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

NCT07087548 | Completed

• 1 other identifier: 2021/324
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Lumbal Disc Herniation

Outcome Measures

Primary Outcomes (1)

• Pain intensity (VAS)

  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

  Before treatment and after treatment (3rd week).

Secondary Outcomes (5)

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

  before treatment and after treatment (3rd week)

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

  before treatment and after treatment (3rd week)

• Quality of Life (SF-36)

  before treatment and after treatment (3rd week)

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

  before treatment and after treatment (3rd week)

• Finger-floor distance measurement

  before treatment and after treatment (3rd week)

Study Arms (2)

Experimental (Peloid Therapy+TENS)

EXPERIMENTAL

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.

Other: Peloid Therapy

Hot pack Therapy (Hotpack+TENS)

ACTIVE COMPARATOR

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

Other: Hotpack Therapy

Interventions

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.

Experimental (Peloid Therapy+TENS)

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

Hot pack Therapy (Hotpack+TENS)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Sancak Tıp Merkezi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Mud Therapy

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: September 1, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: July 28, 2025

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)