Subacromial pain syndrome of the shoulder - comparisons between guided training and home based training with or without mobilizations and a control, in terms of clinical outcome at 6 week, 3 and 6 month follow-up.
| ISRCTN | ISRCTN67469356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67469356 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/03/2017
- Registration date
- 02/06/2017
- Last edited
- 11/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Subacromial pain syndrome (SAPS) is the most common musculoskeletal complaint after low-back and neck pain in patients seeking primary care. It involves the rotator cuff tendon – a tough, rubbery cord that connects the muscles in the shoulder to the top of the arm. The tendon and muscle run through a narrow space at the top of the shoulder called the subacromial space. About 70-85% of cases of SAPS are caused by tendon injuries, rotator cuff tears, and shoulder impingement, where the tendon becomes trapped and scrapes against the bone above, causing pain. Forty percent of patients still have pain after one year. Little is known about the natural recovery of patients with SAPS. Therefore a number of treatment options have been used in the past. Today there is a consensus to use resistance exercises for physiotherapy. Mobilization is suggested to reduce pain through a number of possible mechanisms, but it´s still unclear whether mobilization therapy added to an exercise program is beneficial. The aim of this study is to compare the effect of supervised physiotherapy and home-based training with or without mobilizations in patients with SAPS.
Who can participate?
Patients aged between 20 and 59, who have SAPS for 4 weeks to 1 year
What does the study involve?
This study consists of two separate studies. In study 1, patients from general practice/primary care in Tyresö, Älta and Haninge are randomly allocated into one of three groups. Group A receive guided training at a clinic twice a week for weeks 1-5 and weeks 7-11. Group B receive the same treatment as group A with additional mobilizations (eight times). Group C receive no treatment (control group). In study 2, patients from general practice/primary care in Stockholm (and from Tyresö after the end of study 1) are randomly allocated into two groups. Group A receive home training for weeks 1-5 and weeks 7-11. Group B receive the same treatment as group A with additional mobilizations (eight times). Both groups are compared with the control group from study 1. All participants in both studies are examined at the start of the study and after 6 weeks, 3 and 6 months.
What are the possible benefits and risks of participating?
All patients receive a thorough investigation of their shoulder, including an x-ray and ultrasound scan. As of the start of the study it is not known which treatment is the most effective. No risks are expected for the patients as they are carefully followed and examined. They can stop their participation in the study at any time.
Where is the study run from?
1. Primärvårds rehab (primary care) in Tyresö (Sweden)
2. Innerstadsrehab, primary care (Sweden)
When is the study starting and how long is it expected to run for?
April 2009 to June 2015
Who is funding the study?
Karolinska Institutet (Sweden)
Who is the main contact?
Anna Eliason
Contact information
Public
Centrum för Idrottsforskning och utbildning/CIFU. KI
Box 5605
Stockholm
114 86
Sweden
Study information
| Study design | Two single-center double-blinded controlled interventional randomized trials |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Subacromial pain syndrome of the shoulder - comparisons between different physical therapy treatments in terms of change in the Constant and Murley score index: two randomised controlled trials |
| Study acronym | - |
| Study hypothesis | 1. Does treatment with exercises give a better outcome than a control that don't receive any treatment in patients with subacromial shoulder pain (SAPS)? 2. To determine possible differences in the Constant Score Index in patients with subacromial pain, SAPS treated with a combination of mobilization and guided training of the shoulder stabilizers, guided training alone versus a control group who received no treatment 3. Are there any differences in outcome between guided training or home based training? 4. Is the addition of passive mobilisation of the gleno-humeral joint more effective than exercises alone? |
| Ethics approval(s) | Local Ethics Committee in Stockholm, Sweden, 01/11/2010, ref: 2009/1197-31/2 |
| Condition | Subacromial pain syndrome |
