Condition category
Musculoskeletal Diseases
Date applied
13/11/2008
Date assigned
23/12/2008
Last edited
23/12/2008
Prospective/Retrospective
Retrospectively 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

Prof Jo Nijs

ORCID ID

Contact details

Vrije Universiteit Brussel
Pleinlaan 2
Brussel
1050
Belgium
jo.nijs@vub.ac.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G842

Study information

Scientific title

Treating patients with shoulder impingement: a single-blind effect study using a scapular stabilisation protocol

Acronym

Study hypothesis

Is a scapular stabilisation programme more effective than usual care in patients with shoulder impingement syndrome?

Ethics approval

Medical Ethics Committee of the UZ Brussel University Hospital, Brussels Free University (Vrije Universiteit Brussel), approved on the 15th October 2008 (ref: BUN B14320084388)

Study design

Randomised single-blind usual care-controlled multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Shoulder impingement syndrome

Intervention

Nine sessions (approximatly 30 minutes/session; three sessions/week) of usual care (ultrasound [US], transcutaneous electrical nerve stimulation [TENS], stretching, massage) versus nine sessions of scapular motor control training (exercise therapy for scapular stability muscles).

Total duartion of interventions: three weeks/patient.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The following will be assessed at baseline, after nine therapy sessions and after six months:
1. Pain: Visual Analogue Scale (VAS), Verbal Rating Scale (VRS), Shoulder Disability Questionnaire (SDQ), Hawkins Impingement Test, Neer Impingement Test, the Empty Can Test
2. Mobility: inclinometry
3. Strengh: hand-held dynamometer

Secondary outcome measures

The following will be assessed at baseline, after nine therapy sessions and after six months:
1. Scapular Assistance Test
2. Scapular Reposition Test

Overall trial start date

30/11/2008

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, greater than 18 years of age
2. Primary and secondary impingement

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

46

Participant exclusion criteria

1. Post-surgical
2. Rheumatic arthritis
3. Cervical radicular syndromes
4. Ruptures
5. Less than 18 years of age
6. Congenital
7. Traumatic
8. Instability

Recruitment start date

30/11/2008

Recruitment end date

30/09/2009

Locations

Countries of recruitment

Belgium

Trial participating centre

Vrije Universiteit Brussel
Brussel
1050
Belgium

Sponsor information

Organisation

MSD Europe BVBA (Belgium)

Sponsor details

Neringstraat 7
Londerzeel
1840
Belgium
+32 (0)52 311 452
info@msd-europe.com

Sponsor type

Industry

Website

http://www.msd-europe.com/

Funders

Funder type

Industry

Funder name

MSD Europe BVBA (Belgium)

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

Publication citations

Additional files

Editorial Notes