Comparative Effect of High-Level Versus Low-Level Laser Therapy on Nerve Root Function Among Healthy Young Adults: A Randomized Controlled Trial

November 21, 2025 updated by: Taif A. M. Omran

Study title: Comparative Effect of High-Level Versus Low-Level Laser Therapy on Nerve Root Function Among Healthy Young Adults: A Randomized Controlled Trial You are invited to participate in a research study to investigate the short-term effect of high-intensity laser therapy (HILT), low-level laser therapy (LLLT), and sham laser on nerve root function among healthy adults.

Participation is entirely voluntary, and you may withdraw from the study at any time without penalty or need for justifications if you choose to do so.

What is the aim of the study? The objective of the current study is to investigate the short-term effect of high-intensity laser therapy (HILT), low-level laser therapy (LLLT), and sham laser on nerve root function among healthy adults.

Type of participants? We are recruiting participants aged 18-30 years of both genders without any musculoskeletal or neurological disorder involving the upper extremities, non-smokers, and if they expressed their wellness to participate in the current study.

What will participants be asked to do? The purpose of this study is to investigate the short-term effect of high-intensity laser therapy, low-level laser therapy, and sham laser on nerve root function among healthy adults.

If you agree to take part:

  • First, we will check if you are eligible for the study.

  • If you are eligible and give your consent, you will be randomly placed into one of three groups:

    1. High-intensity laser therapy group
    2. Low-level laser therapy group
    3. Sham (placebo) group - in this group, the laser device will look and feel the same, but it will not actually deliver laser treatment.
  • If you are in the sham group, you will not receive active laser therapy. This is important for the scientific accuracy of the study, as it allows us to compare the effects of real laser therapy with no treatment. You will not know which group you are in during the study, but you will be informed after your participation is complete.
  • You will attend 9 short sessions over 3 weeks (3 sessions per week). Each session will last about 5-10 minutes.

  • To measure nerve function before laser application (Step 1):

    1. A small gel will be used to place two sensors on your head (these can be removed easily).
    2. Three nerves in your arm will be tested using very light, safe electrical pulses delivered through a small hand-held electrode held in place with a strap.
    3. This helps us measure how your nerves are working before laser treatment by measuring the peak-to-peak amplitude and latency of N20 point of the brain through analyzing the brain waves.

  • Laser or sham application (Step 2):

    1. A researcher will apply the laser (or sham) to three spots on your neck.
    2. Each spot will receive laser for about 2 minutes.
    3. The laser used is safe, does not cause heat, and you will not feel any burning.
  • Measuring nerve function again (Step 3):

The same nerve test from step 1 will be repeated to see if there are any changes after the laser application.

  • Men do not need to remove any clothing.
  • Women who wear a headscarf will be asked to temporarily remove it so the head sensors can be placed. This will be done in a private room by a female researcher only, with doors locked and separators used to ensure complete privacy.
  • Male participants will also be attended to by a male researcher in the same respectful and private way.
  • It is very important to note that you may be assigned to a group where the laser is not actually turned on (sham group). This is important for the scientific accuracy of the study.
  • You will be told which group you were in after the study is completed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals deemed to be eligible to participate in the current study if they aged between 18 and 30 years of both genders, without any musculoskeletal or neurological disorder involving the upper extremities, non-smokers, and if they expressed their wellness to participate in the current study.

Exclusion Criteria:

  • Individuals will be excluded if they have a history of cervical spine disorders; significant cervical disc herniation, spinal narrowing, cervical nerve root compression, or cervical spinal cord dysfunction; a history of severe and frequent migraines, shoulder diseases, fibromyalgia, rheumatic or rheumatoid diseases, mental illnesses, severe osteoporosis, significant spinal deformities, or serious neurological, cardiovascular, or pulmonary conditions; the presence of fever, infection, tumors; cognitive or emotional disorders; or pregnant or nursing women (Xie et al., 2025).

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: HILT group
Participants in HILT group will receive laser therapy with a wavelength of 1064 nm, frequency of 25 Hz, output power of 7 W, and energy dose of 120 J/cm^2, intervention will be delivered through non-contact mode, by using the Zimmer MedizinSysteme device (OptonPro, Germany) to deliver high-intensity laser over C6, C7, and C8 nerve roots as they exit the spinal column.
Radiation: High-intensity laser therapy
Participants in HILT group will receive laser therapy with a wavelength of 1064 nm, frequency of 25 Hz, output power of 7 W, and energy dose of 120 J/cm^2, intervention will be delivered through non-contact mode, by using the Zimmer MedizinSysteme device (OptonPro, Germany) to deliver high-intensity laser over C6, C7, and C8 nerve roots as they exit the spinal column.
Active Comparator: LLLT group
Participants in LLLT group will receive laser therapy with wavelength of 905nm, frequency of 5 kHz output power of 25mW, and energy dose of 2 J/cm^2, intervention will be delivered through contact mode, by using the Enraf-Nonius Endolaser device (South Africa) to deliver low-level laser over C6, C7, and C8 nerve roots as the exit the spinal column.
Radiation: Low-level laser therapy
Participants in LLLT group will receive laser therapy with wavelength of 905nm, frequency of 5 kHz output power of 25mW, and energy dose of 2 J/cm^2, intervention will be delivered through contact mode, by using the Enraf-Nonius Endolaser device (South Africa) to deliver low-level laser over C6, C7, and C8 as they exit the spinal column.
Sham Comparator: Sham laser group
For the participants in the sham group, the same procedure will be followed, but with having the laser device turned off.
Radiation: Sham laser
For the participants in the sham group, the same procedure will be followed, but with having the laser device turned off.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
N20 peak-to-peak amplitude and latency
Time Frame: N20 peak-to-peak amplitude and latency of C6, 7, and C8 will be measured at baseline and immediately after laser therapy application.
The main outcome measure used to assess the nerve root function will be the N20 peak-to-peak amplitude and latency by using the dermatomal somatosensory evoked potentials (DSEPs).
N20 peak-to-peak amplitude and latency of C6, 7, and C8 will be measured at baseline and immediately after laser therapy application.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taif A. M. Omran

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sharjah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Taif Omran, University of Sharjah

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC-25-06-24-03-PG

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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