Epicondylitis, Lateral, Epicondylitis of the Elbow
Conditions
Brief summary
Lateral epicondylalgia (LET) is characterized by pain, decreased muscle strength of the wrist extensor muscles, and disability. Among the treatments proposed in the literature, both focal shockwave therapy and radial shockwave therapy have been considered effective in the management of this musculoskeletal disorder. The objective of this study is to compare the safety and effectiveness of these two shockwave applications on the signs and symptoms of subjects with lateral epicondylalgia. In this clinical trial, subjects will be evaluated for elbow pain using a Visual Analog Scale (VAS), grip strength using a handheld dynamometer, and degree of disability using the Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE). A six-month follow-up will be performed. Patients will be randomly divided into three groups. The first group will receive radial shock waves (rESWT), the second group will receive focal shock waves (fESWT), and the third group, which will act as a control, will receive a placebo treatment with very low energy parameters according to the literature. Subjects will receive three sessions, one session per week.
Interventions
OTHERRadial shock waves treatment
Subjects in this group will receive radial shock waves
OTHERFocal Shock Waves treatment
Subjects in this group will receive focal shock waves
OTHERshock waves placebo treatment
Subjects in this group will receive a shock waves placebo treatment with very low energy settings
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pain in the lateral epicondyle \>3 months * Pain when performing resisted grip * Positive Cozen test * Positive Maudsley test
Exclusion criteria
* Pregnancy * Systemic diseases (Fibromyalgia, Diabetes, Arthritis) * Local infection or Cancer * Recent treatments (Physiotherapy, Corticosteroids)-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain with Visual Analogue Scale (VAS) | Change from Baseline pain at 6 month | The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured where "0" on the far left is no pain and "10" on the far right is the worst pain possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | Change from Baseline pain at 6 month | Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It will be recorded using a hand-held dynamometer. The subject is asked to exert grip strength until pain appears. It is measured in newtons. |
| Patient Rated Tennis Elbow Evaluation (PRTEE) | Change from Baseline pain at 6 month | The PRTEE is a population specific 15-item questionnaire designed to measure forearm pain and disability associated with lateral epicondyle tendinopathy. 0% is the best and 100% is the worst disability outcome |
| The Global Rating of Change (GROC) | Change from Baseline pain at 6 month | It's a scale that assesses whether the patient condition has gotten worse, better, or stayed the same and to quantify the magnitude of that change, typically following treatment.Subjects will make global ratings of changes regarding their level of well-being from their neck pain since the initial examination on a 15-point self-report scale (from -7 to 7), where -7 is the worst possible value and 7 is the best possible value. |
Countries
Spain
Contacts
CONTACTYanira Rodriguez-García, Master
Outcome results
None listed