Lumbar RadiculopathyNCT06846970
Effects of Adding Balneotherapy to a Physical Therapy Program in Patients With Chronic Lumbar Radiculopathy
A study testing Experimental and Active Comparator in people with Lumbar Radiculopathy, run by Afyonkarahisar Health Sciences University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of adding balneotherapy to the conventional physical therapy program on neuropathic pain, disability, daily living activities, and sleep quality in patients with chronic lumbar radiculopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Experimental and Active Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 19 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 75 years who have been diagnosed with chronic lumbar radiculopathy based on medical history, physical examination, clinical findings, lumbar MRI, and EMG results, and who present to the outpatient clinic for physical therapy without any contraindications for treatment, will be included in the study after obtaining their informed consent.
Who cannot join
- Patients with thermoregulation disorders or sensory deficits
- Patients with lesions that impair skin integrity
- Patients with decompensated heart failure
- Patients with advanced heart, liver, or kidney failure
- Patients with advanced, uncontrolled peripheral venous insufficiency
- Patients with a history of epilepsy or seizures
Show all 31Show fewer
- Patients with pregnancy, malignancy, or a recent surgical operation
- Patients in the acute exacerbation phase of rheumatic diseases
- Patients with severe anemia
- Patients with tuberculosis
- Patients with febrile infectious diseases
- Patients with diseases associated with bleeding disorders
- Patients who have undergone regular balneotherapy in the past three months
- Patients with polyneuropathy or peripheral nerve damage
- Patients with muscle weakness detected during examination
- Patients with prostheses
- Patients with a history of lumbar surgery Exclusion Criteria for Balneotherapy
- Patients with thermoregulation disorders or sensory deficits
- Patients with lesions that impair skin integrity
- Patients with decompensated heart failure
- Patients with advanced heart, liver, or kidney failure
- Patients with advanced, uncontrolled peripheral venous insufficiency
- Patients with a history of epilepsy or seizures
- Patients with pregnancy, malignancy, or a recent surgical operation
- Patients in the acute exacerbation phase of rheumatic diseases
- Patients with severe anemia
- Patients with tuberculosis
- Patients with febrile infectious diseases
- Patients with diseases associated with bleeding disorders
- Patients who have undergone regular balneotherapy in the past three months
- Patients with polyneuropathy or peripheral nerve damage
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Afyonkarahisar HSU, Afyonkarahisar
Afyonkarahisar, Central, 03030
- Not yet recruiting
Afyonkarahisar HSU
Afyonkarahisar, Central, 03030
About this study
Official title: The Effect of Adding Balneotherapy to the Physical Therapy Program on Neuropathic Pain, Disability, Daily Living Activities, and Sleep Quality in Patients With Chronic Lumbar Radiculopathy
The aim of this study is to investigate the effects of adding balneotherapy to the conventional physical therapy program on neuropathic pain, disability, daily living activities, and sleep quality in patients with chronic lumbar radiculopathy.
Read the detailed description
Condition or Disease: Lumbar Radiculopathy, Neuropathic Pain, Disability, Daily Living Activities, Sleep Quality, Quality of Life Intervention/Treatment: Conventional Physical Therapy, Conventional Physical Therapy and Balneotherapy Phase: Not Applicable
Chronic lumbar radiculopathy is a clinical condition that occurs due to the compression of nerve roots in the lumbar region of the spinal cord, usually resulting from lumbar disc herniation, degenerative disc disease, spinal stenosis, or traumatic injuries. This condition leads to neuropathic pain and functional loss, significantly reducing patients' quality of life.
Neuropathic pain in chronic lumbar radiculopathy is characterized by symptoms such as burning, stinging, tingling, and electric shock-like sensations due to irritation or damage to the nerve roots. This type of pain may be difficult to manage with traditional analgesics and often requires a multidisciplinary treatment approach.
Balneotherapy is known to have analgesic, anti-inflammatory, and muscle-relaxant effects. In patients with chronic lumbar radiculopathy, balneotherapy has been shown to improve tissue oxygenation by increasing blood circulation, reduce muscle spasms, and regulate nerve functions. Additionally, it may enhance patients' functional capacity and participation in daily living activities.
Physical therapy is an effective method applied to reduce pain, increase muscle strength, and restore mobility in patients with chronic lumbar radiculopathy. Postural adjustments and manual therapy techniques can help alleviate nerve root compression and improve patients' quality of life. Modalities such as electrotherapy, ultrasound, and hot-cold applications may also be used to support treatment.
