Treatment of Lateral Epicondylalgia With Shock Waves
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Alcala
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pain in the lateral epicondyle >3 months
Pain when performing resisted grip
Positive Cozen test
Positive Maudsley test
Disqualifiers
Pregnancy
Systemic diseases (Fibromyalgia, Diabetes, Arthritis)
Local infection or Cancer
Recent treatments (Physiotherapy, Corticosteroids)-
Trial design
Design model
Parallel
Treatments tested in this trial
Radial shock waves treatment
Other interventionSubjects in this group will receive radial shock waves
Focal Shock Waves treatment
Other interventionSubjects in this group will receive focal shock waves
shock waves placebo treatment
Other interventionSubjects in this group will receive a shock waves placebo treatment with very low energy settings
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Radial Shock Wave TreatmentExperimental treatment 1 intervention
Group B: Focal Shock Wave TreatmentExperimental treatment 1 intervention
Group C: Placebo Shock WavesPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain with Visual Analogue Scale (VAS)
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.
Time frame
Change from Baseline pain at 6 monthSecondary outcomes
1
Grip strength
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.
Time frame
Change from Baseline pain at 6 month2
Patient Rated Tennis Elbow Evaluation (PRTEE)
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
Time frame
Change from Baseline pain at 6 month3
The Global Rating of Change (GROC)
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.
Time frame
Change from Baseline pain at 6 monthSponsors and contacts
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Source ClinicalTrials.gov