ClinicalTrials.gg
CompletedNCT07088315Updated Jul 30, 2025

Effects of TECAR Therapy in Lipedema Management

An interventional study of TECAR therapy and compression in Lipedema, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Sep 2024, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 41 studies in Lipedema with a site in Turkey — 18 open to participants now, 19 under way, none of them phase 3. Lipedema · Turkey.

Enrollment
11th of 14
30 · median 37
Started
2024
with 3 others
No phase
14 of 41
9 open now
Registered
16th of 41
by date
Lead sponsor
1 of 41
Ankara City Hospital Bilkent

Among the 41 studies in Lipedema with a site in Turkey, this one is the 11th largest by enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2024, is one of 14 with no phase, and was the 16th registered.

Lipedema

85 studies on the registry are indexed under Lipedema; 32 are open to participants now.

This study's enrollment of 30 is below the median of 35 across 42 interventional studies indexed under Lipedema.

Browse Lipedema studies →

Open to participants now

18 of the 41 studies in Lipedema with a site in Turkey are open now, in 1 country. Each count lists the studies.

All 18 open studies →

Where they have run

Who these studies take

Of the 19 Lipedema studies recruiting now, 3 (16%) set no upper age limit and 16 (84%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 60 Years · female · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 41 studies in Lipedema with a site in Turkey, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Lipedema

Browse trials for

Keywords

  • Lipedema
  • TECAR Therapy
  • Pain Management
  • Quality of Life
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Deterioration in general condition,
  • Presence of open wounds or sensory deficits in the area of application,
  • Active infections,
  • ,
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
30 participants (actual)

Study arms

  • 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.

    Other: compression · Other: Exercise

  • 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.

    Device: TECAR therapy · Other: compression · Other: Exercise

Interventions

  • DeviceTECAR 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.

  • Othercompression

    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.

  • OtherExercise

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

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

07

Study locations

1 site
  • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
    Çankaya, Ankara, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — all collected IPD can be shared upon request

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Apr 2025, 7 months.

Of 29 interventional studies with no phase under Lipedema, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2025
First posted
Jul 28, 2025
StartActual
Sep 1, 2024
Primary completionActual
Apr 15, 2025
CompletionActual
May 20, 2025
Last update
Jul 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07088315
Responsible party
Oznur Uzun (MD, Deputy Chief of Physical Medicine and Rehabilitation Hospital, Principal Investigator, Ankara City Hospital Bilkent) — Principal investigator
First posted
Jul 28, 2025
Start date
Sep 1, 2024
Primary completion
Apr 15, 2025
Completion
May 20, 2025
Last update
Jul 30, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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