Optimising physiotherapy for people with tennis elbow

Not Applicable

Completed

• Conditions: Tennis elbow; Musculoskeletal Diseases; Lateral epicondylitis

• Registration Number: ISRCTN64444585
• Lead Sponsor: niversity Hospitals of Derby and Burton NHS Foundation Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35953842/ (added 12/08/2022) 2023 Other publications in https://doi.org/10.1136/bmjopen-2023-072070 qualitative study (added 30/08/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38194841/ (added 12/02/2024) Results article see attached file ISRCTN64444585_ResultsPlainEnglish.pdf (added 12/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-19
• Study Completion: 2023-03-03
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Aged 18 years or over
2. Lateral elbow pain
3. Pain reproduced on palpation of the common extensor origin and on gripping
4. Positive Cozen’s, Mills’ or Maudsley’s tests (at least one positive)

Exclusion Criteria

1. Recent history of significant trauma to the affected limb e.g. a fall on an outstretched hand
2. Previous diagnosis of inflammatory arthritis or gout
3. Previous diagnosis of osteoarthritis of the affected elbow
4. Neurological symptoms in the affected limb correlating with onset of elbow pain e.g. loss of sensation in the hand
5. Co-existing neck pain and stiffness that started at a similar time to the elbow symptoms
6. Unable to understand English or lacking capacity for informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility outcome measures:<br>1. Consent rate - measured as a percentage of eligible patients approached to participate<br>2. Intervention fidelity in the intervention group - measured using data from CRF03. Fidelity to the intervention will be defined by delivery of at least 6 of the prescribed advice/education topics, evidence of exercise prescription and progression in line with the protocol and provision of an elbow clasp splint. Results will be expressed as a percentage of the patients in the intervention group who received treatment assessed as being faithful to the protocol.<br>3. Follow-up rate in the intervention group - the actual number of visits (excluding the baseline visit) divided by the maximum number of possible visits<br>4. Outcome measure completion rate at 6 months – measured as a percentage of outcome measures completed across both the intervention and usual care groups

Secondary Outcome Measures

Name	Time	Method
1. NRS pain on gripping (baseline, 6 weeks, 3 months, 6 months)<br>2. Patient rated tennis elbow evaluation PRTEE (baseline, 6 weeks, 3 months, 6 months)<br>3. Tampa scale of kinesiophobia TSK-11 (baseline, 6 weeks, 3 months, 6 months)<br>4. Pain self-efficacy questionnaire PSEQ (baseline, 6 weeks, 3 months, 6 months)<br>5. Quality of life EQ5D (baseline, 6 weeks, 3 months, 6 months)<br>6. Pain free grip strength (dynamometer) (baseline, 6 weeks, 3 months, 6 months)<br>7. Maximum grip strength (dynamometer) (baseline, 6 weeks, 3 months, 6 months)<br>8. Global rating of change GROC (6 weeks, 3 months, 6 months)<br>9. Exercise adherence rating scale EARS (6 weeks, 3 months, 6 months)