A Study Comparing Peloid Therapy and Hot Pack Treatment in Adults With Chronic Low Back Pain Caused by Lumbar Disc Herniation

NCT ID: NCT07087548

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-06-22

Brief 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

Lumbal Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental (Peloid Therapy+TENS)

The peloid therapy group received 15 sessions of peloid therapy at 45°C for 30 minutes per session, five days a week for three weeks. Peloid was applied to the lumbar region with a brush to a thickness of approximately 15 mm. The area was then wrapped with stretch film and a towel for 30 minutes to minimize heat loss. Peloids produced and packaged in the Afyonkarahisar Sandıklı geothermal region were used. The peloid is gray, odorless, and has a pH of 8.74. It contains humic acid, humin, lignin, hemicellulose, montmorillonite, calcite, and kaolinite. After the peloid application, the area was cleaned, and conventional TENS (80 Hz frequency) was applied to the waist for 20 minutes.

Group Type: EXPERIMENTAL

Peloid Therapy

Intervention Type: OTHER

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.

Hot pack Therapy (Hotpack+TENS)

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

Group Type: ACTIVE_COMPARATOR

Hotpack Therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals ≥18 years old with CLBP due to LDH lasting more than three months
• Individuals who showed degeneration and prolapsed herniation on magnetic resonance imaging
• Individuals were examined by a specialist physician

Exclusion Criteria

• having not received physiotherapy for LDH in the last 6 months,
• severe neurological deficit,
• osteoporosis,
• malignancy, inflammatory disease
• decompensated cardiopulmonary disease,
• uncontrolled hypertension,
• those with an important pathology in routine laboratory tests (liver and kidney dysfunction, individuals with thyroid dysfunction, diabetes),
• vertebral fracture,
• lumbar listhesis
• infectious disease at lumbar level,
• inflammatory lumbar pain,
• individuals with extruded and sequestered herniation as a result of MRI,
• those with neurological deficits,
• communication problems,
• being allergic to peloid or hotpack
• pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fenerbahce University

OTHER

Sponsor Role: lead

Responsible Party

Burcu AKKURT

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sancak Tıp Merkezi

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2021/324

Identifier Type: -

Identifier Source: org_study_id