Subacromial Impingement SyndromeEaSINCT01691157
Exercise in the Physiotherapy Management of Shoulder Impingement
A study testing Evidence based exercise protocol and Usual physiotherapy without exercise in people with Subacromial Impingement Syndrome, run by University of Ulster at 4 sites in United Kingdom.
Trial summary
The purpose of this trial is to investigate the effectiveness of an evidence based exercise program for shoulder impingement. Approximately 1% of adults consult their General Practitioner (GP) with shoulder pain each year, making it the third most common reason for musculoskeletal GP consultations in the UK. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Evidence based exercise protocol and Usual physiotherapy without exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Sep 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be aged 18 years and older.
- Shoulder pain of at least 3/10 in severity that has been diagnosed by a consultant rheumatologist, orthopaedic surgeon or general practitioner within the past 12 months.
- Positive Hawkins-Kennedy test.
- Positive on testing either supraspinatus (empty can test) or infraspinatus (resisted external rotation in neutral).
Who cannot join
- Acute traumatic conditions.
- Evidence of rotator cuff tear (positive drop arm test) or any other shoulder joint pathology (e.g. adhesive capsulitis, labral tears).
- A history of fractures of the upper arm, shoulder or clavicle within the past two years.
- A history of dislocation of the shoulder within the previous two years.
- Postoperative conditions involving the upper arm, shoulder or clavicle.
- Inflammatory or systemic diseases.
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- Current signs and symptoms of acute nerve root pain arising from the cervical or upper thoracic spine.
- Previous physiotherapy for the same condition involving an exercise regime.
- Previous corticosteroid injection of the affected shoulder within the past 6 months.
- Unwilling participant.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Recruiting
The Waveney Hospital
Ballymena, N.I
Colin Brennan, physio, 00442870347853, colin.brennan@hscni.net
- Recruiting
Robinson Memorial Hospital
Ballymoney, N.I, BT53 6HB
Colin Brennan, Physio, 00442870347853, colin.brennan@northerntrust.hscni.net
- Recruiting
Musgrave Park Hospital
Belfast, N.Ireland, BT9 7JB
Ingrid Traynor, Physio, 0044289090 ext. 2078, ingrid.traynor@belfasttrust.hscni.net
- Recruiting
The Fort Centre, Physiotherapy Department
Coleraine, N.I
Colin Brennan, Physio, 00442870347853, colin.brennan@hscni.net
About this study
Official title: The Effectiveness of Exercise in the Physiotherapy Management of Subacromial Impingement Syndrome
The purpose of this trial is to investigate the effectiveness of an evidence based exercise program for shoulder impingement. Approximately 1% of adults consult their General Practitioner (GP) with shoulder pain each year, making it the third most common reason for musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly referred for physiotherapy treatment. This trial aims to compare the effectiveness of an evidence based exercise protocol with usual physiotherapy care.
Read the detailed description
Physiotherapy management of shoulder impingement frequently involves exercise, however there is little evidence underpinning exercise prescription and outcomes are poor. Few trials have investigated which muscles should be targeted and how they should be strengthened with respect to the mode, frequency, duration, intensity and progression. This is a randomized controlled trial(RCT) investigating the effectiveness of an evidence based exercise program for shoulder impingement. This research may have an impact on how physiotherapists provide exercise programs to patients with shoulder impingement.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Evidence based exercise protocol, Usual physiotherapy without exercise
- Keywords
- Subacromial impingement syndrome, Rotator cuff, Exercise, Physiotherapy
- Medical subject headings
- Shoulder Impingement Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence based exercise protocolOther
An evidence based graduated exercise rehabilitation protocol will be provided and supervised by a physiotherapist. patients will receive 6 sessions of supervised physiotherapy
Usual physiotherapy without exerciseOther
Also called Usual care
Will receive modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine.
| Study group | Role | What they receive |
|---|---|---|
| Usual physiotherapy without exercise | Active comparator | Will receive 6 sessions of modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine. Receives: Other: Usual physiotherapy without exercise |
| Exercise | Experimental | Will receive an evidence based exercise protocol but no other physiotherapeutic modalities Receives: Other: Evidence based exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS).
Primary outcome measure: Average pain scores at rest and at night for the week prior to measurement will be recorded using a 100mm visual analogue scale (VAS). The change in pain scores at 6 and 12 weeks from baseline will be measured.
Measured: Outcomes measured at 0, 6 and 12 weeks
Secondary outcomes (4)
Western Ontario Rotator Cuff Index (WORC
Secondary outcome measures will focus on function, disability and quality of life, consisting of a combination of generic, region specific and disease-specific health questionnaires. The change in scores from baseline will be measured.
