Evaluation of an education and activation programme to prevent chronic shoulder complaints: design of a randomised clinical trial

ISRCTN ISRCTN71777817
DOI https://doi.org/10.1186/ISRCTN71777817
Secondary identifying numbers 904-65-901
Submission date
14/02/2005
Registration date
14/02/2005
Last edited
26/02/2021
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

Mr Camiel Peter Carol De Bruijn
Scientific

Mercuriusstraat 27
Brunssum
6446 RM
Netherlands

Phone +31 (0)6 23588088
Email camieldebruijn@hetnet.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleEvaluation of an education and activation programme to prevent chronic shoulder complaints: design of a randomised clinical trial
Study objectivesAn education and activation programme in addition to usual care is more effective in increasing patient perceived recovery and reducing functional limitations than usual care alone.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedShoulder complaints
InterventionUsual care:
Usual care was applied according to the Dutch College of General Practitioners (DCGP) guidelines for shoulder complaints (version 1999). Management during the first two weeks consists of a wait-and-see policy with information and advice about shoulder complaints, possibly supplemented with analgesics or nonsteroidal anti-inflammatory drugs. If this approach has little or no effect, up to three corticosteroid injections can be given. Physiotherapy is considered for complaints persisting after six weeks or more. If the shoulder complaints persist, referral to a hospital-based specialist may be considered.

Education and activation programme in addition to usual care:
The focus of the Education and activation programme was to maintain or induce the proper cognitions by education and to stimulate adequate behaviour by means of advice on activities of daily living using principles of operant conditioning. The Education and activation programme consisted of a minimum of two sessions and a maximum of six follow-up sessions over a period of six weeks. Each session could last up to 20 minutes.
Intervention typeOther
Primary outcome measurePatient perceived recovery after six and 26 weeks.
Secondary outcome measuresChange in functional limitations of activities of daily living after six and 26 weeks.
Overall study start date01/01/2000
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants111
Key inclusion criteria1. Patient with shoulder complaint at rest and/or elicited by movement
2. 18 years and older
3. New episode of shoulder complaints
Key exclusion criteria1. Other episodes of shoulder complaints in previous 12 months
2. Prior fractures and/or surgery of the shoulder
3. (Suspected) referred pain from internal organs
4. Confirmed extrinsic cause
5. Inability to complete a questionnaire independently
6. Presence of dementia or other severe psychiatric abnormalities
Date of first enrolment01/01/2000
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Mercuriusstraat 27
Brunssum
6446 RM
Netherlands

Sponsor information

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands

Phone +31 (0)70 349 5111
Email info@zonmw.nl
Website http://www.zonmw.nl/
ROR logo "ROR" https://ror.org/01yaj9a77

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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?
Protocol article Study protocol 16/02/2005 Yes No
Results article results 15/11/2007 26/02/2021 Yes No

Editorial Notes

26/02/2021: Publication reference added.