| Intervention | Two double-blinded controlled interventional randomized trials, methodically built in the same way in order to be able to compare the results. Randomization with sealed envelopes (4 envelopes for each age group; 20-29, 30-39, 40-49, 50-59 years of age at baseline for women and for men). The patients were randomized in the order they sought care in Primary care in Tyresö in study 1 and in Stockholm City in study 2. After closing study 1, patients were also randomized to study 2 from Primary care in Tyresö. The physical therapist performing the examinations was blinded for allocation. Every third patient went to the control group. The same control group was used in study 2. Study 1: 120 patients aged between 20-59 years were recruited from general practice/primary care in Tyresö, Älta and Haninge between the years 2010-2014. The patients were randomized into two intervention groups with sealed envelopes. Every third patient went to the control group. Group A: week 1-5: guided training at a clinic twice a week, week 7-11 guided training for another 5 weeks, twice a week Group B: additional mobilizations 8 times + same treatment for group A Group C: control: no treatment Study 2: 89 patients with shoulder pain were recruited from general practice/primary care from 3 centers in Stockholm between the years 2011-2015 and from Primary care in Tyresö after closure of data collection to study 1. The patients were randomized into two intervention groups with sealed envelopes. The control group from study 1 was used. Group A: week 1-5: home training, week 7-11 home training another 5 weeks Group B: additional mobilizations 8 times + same treatment as group A Group C: control: no treatment One physiotherapist conducted the examinations at baseline, 6 weeks, 3 and 6 months follow-up in both studies and was blinded for allocation. The patients were blinded for the different treatments. |
| Intervention type | Other |
| Primary outcome measure | Shoulder pain, activities of daily living, range of motion and strength, measured using the Constant and Murley Score at baseline, after 6 week, 3 and 6 months |
| Secondary outcome measures | 1. Pain, measured using the visual analogue scale (VAS) at baseline, 6 weeks, 3 and 6 months 2. Range of motion (ROM), measured using in degrees using a goniometer and a Myerin meter at baseline, 6 weeks, 3 and 6 months 3. Personality, measured using Swedish universities Scales of Personality (SSP) at 6 weeks 4. Health related quality of life (physical symptoms, sports and recreation, work, lifestyle and emotion), measured using the Western Ontario Rotator Cuff (WORC) Index at baseline, 3 and 6 months 5. Single Assessment Numeric Evaluation (SANE) with only one question: "How would you rate your shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?", at baseline, 3 and 6 months |
| Overall study start date | 01/04/2009 |
| Overall study end date | 05/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 59 Years |
| Sex | Both |
| Target number of participants | 33 patients in each group = 165 patients + an additional 10 % making up for drop out rate = 170 patients |
| Participant inclusion criteria | 1. Aged 20-59 years 2. SAPS for 4 weeks to 1 year 3. Normal passive glenohumeral range of motion, a positive Hawkins sign and/or pain with isometric contraction of any of the rotator cuff muscles. For inclusion at least two of these tests must be positive together with a positive painful arc. Patients with rotator cuff ruptures were included if they met these criteria and didn't present with any lag signs |
| Participant exclusion criteria | 1. Bilateral shoulder pain 2. Earlier corticosteroid injection 3. Diabetes mellitus 4. Signs of full-thickness rotator cuff tears with a positive drop arm test 5. Rheumatoid arthritis 6. Arthroses 7. Frozen shoulder 8. Severe fibromyalgia 9. Earlier dislocation of the shoulder and previous operations in the shoulder 10. Thoracic or cervical syndromes |
| Recruitment start date | 01/08/2010 |
| Recruitment end date | 30/12/2014 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Stockholm
135 40
Sweden
Stockholm
113 61
Sweden
Sponsor information
Hospital/treatment centre
Karolinska University Hospital Solna (L1:00)
Department of Molecular Medicine and Surgery
Stockholm
171 76
Sweden
| Phone | +46 (0)8 51776900 |
|---|---|
| info@mmk.ki.se | |
"ROR" |
https://ror.org/04hmgwg30 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
Results and Publications
| Intention to publish date | 01/09/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in a high-impact peer reviewed journal and two conferences scheduled in autumn 2017. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request from Anna Eliason or statistician Gunnar Edman (Gunnar.Edman@ki.se). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Study 1 | 11/05/2021 | 11/07/2023 | Yes | No |
| Results article | Study 2 | 23/02/2022 | 11/07/2023 | Yes | No |
Editorial Notes
11/07/2023: Two publication references added.