Measured: 0, 6 and 12 weeks
The American Shoulder and Elbow Surgeons function score.
Limb specific outcome measure
Measured: 0. 6 and 12 weeks
SF-36 Health Survey • SF-36 Health Survey
Generic measure of health status
Measured: 0, 6 and 12 weeks
Isometric strength and range of movement of shoulder flexion, abduction, external rotation and internal rotation using a hand held dynamometer.
objective measures of strength and ROM
Measured: 0, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Northern Health and Social Care Trust, Mayo Clinic, Keele University
- Responsible party
- Principal investigator, Dr Joseph G McVeigh, University of Ulster
- Investigators
- Joseph G McVeigh, BSc Hons, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691157
- Sponsor's protocol ID
- 11/NI/0026 version 3.1
- Acronym
- EaSI
- Status last verified
- Oct 2012
- First submitted
- 8 Aug 2012
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Exercise in the Physiotherapy Management of Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT01691157
- Acronym / sponsor ID
- EaSI / 11/NI/0026 version 3.1
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Subacromial impingement syndrome, Rotator cuff, Exercise, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Northern Health and Social Care Trust, Mayo Clinic, Keele University
- Study start
- Sep 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to investigate the effectiveness of an evidence based exercise program for shoulder impingement. Approximately 1% of adults consult their General Practitioner (GP) with shoulder pain each year, making it the third most common reason for musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly referred for physiotherapy treatment. This trial aims to compare the effectiveness of an evidence based exercise protocol with usual physiotherapy care.
Detailed description
Physiotherapy management of shoulder impingement frequently involves exercise, however there is little evidence underpinning exercise prescription and outcomes are poor. Few trials have investigated which muscles should be targeted and how they should be strengthened with respect to the mode, frequency, duration, intensity and progression. This is a randomized controlled trial(RCT) investigating the effectiveness of an evidence based exercise program for shoulder impingement. This research may have an impact on how physiotherapists provide exercise programs to patients with shoulder impingement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual physiotherapy without exercise | Active comparator | Other: Usual physiotherapy without exerciseWill receive 6 sessions of modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine. |
| Exercise | Experimental | Other: Evidence based exercise protocolWill receive an evidence based exercise protocol but no other physiotherapeutic modalities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be aged 18 years and older.
- Shoulder pain of at least 3/10 in severity that has been diagnosed by a consultant rheumatologist, orthopaedic surgeon or general practitioner within the past 12 months.
- Positive Hawkins-Kennedy test.
- Positive on testing either supraspinatus (empty can test) or infraspinatus (resisted external rotation in neutral).
Key exclusion criteria (10 listed)
- Acute traumatic conditions.
- Evidence of rotator cuff tear (positive drop arm test) or any other shoulder joint pathology (e.g. adhesive capsulitis, labral tears).
- A history of fractures of the upper arm, shoulder or clavicle within the past two years.
- A history of dislocation of the shoulder within the previous two years.
- Postoperative conditions involving the upper arm, shoulder or clavicle.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence based exercise protocolAn evidence based graduated exercise rehabilitation protocol will be provided and supervised by a physiotherapist. patients will receive 6 sessions of supervised physiotherapy | Other | Exercise |
| Usual physiotherapy without exerciseAlso: Usual careWill receive modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine. | Other | Usual physiotherapy without exercise |
Primary outcome
change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS).
Time frame: Outcomes measured at 0, 6 and 12 weeks
Primary outcome measure: Average pain scores at rest and at night for the week prior to measurement will be recorded using a 100mm visual analogue scale (VAS). The change in pain scores at 6 and 12 weeks from baseline will be measured.
4 secondary outcomes
Western Ontario Rotator Cuff Index (WORC
Time frame: 0, 6 and 12 weeks
The American Shoulder and Elbow Surgeons function score.
Time frame: 0. 6 and 12 weeks
SF-36 Health Survey • SF-36 Health Survey
Time frame: 0, 6 and 12 weeks
Isometric strength and range of movement of shoulder flexion, abduction, external rotation and internal rotation using a hand held dynamometer.
Time frame: 0, 6 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph G McVeigh, BSc Hons principal investigator
University of Ulster
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence based exercise protocol and Usual physiotherapy without exercise in people with Subacromial Impingement Syndrome, run by University of Ulster at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine E Hanratty, BSc Hons (0044 2890 368732, hanratty-c@email.ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in average pain scores at rest and at night using 100mm visual analogue scale (VAS). (time frame: Outcomes measured at 0, 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.