Shoulder pain Musculoskeletal Diseases Pain(s) shoulder
Conditions
Interventions
The informed consent process will commence when the usual-care clinician decides the patient is to be referred for therapeutic injection and meets the eligibility criteria for the SPIRIT trial.
The cl
in the control group, this
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 18 years or above 3. Clinician believes the patient may benefit from corticosteroid treatment
Exclusion criteria
Exclusion criteria: 1. Participants with a history of significant shoulder trauma (fracture or dislocation in last 5 years) 2. Previous shoulder surgery on the affected shoulder 3. Contraindications to APS therapy or CSI 4. A pre-existing neuro-degenerative and/or vascular condition that affects the function of the shoulder. 5. Received CSI/APS injection in 2 months prior to randomisation 6. The participant is unable to follow trial procedures 7. Patient does not have access to email/ smartphone directly or indirectly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The conversion rate of eligible to randomised participants until the end of the recruitment period measured using screening logs 2. Total number of participants recruited until the end of the recruitment period measured using screening logs | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Levels of retention at follow-up dates until the end of follow-up period (will be measured using all patient facing case report forms) 2. Data compliance at follow-up until the end of follow-up period (will be measured using all patient facing case report forms) 3. Completion rates of PROMIS upper limb physical function, PROMIS pain interference questionnaire, Oxford Shoulder Score (OSS), EQ-5D-5L score at baseline, 3 months and 6 months post-randomisation (will be measured using the following questionnaires :PROMIS upper limb physical function, PROMIS pain interference questionnaire, Oxford Shoulder Score (OSS), EQ-5D-5L) 4. Completion rates of Pain visual analogue score (VAS) at baseline, weekly up to 8 weeks, 3 and 6 months post-randomisation (will be measured using the following questionnaires. Pain Visual Analogue score (VAS)) 5. Completion rates of Patient complications up to 6 months post-randomisation (will be measured using patient complication Case report forms) 6. Completion rates of Work Productivity Impairment Questionnaire (WPAI) at baseline, 3 months and 6 months post-randomisation. (will be measured using the following questionnaires. Work Productivity Impairment Questionnaire (WPAI) 7. Patient and hospital reported resource use including referral rates for shoulder surgery at 6 months post-randomisation (will be measured using patient and hospital resource use case report forms) | — |
Countries
England, United Kingdom
Outcome results
None listed