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ISRCTN
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ISRCTN71777817
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ClinicalTrials.gov identifier
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Public title
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Evaluation of an education and activation programme to prevent chronic shoulder complaints: design of a randomised clinical trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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904-65-901
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Shoulder complaints
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Participants - inclusion criteria
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1. Patient with shoulder complaint at rest and/or elicited by movement
2. 18 years and older
3. New episode of shoulder complaints
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2000
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Anticipated end date
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31/12/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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111
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Interventions
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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.
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Primary outcome measure(s)
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Patient perceived recovery after six and 26 weeks.
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Secondary outcome measure(s)
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Change in functional limitations of activities of daily living after six and 26 weeks.
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Trial website
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Publications
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2005 Study protocol on http://www.ncbi.nlm.nih.gov/pubmed/15715914
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Contact name
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Mr
Camiel Peter Carol
De Bruijn
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Address
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Mercuriusstraat 27
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City/town
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Brunssum
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Zip/Postcode
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6446 RM
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Country
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Netherlands
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Tel
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+31 (0)6 23588088
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Fax
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+31 (0)45 5214547
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Email
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camieldebruijn@hetnet.nl
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Sponsor
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Address
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Laan van Nieuw Oost Indië 334
P.O. Box 93245
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City/town
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The Hague
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Zip/Postcode
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2509 AE
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Country
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Netherlands
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Tel
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+31 (0)70 349 5111
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Fax
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+31 (0)70 349 5100
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Email
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info@zonmw.nl
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Sponsor website:
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http://www.zonmw.nl/
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Date applied
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14/02/2005
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Last edited
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10/03/2008
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Date ISRCTN assigned
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14/02/2005
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