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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAfyonkarahisar Health Sciences University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental

    Other intervention

    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

    Other intervention

    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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental: Physical Therapy and BalneotherapyExperimental treatment 1 intervention
Group B: Active Comparator: Physical therapy only: Patients who received a conventional physical therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
Time Frame: Baseline, after 4 weeks and 3 months
2

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
Time Frame: Baseline, after 4 weeks and 3 months
3

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
Time Frame: Baseline, after 4 weeks and 3 months
4

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
Time Frame: Baseline, after 4 weeks and 3 months

Secondary outcomes

1

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.

Time frame
Time Frame: Baseline, after 4 weeks and 3 months
2

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).

Time frame
Time Frame: Baseline, after 4 weeks and 3 mo
3

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.

Time frame
Time Frame: Baseline, after 4 weeks and 3 months

Other outcomes

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