Effects of TECAR Therapy in Lipedema Management

July 27, 2025 updated by: Oznur Uzun, Ankara City Hospital Bilkent

Clinical Effects of TECAR Therapy in the Conservative Management of Lipedema: A Randomized Controlled Trial

The physicians wanted to show the efficacy of a physical therapy device, Transfer Energy Capacitive and Resistive (TECAR) therapy, in women with lipedema which is an abnormal fat buildup on both sides of lower body. They focused on lower limb circumference, pain, functional capacity, and quality of life.

Study Overview

Status

Completed

Conditions

Detailed Description

This study aimed to evaluate the clinical efficacy of Transfer Energy Capacitive and Resistive (TECAR) therapy in women with Stage 2 lipedema, focusing on limb circumference, pain, functional status, and quality of life.

A prospective, randomized controlled trial was conducted with 30 female patients diagnosed with Stage 2 lipedema. Participants were randomized to a TECAR therapy group (n=15) or a control group (n=15). Both groups received compression garments and a structured exercise program; the TECAR group additionally underwent six TECAR sessions over three weeks. Outcomes included lower limb circumference, Visual Analog Scale (VAS) for pain, Lower Extremity Functional Scale (LEFS), and Lymphedema Quality of Life Questionnaire-Leg (LYMQOL-Leg), assessed at baseline and at one and three months post-treatment.

TECAR therapy resulted in greater reductions in lower limb circumference compared to standard care, with sustained improvement in the supramalleolar region at three months (p<0.05). A significant short-term reduction in pain was observed at one month (p = 0.003) only in the TECAR group, but this effect was not maintained at three months (p > 0.05). Functional scores trended toward improvement without reaching significance (p=0.058). The overall quality of life score improved significantly in the TECAR group (p=0.002), although individual LYMQOL subdomains including function, appearance, mood, or symptoms did not reach statistical significance (p > 0.05).

As an adjunct to standard care, TECAR therapy appears to reduce pain and limb volume and enhance overall quality of life in Stage 2 lipedema. Further long-term studies are needed to confirm these findings.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ankara
      • Çankaya, Ankara, Turkey
        • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged 18 to 60 years
  • Clinical diagnosis of Stage 2 lipedema (types 1-3)
  • Body mass index (BMI) which is less than 35

Exclusion Criteria:

  • Deterioration in general condition,
  • Presence of open wounds or sensory deficits in the area of application,
  • Active infections,
  • Malignancy,
  • Autoimmune or systemic inflammatory diseases (e.g., rheumatoid arthritis or systemic lupus erythematosus),
  • Severe cognitive impairment,
  • Uncontrolled chronic systemic disease,
  • History of physiotherapy or regular non-steroidal anti-inflammatory drug (NSAID) use within the last six months
  • Concomitant lymphedema or venous insufficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The control group receiving exercise and compression

All participants were provided with individually fitted compression garments (either pantyhose-type or thigh-high models, in class I [18-21 mmHg] or class II [23-32mmHg] depending on symptom severity and tolerance), and were instructed to wear them during waking hours for a minimum of 8 hours per day. Adherence to garment usage was monitored through patient diaries and reinforced at follow-up visits.

Additionally, all patients were advised to engage in a structured walking program, consisting of moderate-intensity walking (perceived exertion level 11-13 on the Borg scale), for at least 20 minutes per session, three times per week.

