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

NCT06846970 | Recruiting

• 1 other identifier: BTLLDH25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Lumbar Radiculopathy

Keywords

Chronic Lumbal Radiculopathy; balneotherapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.

  Time Frame: Baseline, after 4 weeks and 3 months

Secondary Outcomes (3)

• Change in Pain Quality Assessment Scale (PQAS)

  Time Frame: Baseline, after 4 weeks and 3 months

• Change in Short Form-36 (SF-36)

  Time Frame: Baseline, after 4 weeks and 3 mo

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Time Frame: Baseline, after 4 weeks and 3 months

Study Arms (2)

Experimental: Physical Therapy and Balneotherapy

EXPERIMENTAL

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

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

Other: Active Comparator

Interventions

Experimental 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).

Experimental: Physical Therapy and Balneotherapy

Active Comparator 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).

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (2)

Afyonkarahisar HSU, Afyonkarahisar

Afyonkarahisar, Central, 03030, Turkey (Türkiye)

RECRUITING

Afyonkarahisar HSU

Afyonkarahisar, Central, 03030, Turkey (Türkiye)

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 33183668 BACKGROUND

• 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.

  PMID: 24599676 BACKGROUND

• 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.

  PMID: 21886066 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ersin Bestas Bestas, Principal Investigator

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ersin Bestas, Principal Investigator, MD, PhD

CONTACT

+905068893266; ersinbestas26@gmail.com

Betul Kuçukdag Principal Investigator, MD

CONTACT

+905548484074; yildirimbtl.06@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: March 19, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

TU (2)