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Radiculopathy, Lumbosacral RegionNCT06151704

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 study testing High intensity laser therapy in people with Radiculopathy, Lumbosacral Region and Radiculopathy Lumbar, run by Iran University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 60 years
What is being tested?
High intensity laser therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteIran
Study dates
9 May 2022to 25 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Iran1 site
  • School of Rehabilitation Sciences, Iran University of Medical Sciences

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

Other trials in Iran

About this study

Official title: 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.

Read the 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.

Being tested
High intensity laser therapy, Motor control exercise
Keywords
Low back pain, Disc herniation, Sciatica, High intensity laser therapy, Pain, Functional disability, Range of motion, Pressure pain threshold
Medical subject headings
Radiculopathy, Low Back Pain, Intervertebral Disc Displacement, Sciatica, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High intensity laser therapyRadiation

    Also called High power laser

    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.

  • Motor control exerciseOther

    Also called Stability 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.

Study groups in NCT06151704
Study groupRoleWhat they receive
True high intensity laser therapy on lumbar region, sciatic, tibial, and peroneal nervesExperimentalThe 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.
Receives: Radiation: High intensity laser therapy; Other: Motor control exercise
Deactivated high intensity laser therapy, an audio device will mimic the laser's operational soundSham comparatorthe 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.
Receives: Other: Motor control exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)
  1. Functional Disability

    The functional disability will be evaluated using the validated and reliable Oswestry questionnaire, validated by Mousavi et al. in 2006.

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

  2. Pressure Pain Threshold

    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.

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

  3. Range of Motion

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2023
  2. Study start9 May 2022
  3. Primary completion25 Nov 2024
  4. Study completion25 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06151704
Sponsor's protocol ID
IR.IUMS.REC.1401.089
Other IDs
IRCT20220410054486N1
Status last verified
Nov 2023
First submitted
20 Nov 2023
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sets of this study will be available on a reasonable request to the corresponding author

Publications

  • Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.

    PubMed 29573870
  • Knezevic NN, Candido KD, Vlaeyen JWS, Van Zundert J, Cohen SP. Low back pain. Lancet. 2021 Jul 3;398(10294):78-92. doi: 10.1016/S0140-6736(21)00733-9. Epub 2021 Jun 8.

    PubMed 34115979
  • Farfan HF, Cossette JW, Robertson GH, Wells RV, Kraus H. The effects of torsion on the lumbar intervertebral joints: the role of torsion in the production of disc degeneration. J Bone Joint Surg Am. 1970 Apr;52(3):468-97. No abstract available.

    PubMed 5425641
  • Lundon K, Bolton K. Structure and function of the lumbar intervertebral disk in health, aging, and pathologic conditions. J Orthop Sports Phys Ther. 2001 Jun;31(6):291-303; discussion 304-6. doi: 10.2519/jospt.2001.31.6.291.

    PubMed 11411624
  • Beattie PF. Current understanding of lumbar intervertebral disc degeneration: a review with emphasis upon etiology, pathophysiology, and lumbar magnetic resonance imaging findings. J Orthop Sports Phys Ther. 2008 Jun;38(6):329-40. doi: 10.2519/jospt.2008.2768. Epub 2008 Mar 12.

    PubMed 18515962
  • Kawakami M, Matsumoto T, Kuribayashi K, Tamaki T. mRNA expression of interleukins, phospholipase A2, and nitric oxide synthase in the nerve root and dorsal root ganglion induced by autologous nucleus pulposus in the rat. J Orthop Res. 1999 Nov;17(6):941-6. doi: 10.1002/jor.1100170620.

    PubMed 10632462
  • Wanderman RL, Lamer TJ, Wald JT. Myofascial Inflammation Due to Intervertebral Disc Herniation. Pain Med. 2020 Jun 1;21(6):1295-1297. doi: 10.1093/pm/pnaa008. No abstract available.

    PubMed 32053200
  • Risbud MV, Shapiro IM. Role of cytokines in intervertebral disc degeneration: pain and disc content. Nat Rev Rheumatol. 2014 Jan;10(1):44-56. doi: 10.1038/nrrheum.2013.160. Epub 2013 Oct 29.

    PubMed 24166242
  • Burke JG, Watson RW, McCormack D, Dowling FE, Walsh MG, Fitzpatrick JM. Intervertebral discs which cause low back pain secrete high levels of proinflammatory mediators. J Bone Joint Surg Br. 2002 Mar;84(2):196-201. doi: 10.1302/0301-620x.84b2.12511.

    PubMed 11924650
  • Olmarker K, Rydevik B, Nordborg C. Autologous nucleus pulposus induces neurophysiologic and histologic changes in porcine cauda equina nerve roots. Spine (Phila Pa 1976). 1993 Sep 1;18(11):1425-32.

    PubMed 8235812
  • Imamura M, Imamura ST, Kaziyama HH, Targino RA, Hsing WT, de Souza LP, Cutait MM, Fregni F, Camanho GL. Impact of nervous system hyperalgesia on pain, disability, and quality of life in patients with knee osteoarthritis: a controlled analysis. Arthritis Rheum. 2008 Oct 15;59(10):1424-31. doi: 10.1002/art.24120.

    PubMed 18821657
  • Moloney N, Hall T, Doody C. An investigation of somatosensory profiles in work related upper limb disorders: a case-control observational study protocol. BMC Musculoskelet Disord. 2010 Jan 30;11:22. doi: 10.1186/1471-2474-11-22.

    PubMed 20113518
  • Walsh J, Hall T. Reliability, validity and diagnostic accuracy of palpation of the sciatic, tibial and common peroneal nerves in the examination of low back related leg pain. Man Ther. 2009 Dec;14(6):623-9. doi: 10.1016/j.math.2008.12.007. Epub 2009 Feb 6.

    PubMed 19201249
  • Jepsen JR, Laursen LH, Hagert CG, Kreiner S, Larsen AI. Diagnostic accuracy of the neurological upper limb examination I: inter-rater reproducibility of selected findings and patterns. BMC Neurol. 2006 Feb 16;6:8. doi: 10.1186/1471-2377-6-8.

    PubMed 16483371
  • Hall TM, Elvey RL. Nerve trunk pain: physical diagnosis and treatment. Man Ther. 1999 May;4(2):63-73. doi: 10.1054/math.1999.0172.

    PubMed 10509060

Questions about this trial

What is this clinical trial studying?

A study testing High intensity laser therapy in people with Radiculopathy, Lumbosacral Region and Radiculopathy Lumbar, run by Iran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06151704, which also lists 72 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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