All participants were provided with individually fitted compression garments (either pantyhose-type or thigh-high models, in class I [18-21 mmHg] or class II [23-32mmHg] depending on symptom severity and tolerance), and were instructed to wear them during waking hours for a minimum of 8 hours per day. Adherence to garment usage was monitored through patient diaries and reinforced at follow-up visits.
All patients were advised to engage in a structured walking program, consisting of moderate-intensity walking (perceived exertion level 11-13 on the Borg scale), for at least 20 minutes per session, three times per week.
Experimental: The treatment group receiving exercise and compression plus TECAR Therapy
TECAR therapy was applied to the lower limbs of patients diagnosed with lipedema using the BTL-6000 TR-Therapy PRO device (BTL, Turkiye). All treatment sessions were performed by a physiotherapist with specific experience in TECAR therapy. The device operated at a frequency of approximately 500 kHz and employed three types of electrodes: active, neutral, and static application electrodes. Two types of active electrodes -capacitive and resistive- were utilized and applied directly to the treatment area. The neutral electrode, serving as a reference point, was placed in proximity to the target region to ensure effective energy transfer.
All participants were provided with individually fitted compression garments (either pantyhose-type or thigh-high models, in class I [18-21 mmHg] or class II [23-32mmHg] depending on symptom severity and tolerance), and were instructed to wear them during waking hours for a minimum of 8 hours per day. Adherence to garment usage was monitored through patient diaries and reinforced at follow-up visits.
All patients were advised to engage in a structured walking program, consisting of moderate-intensity walking (perceived exertion level 11-13 on the Borg scale), for at least 20 minutes per session, three times per week.
TECAR therapy was applied to the lower limbs of patients diagnosed with lipedema using the BTL-6000 TR-Therapy PRO device (BTL, Turkiye). All treatment sessions were performed by a physiotherapist with specific experience in TECAR therapy. The device operated at a frequency of approximately 500 kHz and employed three types of electrodes: active, neutral, and static application electrodes. Two types of active electrodes -capacitive and resistive- were utilized and applied directly to the treatment area. The neutral electrode, serving as a reference point, was placed in proximity to the target region to ensure effective energy transfer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circumference measurements
Time Frame: Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.
Circumference measurements were performed using a standard non-elastic tape measure at three anatomically defined landmarks: the mid-thigh, identified as the midpoint between the iliac crest and the lower border of the patella, the pretibial region, defined as the midpoint between the anterior tibial tuberosity and the medial malleolus and supramalleolar region. These regions were selected for their clinical relevance in lipedema and their high reproducibility in anthropometric assessments. To enhance measurement reliability, each site was measured three times consecutively, and the mean value was used for analysis. All measurements were conducted with the patient in a relaxed standing position by the same examiner to minimize inter-observer variability.
Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.
visual analogue scale (VAS)
Time Frame: Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.
Pain intensity was evaluated using the Visual Analog Scale (VAS), a 10-cm horizontal line representing a continuum of pain experience, where 0 indicates "no pain" and 10 denotes the "worst imaginable pain". Participants were asked to mark the point that best reflected their pain perception at each evaluation time point.
Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.
The Lower Extremity Functional Scale (LEFS)
Time Frame: Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.
Functional status was evaluated using the LEFS, a widely validated, patient-reported outcome measure specifically designed to assess lower extremity functional impairment. The LEFS consists of 20 items, each addressing a different daily or recreational activity involving the legs, such as walking, climbing stairs, squatting, or running. Participants rated the level of difficulty they experienced performing each activity on a 5-point Likert scale, ranging from 0 (extreme difficulty or unable to perform) to 4 (no difficulty).The total score ranges from 0 to 80, with higher scores reflecting greater functional capacity and less disability
Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.
The Lymphedema Quality of Life Questionnaire for the Leg (LYMQOL-Leg)
Time Frame: Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.
Quality of life was assessed using LYMQOL-Leg, a disease-specific instrument originally designed to evaluate health-related quality of life in patients with lower limb lymphedema. The questionnaire includes 24 items grouped into four distinct domains: function (activities of daily living and physical capacity), appearance (self-perception of leg aesthetics), mood (emotional and psychological well-being), and symptoms (such as heaviness, swelling, and pain). Each item is scored on a Likert scale from 1 to 4, with lower scores indicating greater impairment. In addition to domain scores, the LYMQOL includes a global quality of life score (rated on a scale from 0 to 10), where higher values reflect better overall quality of life [23, 24]. Although originally developed for lymphedema, LYMQOL has been effectively applied in lipedema studies due to symptom overlap.
Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

July 19, 2025

First Submitted That Met QC Criteria

July 19, 2025

First Posted (Actual)

July 28, 2025

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 27, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED 1-24-324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD can be shared upon request

IPD Sharing Time Frame

Beginning 3 months and ending 3 years after the publication of results

IPD Sharing Access Criteria

The doctors specialized in physical medicine and rehabilitation may reach principal investigator through email

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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