As a conclusion, a multidisciplinary treatment approach is necessary to control neuropathic pain and improve the quality of life and sleep quality of patients with chronic lumbar radiculopathy. The combination of balneotherapy and physical therapy may be effective in alleviating symptoms and enhancing functional capacity. Further clinical research is needed to more comprehensively determine the effectiveness of these treatment methods.
In this study, patients aged 18-75 years who have been diagnosed with chronic lumbar radiculopathy based on history, physical examination, clinical findings, lumbar MRI, and EMG results will be included. One group will receive a physical therapy program, while the other group will receive both a physical therapy program and balneotherapy.
Both groups will be assessed at baseline, after four weeks of treatment, and at the third month through physician evaluations and examinations. The study will employ scales such as the Visual Analog Scale (VAS), Oswestry Disability Index, Douleur Neuropathique 4 Questionnaire (DN4), Pain Quality Assessment Scale, LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Neuropathic Pain Scale, Short Form-36 (SF-36), and Pittsburgh Sleep Quality Index (PSQI) to investigate whether adding balneotherapy to a physical therapy program affects neuropathic pain, disability, daily living activities, and sleep quality in patients with chronic lumbar radiculopathy.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Experimental, Active Comparator
- Keywords
- Chronic Lumbal Radiculopathy, balneotherapy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Patients will receive a conventional physical therapy program consisting of 20 sessions of exercise, hot pack, TENS, ultrasound and balneotherapy, five days a week and once a day for four weeks. Exercise, hot pack, TENS, ultrasound therapy, and balneotherapy will be performed under the supervision of a specialist physiotherapist.
In both groups, patients will be evaluated by a physician at the beginning of the treatment, at the end of the 4-week treatment period, and at the 3rd month through clinical examination and assessment using the Visual Analog Scale (VAS), Oswestry Disability Index, Douleur Neuropathique 4 Questionnaire (DN4), Pain Quality Assessment Scale, LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Neuropathic Pain Scale, Short Form-36 (SF-36), and Pittsburgh Sleep Quality Index (PSQI).
Active ComparatorOther
Patients will receive a conventional physical therapy program consisting of 20 sessions of exercise, hot pack, tens and ultrosound therapy five days a week and once a day for four weeks. It was planned to perform exercise, hot pack, tens, ultrasound therapy accompanied by a specialist physiotherapist.
In both groups, patients will be evaluated by a physician at the beginning of the treatment, at the end of the 4-week treatment period, and at the 3rd month through clinical examination and assessment using the Visual Analog Scale (VAS), Oswestry Disability Index, Douleur Neuropathique 4 Questionnaire (DN4), Pain Quality Assessment Scale, LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Neuropathic Pain Scale, Short Form-36 (SF-36), and Pittsburgh Sleep Quality Index (PSQI).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Physical Therapy and Balneotherapy | Experimental | Experimental: Physical Therapy and Balneotherapy Patients who received a conventional physical therapy and balneotherapy Receives: Other: Experimental |
| Active Comparator: Physical therapy only: Patients who received a conventional physical therapy | Active comparator | Active Comparator: Physical therapy only: Patients who received a conventional physical therapy Receives: Other: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visuel Analog Scale (VAS)
The musculoskeletal pain intensity of the patients is assessed using the Visual Analog Scale (VAS). The meanings of the numbers placed on a 10 cm line ranging from 0 to 10 are explained to the patients. A score of 0 indicates no pain, 10 represents the most severe pain ever experienced, and 5 is explained as moderate pain. Based on this explanation, patients are asked to rate their pain levels by considering the past week.
Measured: Time Frame: Baseline, after 4 weeks and 3 months
Change in Oswestry Disability Index (ODI)
Oswestry Disability Index is a crucial tool used to assess the severity of low back pain and functional impairment. It is widely utilized in clinical practice, research, and treatment planning. The questionnaire evaluates ten different categories of activities that affect participants' daily lives. These categories include walking, sitting, standing, rising, sleeping, personal care, and the ability to perform work-related tasks. Participants are asked to rate each activity on a specific scale. The results are calculated as a percentage
Measured: Time Frame: Baseline, after 4 weeks and 3 months
Change in Douleur Neuropathique 4 Questionnaire (DN4)
DN4 is a short-form questionnaire designed to detect and diagnose neuropathic pain symptoms. The questionnaire consists of 10 questions that assess the symptoms experienced by the patient, specifically targeting characteristics associated with neuropathic pain. A score ranging from 0 to 10 is assigned based on the responses.
Measured: Time Frame: Baseline, after 4 weeks and 3 months
Change in LANSS Neuropathic Pain Assessment Scale
To determine the presence of neuropathic pain, all patients will be assessed using the Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) Scale. The S-LANSS scale is designed to differentiate neuropathic pain from nociceptive pain. Unlike the standard LANSS scale, the S-LANSS does not require a physician's physical examination, making it easier to administer.
The S-LANSS scale consists of seven questions, which are self-reported by the patient. The first five questions assess pain-related symptoms, while the last two questions involve self-applied clinical examination. Responses are yes/no, with different point values assigned to each question. The total score is 24, and a score of 12 or higher suggests the presence of neuropathic pain. The Turkish version of the S-LANSS scale has been validated for reliability and accuracy.
Measured: Time Frame: Baseline, after 4 weeks and 3 months
Secondary outcomes (3)
Change in Pain Quality Assessment Scale (PQAS)
The Pain Quality Assessment Scale is commonly used to evaluate the characteristic features of pain. These features include pain description (e.g., sharp, burning, stabbing), pain distribution (localized, widespread), accompanying symptoms (e.g., swelling, redness), and pain duration (acute, chronic). A scoring system ranging from 0 to 10 is applied for each question. This scale is widely used in clinical settings, pain research, and pain management planning.
Measured: Time Frame: Baseline, after 4 weeks and 3 months
Change in Short Form-36 (SF-36)
The Short Form-36 (SF-36) Health Survey is a generic self-administered quality of life assessment tool consisting of 36 items. It has been validated for reliability and validity in patients with musculoskeletal disorders. The SF-36 measures eight dimensions of health-related quality of life:
- Physical Functioning (10 items)
- Social Functioning (2 items)
- Role Limitations due to Physical Problems (3 items)
- Mental Health (5 items)
- Energy/Vitality (4 items)
- Pain (2 items)
- General Health Perceptions (5 items) The SF-36 assesses both positive and negative aspects of health status, considering the past four weeks. In six of the eight dimensions, patients are asked to rate their status on a three- or six-point scale. The scores for each domain are coded and converted into a scale ranging from 0 (worst health status) to 100 (best health status).
Measured: Time Frame: Baseline, after 4 weeks and 3 mo
Change in Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index is a self-reported questionnaire designed to evaluate sleep quality over the past four weeks. It consists of 24 items that assess various aspects of sleep. The PSQI includes seven components, each scored on a scale of 0 to 3. The total PSQI score ranges from 0 to 21, with scores above 5 indicating poor sleep quality. The Turkish version of the PSQI has been validated for reliability and accuracy.
Measured: Time Frame: Baseline, after 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start19 Mar 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Küçükdağ, Afyonkarahisar Health Sciences University
- Investigators
- Ersin Bestas Bestas, Principal Investigator, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846970
- Sponsor's protocol ID
- BTLLDH25
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dilekci E, Ozkuk K, Kaki B. The short-term effects of balneotherapy on pain, disability and fatigue in patients with chronic low back pain treated with physical therapy: A randomized controlled trial. Complement Ther Med. 2020 Nov;54:102550. doi: 10.1016/j.ctim.2020.102550. Epub 2020 Sep 4.
PubMed 33183668Onat SS, Tasoglu O, Guneri FD, Ozisler Z, Safer VB, Ozgirgin N. The effectiveness of balneotherapy in chronic low back pain. Clin Rheumatol. 2014;33(10):1509-15. doi: 10.1007/s10067-014-2545-y. Epub 2014 Mar 6.
PubMed 24599676Dogan M, Sahin O, Elden H, Hayta E, Kaptanoglu E. Additional therapeutic effect of balneotherapy in low back pain. South Med J. 2011 Aug;104(8):574-8. doi: 10.1097/SMJ.0b013e318224644f.
PubMed 21886066
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Balneotherapy to the Physical Therapy Program on Neuropathic Pain, Disability, Daily Living Activities, and Sleep Quality in Patients With Chronic Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT06846970
- Acronym / sponsor ID
- BTLLDH25
- Conditions
- Lumbar Radiculopathy
- Keywords
- Chronic Lumbal Radiculopathy, balneotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Feb 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 aim of this study is to investigate the effects of adding balneotherapy to the conventional physical therapy program on neuropathic pain, disability, daily living activities, and sleep quality in patients with chronic lumbar radiculopathy.
