Physiotherapy for shoulder impingement syndrome

ISRCTN	ISRCTN86900354
DOI	https://doi.org/10.1186/ISRCTN86900354
Protocol serial number	N/A
Sponsor	Physiotherapiezentrum T.O.Kromer (Germany)
Funder	Maastricht University (Netherlands) - Department of Epidemiology

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 of protocol

Not provided at time of registration

Contact information

Mr Thilo Oliver Kromer
Scientific

Physiotherapiezentrum
Grube 21
Penzberg
82377
Germany

Email	Thilo.Kromer@epid.unimaas.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomized controlled parallel group trial
Secondary study design	Randomised controlled trial
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 objectives	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).
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	90
Key inclusion criteria	Patients between 18 and 75 years of age presenting to primary care with clinical signs and symptoms of shoulder impingement syndrome.
Key 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
Date of first enrolment	29/03/2010
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

Germany

Study participating centre

Physiotherapiezentrum

Penzberg
82377
Germany

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?
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.