Mr Thilo Oliver Kromer
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.
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.
Medical Ethics Committee of the Munich University Hospital, Ludwig-Maximilians-University Munich, Germany, approved on the 19th February 2010 (Project-No. 018-10).
Multicentre randomised controlled parallel group trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Shoulder impingement syndrome
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.
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 trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Patients between 18 and 75 years of age presenting to primary care with clinical signs and symptoms of shoulder impingement syndrome.
Target number of participants
Participant exclusion criteria
1. Primary scapulothoracic dysfunction
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
Recruitment end date
Countries of recruitment
Trial participating centre
Maastricht University (Netherlands) - Department of Epidemiology
Funding Body Type
Funding Body Subtype
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
Basic results (scientific)
Kromer TO, de Bie RA, Bastiaenen CH, Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial., BMC Musculoskelet Disord, 2010, 11, 114, doi: 10.1186/1471-2474-11-114.
Kromer TO, Sieben JM, de Bie RA, Bastiaenen CH, Influence of fear-avoidance beliefs on disability in patients with subacromial shoulder pain in primary care: a secondary analysis, Phys Ther, 2014, 94, 12, 1775-1784, doi: 10.2522/ptj.20130587.