HealthyNCT07260994
Comparative Effect of High-Level Versus Low-Level Laser Therapy on Nerve Root Function Among Healthy Young Adults: A Randomized Controlled Trial
A study testing High-intensity laser therapy and Low-level laser therapy in people with Healthy, run by Taif A. M. Omran at 1 site in United Arab Emirates.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-intensity laser therapy and Low-level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 24 Nov 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site
University of Sharjah
Sharjah city
Dr. Tamer Shousha, PhD, +97165057505, tshousha@sharjah.ac.ae
About this study
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.
Read more
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:
- High-intensity laser therapy group
- Low-level laser therapy group
- 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):
- A small gel will be used to place two sensors on your head (these can be removed easily).
- 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.
- 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):
- A researcher will apply the laser (or sham) to three spots on your neck.
- Each spot will receive laser for about 2 minutes.
- 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.
- Conditions
- Healthy
- Being tested
- High-intensity laser therapy, Low-level laser therapy, Sham laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity laser therapyRadiation
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.
Low-level laser therapyRadiation
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 laserRadiation
For the participants in the sham group, the same procedure will be followed, but with having the laser device turned off.
| Study group | Role | What they receive |
|---|---|---|
| HILT group | Active comparator | 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. Receives: Radiation: High-intensity laser therapy |
| LLLT group | Active comparator | 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. Receives: Radiation: Low-level laser therapy |
| Sham laser group | Sham comparator | For the participants in the sham group, the same procedure will be followed, but with having the laser device turned off. Receives: Radiation: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
N20 peak-to-peak amplitude and latency
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).
Measured: N20 peak-to-peak amplitude and latency of C6, 7, and C8 will be measured at baseline and immediately after laser therapy application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start24 Nov 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taif A. M. Omran
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sharjah
- Responsible party
- Sponsor-investigator, Taif A. M. Omran, University of Sharjah
- Investigators
- Taif Omran, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260994
- Sponsor's protocol ID
- REC-25-06-24-03-PG
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of High-Level Versus Low-Level Laser Therapy on Nerve Root Function Among Healthy Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07260994
- Acronym / sponsor ID
- REC-25-06-24-03-PG
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Taif A. M. OmranUniversity, hospital or other
- Collaborators
- University of Sharjah
- Study start
- 24 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- High-intensity laser therapy group
- Low-level laser therapy group
- 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):
- A small gel will be used to place two sensors on your head (these can be removed easily).
- 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.
- 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):
- A researcher will apply the laser (or sham) to three spots on your neck.
- Each spot will receive laser for about 2 minutes.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HILT group | Active comparator | Radiation: High-intensity laser therapyParticipants 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. |
| LLLT group | Active comparator | Radiation: Low-level laser therapyParticipants 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. |
| Sham laser group | Sham comparator | Radiation: Sham laserFor the participants in the sham group, the same procedure will be followed, but with having the laser device turned off. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity laser therapyParticipants 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 | HILT group |
| Low-level laser therapyParticipants 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. | Radiation | LLLT group |
| Sham laserFor the participants in the sham group, the same procedure will be followed, but with having the laser device turned off. | Radiation | Sham laser group |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taif Omran principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity laser therapy and Low-level laser therapy in people with Healthy, run by Taif A. M. Omran at 1 site in United Arab Emirates.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 3 Dec 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 United Arab Emirates. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taif Omran (+971551610573, U23102812@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025.