Effects of TECAR Therapy in Lipedema Management

NCT07088315 | Completed

• 1 other identifier: TABED 1-24-324
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema

Keywords

Lipedema; TECAR Therapy; Pain Management; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Circumference measurements

  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)

  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)

  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)

  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.

Study Arms (2)

The control group receiving exercise and compression

ACTIVE COMPARATOR

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.

Other: compression; Other: Exercise

The treatment group receiving exercise and compression plus TECAR Therapy

EXPERIMENTAL

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.

Device: TECAR therapy; Other: compression; Other: Exercise

Interventions

TECAR therapy DEVICE

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.

The treatment group receiving exercise and compression plus TECAR Therapy

compression OTHER

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.

The control group receiving exercise and compression; The treatment group receiving exercise and compression plus TECAR Therapy

Exercise OTHER

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.

The control group receiving exercise and compression; The treatment group receiving exercise and compression plus TECAR Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Çankaya, Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• Atan T, Bahar-Ozdemir Y. The Effects of Complete Decongestive Therapy or Intermittent Pneumatic Compression Therapy or Exercise Only in the Treatment of Severe Lipedema: A Randomized Controlled Trial. Lymphat Res Biol. 2021 Feb;19(1):86-95. doi: 10.1089/lrb.2020.0019. Epub 2020 Dec 9.

  PMID: 33297826 BACKGROUND

• Kruppa P, Gohlke S, Lapinski K, Garcia-Carrizo F, Soultoukis GA, Infanger M, Schulz TJ, Ghods M. Lipedema stage affects adipocyte hypertrophy, subcutaneous adipose tissue inflammation and interstitial fibrosis. Front Immunol. 2023 Jul 28;14:1223264. doi: 10.3389/fimmu.2023.1223264. eCollection 2023.

  PMID: 37575263 BACKGROUND

• Kruppa P, Georgiou I, Biermann N, Prantl L, Klein-Weigel P, Ghods M. Lipedema-Pathogenesis, Diagnosis, and Treatment Options. Dtsch Arztebl Int. 2020 Jun 1;117(22-23):396-403. doi: 10.3238/arztebl.2020.0396.

  PMID: 32762835 BACKGROUND

• Faerber G, Cornely M, Daubert C, Erbacher G, Fink J, Hirsch T, Mendoza E, Miller A, Rabe E, Rapprich S, Reich-Schupke S, Stucker M, Brenner E. S2k guideline lipedema. J Dtsch Dermatol Ges. 2024 Sep;22(9):1303-1315. doi: 10.1111/ddg.15513. Epub 2024 Aug 27.

  PMID: 39188170 BACKGROUND

MeSH Terms

Conditions

Lipedema; Agnosia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Deputy Chief of Physical Medicine and Rehabilitation Hospital, Principal Investigator

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: September 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: May 20, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: The doctors specialized in physical medicine and rehabilitation may reach principal investigator through email

Locations

TU (1)