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

November 28, 2023 updated by: Iran University of Medical Sciences

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: A Double-blind Randomised Controlled Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Risk factors contributing to discopathy disorders encompass repeated asymmetric bending and straightening, which predominantly inflicts damage to the posterolateral portion of the disc. Age constitutes another significant risk factor, with the highest incidence observed between the ages of 30 to 50 due to the watery intervertebral disc. Malignant changes associated with infection, end-plate defect, disease, herniation, genetics, and lifestyle (such as smoking) can lead to a loss of organization of the annulus fibrosus (as seen in myxomatous disease) and a fibrotic nucleus. One of the principal causes of sciatica symptoms is the presence of inflammatory cytokines at the site of the nerve root. These cytokines are released upon damage to the nucleus pulposus, instigating inflammation throughout the surrounding tissues. Given that the majority of disc herniations occur within the canal, inflammation typically affects the nerve roots as well. Mediators such as TNF α, prostaglandin E2, the interleukin group, and phospholipase A2 are implicated in this process." In a study conducted in 1993 by Olmarker et al., an experiment was performed where a fragment of the nucleus was positioned adjacent to a pig's cauda equina nerve, devoid of any mechanical pressure. The conclusion drawn from this experiment was that radicular pain did not originate from a mechanical phenomenon, but rather it led to a reduction in sensation and a decrease in the nerve rate. In a separate group of pigs, a singular mechanical stress was introduced, and the lack of symptoms was subsequently demonstrated. The observations of both localized and extensive hyperalgesia indicate the possibility of pain sensitization. Certain chronic conditions, such as nonspecific shoulder pain, lower back pain, and upper limb disorders, have shown a heightened sensitivity to nerve touch. It has been proposed that this sensitivity of the nerves can be attributed to peripheral sensitization mechanisms, wherein neurogenic inflammation results in the sensitization of neural mechanoreceptors, also known as nervi-nervorum. Furthermore, central sensitization mechanisms may also play a role in nerve sensitization, where non-noxious stimuli from the mechanoreceptors undergo abnormal processing in the central nervous system.

"Numerous studies have meticulously examined the available treatments for intervertebral disc lesions, encompassing both invasive and non-invasive approaches. Surgical interventions, a common modality, have been thoroughly evaluated. However, it is essential to note that patients who underwent surgery did not experience significantly greater pain relief or a more expedited return to work after a 4-year period compared to those who did not undergo surgery. Another invasive treatment involves the administration of injectable corticosteroids. A systematic review conducted by Yang et al. in 2020 meticulously compared physiotherapy interventions (excluding laser therapy) with epidural corticosteroid injections. Surprisingly, the long-term effects of epidural corticosteroid injections were found to be no more efficacious than those of physiotherapy treatments. In a 2015 study by Johnson et al., the pivotal role of TNF-α and IL-1β was elucidated. While these mediators are indispensable for normal physiological function, excessive secretion can indeed be detrimental. The study underscored the importance of precisely controlling the timing of inflammatory secretions and preventing an unwarranted surge in mediator levels to enhance the effectiveness of future treatments." In a 2015 guideline study of medical interventions, including medication, researchers found insufficient evidence to either accept or reject the effects of NSAIDs, muscle relaxants, oral corticosteroids, analgesics, and neuromodulators. Similarly, in a 2017 study by Ghaseem et al., although the evidence for laser therapy was limited, the guideline recommended the use of lasers for patients with low back pain. A study conducted by Maher et al. in 2004 examined the effectiveness of various physiotherapy treatments in systematic studies. Among these treatments, exercise therapy, laser therapy, and manual therapy were the most effective. However, treatments such as hydrotherapy, traction, magnet, and TENS lacked sufficient evidence. Recent studies by Alayat et al. in 2014 did not accept laser therapy as a standalone treatment; its effectiveness has been described only in combination with other physiotherapy treatments.

"Laser, an acronym for Light Amplification by Stimulated Emission of Radiation, possesses three distinct characteristics in the realm of light: 1) Monochromaticity, 2) Coherence (identical phase), and 3) Collimation (high convergence). In this methodology, light energy is projected onto the tissues of the body and absorbed, thereby stimulating or inhibiting enzymatic activity at the cellular level. This instigates physiological reactions, as well as anti-inflammatory and analgesic processes.

Laser therapy promotes interactions between the nucleus and the cytoplasm by augmenting physiological activity within the cell. Near-infrared wavelengths enhance the production of Adenosine Triphosphate (ATP) and alleviate pain and edema by stimulating Cytochrome c oxidase (CcO) at the mitochondrial level. Post-laser irradiation in tissues, there is an observed increase in the levels of beta-endorphins and morphine-mimetic substances, which are natural analgesics produced by the body.

Furthermore, laser irradiation augments lymph flow, decreases prostaglandin synthesis, mitigates the severity of inflammation, and expedites wound healing by enhancing growth factors and phagocytosis, increasing cytokine secretion, promoting angiogenesis, and stimulating fibroblasts and keratinocytes.

Therapeutic lasers, exhibiting a photobiomodulation effect and utilized for pain reduction, are categorized into two types: Low-Level Laser Therapy (power ranging from 5 to 500 mW) and High-Intensity Laser Therapy (power exceeding 500 mW). Laser power is defined as energy per unit time, hence, the use of a high-power laser enables energy to reach the target tissue in a shorter span of time, rendering it more suitable for the treatment of larger areas.

According to the Arendt-Schulz law, a physiological response is elicited in the target tissue once sufficient energy has been delivered to it. In this context, the parameters of the laser and its therapeutic capabilities are of paramount importance." The objective of this study was to ascertain the impact of high-intensity lasers on patients suffering from lower back pain, accompanied by radicular pain in a lower limb, a condition attributed to intervertebral disc herniation. Existing evidence implies that the chronic stage of intervertebral disc herniation may involve inflammatory factors, which could be a primary cause of lower back pain with radicular pain. Given its anti-inflammatory properties and absence of side effects for the patient, the high-power laser could serve as an effective treatment modality in the realm of physiotherapy for patients experiencing radicular lower back pain. This, however, is contingent on the physiotherapist's understanding of dosimetry and the aim of specific dosing therapy. Conversely, the dearth of current research on high-intensity lasers and their impact on lower back pain resulting from intervertebral disc herniation, coupled with diffuse pain in the lower extremities, and the absence of an appropriate treatment protocol, such as the application of high-intensity lasers on pain propagation and proper dosimetry with clinical symptoms, led us to identify a need for community therapy in this study.

The rationale behind selecting exercise therapy as a standard treatment for both groups was the advantageous effects of laser therapy when used in conjunction with exercise therapy. Current studies on the influence of motor control exercises on disc health and on patients with disc herniation suggest that this type of intervention surpasses other exercises (such as strengthening/resistance exercises, cardiovascular, etc.) and other conventional interventions (such as TENS). The treatment plan for patients with disc herniation can have a positive impact on the process of enhancing the reabsorption of herniated disc contents, disc height, disc diffusion rate, and the improvement of radicular symptoms.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, P.O. Box 4391-15875
        • School of Rehabilitation Sciences, Iran University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: True high intensity laser therapy on lumbar region, sciatic, tibial, and peroneal nerves
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
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.
Other Names:
  • High power laser
Other: Motor control exercise
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.
Other Names:
  • Stability exercise
Sham Comparator: Deactivated high intensity laser therapy, an audio device will mimic the laser's operational sound
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
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.
Other Names:
  • Stability exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Disability
Time Frame: This assessment will be conducted by the assessor before the start of treatment, four weeks after start of tratment , and one month post-treatment.
The functional disability will be evaluated using the validated and reliable Oswestry questionnaire, validated by Mousavi et al. in 2006.
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
Time Frame: These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment.
An algometer will be employed to measure the pressure pain threshold. The algometer will record each point thrice, and the average value per point will be documented. The measurements will be taken at specific points on the body, including 2 and 5 cm lateral to the first and third lumbar vertebrae, 2 cm lateral to the fifth lumbar vertebra, on the common peroneal nerve, tibial nerve, and the sciatic nerve.
These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment.
Range of Motion
Time Frame: These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment.
The active range of motion of the lumbar region (measured using the modified-modified Schubert test) and the Straight Leg Raise (SLR) range of motion of the affected lower limb (measured using a goniometer) will be assessed.
These assessments will be conducted before the start of treatment, four weeks after treatment, and one month post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iran University of Medical Sciences

Investigators

  • Principal Investigator: Seyed Mostafa Teymouri, Msc student, Iran University of Medical Sciences
  • Study Director: Mohammadreza Pourahmadi, Assistant professor, Iran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2022

Primary Completion (Estimated)

April 25, 2024

Study Completion (Estimated)

April 25, 2024

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.IUMS.REC.1401.089
  • IRCT20220410054486N1 (Registry Identifier: Iranian Rigestry of Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets of this study will be available on a reasonable request to the corresponding author

IPD Sharing Time Frame

Starting 6 months after the publication.

IPD Sharing 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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