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LipedemaNCT07088315

Effects of TECAR Therapy in Lipedema Management

A study testing TECAR therapy, compression and Exercise in people with Lipedema, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Lipedema
What is being tested?
TECAR therapy, compression and Exercise
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2024to 20 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

    Çankaya, Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Lipedema
Being tested
TECAR therapy, compression, Exercise
Keywords
Lipedema, TECAR Therapy, Pain Management, Quality of Life
Medical subject headings
Lipedema, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TECAR therapyDevice

    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.

  • compressionOther

    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.

  • ExerciseOther

    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.

Study groups in NCT07088315
Study groupRoleWhat they receive
The control group receiving exercise and compressionActive comparatorAll 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.
Receives: Other: compression; Other: Exercise
The treatment group receiving exercise and compression plus TECAR TherapyExperimentalTECAR 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.
Receives: Device: TECAR therapy; Other: compression; Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.

  2. 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.

    Measured: Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.

  3. 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

    Measured: Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.

  4. 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.

    Measured: Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2025
  2. Study start1 Sep 2024
  3. Primary completion15 Apr 2025
  4. Study completion20 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07088315
Sponsor's protocol ID
TABED 1-24-324
Status last verified
Jul 2025
First submitted
19 Jul 2025
Last updated
30 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD can be shared upon request

Publications

  • 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.

    PubMed 33297826
  • 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.

    PubMed 37575263
  • 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.

    PubMed 32762835
  • 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.

    PubMed 39188170

Questions about this trial

What is this clinical trial studying?

A study testing TECAR therapy, compression and Exercise in people with Lipedema, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circumference measurements (time frame: Clinical assessments were conducted at baseline, as well as at 1 and 3 months following the treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07088315, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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