Effects of Adding Balneotherapy to a Physical Therapy Program in Patients with Chronic Lumbar Radiculopathy

NCT ID: NCT06846970

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2025-12-31

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.

Conditions

Lumbar Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Physical Therapy and Balneotherapy

Experimental: Physical Therapy and Balneotherapy Patients who received a conventional physical therapy and balneotherapy

Group Type: EXPERIMENTAL

Experimental

Intervention Type: OTHER

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 Comparator: Physical therapy only: Patients who received a conventional physical therapy

Active Comparator: Physical therapy only: Patients who received a conventional physical therapy

Group Type: ACTIVE_COMPARATOR

Active Comparator

Intervention Type: OTHER

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).

Interventions

Experimental

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).

Intervention Type: OTHER

Active Comparator

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).

Intervention Type: OTHER

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Betül Küçükdağ

Principal Investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ersin Bestas Bestas, Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

Afyonkarahisar HSU, Afyonkarahisar

Afyonkarahisar, Central, Turkey (Türkiye)

Site Status: RECRUITING

Afyonkarahisar HSU

Afyonkarahisar, Central, Turkey (Türkiye)

Site Status: NOT_YET_RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ersin Bestas, Principal Investigator, MD, PhD

Role: CONTACT

ersinbestas26@gmail.com

+905068893266

Betul Kuçukdag Principal Investigator, MD

Role: CONTACT

yildirimbtl.06@gmail.com

+905548484074

References

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.

Reference Type: BACKGROUND

PMID: 33183668 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24599676 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21886066 (View on PubMed)

Other Identifiers

BTLLDH25

Identifier Type: -

Identifier Source: org_study_id