Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection

Study Overview
=================
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.

Official Title
-----------------
Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection

Conditions
-----------------
Shoulder Pain, Rotator Cuff Impingement

Intervention / Treatment
-----------------
* Other: Rotator cuff rehabilitation classes
* Other: Individual Physiotherapy
* Drug: Triamcinolone Injection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blind randomised trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Physiotherapy<br>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 | Other: Rotator cuff rehabilitation classes<br> <br> Drug: Triamcinolone Injection<br>* Subacromial Injection 40mg/1ml<br>* Other names: Kenalog Injection;|
| Active Comparator: Routine Physiotherapy<br>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. | Other: Individual Physiotherapy<br> <br> Drug: Triamcinolone Injection<br>* Subacromial Injection 40mg/1ml<br>* Other names: Kenalog Injection;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain And Disability Index (SPADI) | The shoulder pain and disability index | 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active range of external rotation | Range of active external rotation of the shoulder measured by goniometer. | 26 weeks | 
| Internal rotation | Measures as distance in centimetres between thumb tip and C7 spinous process) | 26 weeks | 
| 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. | 26 weeks | 
| 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. | 26 weeks | 
| 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. | 26 weeks | 
| 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 | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiotherapy, Group Treatment