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 |
| Protocol serial number | 904-65-901 |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- 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
Scientific
Mercuriusstraat 27
Brunssum
6446 RM
Netherlands
| Phone | +31 (0)6 23588088 |
|---|---|
| camieldebruijn@hetnet.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Evaluation of an education and activation programme to prevent chronic shoulder complaints: design of a randomised clinical trial |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Patient perceived recovery after six and 26 weeks. |
| Key secondary outcome measure(s) |
Change in functional limitations of activities of daily living after six and 26 weeks. |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 111 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Mercuriusstraat 27
Brunssum
6446 RM
Netherlands
6446 RM
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/11/2007 | 26/02/2021 | Yes | No |
| Protocol article | Study protocol | 16/02/2005 | Yes | No |
Editorial Notes
26/02/2021: Publication reference added.
