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NCT Number: NCT06831227

High Power Laser Therapy for Herniated Disc and Lumbosacral Radiculopathy

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

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Key information

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Giza, Egypt

About this study

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) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High power Laser therapy

Device

A total course protocol: 18 sessions, for 6 weeks ,3 sessions per week. Patients will receive High power Laser treatment. manually set to bio stimulation mode with high peak power (5 - 6 W), energy per impulse 150 mJ/c2, wavelength measuring 1064 nm, and spot beam diameter area of 1 cm2.

The hand piece was positioned in contact with and perpendicular to the treated area with the patient inside lying position with knee to chest. Scanning will perform transversely and longitudinally paravertebral region on the lower lumbar area at the level of the disc concerned. Each session included three phases (fast scan, sensitive trigger points, slow scan) and had a total duration of 20 minutes. During each session, a total energy of 3000 J was applied through three phases of treatment.

physical therapy exercise program and hot pack

Device

this group will receive the same selected physical therapy exercise program (45 minutes) and hot pack (10 min) for 18 session. All patients will attend the physical therapy clinic three times weekly for 6 weeks

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 3 to 6 months

    Visual Analogue Scale (VAS):

    This scale is used to assess the severity of pain. It consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain (10) that the patient could feel

  2. Back Pain Related Disability (ODI) using Oswestry low back pain disability questionnaire

    Time frame: 3-6 months

    Modified Oswestry low back disability questionnaire will be used to evaluate patient functional disability. It consists of 10 sections of activities of daily life. Patient asked to answer by checking ONE box in each section for the statement which best applies to her. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5.

Study contacts

Contact information is provided by the study sponsor or research team.

hossam mohamed hammad, MD

CONTACT

[email protected]

+201004198882

wessam mohamed alrefaie, master degree

CONTACT

[email protected]

+201063045651

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of High-Power Laser Therapy on the Size of Herniated Disc and Functional Outcome in Patients with Lumbosacral Radiculopathy.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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