Effect of High-Power Laser Therapy on the Size of Herniated Disc and Functional Outcome in Patients with Lumbosacral Radiculopathy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Vascular Impairment.
- •Pregnancy and Gynecological problems
- •Red flags: spinal tumors, spinal fractures, osteoporosis, infection.
Arms & Interventions
HPLT
this group will receive high power laser therapy (HPLT) for 20 minutes in addition to selected physical therapy exercise program 25 minutes and hot pack ten for 18 sessions three times weekly for 6 weeks.
Intervention: High power Laser Therapy (Device)
HPLT
this group will receive high power laser therapy (HPLT) for 20 minutes in addition to selected physical therapy exercise program 25 minutes and hot pack ten for 18 sessions three times weekly for 6 weeks.
Intervention: physical therapy exercise program and hot pack (Device)
physical therapy exercise program and hot pack
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
Intervention: physical therapy exercise program and hot pack (Device)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
wessam abelfattah mohamed alrefaie
assistant lecture of Physical Therapy for Neurology and Neurosurgery
Cairo University