Detailed description
Condition or Disease: Lumbar Radiculopathy, Neuropathic Pain, Disability, Daily Living Activities, Sleep Quality, Quality of Life Intervention/Treatment: Conventional Physical Therapy, Conventional Physical Therapy and Balneotherapy Phase: Not Applicable
Chronic lumbar radiculopathy is a clinical condition that occurs due to the compression of nerve roots in the lumbar region of the spinal cord, usually resulting from lumbar disc herniation, degenerative disc disease, spinal stenosis, or traumatic injuries. This condition leads to neuropathic pain and functional loss, significantly reducing patients' quality of life.
Neuropathic pain in chronic lumbar radiculopathy is characterized by symptoms such as burning, stinging, tingling, and electric shock-like sensations due to irritation or damage to the nerve roots. This type of pain may be difficult to manage with traditional analgesics and often requires a multidisciplinary treatment approach.
Balneotherapy is known to have analgesic, anti-inflammatory, and muscle-relaxant effects. In patients with chronic lumbar radiculopathy, balneotherapy has been shown to improve tissue oxygenation by increasing blood circulation, reduce muscle spasms, and regulate nerve functions. Additionally, it may enhance patients' functional capacity and participation in daily living activities.
Physical therapy is an effective method applied to reduce pain, increase muscle strength, and restore mobility in patients with chronic lumbar radiculopathy. Postural adjustments and manual therapy techniques can help alleviate nerve root compression and improve patients' quality of life. Modalities such as electrotherapy, ultrasound, and hot-cold applications may also be used to support treatment.
As a conclusion, a multidisciplinary treatment approach is necessary to control neuropathic pain and improve the quality of life and sleep quality of patients with chronic lumbar radiculopathy. The combination of balneotherapy and physical therapy may be effective in alleviating symptoms and enhancing functional capacity. Further clinical research is needed to more comprehensively determine the effectiveness of these treatment methods.
In this study, patients aged 18-75 years who have been diagnosed with chronic lumbar radiculopathy based on history, physical examination, clinical findings, lumbar MRI, and EMG results will be included. One group will receive a physical therapy program, while the other group will receive both a physical therapy program and balneotherapy.
Both groups will be assessed at baseline, after four weeks of treatment, and at the third month through physician evaluations and examinations. The study will employ scales such as the Visual Analog Scale (VAS), Oswestry Disability Index, Douleur Neuropathique 4 Questionnaire (DN4), Pain Quality Assessment Scale, LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Neuropathic Pain Scale, Short Form-36 (SF-36), and Pittsburgh Sleep Quality Index (PSQI) to investigate whether adding balneotherapy to a physical therapy program affects neuropathic pain, disability, daily living activities, and sleep quality in patients with chronic lumbar radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Physical Therapy and Balneotherapy | Experimental | Other: ExperimentalExperimental: Physical Therapy and Balneotherapy Patients who received a conventional physical therapy and balneotherapy |
| Active Comparator: Physical therapy only: Patients who received a conventional physical therapy | Active comparator | Other: Active ComparatorActive Comparator: Physical therapy only: Patients who received a conventional physical therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 18 and 75 years who have been diagnosed with chronic lumbar radiculopathy based on medical history, physical examination, clinical findings, lumbar MRI, and EMG results, and who present to the outpatient clinic for physical therapy without any contraindications for treatment, will be included in the study after obtaining their informed consent.
Key exclusion criteria (31 listed)
- Patients with thermoregulation disorders or sensory deficits
- Patients with lesions that impair skin integrity
- Patients with decompensated heart failure
- Patients with advanced heart, liver, or kidney failure
- Patients with advanced, uncontrolled peripheral venous insufficiency
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 |
|---|---|---|
| ExperimentalPatients will receive a conventional physical therapy program consisting of 20 sessions of exercise, hot pack, TENS, ultrasound and balneotherapy, five days a week and once a day for four weeks. Exercise, hot pack, TENS, ultrasound therapy, and balneotherapy will be performed under the supervision of a specialist physiotherapist. In both groups, patients will be evaluated by a physician at the beginning of the treatment, at the end of the 4-week treatment period, and at the 3rd month through clinical examination and assessment using the Visual Analog Scale (VAS), Oswestry Disability Index, Douleur Neuropathique 4 Questionnaire (DN4), Pain Quality Assessment Scale, LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Neuropathic Pain Scale, Short Form-36 (SF-36), and Pittsburgh Sleep Quality Index (PSQI). | Other | Experimental: Physical Therapy and Balneotherapy |
| Active ComparatorPatients will receive a conventional physical therapy program consisting of 20 sessions of exercise, hot pack, tens and ultrosound therapy five days a week and once a day for four weeks. It was planned to perform exercise, hot pack, tens, ultrasound therapy accompanied by a specialist physiotherapist. In both groups, patients will be evaluated by a physician at the beginning of the treatment, at the end of the 4-week treatment period, and at the 3rd month through clinical examination and assessment using the Visual Analog Scale (VAS), Oswestry Disability Index, Douleur Neuropathique 4 Questionnaire (DN4), Pain Quality Assessment Scale, LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Neuropathic Pain Scale, Short Form-36 (SF-36), and Pittsburgh Sleep Quality Index (PSQI). | Other | Active Comparator: Physical therapy only: Patients who received a conventional physical therapy |
Primary outcome
Change in Visuel Analog Scale (VAS)
Time frame: Time Frame: Baseline, after 4 weeks and 3 months
The musculoskeletal pain intensity of the patients is assessed using the Visual Analog Scale (VAS). The meanings of the numbers placed on a 10 cm line ranging from 0 to 10 are explained to the patients. A score of 0 indicates no pain, 10 represents the most severe pain ever experienced, and 5 is explained as moderate pain. Based on this explanation, patients are asked to rate their pain levels by considering the past week.
Change in Oswestry Disability Index (ODI)
Time frame: Time Frame: Baseline, after 4 weeks and 3 months
Oswestry Disability Index is a crucial tool used to assess the severity of low back pain and functional impairment. It is widely utilized in clinical practice, research, and treatment planning. The questionnaire evaluates ten different categories of activities that affect participants' daily lives. These categories include walking, sitting, standing, rising, sleeping, personal care, and the ability to perform work-related tasks. Participants are asked to rate each activity on a specific scale. The results are calculated as a percentage
Change in Douleur Neuropathique 4 Questionnaire (DN4)
Time frame: Time Frame: Baseline, after 4 weeks and 3 months
DN4 is a short-form questionnaire designed to detect and diagnose neuropathic pain symptoms. The questionnaire consists of 10 questions that assess the symptoms experienced by the patient, specifically targeting characteristics associated with neuropathic pain. A score ranging from 0 to 10 is assigned based on the responses.
Change in LANSS Neuropathic Pain Assessment Scale
Time frame: Time Frame: Baseline, after 4 weeks and 3 months
To determine the presence of neuropathic pain, all patients will be assessed using the Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) Scale. The S-LANSS scale is designed to differentiate neuropathic pain from nociceptive pain. Unlike the standard LANSS scale, the S-LANSS does not require a physician's physical examination, making it easier to administer. The S-LANSS scale consists of seven questions, which are self-reported by the patient. The first five questions assess pain-related symptoms, while the last two questions involve self-applied clinical examination. Responses are yes/no, with different point values assigned to each question. The total score is 24, and a score of 12 or higher suggests the presence of neuropathic pain. The Turkish version of the S-LANSS scale has been validated for reliability and accuracy.
3 secondary outcomes
Change in Pain Quality Assessment Scale (PQAS)
Time frame: Time Frame: Baseline, after 4 weeks and 3 months
Change in Short Form-36 (SF-36)
Time frame: Time Frame: Baseline, after 4 weeks and 3 mo
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Time Frame: Baseline, after 4 weeks and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Results publication: PubMed 33183668Dilekci E, Ozkuk K, Kaki B. The short-term effects of balneotherapy on pain, disability and fatigue in patients with chronic low back pain treated with physical therapy: A randomized controlled trial. Complement Ther Med. 2020 Nov;54:102550. doi: 10.1016/j.ctim.2020.102550. Epub 2020 Sep 4.
- Results publication: PubMed 24599676Onat SS, Tasoglu O, Guneri FD, Ozisler Z, Safer VB, Ozgirgin N. The effectiveness of balneotherapy in chronic low back pain. Clin Rheumatol. 2014;33(10):1509-15. doi: 10.1007/s10067-014-2545-y. Epub 2014 Mar 6.
- Results publication: PubMed 21886066Dogan M, Sahin O, Elden H, Hayta E, Kaptanoglu E. Additional therapeutic effect of balneotherapy in low back pain. South Med J. 2011 Aug;104(8):574-8. doi: 10.1097/SMJ.0b013e318224644f.
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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.
Ersin Bestas Bestas, Principal Investigator principal investigator
Afyonkarahisar Health Sciences University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and Active Comparator in people with Lumbar Radiculopathy, run by Afyonkarahisar Health Sciences University at 2 sites 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 1 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ersin Bestas, Principal Investigator, MD, PhD (+905068893266, ersinbestas26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visuel Analog Scale (VAS) (time frame: Time Frame: Baseline, after 4 weeks and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06846970, which also lists 3 linked publications.
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 21 Mar 2025.