ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction
CompletedNot applicableNCT03255733
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study evaluates the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal tissue pain reduction began in July 2015 and was completed in March 2017. The More Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by the Principal Investigator. Patients were followed for up to 6 months after the first treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up at 26 weeks after the first treatment.
Study details
- Official title
- Intense Therapeutic Ultrasound for Chronic, Subcutaneous Lateral Epicondylitis Musculoskeletal Pain Reduction
- Conditions
- Tennis Elbow
- Interventions
- Device: Intense Therapeutic Ultrasound Treatment
- Sponsor
- Guided Therapy Systems
- Collaborators
- More Foundation
- Start date
- 2015-07-14
- Primary completion
- 2017-03-13
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Chronic Pain (\>90 days) from previously diagnosed Lateral Epicondylitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy. * No History of surgery to the affected anatomy. * No alternative treatment procedures within the last 90 days. * Unilateral Pain * Willingness to complete treatment and post treatment regimen as described. * Patients who have provided written and verbal informed consent. Exclusion Criteria: * Patients currently enrolled in any other non-conservative, device, or Investigational New Device (IND) clinical trial, or who have participated in a clinical study involving the Common Extensor Tendon, thirty days prior to study initiation; * Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study; * Patients who have received previous treatment in the symptomatic limb (not including conservative treatment); * At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03255733