Tennis elbow Musculoskeletal Diseases
Conditions
Interventions
Participants are randomised in a 1:1 ratio between treatments, stratified by site and completed via REDCap centrally to ensure allocation concealment.
Surgical arm:
Open or arthroscopic debridement o
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults (aged =18 years) with unilateral tennis elbow characterised by =6 months of lateral elbow pain 2. Pain on palpation of the common extensor origin and pain on gripping 3. Positive Cozen’s, Mills’ or Maudsley’s test
Exclusion criteria
Exclusion criteria: 1. Suspected tumour or infection around the elbow 2. Recent significant elbow trauma or previous elbow surgery likely to affect outcomes 3. Cervical pain or radiculopathy that may be causing lateral elbow pain 4. Medial or anterior or posterior elbow pain in the same elbow, or pain in the contralateral elbow 5. Pregnancy 6. Comorbidities preventing surgical intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate, defined as the proportion of eligible participants who go on to be randomised, measured using screening and enrolment data at the point of randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment metrics: screening, eligibility, approach, consent and randomisation numbers measured using site logs continuously throughout recruitment period 2. Time to surgery: time from randomisation to surgical procedure measured using surgical CRF from post randomisation until surgery 3. Physiotherapy attendance and timing: number of sessions attended and time to first session, meaasured using physio CRF post randomisation 4. Exercise adherence measured using the Exercise Adherence Rating Scale (EARS) at 3, 6 and 12 months 5. Retention: completion of follow-up questionnaires measured using follow-up CRFs at 3, 6 and 12 months Exploratory clinical outcomes: 1. Pain and function measured using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at baseline, intervention delivery, 3, 6, 12 months 2. Health-related quality of life measured using EQ 5D 5L at baseline, intervention delivery, 3, 6, 12 months 3. Pain on gripping measured using the Numerical Rating Scale (NRS) at baseline, intervention delivery, 3, 6, 12 months 4. Work limitation and time off work measured using work limitation questionnaire at baseline, 3, 6, 12 months 5. Health resource utilisation measured using resource use questionnaire at intervention delivery, 3, 6, 12 months | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactLiz Cook
Outcome results
None listed