Loading clinical trials...
Loading clinical trials...
Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation
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.
Efficacy of High Intensity Laser Therapy in Patients with Chronic Lumbar Radiculopathy Due to Disc Herniation , Ankara 2025 Low back pain is an important and widespread health problem that negatively affects the quality of life from past to present, causes deterioration in functional status and may cause disability and psychologically wears out human health in the chronic period. In epidemiological studies, the prevalence of low back pain has been found to be approximately 40% throughout life. Low back pain is classified as acute, subacute and chronic according to its duration and as mechanical and inflammatory according to the character of the pain. Low back pain lasting more than 12 weeks is defined as chronic low back pain. Etiological factors include fracture, malignancy, infection, trauma, osteoporosis, inflammatory diseases, myogenic causes, etc. One of the most important and common causes of mechanical causes is intervertebral disc herniation. Disc herniation may also cause radicular pain in the form of numbness, burning, electrification, pins and needles in the dermatome area of the related nerve due to neural root compression. There are many treatment modalities for radicular low back pain due to lumbar disc herniation. These include medical treatment, lumbar and abdominal strengthening exercises given outside the acute painful period, physical therapy modalities, alternative medicine methods, laser therapy, epidural steroid injections and surgical treatment. The term laser is defined as "light amplification by stimulated radiation emission". It is a non-invasive and painless treatment. There are two types of laser therapy, low and high intensity, with different intensity according to peak power and wavelength. Pulsed neodymium-doped yttrium aluminium garnet (Nd:YAG) high intensity laser, HILT, works with high peak power and 1.064nm wavelength. The laser has 5 basic mechanisms of action: thermal, mechanical, electrical, photochemical, biostimulate. Biostimulation, antiedema, analgesic and anti-inflammatory effects in the applied area are more pronounced due to its high intensity and specific wavelength, but the exact mechanism of action in reducing pain has not yet been clearly clarified. This study, aimed to investigate the effects of high-intensity laser therapy (HILT) on the patient's disability, functionality, and neuropathic and nociceptive patterns of pain in radicular pain due to lumbar disc herniation in the chronic period and its superiority over the conventional electrotherapy modalities we frequently use. The study was designed as a randomised, placebo-controlled, double-blind, prospective study. This study includes patients admitted to the outpatient clinics of Ankara City Hospital Physical Medicine and Rehabilitation Hospital who have low back pain radiating to the lower extremities for more than 12 weeks and have sensory deficit and/or pain sensation in dermatomal distribution due to radicular lesion accompanying lumbar disc herniation shown by lumbar MRI. Patients will be randomly divided into two groups. A total of 70 patients aged 18-65 years of male and female sex will be included in the study and the patients will be randomly divided into two groups of equal number. Patients in Group A (n:35) will receive 15 sessions of hotpack and 15 sessions of TENS (transcutaneous electrical nerve stimulation) five days a week for 3 weeks, 15 sessions of HIRO TT (ASA Laser, Arcugnano, Italy) device in lumbosciatica mode in three phases (fast scanning, trigger point, slow scanning) over an area of 25 cm². Isometric lumbar strengthening and core stabilisation exercises will be given to the patients as a home programme. Patients in group B (n:35) will receive TENS (Transcutaneous Electrical Nerve Stimulation), Hotpack, Lumbar and Core Stabilisation Exercises and sham High Intensity Laser treatments and the protocols will be the same as in group A. Patients will be evaluated 3 times in total: pre-treatment, post-treatment and 3 months.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Ankara Bilkent City Hospital
Ankara, Cankaya, Turkey (Türkiye)
Start Date
May 15, 2024
Primary Completion Date
January 15, 2025
Completion Date
February 15, 2025
Last Updated
October 26, 2024
70
ESTIMATED participants
High intensity laser therapy
DEVICE
Sham Comparator
DEVICE
Lead Sponsor
Ankara City Hospital Bilkent
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions