GRASP - Getting it right: addressing shoulder pain

Conditions

Rotator cuff problem Musculoskeletal Diseases Rotator cuff problem

Sally Hopewell, David J. Keene, Peter Heine, Ioana R. Marian, Melina Dritsaki et al. (16 authors)

Health Technology Assessment2021-08-0150 citations

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)

Lucy Cureton, Ioana R. Marian, Vicki S Barber, Adwoa Parker, David Torgerson et al. (6 authors)

Trials2021-07-2811 citations

10.1186/s13063-021-05452-w

Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial.

Hopewell S, Keene DJ, Marian IR, Dritsaki M, Heine P, Cureton L, Dutton SJ, Dakin H, Carr A, Hamilton W, Hansen Z, Jaggi A, Littlewood C, Barker KL, Gray A, Lamb SE, GRASP Trial Group.

2021-07-1281 citations

10.1016/s0140-6736(21)00846-1

Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: statistical analysis plan for the Getting it Right: Addressing Shoulder Pain (GRASP) 2 × 2 factorial multicentre randomised controlled trial

Ioana R. Marian, Sally Hopewell, David J. Keene, Lucy Cureton, Sarah E Lamb et al. (6 authors)

Trials2020-09-073 citations

10.1186/s13063-020-04704-5

Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the ‘Getting it Right: Addressing Shoulder Pain’ (GRASP) trial

David J. Keene, Hessam Soutakbar, Sally Hopewell, Peter Heine, Anju Jaggi et al. (11 authors)

Physiotherapy2019-07-0916 citations

10.1016/j.physio.2019.07.002

Clinical and cost-effectiveness of progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: protocol for a 2x2 factorial randomised controlled trial (the GRASP trial)

Sally Hopewell, David J. Keene, Michael Maia Schlüssel, Melina Dritsaki, Susan Dutton et al. (15 authors)

BMJ Open2017-07-0124 citations

10.1136/bmjopen-2017-018004

Interventions

GRASP: Consented participants will be randomised to intervention groups (1:1:1:1) using the centralised computer randomisation service RRAMP (https://rramp.octru.ox.ac.uk) provided by the Oxford Clini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: GRASP: 1. Men and women aged 18 years and above 2. New episode of shoulder pain (i.e., within the last 6 months) attributable to a rotator cuff disorder (e.g., cuff tendonitis, impingement syndrome, tendinopathy or rotator cuff tear) using the diagnostic criteria set out in the BESS guidelines 3. Not currently receiving physiotherapy 4. Not being considered for surgery PROMPTS (embedded retention trial): All participants in the PROMPTS study will have consented and be enrolled in the GRASP trial which will act as the host trial. In addition to meeting the inclusion criteria for the GRASP trial, the following inclusion criteria will apply for participants enrolled in the embedded PROMPTS study: 1. Participants will have the use of a mobile telephone, 2. Participants will be willing to provide this mobile telephone number and consent for contact to be made by the GRASP trial team using this number

Exclusion criteria

Exclusion criteria: 1. Participants with a history of significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) 2. Those with a neurological disease affecting the shoulder 3. Those with other shoulder disorders (e.g., inflammatory arthritis, frozen shoulder, glenohumeral joint or instability) or with red flags consistent with the criteria set out in the BESS guidelines 4. Those who have received corticosteroid injection or physiotherapy for shoulder pain in the last 6 months 5. Those with contra-indications to corticosteroid injection

Design outcomes

Primary

Measure	Time frame
GRASP: Shoulder pain and function is measured using the Shoulder Pain and Disability Index (SPADI) at baseline, 8 weeks, 6 and 12 months. PROMPTS (embedded retention trial): Questionnaire response rate, defined as the proportion of GRASP follow up questionnaires returned by participants.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 09/07/2018: GRASP: 1. Pain is measured using the Shoulder Pain and Disability Index (SPADI) 5-item subscale at baseline, 8 weeks, 6 and 12 months 2. Function is measured using the Shoulder Pain and Disability Index (SPADI) 8-item subscale at baseline, 8 weeks, 6 and 12 months 3. Health-related quality life is measured using the EQ-5D-5L at baseline, 8 weeks, 6 and 12 months 4. Psychological factors are measured using the Fear Avoidance Belief Questionnaire – physical activity 5-item subscale and Pain Self-efficacy questionnaire (short form) at baseline, 8 weeks, 6 and 12 months 5. Sleep disturbance is measured using the Insomnia Severity Index at baseline, 8 weeks, 6 and 12 months 6. Global impression of treatment is measured using the Patient-rated Likert scale at 8 weeks, 6 and 12 months 7. Return to desired activities is measured using the Patient-reported return to desired activities including work, social life and sport activities at 0, 8 weeks, 6 and 12 months 8. Exercise adherence is measured using the Patient-reported adherence to exercise at 8 weeks, 6 and 12 months 9. Medication usage is measured using the Patient-reported prescribed and over the counter medications, additional steroid injection at 8 weeks, 6 and 12 months 10. Work disability is measured by recording the number of days of sick leave taken at 8 weeks, 6 and 12 months 11. Healthcare use is measured by collecting NHS usage data at 8 weeks, 6 and 12 months 12. Out-of-pocket expenses are measured using patient related recording of out of pocket expenses at 8 weeks, 6 and 12 months PROMPTS (embedded retention trial): 1. Time to response, defined as the number of days which elapse between the GRASP follow up questionnaire being mailed out to participants and the questionnaire recorded as being returned to the GRASP trial team 2. The proportion of participants sent a reminder follow up questionnaire 3. The cost-effectiveness of the text message interventio	—

Measure

Time frame

Current secondary outcome measures as of 09/07/2018: GRASP: 1. Pain is measured using the Shoulder Pain and Disability Index (SPADI) 5-item subscale at baseline, 8 weeks, 6 and 12 months 2. Function is measured using the Shoulder Pain and Disability Index (SPADI) 8-item subscale at baseline, 8 weeks, 6 and 12 months 3. Health-related quality life is measured using the EQ-5D-5L at baseline, 8 weeks, 6 and 12 months 4. Psychological factors are measured using the Fear Avoidance Belief Questionnaire – physical activity 5-item subscale and Pain Self-efficacy questionnaire (short form) at baseline, 8 weeks, 6 and 12 months 5. Sleep disturbance is measured using the Insomnia Severity Index at baseline, 8 weeks, 6 and 12 months 6. Global impression of treatment is measured using the Patient-rated Likert scale at 8 weeks, 6 and 12 months 7. Return to desired activities is measured using the Patient-reported return to desired activities including work, social life and sport activities at 0, 8 weeks, 6 and 12 months 8. Exercise adherence is measured using the Patient-reported adherence to exercise at 8 weeks, 6 and 12 months 9. Medication usage is measured using the Patient-reported prescribed and over the counter medications, additional steroid injection at 8 weeks, 6 and 12 months 10. Work disability is measured by recording the number of days of sick leave taken at 8 weeks, 6 and 12 months 11. Healthcare use is measured by collecting NHS usage data at 8 weeks, 6 and 12 months 12. Out-of-pocket expenses are measured using patient related recording of out of pocket expenses at 8 weeks, 6 and 12 months PROMPTS (embedded retention trial): 1. Time to response, defined as the number of days which elapse between the GRASP follow up questionnaire being mailed out to participants and the questionnaire recorded as being returned to the GRASP trial team 2. The proportion of participants sent a reminder follow up questionnaire 3. The cost-effectiveness of the text message interventio

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Countries

England, United Kingdom

Contacts

Public ContactLucy Cureton

grasp@ndorms.ox.ac.uk+44 1865 737432

Outcome results

None listed