Effects of TECAR Therapy in Lipedema Management

Not Applicable

Completed

• Conditions: Lipedema

• Registration Number: NCT07088315
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

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 Timeline

• Study Start: 2024-09-01
• Primary Completion: 2025-04-15
• Study Completion: 2025-05-20
• Status Verified: 2025-07
• Study First Submitted: 2025-07-19
• Study First Submitted QC: 2025-07-19
• Last Update Submitted: 2025-07-27
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Circumference measurements	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.
visual analogue scale (VAS)	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.
The Lower Extremity Functional Scale (LEFS)	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
The Lymphedema Quality of Life Questionnaire for the Leg (LYMQOL-Leg)	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.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital; 🇹🇷 Çankaya, Ankara, Turkey