatient clinic, providing a brief group education intervention and individual consultations according to the patients' individual needs will be more cost-efficient than a traditional individual outpatient clinic for patients with OA in hip, knee, hand and/or generalised OA.
6. On the longer term, a multidisciplinary outpatient clinic and a telephone follow-up interview will be more cost-efficient than a traditional individual outpatient clinic with follow-up 'as usual' for patients with OA in hip, knee, hand and/or generalised OA.

Ethics approval

The Ethics Committee for Medical Research, Oslo, Norway, approved on the 7th of March 2006 (ref. no: 156-06073 1.2006.598).

Study design

Randomised single-blind controlled study with four arms and one year of follow-up

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

OsteoArthritis (OA)

Intervention

Both interventions are carried out in an outpatient clinic for rheumatology diseases:

The first intervention is a traditional individual outpatient clinic, in which the patients are referred to a rheumatologist. If they need further investigation, the patients may be referred to other specialists such as physiotherapist, occupational therapist, etc...,

The second intervention is a new multidisciplinary intervention, in which the referred patients first receive a four hour group education on OA ("OA school") and then receive individual consultations according to their needs: that is six specialist groups are available for consultation after the education part: rheumatologist, orthopedian specialist, physiotherapist, occupational therapist, pharmacist, and dietician.

In the second part of the trial, after first follow-up, one group of patients receive a brief telephone follow-up interview of approximately ten minutes. The other group of patients is followed ‘as usual’, that is the patients may contact the clinic if they need.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Patient satisfaction with the health service and their health status
2. Cost-efficiency

Secondary outcome measures

The secondary outcome(s) are pain and disability assessed by standardised disease-specific and generic outcome measures.

Overall trial start date

01/08/2006

Overall trial end date

01/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women between 40 and 80 years old
2. OA in hip, knee, hand and/or generalised OA
3. Referred to a specialist clinic at a hospital in Norway

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Cognitive impairments
2. Recent trauma in the extremities
3. Recent surgery, other specified diseases such as rheumatoid arthritis, cancer etc..,
4. Difficulties understanding Norwegian (both verbal and written language)

Recruitment start date

01/08/2006

Recruitment end date

01/08/2009

Locations

Countries of recruitment

Norway

Trial participating centre

National Resource Center for Rehabilitation in Rheumatology
Oslo
0319
Norway

Sponsor information

Organisation

National Resource Center for Rehabilitation in Rheumatology (Norway)

Sponsor details

Diakonhjemmet Hospital
P.O.Box 23
Vinderen
Oslo
N-0319
Norway

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

National Resource Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital (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

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21040556
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22923755

Publication citations

  1. Protocol

    Moe RH, Uhlig T, Kjeken I, Hagen KB, Kvien TK, Grotle M, Multidisciplinary and multifaceted outpatient management of patients with osteoarthritis: protocol for a randomised, controlled trial., BMC Musculoskelet Disord, 2010, 11, 253, doi: 10.1186/1471-2474-11-253.

  2. Results

    Moe RH, Grotle M, Kjeken I, Hagen KB, Kvien TK, Uhlig T, Disease impact of hand OA compared with hip, knee and generalized disease in specialist rheumatology health care., Rheumatology (Oxford), 2013, 52, 1, 189-196, doi: 10.1093/rheumatology/kes215.

Additional files

Editorial Notes