Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation.

NCT06651775 · tracked via the Priya Life Science Turkey tracker

Sponsor

Ankara City Hospital Bilkent

Phase

Not applicable

Started

2024-05-15

Last updated

2024-10-26

Condition(s) studied

Lumbar Radiculopathy

Investigational drug(s) / intervention(s)

High intensity laser therapySham Comparator

High intensity laser therapy: lumbosciatalgia mode of the HILT device

Sham Comparator: sham mode of the HILT device

Study summary

The aim of the researchers in this intervention study was to see the effects of High Intensity Laser Therapy (HILT) on participants' disability, functionality and pain parameters in chronic radicular low back pain due to lumbar disc herniation, and to investigate its superiority over widely used conventional electrotherapy modalities.

The main question it aims to answer is:

What is the short and long term effect of high intensity laser therapy on low back and leg pain in patients with chronic lumbar radiculopathy due to disc herniation?

35 patients in group A will receive the planned Hotpack, TENS, High Intensity Laser Therapy (HILT) and exercise treatments for lumbar radicular low back pain. In group B (comparison group) 35 patients will receive Hotpack, TENS, sham HILT, and exercise treatments.

Participants will receive 15 sessions of treatment and exercises will be given as a home program. Both groups will complete questionnaires about disability, life functions and pain before and after treatment and at the 3rd month follow-up.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Patients diagnosed with lumbar radiculopathy due to lumbar disc herniation and whose complaints are correlated with lumbar MRI * Patients aged 18-65 years * Patients who agreed to participate in the study * Literate patients Exclusion Criteria: * Pregnancy * Patients with cardiac pacemakers * Patients with a diagnosis of inflammatory rheumatic disease, * Patients with a diagnosis of polyneuropathy that precludes receiving treatment, * Patients with active or history of malignancy within the last 1 year and currently receiving chemotherapy and/or radiotherapy, * Patients with serious psychiatric illness, * Patients with severe coagulation disorders, * Spinal Stenosis (patients with spinal canal diameter less than 8 mm) * Patients with neurologic deficits that prevent them from receiving treatment, * Patients with active infection, * Patients with vasculitis, * Patients with skin disease in the treated area, * Patients who received steroid injections and/or physical therapy for the lumbar region within the last 3 months, * Patients undergoing lumbar spine surgery, * Patients with acute trauma, * Patients with a history of lumbar instability, * Patients with uncontrolled or severe cardiovascular or metabolic disorders

Primary outcome measure(s)

Visual Analogue Scale (VAS) — pre-treatment, immediately post-treatment and three months follow-up
Visual Analogue Scale (VAS) is used to convert some values that cannot be measured numerically into numerical form. On the two ends of a 100 mm line, two extreme definitions of the parameter to be evaluated are written and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line or putting a point or pointing. For example, for pain, no pain is written on one end, very severe pain is written on the other end and the patient marks his/her current situation on this line. The length of the distance from the point of no pain to the point marked by the patient indicates the patient's pain. The test has proven itself for a very long time and is recognised in the world literature. In our study, the VAS values of the patients for low back and leg pain at rest and in motion will be questioned and followed up.
Revised Oswestry Disability Index (ODI) — pre-treatment, immediately post-treatment and three months follow-up
It was developed to assess the degree of loss of function in low back pain. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleeping, the degree of change in pain, travelling and social life. Under each item, there are six statements that the patient marks the appropriate one for his/her condition. The first statement is scored as "0" and the sixth statement as "5". When the total score is calculated, it is multiplied by two and expressed as a percentage. The maximum score is "100" and the minimum score is "0". The higher the total score, the higher the level of disability. Revised Oswestry Disability Index (ODI) consists of 10 items. Turkish validity and reliability was demonstrated in 2004.

Trial sites (1)

Facility	City	Region	Status
Ankara Bilkent City Hospital	Ankara	Cankaya	Recruiting

More Ankara City Hospital Bilkent trials in Turkey

Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery Recruiting

Manual Versus Autoflow Ventilation During Anesthesia Inductıon in Geriatric Patients Recruiting

Evaluation of Post-Induction Hypotension Treatment with PRAM Method Active, not recruiting

Can Gdf-15 Level Predict Progression to Multiple Organ Failure in Patients With Septic Shock Enrolling by invitation

The Effects of Intra-articular and Peri-articular Platelet-rich Plasma (PRP) Injections ın Chronic Knee Osteoarthritis Recruiting

Other trials for the same condition

How Reliable Are Routine Radiological Imaging Methods in Diagnosing Lumbosacral Transitional Vertebrae and Identifying the Pathological Disc Level? Starting soon

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

PLDD With or Without Transforaminal Epidural Steroid Injection in Lumbar Disc Herniation Starting soon

High-Intensity Laser Therapy Versus Transforaminal Epidural Steroid Injection in Chronic Lumbar Disc Herniation-Related Low Back and Radicular Pain Recruiting

The Role of Temporal Changes in Pain Response After Transforaminal Epidural Steroid Injection on Treatment Success Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06651775 on ClinicalTrials.gov ↗ ← All trials in Turkey