Trials / Completed
CompletedNCT07087548
A Study Comparing Peloid Therapy and Hot Pack Treatment in Adults With Chronic Low Back Pain Caused by Lumbar Disc Herniation
Chronic Lumbar Disc Herniation: A Randomized Single-Blind Study on the Comparative Efficacy of Peloid Therapy Versus Hot Pack Therapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Fenerbahce University · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to compare the effectiveness of peloid therapy versus hot pack therapy in adults aged 18-50 with chronic lumbar disc herniation (LDH). The main questions it aims to answer are: Does peloid therapy reduce pain more effectively than hot pack therapy in patients with chronic LDH? Does peloid therapy improve functional status, range of motion, and quality of life more than hot pack therapy? Researchers will compare peloid therapy (45°C for 30 minutes, 5 days/week) to hot pack therapy (20 minutes, 5 days/week) to see which treatment offers better clinical outcomes. Participants will: Receive either peloid therapy or hot pack therapy for 3 weeks (15 sessions total). Undergo standard TENS therapy (20 minutes to the lumbar region) after each session. Complete assessments before and after treatment including: Pain intensity (Visual Analog Scale - VAS) Functional status (Back Pain Functional Scale - BPFS) Disability level (Oswestry Disability Index - ODI) Quality of life (Short Form-36 - SF-36) Lumbar range of motion and finger-to-floor distance (FFD)
Detailed description
Chronic lumbar disc herniation (LDH) is a common spinal disorder that causes pain, functional limitations, and reduced quality of life. Non-invasive physical therapy modalities such as thermotherapy and electrotherapy are frequently used in conservative management. Peloid therapy, a form of thermal mud treatment, has been proposed to exert anti-inflammatory, analgesic, and muscle-relaxing effects. However, limited controlled studies have compared its clinical effectiveness with more commonly used superficial heat modalities like hot packs. This single-blind, randomized controlled trial was designed to evaluate and compare the effects of peloid therapy and hot pack therapy in adults diagnosed with chronic LDH. A total of 60 participants were randomly allocated into two treatment arms. The peloid group received a localized application of therapeutic mud (peloid) at 45°C for 30 minutes per session, five days per week for three weeks (total 15 sessions). The control group received conventional hot pack therapy for 20 minutes under the same session frequency and duration. Both groups additionally received transcutaneous electrical nerve stimulation (TENS) to the lumbar region following each thermotherapy session. Outcome measures were recorded before and after the intervention period and included pain intensity (VAS), functional ability (BPFS), disability index (ODI), quality of life (SF-36), lumbar range of motion (flexion, extension, lateral flexion, and rotation), and finger-to-floor distance (FFD). Statistical analysis was performed to assess within-group and between-group changes. This study provides comparative data on the efficacy of peloid therapy and conventional hot pack application in a homogeneous patient population with chronic LDH and may inform future guidelines on the selection of conservative treatment modalities in physical therapy practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Peloid Therapy | Peloid therapy will be applied using medical mud packs at 45°C for 30 minutes per session, 5 sessions per week for 3 consecutive weeks. The therapy will be administered to the lower back region in patients diagnosed with chronic lumbar disc herniation. This intervention aims to reduce pain and improve function through thermomechanical and biochemical effects of natural peloid. |
| OTHER | Hotpack Therapy | The hot pack group applied 20 minutes, 5 days a week, once a day, for 15 sessions on the lumbar region. The boiler temperature of the hot packs used was 90 °C. Two towels were used, with the thickest side of the towels placed on the lumbar area of the individuals. Then, conventional TENS (80 Hz frequency) was applied to the painful area in the lumbar region for 20 minutes |
Timeline
- Start date
- 2021-09-01
- Primary completion
- 2022-06-22
- Completion
- 2022-06-22
- First posted
- 2025-07-28
- Last updated
- 2025-07-28
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07087548. Inclusion in this directory is not an endorsement.