The Effect of High-power Laser Therapy on Pain, Functional Disability, Range of Motion and Pressure Pain Threshold in Subjects With Radicular Low Back Pain Due to Intervertebral Disc Herniation

NCT06151704 | Completed

• 2 other identifiers: IR.IUMS.REC.1401.089IRCT20220410054486N1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is the predominant cause of disability on a global scale. In the year 2015, the worldwide point prevalence of activity-limiting low back pain stood at 7·3%, suggesting that at any given moment, 540 million individuals were afflicted. In that same year, low back pain emerged as the primary cause of involuntary labor leave and premature retirement within Europe. In the United States, 44% of patients have utilized their health insurance for low back pain at least once, and 1 to 2% (approximately 3 million individuals) exhibit symptoms of sciatica as a result of a lumbar intervertebral disc herniation. Given the prevalence of disorders attributable to L4-L5 and L5-S1 intervertebral disc herniation, it is imperative to consider the potential risks associated with both surgical and non-surgical medical interventions, such as corticosteroid injections. Laser therapy emerges as a viable modality within the realm of physical therapy, particularly in the mitigation of inflammation. The modulating effects of laser therapy on inflammation have been documented, with no significant side effects reported thus far. Should the efficacy of laser therapy be substantiated, it could be incorporated into the suite of treatments endorsed by authoritative guidelines pertaining to back pain. Patients afflicted with radicular back pain have been the beneficiaries of assistance from physiotherapists possessing specialized knowledge in effective dosimetry. The objectives of this assistance include the amelioration of pain symptoms, the enhancement of functional indicators, the augmentation of the range of motion, and the modulation of the pressure pain threshold, all without the concern of side effects. Furthermore, adherence to the correct treatment protocol is of paramount importance. The main objective of this study is to evaluate the effect of active high-power laser compared to sham laser on pain, disability, range of motion, and pressure pain threshold in patients with radicular low back pain due to lumbar intervertebral disc herniation.

Conditions

Radiculopathy, Lumbosacral Region; Radiculopathy Lumbar

Keywords

Low back pain; Disc herniation; Sciatica; High intensity laser therapy; Pain; Functional disability; Range of motion; Pressure pain threshold

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  The Visual Analog Scale, rated from zero (indicating no pain) to 10 (representing the most severe pain conceivable), will be utilized to assess lumbar and affected extremity pain

  This scale will be measured by the assessor prior to the intervention, four weeks after start of treatment, and one month post-treatment. The average pain experienced over the preceding seven days will be recorded as the VAS score

Secondary Outcomes (3)

• Functional Disability

  This assessment will be conducted by the assessor before the start of treatment, four weeks after start of tratment , and one month post-treatment.

• Pressure Pain Threshold

  These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment.

• Range of Motion

  These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment.

Study Arms (2)

True high intensity laser therapy on lumbar region, sciatic, tibial, and peroneal nerves

EXPERIMENTAL

The laser scanner, 50 cm from the skin, will target the area from the 12th ribs to the upper iliac crest, 4.2 cm lateral to the spine. The sciatic, tibial, and peroneal nerves will also be irradiated.

Radiation: High intensity laser therapy; Other: Motor control exercise

Deactivated high intensity laser therapy, an audio device will mimic the laser's operational sound

SHAM COMPARATOR

the laser will remain deactivated, and an audio device will generate a simulation of the operational sound of the device. The subject will also participate in the same foundational treatment regimen involving motor control exercises as the intervention group.

Other: Motor control exercise

Interventions

High intensity laser therapy RADIATION

The subject will receive high-intensity laser therapy in a prone position with a cushion under the abdomen and eye protection. The laser scanner, 50 cm from the skin, will target the area from the 12th ribs to the upper iliac crest, 4.2 cm lateral to the spine. The sciatic, tibial, and peroneal nerves will also be irradiated. A GaAlAs laser device will be used, with a power of 1.6 watts and a wavelength of 808nm. The initial dose will be 10 joules/cm², with an increment of 2 joules after every three sessions. The final dose will be 16 joules/cm².

Also known as: High power laser

True high intensity laser therapy on lumbar region, sciatic, tibial, and peroneal nerves

Motor control exercise OTHER

Motor control exercise is defined as an exercise to increase control and coordination of the spine and pelvis. Normally, Motor control exercise increases the weak deep trunk muscles, such as transversus abdominis and multifidus, and reduces the overactive large external trunk muscles, such as rectus abdominal and erector spinae muscles. . All subjects participate in a foundational treatment regimen involving motor control exercises: isolated and combined contractions of the transverse abdominis and multifidus muscles in various positions. Contractions will initially be performed up to a maximum of 10 repetitions per movement, with each contraction sustained for a duration of 10 seconds. Commencing from the third week, the subject should be capable of comfortably executing 10 repetitions, sustaining the contraction for 10 seconds, and progressively increasing the intensity.

Also known as: Stability exercise

Deactivated high intensity laser therapy, an audio device will mimic the laser's operational sound; True high intensity laser therapy on lumbar region, sciatic, tibial, and peroneal nerves

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The diagnosis of radicular low back pain, originating from an intervertebral disc herniation between the fourth lumbar and first sacral vertebrae, is confirmed by a neurosurgeon
• A minimum of 12 weeks have elapsed since the onset of symptoms. The patient experiences persistent pain or paraesthesia (numbness and/or tingling) in the lower back or both limbs, attributable to the herniation of the lumbar intervertebral disc impinging on the nerve root dermatome
• Magnetic Resonance Imaging (MRI) scans of the patients reveal either protrusion or extrusion disc herniation.

You may not qualify if:

• Local or systemic infection, rheumatic disease, diabetes
• Vertebral and sacroiliac joint dysfunction (Gillette test positive)
• Pregnancy
• History of previous surgery in the area
• Patients with MRI of spinal canal stenosis or spondylolisthesis
• Patients with vascular disorders, cancer and tumors and synovial cysts
• History of physiotherapy for at least the last 12 weeks
• sciatic nerve Contusion
• psychiatric illnesses
• Active trigger point of gluteus minimus muscle (diffuse sciatica-like pain)

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Study Sites (1)

School of Rehabilitation Sciences, Iran University of Medical Sciences

Tehran, Tehran Province, P.O. Box 4391-15875, Iran

Location

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MeSH Terms

Conditions

Radiculopathy; Low Back Pain; Intervertebral Disc Displacement; Sciatica; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Sciatic Neuropathy; Mononeuropathies; Neuralgia

Study Officials

• Seyed Mostafa Teymouri, Msc student

  Iran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mohammadreza Pourahmadi, Assistant professor

  Iran University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: both the patients and the outcome assessor are blinded to the treatment groups. Initially, the assessor measures the outcomes before the patients are included in the study. The therapist then administers the treatments for both groups, with the assessor remaining unaware of the specific treatment throughout the study. Patients are first provided with a comprehensive explanation that the study is a clinical trial consisting of two groups, and they will be randomly assigned to either the intervention group or the control group. All patients are required to wear a protective blindfold during treatment due to the laser procedure. To create authentic therapeutic conditions for the placebo group, the patient is positioned prone with a pillow under their abdomen and wears a protective blindfold. The only difference is that the laser is turned off, and an audio player simulates the sound of the laser device. Upon completion of the study, the examiner conducts the final evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The present study is designed as a randomized, double-blind, controlled clinical trial, with control established through sham treatment. The variable block method, comprising four-letter blocks, will be employed for random allocation. The allocation sequence will be determined using the website Generatorslist.com

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 30, 2023
• Study Start: May 9, 2022
• Primary Completion: November 25, 2024
• Study Completion: December 25, 2024
• Last Updated: September 18, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after the publication.
• Access Criteria: The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders and spine centers. The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of low back pain. Applicants can contact Seyed Mostafa Teymouri by Email. Email Address:teymouri.seyedmostafa@gmail.com Applicants should explain their project and how the data/documents of the study will be used in their project in detail. Then, the data/documents files will be sent by email to applicants on request. This process may take 10-12 working days

Locations

IR (1)