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| Name | Class |
|---|---|
| University of Sharjah | OTHER |
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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:
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):
Laser or sham application (Step 2):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity laser therapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | N20 peak-to-peak amplitude and latency of C6, 7, and C8 will be measured at baseline and immediately after laser therapy application. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taif Omran | Contact | +971551610573 | U23102812@sharjah.ac.ae | |
| Dr. Tamer Shousha, PhD | Contact | +971562224469 | tshousha@sharjah.ac.ae |
| Name | Affiliation | Role |
|---|---|---|
| Taif Omran | University of Sharjah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sharjah | Sharjah city | United Arab Emirates |
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The study will be single-blind where the participants will be blinded to group assignments. While the primary investigator will be aware about the group assignment. Participants will be kept unaware about their group assignment, will be asked to complete a consent form explaining the study thoroughly, except the information related to the number of groups involved in the study, and will be provided by the additional information related to the group assignment after the completion of the study (Monaghan et al., 2021; Simon et al., 2021).
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| Low-level laser therapy | Radiation | 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 laser | Radiation | For the participants in the sham group, the same procedure will be followed, but with having the laser device turned off. |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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