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
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