Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
Primary Purpose
Shoulder Pain, Rotator Cuff Impingement
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Rotator cuff rehabilitation classes
Individual Physiotherapy
Triamcinolone Injection
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Physiotherapy, Group Treatment
Eligibility Criteria
Inclusion Criteria:
- unilateral shoulder pain of more than 4 weeks duration and a Shoulder Pain and Disability Index (SPADI) score of >= 30 as this represents significant disability. Shoulder pain is defined as pain in the shoulder region, including the upper arm, elicited by active or passive shoulder movement. The diagnosis of "subacromial pain" is defined by range as no limitation in passive range of movement or restriction of passive range of movement mainly in abduction rather than external rotation.
Exclusion Criteria:
- inability to give informed consent
- physiotherapy or injection treatment for current shoulder pain in previous 3 months
- blood coagulation disorders
- bilateral shoulder pain
- evidence of systemic infection
- abnormal shoulder X-ray defined as significant glenohumeral or subacromial joint space narrowing suggesting osteoarthritis of glenohumeral joint or complete rotator cuff rupture,
- evidence of rotator cuff tear, tested by external rotation lag sign, drop sign, internal rotation lag sign and static muscle resistance in external rotation, internal rotation and abduction,
- history of significant trauma to the shoulder,
- inflammatory joint disease,
- history of cerebrovascular accident,
- allergy or contraindication to Triamcinolone/contraindication to injection.
- evidence of referred pain from cervical spine disease.
- pregnancy or breast feeding
- patients whose first language is not English
Sites / Locations
- Ian Ryans
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group Physiotherapy
Routine Physiotherapy
Arm Description
1 class per week for 6 weeks (30 min length) aiming for 5-10 participants per class. Classes included advice on the nature of the condition and exercises for scapulo-humeral mobility, scapulo-humeral stability and specific rotator cuff rehabilitation exercises
Individual physiotherapy sessions: 6 sessions weekly (30 min) for 6 weeks. Treatment was based on evidence-based guidelines for the treatment of shoulder impingement (CSP 2005) and consisted of mobilisation techniques, supervised exercises and stretches.
Outcomes
Primary Outcome Measures
Shoulder Pain And Disability Index (SPADI)
The shoulder pain and disability index
Secondary Outcome Measures
Active range of external rotation
Range of active external rotation of the shoulder measured by goniometer.
Internal rotation
Measures as distance in centimetres between thumb tip and C7 spinous process)
Global patient self-assessment
Self assessment of global wellbeing measured by a 100mm visual analogue scale. Score minimum 0 and maximum 100 higher score indicates higher wellbeing.
Short Form 36 version 2 (SF36v2)
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.
Each scale is transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
EuroQuol 5 - Dimensions - 3 Levels (EQ-5D-3L)
EuroQol's EQ-5D is a generic instrument to measure and evaluate health status. The EQ-5D 3L version, describes general health based on five distinct dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 Levels (indicating no problem, some or moderate problem and extreme problem). EQ-5D comprises of five domains, each with three possible levels, a combination of the characteristic levels produces 243 possible health states (ranging from 11111 to 33333). The EQ-5D index scores are utilities derived from the respondents profile and ranges from 0 to 1; 0 meaning death and 1 complete health.
Hospital Anxiety and Depression Scale (HADS)
The HAD questionnaire comprises seven questions for anxiety and seven questions for depression. The anxiety and depression questions are interspersed within the questionnaire but are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety has a specificity of 0.78 and a sensitivity of 0.9, and for depression a specificity of 0.79 and a sensitivity of 0.83. Each scale has a range of 0-21. Scores of 15-21 indicate severe, 11-14, moderate and 8-10 mild, 7 or less indicates no case
Full Information
NCT ID
NCT04058522
First Posted
August 14, 2019
Last Updated
August 14, 2019
Sponsor
South Eastern Health and Social Care Trust
Collaborators
Northern Ireland Clinical Trials Unit, University of Ulster, Queen's University, Belfast
1. Study Identification
Unique Protocol Identification Number
NCT04058522
Brief Title
Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
Official Title
Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 19, 2008 (Actual)
Primary Completion Date
February 10, 2013 (Actual)
Study Completion Date
February 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Eastern Health and Social Care Trust
Collaborators
Northern Ireland Clinical Trials Unit, University of Ulster, Queen's University, Belfast
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is therefore to examine the clinical effectiveness and provide an economic analysis of individual versus group physiotherapy, following corticosteroid injection, for management of Subacromial Impingement (SAI) of the shoulder.
Detailed Description
This trial was a single blind, randomised, equivalence trial comparing rotator cuff rehabilitation classes with traditional individual physiotherapy in subacromial impingement of the shoulder. A total of 200 patients were planned to be recruited from patients with painful shoulder referred to the Ulster Community and Hospitals Trust and community physiotherapy at the Ulster, Ards and Bangor sites or injection clinics at the Ulster Hospital. Local General Practitioners were also informed of the study and invited to refer appropriate patients.
Intervention - Triamcinolone 40 mg (1 ml) and 6 weekly rotator cuff rehabilitation classes Control - Triamcinolone 40 mg (1 ml) and routine physiotherapy 6 sessions weekly for 6 weeks
The injection technique involving a lateral approach to the subacromial space was used. An interval of between 1 and 3 weeks was allowed between injection and commencement of classes or physiotherapy.
