RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will investigate whether the impact of PEMF and RF therapies is safe and efficacious for the treatment of pain associated with soft tissue injuries as compared to treatment with ultrasound, and to show the effects of PEMF and RF therapies on range of motion and blood flow associated with soft tissue injuries as compared to ultrasound therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Myofascial Release vs. Stretching With Ultrasound for Trapezius Trigger Points in Athletes: A Randomized Clinical Trial

NCT07002593

Active Trapezius Trigger Point Pain

COMPLETED NA

The Effects of Ultrasound-guided PRF Versus DN in Myofascial Pain Patients

NCT06851000

Myofascial Pain

NOT_YET_RECRUITING NA

Instrument-Assisted Soft Tissue Mobilization Versus High Power Pain Threshold Ultrasound For Trapezius Myofascial Trigger Points

NCT05288933

Myofascial Pain Syndrome of Neck

COMPLETED NA

Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of MFPP

NCT04746352

Myofascial Pelvic Pain

COMPLETED NA

Masseter Muscle Stiffness After Heat Application and Percussion Therapy

NCT07237087

Healthy Participants

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, controlled study of the safety and efficacy of a radiofrequency (RF) and pulsed electromagnetic fields (PEMF) device compared to ultrasound (US) for the treatment of pain associated with soft tissue injuries, and to show the comparative effects on blood flow (BF) and range of motion (ROM). Total expected duration of the clinical study is approximately 6 months (enrollment period of 4 months and a follow-up period of 3 weeks) while individual participation will take three weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Soft Tissue Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participant is not aware which group they will be randomized into upon entering the study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Freeze Plus

Subjects in this arm will receive treatment using RF and PEMF

Group Type EXPERIMENTAL

RF and PEMF

Intervention Type DEVICE

RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment

Ultrasound

Subjects in this arm will receive treatment using ultrasound

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RF and PEMF

RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment

Intervention Type DEVICE

Ultrasound

Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Able to read, understand and provide written informed consent to receive treatment.
2. Healthy, adult male or female, 18 - 75 years of age.
3. Sustained recent (within 30 days), painful unilateral mild to moderate soft tissue injury.
4. Seeking treatment for pain associated with mild to moderate soft tissue injury.
5. BMI score is greater than 18.5 and less than 29.9.
6. Able and willing to comply with the treatment and follow-up schedule and requirements.

Exclusion Criteria

1. Pregnant, planning to become pregnant or nursing during the ocurse of the study.
2. Open wound or infection at site of soft tissue injury.
3. Evidence of severe injury, including fracture or nerve injury.
4. History of musculoskeletal disorders, including arthritis, tendonitis, bursitis, ankylosing spondylitis.
5. Moderate to severe ligament tear.
6. Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of anticoagulant use as per the subject's physician discretion is permitted).
7. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
8. Having an anesthetic or corticosteroid injection within 4 weeks of study enrollment.
9. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
10. Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
11. History of any form of cancer or pre-malignancy in the treatment area.
12. Severe concurrent conditions, such as cardiac disorders, uncontrolled hypertension, etc.
13. Patients with history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area.
14. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
15. Poorly controlled endocrine disorders, such as diabetes.
16. Skin piercings in the treatment area.
17. Having a history of anxiety-depression syndromes.
18. Any condition which in the opinion of the investigator may jeopardize the patient's safe participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes