Clinical trial NCT06651775: Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation.
Official title: Effectiveness of High Intensity Laser Therapy (HILT) in Patients With Chronic Lumbar Radiculopathy Due to Disc Herniation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: Activity of Daily Living
chronic low back pain
high intensity laser therapy
pain
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: pre-treatment, immediately post-treatment and three months follow-up
measure: Revised Oswestry Disability Index (ODI)
timeFrame: pre-treatment, immediately post-treatment and three months follow-up
Secondary outcomes:
measure: Nottingham Health Profile (NHP)
timeFrame: pre-treatment, immediately post-treatment and three months follow-up
measure: LANSS Pain Scale
timeFrame: pre-treatment, immediately post-treatment and three months follow-up
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Cankaya
Study officials:
References: