Topic: Primary Care Research Network for England, Musculoskeletal
Conditions
Interventions
Patients who provide written informed consent for trial participation will be randomised to one of four treatment groups, namely:
1. Ultrasound-guided corticosteroid injection, with ph
Sponsors
Keele University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years and over, referred to interface service shoulder clinics with shoulder problems 2. No history of significant shoulder trauma, for example, fracture or full thickness cuff tear 3. A clinical diagnosis of subacromial impingement syndrome (SIS) i.e. pain in deltoid insertion area, positive Neer and HawkinsKennedy tests, pain on shoulder abduction Accurate diagnosis of SIS is challenging, but a combination of the patients? history and response to Neer and HawkinsKennedy tests (to rule SIS out with a negative test) and pain on shoulder abduction (to rule SIS in with a positive test) provides optimal sensitivity and specificity. Patients will not be required to undergo diagnostic imaging (eg MRI) to reflect current practice where treatment choices are informed by clinical findings; Target Gender: Male & Female ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: ·1. Below 18 years old 2. Those whose main complaint is due to neck problems, acromioclavicular pathology, or other primary shoulder disorders including adhesive capsulitis or full thickness cuff tear 3. Potentially serious pathology (inflammatory arthritis, polymyalgia rheumatica, malignancy etc) or ipsilateral shoulder surgery/replacement 4. Those already on a surgical waiting list for shoulder surgery 5. Contraindications to local corticosteroid injection (known blood coagulation disorders, warfarin therapy) 6. Participation in a shoulderfocused exercise programme or shoulder injection in the last month 7. Inability to provide written informed consent, complete written questionnaires, or read instruction leaflets written in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Shoulder Pain and Disability Index (SPADI); Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 11-item Tampa scale of kinesophobia; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months 2. Brief Illness Perception Questionnaire (5-items); Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months 3. Confidence in treatment; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire 4. Consultation in primary and secondary care; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire 5. Current employment status; Timepoint(s): : Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months 6. Effect of shoulder disability on typical everyday activities; Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months 7. EURO-QOL (EQ5D); Timepoint(s): Baseline questionnaire, 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months 8. Exercise adherence; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire 9. Global Change; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire 10. Hospital Admission; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire 11. Medical investigations; Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire 12. Medication use (prescribed and over-the-counter); Timepoint(s): 6 weeks follow-up questionnaire, 6 months follow-up questionnaire and 12 months follow-up questionnaire | — |
Countries
United Kingdom
Outcome results
None listed