Condition category
Musculoskeletal Diseases
Date applied
02/03/2010
Date assigned
17/03/2010
Last edited
13/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Thilo Oliver Kromer

ORCID ID

Contact details

Physiotherapiezentrum
Grube 21
Penzberg
82377
Germany
-
Thilo.Kromer@epid.unimaas.nl

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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

29/03/2010

Overall trial end date

30/09/2011

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial participating centre

Physiotherapiezentrum
Penzberg
82377
Germany

Sponsor information

Organisation

Physiotherapiezentrum T.O.Kromer (Germany)

Sponsor details

Grube 21
Penzberg
82377
Germany

Sponsor type

Hospital/treatment centre

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20534140
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25060955

Publication citations

  1. Protocol

    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.

  2. Results

    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.

Additional files

Editorial Notes