N/A
N=29
ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction
Tennis Elbow
Bottom Line
View on ClinicalTrials.gov: NCT03255733 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Percentage of Patients Reporting at Least 25% Overall Pain Reduction — 88 percentage of patients with less pain
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intense Therapeutic Ultrasound Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guided Therapy Systems
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Reporting at Least 25% Overall Pain Reduction |
88 | — |
| SECONDARY Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities |
-58 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03255733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.