Lumbal Disc HerniationNCT07087548
A Study Comparing Peloid Therapy and Hot Pack Treatment in Adults With Chronic Low Back Pain Caused by Lumbar Disc Herniation
A study testing Peloid Therapy and Hotpack Therapy in people with Lumbal Disc Herniation, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lumbal Disc Herniation
- What is being tested?
- Peloid Therapy and Hotpack Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- having not received physiotherapy for LDH in the last 6 months,
- severe neurological deficit,
- osteoporosis,
- malignancy, inflammatory disease
- decompensated cardiopulmonary disease,
- uncontrolled hypertension,
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Lumbar Disc Herniation: A Randomized Single-Blind Study on the Comparative Efficacy of Peloid Therapy Versus Hot Pack Therapy
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?
Read more
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)
Read the 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
- Being tested
- Peloid Therapy, Hotpack Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peloid TherapyOther
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 TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Hotpack Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before treatment and after treatment (3rd week).
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: before treatment and after treatment (3rd week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Sep 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbal Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu AKKURT, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087548
- Sponsor's protocol ID
- 2021/324
- Status last verified
- Sep 2021
- First submitted
- 19 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Lumbar Disc Herniation: A Randomized Single-Blind Study on the Comparative Efficacy of Peloid Therapy Versus Hot Pack Therapy
- ClinicalTrials.gov ID
- NCT07087548
- Acronym / sponsor ID
- 2021/324
- Conditions
- Lumbal Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Peloid Therapy+TENS) | Experimental | Other: Peloid TherapyThe 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. |
| Hot pack Therapy (Hotpack+TENS) | Active comparator | Other: Hotpack TherapyThe 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- having not received physiotherapy for LDH in the last 6 months,
- severe neurological deficit,
- osteoporosis,
- malignancy, inflammatory disease
- decompensated cardiopulmonary disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peloid TherapyPeloid 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 | Experimental (Peloid Therapy+TENS) |
| Hotpack TherapyThe 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 | Hot pack Therapy (Hotpack+TENS) |
Primary outcome
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
5 secondary outcomes
Impact of daily activities on a person's life (Oswestry Disability Index)
Time frame: before treatment and after treatment (3rd week)
Assessing functional loss due to low back pain (Back Pain Functional Scale )
Time frame: before treatment and after treatment (3rd week)
Quality of Life (SF-36)
Time frame: before treatment and after treatment (3rd week)
Active ROM measurements (flexion, extension, left and right lateral flexion, and rotation)
Time frame: before treatment and after treatment (3rd week)
Finger-floor distance measurement
Time frame: before treatment and after treatment (3rd week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peloid Therapy and Hotpack Therapy in people with Lumbal Disc Herniation, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (VAS) (time frame: Before treatment and after treatment (3rd week).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.