Ian Ryans
Dundonald, Co Down, BT16 2LN, United Kingdom
NCT Number: NCT04058522
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Dundonald, Co Down, BT16 2LN, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subacromial Injection 40mg/1ml
Other names: Kenalog Injection
Time frame: 26 Weeks
The shoulder pain and disability index
Time frame: 26 weeks
Range of active external rotation of the shoulder measured by goniometer.
Time frame: 26 weeks
Measures as distance in centimetres between thumb tip and C7 spinous process)
Time frame: 26 weeks
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
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
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
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
South Eastern Health and Social Care Trust
Other
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