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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of daily activities on a person's life (Oswestry Disability Index) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sancak Tıp Merkezi | Istanbul | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2025 | Jul 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009094 | Mud Therapy |
| ID | Term |
|---|---|
| D001452 | Balneology |
| D013812 | Therapeutics |
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| 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 |
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| before treatment and after treatment (3rd week) |
| Assessing functional loss due to low back pain (Back Pain Functional Scale ) | 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. | before treatment and after treatment (3rd week) |
| Quality of Life (SF-36) | 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) | before treatment and after treatment (3rd week) |
| Active ROM measurements (flexion, extension, left and right lateral flexion, and rotation) | 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. | before treatment and after treatment (3rd week) |
| Finger-floor distance measurement | 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. | before treatment and after treatment (3rd week) |