High Power Laser Therapy for Herniated Disc and Lumbosacral Radiculopathy

NCT06831227 | Not Yet Recruiting DMC

• 1 other identifier: Pٌٌ.T.REC/012/005509
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Herniated Lumbar Disc

Keywords

High Power Laser; Herniated disc; LUMBOSACRAL RADICULOPATHY

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

  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

  3 to 6 months

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

  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.

  3-6 months

Study Arms (2)

HPLT

ACTIVE COMPARATOR

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.

Device: High power Laser Therapy; Device: physical therapy exercise program and hot pack

physical therapy exercise program and hot pack

SHAM COMPARATOR

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

Device: physical therapy exercise program and hot pack

Interventions

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.

HPLT

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

HPLT; physical therapy exercise program and hot pack

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33031293 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• ashraf ahmed abdelmonem, md

  assistant professor of physical therapy

  STUDY DIRECTOR

Central Study Contacts

wessam mohamed alrefaie, master degree

CONTACT

+201063045651; wessamrefaay1991@gmail.com

hossam mohamed hammad, MD

CONTACT

+201004198882; drhossssam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecture of Physical Therapy for Neurology and Neurosurgery

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 18, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

EG (1)