Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06846970

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

Led by Afyonkarahisar Health Sciences University · Updated on 2025-03-21

120

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of adding balneotherapy to a conventional physical therapy program for patients with chronic lumbar radiculopathy, a condition caused by nerve root compression in the lower spine. This condition leads to neuropathic pain and functional loss, impacting daily activities, sleep quality, and overall quality of life. The study aims to assess whether combining these treatments improves pain, disability, daily living activities, and sleep compared to physical therapy alone. Participants will be randomly assigned to one of two groups. One group will receive conventional physical therapy including exercise, hot pack, TENS, and ultrasound therapy five days a week for four weeks. The other group will receive the same physical therapy program combined with balneotherapy under specialist physiotherapist supervision. Both groups will be assessed at the start, after four weeks of treatment, and three months later. During the study, participants will undergo evaluations using several scales including the Visual Analog Scale (VAS), Oswestry Disability Index, Douleur Neuropathique 4 Questionnaire, LANSS Neuropathic Pain Scale, Pain Quality Assessment Scale, Short Form-36, and Pittsburgh Sleep Quality Index. These assessments will measure changes in pain, disability, sleep quality, and quality of life. The study will monitor participants over a period of three months to evaluate treatment effects and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 18 and 75 years
  • Diagnosed with chronic lumbar radiculopathy based on medical history, physical examination, lumbar MRI, and EMG results
  • Presenting to the outpatient clinic for physical therapy without contraindications
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Thermoregulation disorders or sensory deficits
  • Lesions impairing skin integrity
  • Decompensated heart failure
  • Advanced heart, liver, or kidney failure
  • Advanced, uncontrolled peripheral venous insufficiency
  • History of epilepsy or seizures
  • Pregnancy or malignancy
  • Recent surgical operation
  • Acute exacerbation phase of rheumatic diseases
  • Severe anemia
  • Tuberculosis
  • Febrile infectious diseases
  • Diseases associated with bleeding disorders
  • Regular balneotherapy in the past three months
  • Polyneuropathy or peripheral nerve damage
  • Muscle weakness detected during examination
  • Presence of prostheses
  • History of lumbar surgery
  • Exclusion criteria specifically for balneotherapy include thermoregulation disorders, sensory deficits, skin lesions, heart failure, advanced organ failure, uncontrolled venous insufficiency, epilepsy, pregnancy, malignancy, recent surgery, rheumatic disease exacerbation, anemia, tuberculosis, infectious diseases, bleeding disorders, recent balneotherapy, and peripheral nerve damage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive a physical therapy program consisting of 20 sessions of exercise, hot pack, TENS, and ultrasound therapy, either alone or combined with balneotherapy. These sessions are supervised by a specialist physiotherapist to help reduce neuropathic pain and improve functional capacity.

5 visits per week, once daily

Follow-up

Duration - Up to 3 months after treatment

Participants are evaluated by a physician at the end of treatment and again at three months to assess changes in pain, disability, daily living activities, and sleep quality using various clinical scales.

2 visits (in-person)

Trial Site Locations

Total: 2 locations

1

Afyonkarahisar HSU, Afyonkarahisar

Afyonkarahisar, Central, Turkey (Türkiye), 03030

Actively Recruiting

2

Afyonkarahisar HSU

Afyonkarahisar, Central, Turkey (Türkiye), 03030

Not Yet Recruiting

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Research Team

E

Ersin Bestas, Principal Investigator, MD, PhD

B

Betul Kuçukdag Principal Investigator, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Erdal Dilekçi, Kağan Özkuk, Barış Kaki

https://pubmed.ncbi.nlm.nih.gov/33183668