This randomised, controlled, double-blind experimental study is designed to evaluate the efficacy of a standardised manual physiotherapy protocol for treating lateral epicondylalgia of the humerus, commonly known as 'tennis elbow'. The study will compare the results for patients receiving active treatment with those for a control group who will follow a watchful waiting approach. Secondary objectives include analysing the relationship between pain, grip strength and joint mobility in the elbow and cervical spine. A sample of healthy subjects will also be included to establish baseline data and measure the effects of the protocol in an asymptomatic population.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of epicondylalgia.
* Pain on palpation of the epicondyle. Performed and measured with an algometer.
* Pain on isometric contraction against resistance of the wrist extensors (epicondylar muscles).
* Pain on contraction of the wrist and finger flexor muscles or pressure force. Performed and measured with a JAMAR manual pressure dynamometer.
* Pain on stretching-elongation of the epicondylar muscles or Mills test (wrist and finger flexion, forearm pronation and elbow extension).
* Pain during prono-supination movements of the forearm and/or flexion-extension of the elbow.
Subjects must meet a minimum of 4 of the 5 inclusion criteria to be part of the study. In addition to the inclusion criteria, subjects must be between 18 and 60 years of age, able to answer questionnaires in Spanish, and give their written consent.
Exclusion Criteria:
* History of elbow fractures or cracks during the last twelve months.
* History of elbow dislocations and/or subluxations during the last twelve months.
* History of elbow surgery.
* Congenital and/or acquired elbow deformity.
* Organic elbow condition (osteoarthritis, arthritis).
* Radio-humeral bursitis.
* Radio-humeral chondromalacia.
* Tear of the annular ligament.
* Detachment of the periosteum.
* Tendon rupture in the elbow.
* Metabolic or infectious arthropathy.
* Cervical pathology or cervicobrachial neuralgia.
* Bilateral elbow pain.
* Radial nerve compression neuropathy.
* Participating in pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.