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
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
-
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.