Clinical trial NCT06846970: Effects of Adding Balneotherapy to a Physical Therapy Program in Patients with Chronic Lumbar Radiculopathy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: Chronic Lumbal Radiculopathy
balneotherapy
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in Visuel Analog Scale (VAS)
timeFrame: Time Frame: Baseline, after 4 weeks and 3 months
measure: Change in Oswestry Disability Index (ODI)
timeFrame: Time Frame: Baseline, after 4 weeks and 3 months
measure: Change in Douleur Neuropathique 4 Questionnaire (DN4)
timeFrame: Time Frame: Baseline, after 4 weeks and 3 months
measure: Change in LANSS Neuropathic Pain Assessment Scale
timeFrame: Time Frame: Baseline, after 4 weeks and 3 months
Secondary outcomes:
measure: Change in Pain Quality Assessment Scale (PQAS)
timeFrame: Time Frame: Baseline, after 4 weeks and 3 months
measure: Change in Short Form-36 (SF-36)
timeFrame: Time Frame: Baseline, after 4 weeks and 3 mo
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Time Frame: Baseline, after 4 weeks and 3 months
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar HSU, Afyonkarahisar
state: Central
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar HSU
state: Central
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Ersin Bestas Bestas, Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Onat 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.
citation: Dogan 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.