Painful Diabetic Peripheral Neuropathy Diabetic Neuropathies Neuralgia Diabetic Foot Massage Medicine, Thai Traditional
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1 Aged 18 to 85 years., 2 Diagnosed with Type 2 Diabetes Mellitus., 3 Presents with neuropathic pain in the feet., 4 DN4 (Douleur Neuropathique 4) score more than 4., 5 Moderate pain intensity at baseline, defined as a Visual Analog Scale (VAS) score of 4-6., 6 On a stable dosage of medication for Painful Diabetic Peripheral Neuropathy (pDPN) for at least 3 months prior to study enrollment., 7 Willing and able to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1 Contraindications for foot massage, including: Open wounds, ulcers, or skin infections on the feet or lower legs., History of recent fractures in the feet or lower legs., Bleeding disorders or coagulopathy., 2 Unstable hemodynamic status., 3 Uncontrolled systemic infection., 4 Neuropathy caused by factors other than diabetes, such as chemotherapy-induced peripheral neuropathy (CIPN) or alcoholic neuropathy., 5 Musculoskeletal pain in the feet and lower legs originating from causes unrelated to diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score 3 time points: Baseline (Week 0), End of first treatment phase (Week 4), and End of study (Week 8) Visual Analog Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life 3 time points: Baseline (Week 0), End of first treatment phase (Week 4), and End of study (Week 8) EuroQol-5D-5L,Durability of treatment effect (Intervention group only) from Week 4 to Week 8 changes in Visual Analog Scale and EuroQol-5D-5L | — |
Countries
Thailand
Contacts
King Chulalongkorn Memorial Hospital