clinical trials protocol lateral epicondylitis (tennis elbow)

Clinical trials protocol will follow CONSORT guidelines

clinical trials protocol

The New Zealand Clinical Trials Protocol in detail;

The trial will follow CONSORT guidelines for conducting and reporting of clinical trials.


Forty participants diagnosed with Lateral Epicondylitis will be recruited via advertising in local media and primary health care facilities. Past experience has shown that approximately 60% of volunteers assessed meet inclusion criteria.


Therefore, it is envisaged that approximately 60 volunteers would need assessment to recruit 40 participants. Participants will be randomized into two groups of 20 using computer generated sequence and group allocation will be performed by a person external to the research team.


One group receives 3 treatments of active ultrasound, the other group receives 3 treatments of placebo ultrasound, by all outward appearances the machine looks as though it is working normally, but it emits no energy.


According to New Zealand Ethical standards, one cannot deny a person a treatment that is believed to deliver benefit, therefore after the data collection period is over, the group receiving placebo treatment will be offered 3 treatments of active ultrasound. Treatment will be delivered on day 1, day 3, and day 10.


Blinding: the assessor and the patient will be blinded to group allocation. The physiotherapist providing treatment will know whether the ultrasound is active or placebo.


Inclusion criteria during the clinical trials protocol: participants between 18 - 70 years of age referred from physicians or physiotherapists or self-referred, with lateral elbow pain for more than 2 months, reproduced by resisted wrist and/or middle finger extension and tenderness over the lateral epicondyle; a clinical diagnosis of Lateral Epicondylalgia.


Exclusion criteria: bilateral elbow pain, symptoms of radio-ulnar joint OA, neurological symptoms or cervical radiculopathy. Injection into the common extensor tendon within the previous 3 months. Any contraindications to Ultrasound therapy.


Outcome Measures: will be assessed before randomization, after 3 treatments, at week 4, and at week 12. Measures of pain and disability will be included such as the numeric pain rating scale (NPRS), the Patient Rated Tennis Elbow Evaluation (PRTEE), pain free grip strength, and temperature of the skin over the elbow using a medical infrared thermography device.   


Statistical Analysis will be performed on an intention to treat basis using SPSS software to conduct a repeated measures ANOVA. Change from baseline scores will be analysed to explore within and between group differences, as well as any group/time interaction. Covariates of baseline scores will be taken into account.