Physiotherapy for shoulder impingement syndrome
| ISRCTN | ISRCTN86900354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86900354 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/03/2010
- Registration date
- 17/03/2010
- Last edited
- 29/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr Thilo Oliver Kromer
Scientific
Scientific
Physiotherapiezentrum
Grube 21
Penzberg
82377
Germany
| Thilo.Kromer@epid.unimaas.nl |
Study information
| Study design | Multicentre randomized controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effectiveness of individualised physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome of the shoulder. A randomised controlled trial. |
| Study hypothesis | To investigate the effect of individually planned physiotherapy on pain and functioning compared to a standard exercise protocol in patients with clinical signs of subacromial impingement syndrome. To compare direct and indirect costs between both interventions. |
| Ethics approval(s) | Medical Ethics Committee of the Munich University Hospital, Ludwig-Maximilians-University Munich, Germany, approved on the 19th February 2010 (Project-No. 018-10). |
| Condition | Shoulder impingement syndrome |
| Intervention | Intervention group: Ten sessions (approximatly 30 minutes/session; two sessions per week) of individualised physiotherapy (including manual therapy for the shoulder complex, the cervical and thoracic spine, education) based on clinical examination results plus a home-based standard exercise protocol. Control group: Ten supervised sessions of a standard exercise protocol (including stretching, strengthening, and mobility exercises for the rotator cuff and the shoulder girdle). Total duration of intervention: five weeks. Follow up: five weeks, three and twelve months. |
| Intervention type | Other |
| Primary outcome measure | 1. Shoulder Pain and Disability Index (SPADI); 13 items (5 for pain, 8 for function) scored on a 100mm visual analogue scale; will be assessed at baseline and after 5 weeks, 3 and 12 months 2. Patients' global impression of change; ordinal scale (1-much worse, 2-slightly worse, 3-no change, 4-slightly better, 5-much better); will be assessed after 5 weeks, 3 and 12 months |
| Secondary outcome measures | 1. Generic patient-specific scale; 11 point visual numeric rating scale (end descriptors of 0 = impossible to do, 10 = no difficulties at all); will be assessed at baseline and after 5 weeks, 3 and 12 months 2. Average weekly pain score; 11 point visual numeric rating scale (end descriptors of 0 = no pain, 10 = worst pain possible); will be assessed at baseline, after 5 weeks and 3 months 3. Patients' satisfaction with treatment; 11 point visual numeric rating scale (end descriptors of 0 = completely dissatisfied, 10 = completely satisfied); will be assessed after 5 weeks 4. Shoulder exercise log book; will be assessed after 5 weeks, 3 and 12 months 5. Costs; cost diary (disease specific healthcare utilization, sick leave, drug use, paid help); will be assessed after 5 weeks, 3 and 12 months |
| Overall study start date | 29/03/2010 |
| Overall study end date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 90 |
| Participant inclusion criteria | Patients between 18 and 75 years of age presenting to primary care with clinical signs and symptoms of shoulder impingement syndrome. |
| Participant exclusion criteria | 1. Primary scapulothoracic dysfunction 2. Instability 3. Adhesive capsulitis 4. Loss of active shoulder function 5. Previous shoulder surgery 6. Cervical radicular symptoms 7. Rheumatoid arthritis 8. Intake of psychotherapeutic drugs |
| Recruitment start date | 29/03/2010 |
| Recruitment end date | 30/09/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Physiotherapiezentrum
Penzberg
82377
Germany
82377
Germany
Sponsor information
Physiotherapiezentrum T.O.Kromer (Germany)
Hospital/treatment centre
Hospital/treatment centre
Grube 21
Penzberg
82377
Germany
Funders
Funder type
University/education
Maastricht University (Netherlands) - Department of Epidemiology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/06/2010 | Yes | No | |
| Other publications | Secondary analysis | 01/12/2014 | Yes | No | |
| Other publications | Secondary analysis | 24/07/2024 | 29/07/2024 | Yes | No |
Editorial Notes
29/07/2024: Publication reference added.
