Condition category
Musculoskeletal Diseases
Date applied
14/02/2005
Date assigned
14/02/2005
Last edited
10/03/2008
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

Mr Camiel Peter Carol De Bruijn

ORCID ID

Contact details

Mercuriusstraat 27
Brunssum
6446 RM
Netherlands
+31 (0)6 23588088
camieldebruijn@hetnet.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

904-65-901

Study information

Scientific title

Acronym

Study hypothesis

An 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Shoulder complaints

Intervention

Usual 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patient perceived recovery after six and 26 weeks.

Secondary outcome measures

Change in functional limitations of activities of daily living after six and 26 weeks.

Overall trial start date

01/01/2000

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient with shoulder complaint at rest and/or elicited by movement
2. 18 years and older
3. New episode of shoulder complaints

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

111

Participant exclusion criteria

1. 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

Recruitment start date

01/01/2000

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Mercuriusstraat 27
Brunssum
6446 RM
Netherlands

Sponsor information

Organisation

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

Sponsor details

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl/

Funders

Funder type

Research organisation

Funder name

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

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

2005 Study protocol on http://www.ncbi.nlm.nih.gov/pubmed/15715914

Publication citations

  1. Study protocol

    Bruijn CD, de Bie R, Geraets J, Goossens M, Köke A, van den Heuvel W, van der Heijden G, Dinant GJ, Evaluation of an education and activation programme to prevent chronic shoulder complaints: design of an RCT [ISRCTN71777817]., BMC Fam Pract, 2005, 6, 1, 7, doi: 10.1186/1471-2296-6-7.

Additional files

Editorial Notes