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Completed

NCT Number: NCT07087548

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

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)

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Key information

Conditions

Lumbal Disc Herniation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sancak Tıp Merkezi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peloid Therapy

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.

Hotpack therapy

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

Primary outcomes

  1. Pain intensity (VAS)

    Time frame: Before treatment and after treatment (3rd week).

    Pain severity was assessed with the Visual Analog Scale (VAS), which is scored between 0 and 10, and is used to evaluate pain. 0 denotes no pain and 10 denotes unbearably severe pain. Participants were instructed to indicate the level of pain they experienced by marking a point along a 10 cm straight line, and the value found was recorded in cm

Secondary outcomes

  1. Impact of daily activities on a person's life (Oswestry Disability Index)

    Time frame: before treatment and after treatment (3rd week)

    The Oswestry Disability Index (ODI) is an evaluation questionnaire that assesses the impact of daily activities on a person's life. It has 10 subgroups, each with 6 questions scored from 0 to 5. The subgroups cover pain severity, self-care, lifting-carrying, walking, sitting, standing, sleep, sexual life, travel, and social life. The total score ranges from 0 to 50, with higher scores indicating a greater disability.

  2. Assessing functional loss due to low back pain (Back Pain Functional Scale )

    Time frame: before treatment and after treatment (3rd week)

    The Back Pain Functional Scale (BPFS), is an easy-to-use tool developed by WHO for assessing functional loss due to low back pain, completed by the participant. It evaluates the impact on work, school, home activities, habits, bending, wearing shoes or socks, lifting, sleeping, sitting, standing, walking, climbing stairs, and driving (or traveling if the participant does not drive). Each item is scored from 0 to 5, with 0 indicating the activity is impossible and 5 indicating no difficulty. The total score ranges from 0 to 60, with 60 indicating no difficulty in any activity.

  3. Quality of Life (SF-36)

    Time frame: before treatment and after treatment (3rd week)

    The Short Form Health Survey (SF-36), is a scale consisting of 36 items and measures eight health dimensions: physical function, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty, and mental health. It evaluates the last four weeks, with higher SF-36 scores indicating a better health-related quality of life. Scores range from 0 (worst health) to 100 (best health)

  4. Active ROM measurements (flexion, extension, left and right lateral flexion, and rotation)

    Time frame: before treatment and after treatment (3rd week)

    Active ROM measurements (flexion, extension, left and right lateral flexion, and rotation) of individuals were done with a universal goniometer. Kendall and Mccreary's system was based on the value of degrees. Measurements were taken with participants standing, repeated three times without causing fatigue.

  5. Finger-floor distance measurement

    Time frame: before treatment and after treatment (3rd week)

    Finger-floor distance (FFD) measurement is used for trunk flexibility and mobility. Currently, there is no unified reference value range for FFD measurement. Values of 0 or close to 0 typically indicate good spinal mobility, while higher values usually suggest abnormal or pathological spinal mobility.

Sponsors and collaborators

Lead sponsor

Fenerbahce University

Other

Registry information

Official study title

Chronic Lumbar Disc Herniation: A Randomized Single-Blind Study on the Comparative Efficacy of Peloid Therapy Versus Hot Pack Therapy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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