- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07919574
Effectiveness of Kinesio Taping as an Adjunct to Conservative Treatment in Women With Lipedema
Effectiveness of Kinesio Taping as an Adjunct to Conservative Treatment in Women With Stage II Lipedema: A Prospective, Randomized Controlled Trial
This prospective, randomized controlled trial aims to evaluate the effectiveness of kinesio taping as an adjunct to standard conservative treatment in women with stage II lower-extremity lipedema.
A total of 30 women will be randomly assigned to two groups: a control group receiving standard conservative treatment and an intervention group receiving kinesio taping in addition to standard conservative treatment. Both groups will receive patient education, physical activity recommendations, and a standardized home exercise program. The intervention group will additionally receive bilateral lower-extremity kinesio taping twice weekly for six weeks.
Participants will be assessed at baseline, week 6 (end of treatment), and week 10 (four-week follow-up). The primary outcome will be the change in pain intensity measured using the Visual Analog Scale (VAS) at week 6. Secondary outcomes will include lower-extremity functional status (LEFS), quality of life (EQ-5D-3L), walking performance (4-meter walk test), lower-extremity circumference measurements, and pressure pain threshold assessed using an algometer.
The study aims to determine whether adding kinesio taping to standard conservative treatment provides additional clinical benefits in women with lipedema.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hatice Zehra FERHATLAR
- Numéro de téléphone: 05367387869
- E-mail: haticezehraferhatlar@gmail.com
Lieux d'étude
-
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Istanbul
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Küçükçekmece, Istanbul, Turquie (Türkiye), 34307
- Recrutement
- Kanuni Sultan Suleyman Training and Research Hospital
-
Contact:
- Hatice Zehra FERHATLAR, MD
- Numéro de téléphone: 05367387869
- E-mail: haticezehraferhatlar@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
**Inclusion Criteria:**
- Female participants aged 18-65 years.
- Clinical diagnosis of stage II bilateral lower-extremity lipedema.
- Ability to walk independently.
- Ability and willingness to comply with the treatment and assessment schedule throughout the study.
- Provision of written informed consent.
**Exclusion Criteria:**
- Presence of primary or secondary lymphedema or lipolymphedema.
- Pregnancy or breastfeeding.
- Active infection, cellulitis, open wounds, or active dermatological disease in the areas where kinesio taping will be applied.
- Known allergy or hypersensitivity to kinesio tape or its adhesive components.
- Active deep vein thrombosis or thromboembolic disease.
- Severe neurological, rheumatological, or orthopedic disorders that may significantly affect lower-extremity function or walking performance.
- Severe cardiac, renal, or hepatic failure.
- Lipedema-related surgery or liposuction within the previous three months.
- Concurrent participation in another intensive physical therapy or manual lymphatic drainage program that may affect study outcomes.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Conservative Treatment + Kinesio Taping
|
Kinesio taping will be applied bilaterally to the lower extremities of participants in the experimental group twice weekly for six weeks, for a total of 12 applications. Kinesio taping will be administered in addition to standard conservative treatment. Standard conservative treatment will consist of patient education regarding lipedema and symptom management, physical activity recommendations, and a standardized lower-extremity home exercise program. This treatment will be provided to participants in both groups during the six-week intervention period. |
|
Comparateur actif: Conservative Treatment Alone
|
Standard conservative treatment will consist of patient education regarding lipedema and symptom management, physical activity recommendations, and a standardized lower-extremity home exercise program. This treatment will be provided to participants in both groups during the six-week intervention period. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change in Pain Intensity Measured by the Visual Analog Scale (VAS)
Délai: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change in Lower Extremity Functional Scale (LEFS) Score
Délai: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
|
Change in Health-Related Quality of Life Measured by EQ-5D-3L
Délai: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
|
Change in Walking Performance Assessed by the 4-Meter Walk Test
Délai: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
|
Change in Lower Extremity Circumference Measurements
Délai: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
|
Change in Pressure Pain Threshold (PPT) Measured by Algometry
Délai: Baseline (week 0), week 6, and week 10
|
Baseline (week 0), week 6, and week 10
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Michelini S, Musa F, Vetrano M, Santoboni F, Nusca SM, Latini E, Trischitta D, Michelini S, Iosa M, Vulpiani MC. Defocused and Radial Shock Wave Therapy, Mesotherapy, and Kinesio Taping Effects in Patients with Lipedema: A Pilot Study. Lymphology. 2023;56(1):13-26.
- Rio-Gonzalez A, Delgado-Perez E, Garcia-Garcia E, Gonzalez-Fernandez L, Garcia-Isidoro S, Cerezo-Tellez E. Physiotherapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery-Observational Study. J Clin Med. 2025 Mar 21;14(7):2137. doi: 10.3390/jcm14072137.
- Fetzer A. Specialist approaches to managing lipoedema. Br J Community Nurs. 2016 Apr;Suppl:S30-5. doi: 10.12968/bjcn.2016.21.Sup4.S30.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LIPE-KT-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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