Contact information
Type
Scientific
Contact name
Mr Thilo Oliver Kromer
ORCID ID
Contact details
Physiotherapiezentrum
Grube 21
Penzberg
82377
Germany
-
Thilo.Kromer@epid.unimaas.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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.
Acronym
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).
Study design
Multicentre randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
75 Years
Sex
Both
Target number of participants
90
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
Funders
Funder type
University/education
Funder name
Maastricht University (Netherlands) - Department of Epidemiology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/06/2010 | Yes | No | |
| Results article | results | 01/12/2014 | Yes | No |