Clinical trial NCT06831227: High Power Laser Therapy for Herniated Disc and Lumbosacral Radiculopathy
Official title: Effect of High-Power Laser Therapy on the Size of Herniated Disc and Functional Outcome in Patients with Lumbosacral Radiculopathy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Herniated Lumbar Disc
Keywords: High Power Laser
Herniated disc
LUMBOSACRAL RADICULOPATHY
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the effect of high-power laser therapy on the size of herniated disc and functional outcome in patients with lumbosacral radiculopathy.

Detailed description: A herniated disc is a condition in which annulus fibrosus is damaged enabling the nucleus pulposus (which is normally located within the center of the disc) to herniate. It is a common cause of back pain. Unlike mechanical back pain, herniated disc pain is often burning or stinging, and may radiate into the lower extremity. Furthermore, in more severe cases, there can be associated with weakness or sensation changes. herniated disc injury may compress the nerve or the spinal cord causing pain consistent with nerve compression or spinal cord dysfunction, also known as myelopathy.

Lumbosacral radiculopathy is a disorder that causes pain in the lower back and hip which radiates down the back of the thigh into the leg. This damage is caused by compression of the nerve roots which exit the spine at levels of L1- S4. The compression can result in tingling, radiating pain, numbness, paraesthesia, and occasional shooting pain.

A combination of factors including pressure, inflammation, and an immune response seem to be implicated in the pathogenesis of both acute and chronic radicular pain. Pressure would not be a cause of pain, but rather of nerve dysfunction such as weakness and numbness, while the addition of both inflammation and immune response could explain the severe pain experienced by patients suffering from radicular pain.

High power laser therapy (HPLT) is a new, non-invasive, painless, and powerful method with anti-inflammatory and reparative effects. HPLT has therapeutic benefits through photochemical, photothermal, and photomechanical mechanisms, possibly due to its potential for reducing inflammation, enhancing microcirculation, and stimulating immunological proteins and nerve regeneration and secretion of β-endorphins.

MRI: It is the study of choice to visualize herniated disc. MRI findings will help surgeons and other providers plan procedural care if it is indicated. Disc protrusion and nerve root compression can be identified. As Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.

Imaging for diagnosis disc herniation are X-rays: These are very accessible at most clinics and outpatient offices. This imaging technique can be used to assess for any structural instability. If x-rays show an acute fracture, it needs to be further investigated using a computed tomogram (CT) scan or magnetic resonance imaging (MRI) .

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed by orthopedic or neurological consultants depended on MRI assessment as disc herniation (L4-L5/L5-S1levels) with lumbar radiculopathy.
* patients from both genders.
* The patient age will range from 30-45 years old.
* Duration of illness ranged from 3 to 6 months.
* All patients in the study should be ambulant independently.
* Medically and psychologically stable patients.

Exclusion Criteria:

* Previous lumbar or hip surgery.
* Cauda equina syndrome
* Fracture of the bones of lower extremity.
* Major neurological condition (e.g., stroke, multiple sclerosis, Epilepsy, Meningitis, and Brain tumor).
* BMI not more than 30.
* Vascular Impairment.
* Pregnancy and Gynecological problems
* Red flags: spinal tumors, spinal fractures, osteoporosis, infection.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 3 to 6 months
measure: Back Pain Related Disability (ODI) using Oswestry low back pain disability questionnaire
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: assistant professor of physical therapy
name: ashraf ahmed abdelmonem, md
role: STUDY_DIRECTOR
References:
citation: Huang Y, Gao D. The effectiveness of high intensity laser therapy in the patients with lumbar disc herniation: A protocol of randomized placebo-controlled trial. Medicine (Baltimore). 2020 Oct 9;99(41):e22520. doi: 10.1097/MD.0000000000022520.