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ISRCTN
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ISRCTN86900354
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ClinicalTrials.gov identifier
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Public title
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Physiotherapy for shoulder impingement syndrome
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Scientific title
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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.
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Medical Ethics Committee of the Munich University Hospital, Ludwig-Maximilians-University Munich, Germany, approved on the 19th February 2010 (Project-No. 018-10).
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Study design
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Multicentre randomised controlled parallel group trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Shoulder impingement syndrome
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Participants - inclusion criteria
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Patients between 18 and 75 years of age presenting to primary care with clinical signs and symptoms of shoulder impingement syndrome.
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Participants - exclusion criteria
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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
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Anticipated start date
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29/03/2010
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Anticipated end date
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30/09/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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90
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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Maastricht University (Netherlands) - Department of Epidemiology
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Trial website
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Publications
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2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20534140
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Contact name
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Mr
Thilo Oliver
Kromer
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Address
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Physiotherapiezentrum
Grube 21
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City/town
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Penzberg
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Zip/Postcode
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82377
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Country
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Germany
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Email
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Thilo.Kromer@epid.unimaas.nl
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Sponsor
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Physiotherapiezentrum T.O.Kromer (Germany)
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Address
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Grube 21
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City/town
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Penzberg
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Zip/Postcode
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82377
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Country
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Germany
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Date applied
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02/03/2010
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Last edited
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20/07/2010
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Date ISRCTN assigned
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17/03/2010
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