Classes were planned to be run by a rotating group of physiotherapists with at least 1 year of musculoskeletal outpatient's experience. They were to receive instruction on the protocol to use in the classes. Classes were to consist of six 30 min sessions on a weekly basis. A minimum of 5 and maximum of 10 participants were to attend. Advice was to be given on the nature of the condition. Subjects were to be instructed and supervised in exercises for scapulo-humeral mobility, scapulo-humeral stability and specific rotator cuff rehabilitation exercises. Subjects were to be introduced to ongoing classes as they are recruited to the trial.
Six sessions of routine physiotherapy at weekly intervals were to be undertaken. Treatment was to be based on evidence-based guidelines for the treatment of shoulder impingement (Evidence-based clinical guidelines for the diagnosis, assessment and physiotherapy management of shoulder impingement syndrome Chartered Society of Physiotherapists 2005) and consist of mobilisation techniques and supervised exercises and stretches. A therapist with at least 1 year of musculoskeletal outpatients experience was to provide treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Rotator Cuff Impingement
Keywords
Physiotherapy, Group Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind randomised trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Off site randomisation
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Physiotherapy
Arm Type
Experimental
Arm Description
1 class per week for 6 weeks (30 min length) aiming for 5-10 participants per class. Classes included advice on the nature of the condition and exercises for scapulo-humeral mobility, scapulo-humeral stability and specific rotator cuff rehabilitation exercises
Arm Title
Routine Physiotherapy
Arm Type
Active Comparator
Arm Description
Individual physiotherapy sessions: 6 sessions weekly (30 min) for 6 weeks. Treatment was based on evidence-based guidelines for the treatment of shoulder impingement (CSP 2005) and consisted of mobilisation techniques, supervised exercises and stretches.
Intervention Type
Other
Intervention Name(s)
Rotator cuff rehabilitation classes
Intervention Type
Other
Intervention Name(s)
Individual Physiotherapy
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Injection
Other Intervention Name(s)
Kenalog Injection
Intervention Description
Subacromial Injection 40mg/1ml
Primary Outcome Measure Information:
Title
Shoulder Pain And Disability Index (SPADI)
Description
The shoulder pain and disability index
Time Frame
26 Weeks
Secondary Outcome Measure Information:
Title
Active range of external rotation
Description
Range of active external rotation of the shoulder measured by goniometer.
Time Frame
26 weeks
Title
Internal rotation
Description
Measures as distance in centimetres between thumb tip and C7 spinous process)
Time Frame
26 weeks
Title
Global patient self-assessment
Description
Self assessment of global wellbeing measured by a 100mm visual analogue scale. Score minimum 0 and maximum 100 higher score indicates higher wellbeing.
Time Frame
26 weeks
Title
Short Form 36 version 2 (SF36v2)
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.
Each scale is transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
26 weeks
Title
EuroQuol 5 - Dimensions - 3 Levels (EQ-5D-3L)
Description
EuroQol's EQ-5D is a generic instrument to measure and evaluate health status. The EQ-5D 3L version, describes general health based on five distinct dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 Levels (indicating no problem, some or moderate problem and extreme problem). EQ-5D comprises of five domains, each with three possible levels, a combination of the characteristic levels produces 243 possible health states (ranging from 11111 to 33333). The EQ-5D index scores are utilities derived from the respondents profile and ranges from 0 to 1; 0 meaning death and 1 complete health.
Time Frame
26 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The HAD questionnaire comprises seven questions for anxiety and seven questions for depression. The anxiety and depression questions are interspersed within the questionnaire but are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety has a specificity of 0.78 and a sensitivity of 0.9, and for depression a specificity of 0.79 and a sensitivity of 0.83. Each scale has a range of 0-21. Scores of 15-21 indicate severe, 11-14, moderate and 8-10 mild, 7 or less indicates no case
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
unilateral shoulder pain of more than 4 weeks duration and a Shoulder Pain and Disability Index (SPADI) score of >= 30 as this represents significant disability. Shoulder pain is defined as pain in the shoulder region, including the upper arm, elicited by active or passive shoulder movement. The diagnosis of "subacromial pain" is defined by range as no limitation in passive range of movement or restriction of passive range of movement mainly in abduction rather than external rotation.
Exclusion Criteria:
inability to give informed consent
physiotherapy or injection treatment for current shoulder pain in previous 3 months
blood coagulation disorders
bilateral shoulder pain
evidence of systemic infection
abnormal shoulder X-ray defined as significant glenohumeral or subacromial joint space narrowing suggesting osteoarthritis of glenohumeral joint or complete rotator cuff rupture,
evidence of rotator cuff tear, tested by external rotation lag sign, drop sign, internal rotation lag sign and static muscle resistance in external rotation, internal rotation and abduction,
history of significant trauma to the shoulder,
inflammatory joint disease,
history of cerebrovascular accident,
allergy or contraindication to Triamcinolone/contraindication to injection.
evidence of referred pain from cervical spine disease.
pregnancy or breast feeding
patients whose first language is not English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Ryans, MD
Organizational Affiliation
Dundonald Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ian Ryans
City
Dundonald
State/Province
Co Down
ZIP/Postal Code
BT16 2LN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32752234
Citation
Ryans I, Galway R, Harte A, Verghis R, Agus A, Heron N, McKane R. The Effectiveness of Individual or Group Physiotherapy in the Management of Sub-Acromial Impingement: A Randomised Controlled Trial and Health Economic Analysis. Int J Environ Res Public Health. 2020 Aug 1;17(15):5565. doi: 10.3390/ijerph17155565.
Results Reference
derived
Learn more about this trial
Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
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