Health TrialsbyHealthPanel

ESWT for Primary Lipedema

ConditionLipedema
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorFatih Bagcier

About this trial

This randomized controlled clinical trial aims to evaluate the effectiveness of extracorporeal shockwave therapy (ESWT) when added to standard conservative treatment in women with primary lipedema. Participants will be randomly assigned to receive either standard conservative therapy alone or standard therapy combined with radial ESWT. The study will assess changes in pain intensity (VAS), limb circumference measurements, quality of life (SF-36), and patient satisfaction over an 8-week period. Evaluations will be performed at baseline, at the end of the 4-week treatment phase, and at 4-week follow-up. This trial seeks to provide evidence on whether ESWT offers additional clinical benefit in the management of primary lipedema.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Conservative Therapy

    Other intervention

    Manual lymphatic drainage, pneumatic compression, Class II compression garments, and a home-based exercise program.

  • radial ESWT

    Device

    adial extracorporeal shockwave therapy using a BTL device (2.0-2.5 bar, 12 Hz, 1000 shocks per region, 20-mm head), twice weekly for 4 weeks (8 sessions).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Standard Conservative TherapyActive comparator 1 intervention
Group B: Standard Therapy plus ESWTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Limb Circumference Measurements

Circumference will be measured at the thigh (+10 cm and +20 cm above the patella), calf (10 cm above the medial malleolus), and ankle (narrowest point). The change from baseline will be compared at Week 4 and Week 8.

Time frame
Baseline (T0), Week 4 (T1), Week 8 (T2)

Secondary outcomes

1

Visual Analog Scale (VAS)

Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). The primary analysis will compare the change in VAS score between baseline and the end of the 4-week treatment period.

Time frame
Baseline (T0), Week 4 (T1), Week 8 (T2)
2

Short Form-36 Health Survey (SF-36)

Quality of life will be evaluated using the SF-36 questionnaire. Changes in physical and mental component scores will be assessed across time points.

Time frame
Baseline (T0), Week 4 (T1), Week 8 (T2)
3

Treatment Satisfaction (Likert Scale)

Patient satisfaction will be assessed using a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied).

Time frame
Week 4 (T1), Week 8 (T2)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fatih Bagcier

Lead sponsor

Kars State Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: