Neck PainNCT07262697
Laser Therapy for Patients With Nonspecific Neck Pain
A study testing HILT and LLLT in people with Neck Pain and Non Specific Neck Pain, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Background and Purpose: Neck pain is widespread and stands as the sixth most common cause of disability globally. While laser therapy has been used for many years to treat non-specific neck pain (NNP), there is still a shortage of research directly comparing different laser modalities. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain, Non Specific Neck Pain
- What is being tested?
- HILT and LLLT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2023to 1 Apr 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chonic neck pain lasting more than 30 days with no evidence of foraminal compression;
- age 18 years or older;
- experiencing considerable pain, stiffness, or discomfort localized to the neck area, without associated numbness or radiation of pain to the upper limbs;
- a visual analog scale (VAS) pain rating of 3 or above;
- no therapeutic intervention within the last month
Who cannot join
- Previous cervical spine trauma or surgery;
- significant cervical disc prolapse, cervical nerve root compression or spinal cord manifestations;
- history of severe and frequent migraines, fibromyalgia, shoulder diseases, rheumatic or rheumatoid diseases, severe osteoporosis, mental illnesses, significant spinal deformities, or serious cardiovascular, pulmonary, or neurological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of High-intensity Laser Therapy and Low-Level Laser Therapy in Patients With Non-specific Neck Pain
Background and Purpose: Neck pain is widespread and stands as the sixth most common cause of disability globally. While laser therapy has been used for many years to treat non-specific neck pain (NNP), there is still a shortage of research directly comparing different laser modalities. The aim of this study was to evaluate and compare the therapeutic effectiveness of low-level laser therapy (LLLT) and high intensity laser therapy (HILT) in managing NNP.
Methods: sixty patients diagnosed with NNP were equally randomized into three groups. HILT group received 10 weeks of HILT, LLLT group received 10 weeks of LLLT and a control group that received a home program. Outcome measures were evaluated at baseline and after the intervention period and included pain intensity, neck disability, active cervical range of motion (ROM), and quality of life.
Read the detailed description
Study Design This study was designed as randomized comparative trial. The study procedures were conducted in the electrotherapy laboratory in the Department of Rehabilitation and Health Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia between March 2023 and April 2024. The study involved recruitment of 75 subjects from the university hospital and local clinics. Initial evaluation was performed by an orthopedist. The study sample included participants diagnosed with chronic non-specific neck pain (NNP) according to clinical and radiological tests. Study subjects were randomly assigned to one of three groups high intensity laser therapy (HILT) group, low-level laser therapy (LLLT) group, and a control group. The HILT group subjects underwent 10 weeks of HILT in addition to a home exercise program while the LLLT group subjects underwent 10 weeks of LLLT in addition to a home exercise program. The third group was a control group where group subjects performed only a home exercise program and did not receive laser therapy. The use of analgesics or nonsteroidal anti-inflammatory medications was not allowed during the intervention period (17).
The randomization process was conducted using SPSS statistical software, following a 1:1 allocation ratio and stratified by center, with random block sizes of four to ensure balanced distribution. An independent researcher, who was not involved in recruiting participants or delivering the interventions, generated the randomization sequence. Group assignments were recorded on numbered cards and sealed in opaque envelopes by this independent researcher. These envelopes were later opened by the intervention researchers, who administered the respective treatment according to group allocation.
Blinding was maintained throughout the study. All participants were unaware of their assigned group, ensuring subject blinding. Although the therapists delivering the treatments knew which group participants belonged to, they were blinded to the specific laser parameters, as these settings were predetermined by an independent researcher. The therapists' role was limited to implementing standardized treatment protocols without access to detailed device settings. Furthermore, all outcome evaluations were performed by an assessor who was blinded to group allocation, thereby minimizing assessment bias and maintaining the integrity of the study's double-blind design.
- Conditions
- Neck Pain, Non Specific Neck Pain
- Being tested
- HILT, LLLT, CONTROL
- Keywords
- laser, neck pain, neck disability
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HILTOther
Also called Home program
The first phase consisted of rapid manual scanning, delivering a total energy of 1000 J/cm². During the second phase, HILT was applied to eight trigger points, with four applications per point, continuing until pain reduction reached approximately 70-80%; a total of 200 J was delivered in this phase. The final phase was performed with slow manual scanning with the same parameters as the initial phase. The complete HILT procedure lasted around 30 minutes, with a total energy dose of approximately 2050 J (19).
LLLTOther
Also called HOME PROGRAM
The laser probe was positioned directly on specific points along the cervical spine while the participant's head remained in a neutral position. Each point was treated for 2 minutes. A total of eight points were marked bilaterally over the trapezius and sternocleidomastoid muscles, covering an area of 24 cm². The total treatment duration was 18 minutes, with an energy dose of 2 J/cm² applied to each point (20).
CONTROLOther
The home program involved stretching exercises for levator scapulae and upper trapezius, strengthening exercises for neck extensors, and scapular stabilizer exercises. Each exercise was executed with a 5-second hold and 10 repetitions per set, for a total of three sets repeated three times per week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HILT | Experimental | The first phase consisted of rapid manual scanning, delivering a total energy of 1000 J/cm². During the second phase, HILT was applied to eight trigger points, with four applications per point, continuing until pain reduction reached approximately 70-80%; a total of 200 J was delivered in this phase. The final phase was performed with slow manual scanning with the same parameters as the initial phase. The complete HILT procedure lasted around 30 minutes, with a total energy dose of approximately 2050 J (19). Receives: Other: HILT; Other: CONTROL |
| LLLT | Experimental | LLLT sessions were carried out using the diode laser device (Chattanooga Group, USA) of gallium-aluminum-arsenide (GaAlAs, infrared laser) with an 850 nm wavelength, 800 mW power, and constant wave with 1 cm spot size was utilized for the treatment procedures. The laser probe was positioned directly on specific points along the cervical spine while the participant's head remained in a neutral position. Each point was treated for 2 minutes. A total of eight points were marked bilaterally over the trapezius and sternocleidomastoid muscles, covering an area of 24 cm². The total treatment duration was 18 minutes, with an energy dose of 2 J/cm² applied to each point (20). Receives: Other: LLLT; Other: CONTROL |
| CONTROL | Active comparator | The home program involved stretching exercises for levator scapulae and upper trapezius, strengthening exercises for neck extensors, and scapular stabilizer exercises. Each exercise was executed with a 5-second hold and 10 repetitions per set, for a total of three sets repeated three times per week for 10 weeks. Receives: Other: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
VAS is a reliable tool for measuring pain intensity. Each participant was asked to mark a point on a 10 cm line corresponding to the severity of their pain, with scores ranging from 0 to 10-where 0 indicates no pain and 10 represents the most severe pain. Previous research has demonstrated that the VAS is a reliable and valid tool for assessing the intensity of neck pain
Measured: 10 weeks
Secondary outcomes (3)
Active ROM of the cervical spine
A universal goniometer was employed to quantify the angle of motion in each direction. Each movement was measured three times to ensure consistency, and the mean of the three readings was recorded as the final value. This standardized method minimizes measurement error and improves reproducibility. Previous studies have reported that cervical active ROM assessment using a goniometer provides excellent intra- and inter-rater reliability, making it a valid and dependable tool for evaluating neck mobility (23).
Measured: 10 weeks
Functional disability
The Neck Disability Index (NDI) was employed to assess functional disability in the study participants. This instrument consists of 10 items divided into two domains: neck pain-related symptoms and the capacity to carry out daily activities. Each item is scored from 0 to 5, yielding a maximum total score of 50, with higher scores indicating greater cervical functional impairment (24). The NDI was expressed as a percentage of disability, determined by the formula (total score/50 × 100). The NDI has good internal consistency and test-retest reliability
Measured: 10 weeks
SF-36 Quality of life
The SF-36 consists of 36 items that assess both physical and mental health, allowing participants to rate their perceived health status on a scale from 0 to 100, where 0 indicates the poorest health and 100 indicates the best possible health (26). This questionnaire provides a reliable measure of two distinct domains: physical and mental health (27).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Model description
- th
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Moustafa Aldosoukki Hegazy, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262697
- Sponsor's protocol ID
- RHPT/022/041
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ezzati K, Laakso EL, Saberi A, Yousefzadeh Chabok S, Nasiri E, Bakhshayesh Eghbali B. A comparative study of the dose-dependent effects of low level and high intensity photobiomodulation (laser) therapy on pain and electrophysiological parameters in patients with carpal tunnel syndrome. Eur J Phys Rehabil Med. 2020 Dec;56(6):733-740. doi: 10.23736/S1973-9087.19.05835-0. Epub 2019 Nov 18.
PubMed 31742366Alayat MSM, Alshehri MA, Shousha TM, Abdelgalil AA, Alhasan H, Khayyat OK, Al-Attar WS. The effectiveness of high intensity laser therapy in the management of spinal disorders: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2019;32(6):869-884. doi: 10.3233/BMR-181341.
PubMed 30932879
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-intensity Laser Therapy and Low-Level Laser Therapy in Patients With Non-specific Neck Pain
- ClinicalTrials.gov ID
- NCT07262697
- Acronym / sponsor ID
- RHPT/022/041
- Conditions
- Neck Pain, Non Specific Neck Pain
- Keywords
- laser, neck pain, neck disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 4 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.
Background and Purpose: Neck pain is widespread and stands as the sixth most common cause of disability globally. While laser therapy has been used for many years to treat non-specific neck pain (NNP), there is still a shortage of research directly comparing different laser modalities. The aim of this study was to evaluate and compare the therapeutic effectiveness of low-level laser therapy (LLLT) and high intensity laser therapy (HILT) in managing NNP.
Methods: sixty patients diagnosed with NNP were equally randomized into three groups. HILT group received 10 weeks of HILT, LLLT group received 10 weeks of LLLT and a control group that received a home program. Outcome measures were evaluated at baseline and after the intervention period and included pain intensity, neck disability, active cervical range of motion (ROM), and quality of life.
Detailed description
Study Design This study was designed as randomized comparative trial. The study procedures were conducted in the electrotherapy laboratory in the Department of Rehabilitation and Health Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia between March 2023 and April 2024. The study involved recruitment of 75 subjects from the university hospital and local clinics. Initial evaluation was performed by an orthopedist. The study sample included participants diagnosed with chronic non-specific neck pain (NNP) according to clinical and radiological tests. Study subjects were randomly assigned to one of three groups high intensity laser therapy (HILT) group, low-level laser therapy (LLLT) group, and a control group. The HILT group subjects underwent 10 weeks of HILT in addition to a home exercise program while the LLLT group subjects underwent 10 weeks of LLLT in addition to a home exercise program. The third group was a control group where group subjects performed only a home exercise program and did not receive laser therapy. The use of analgesics or nonsteroidal anti-inflammatory medications was not allowed during the intervention period (17).
The randomization process was conducted using SPSS statistical software, following a 1:1 allocation ratio and stratified by center, with random block sizes of four to ensure balanced distribution. An independent researcher, who was not involved in recruiting participants or delivering the interventions, generated the randomization sequence. Group assignments were recorded on numbered cards and sealed in opaque envelopes by this independent researcher. These envelopes were later opened by the intervention researchers, who administered the respective treatment according to group allocation.
Blinding was maintained throughout the study. All participants were unaware of their assigned group, ensuring subject blinding. Although the therapists delivering the treatments knew which group participants belonged to, they were blinded to the specific laser parameters, as these settings were predetermined by an independent researcher. The therapists' role was limited to implementing standardized treatment protocols without access to detailed device settings. Furthermore, all outcome evaluations were performed by an assessor who was blinded to group allocation, thereby minimizing assessment bias and maintaining the integrity of the study's double-blind design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- th
| Arm | Type | Receives |
|---|---|---|
| HILT | Experimental | Other: HILT, Other: CONTROLThe first phase consisted of rapid manual scanning, delivering a total energy of 1000 J/cm². During the second phase, HILT was applied to eight trigger points, with four applications per point, continuing until pain reduction reached approximately 70-80%; a total of 200 J was delivered in this phase. The final phase was performed with slow manual scanning with the same parameters as the initial phase. The complete HILT procedure lasted around 30 minutes, with a total energy dose of approximately 2050 J (19). |
| LLLT | Experimental | Other: LLLT, Other: CONTROLLLLT sessions were carried out using the diode laser device (Chattanooga Group, USA) of gallium-aluminum-arsenide (GaAlAs, infrared laser) with an 850 nm wavelength, 800 mW power, and constant wave with 1 cm spot size was utilized for the treatment procedures. The laser probe was positioned directly on specific points along the cervical spine while the participant's head remained in a neutral position. Each point was treated for 2 minutes. A total of eight points were marked bilaterally over the trapezius and sternocleidomastoid muscles, covering an area of 24 cm². The total treatment duration was 18 minutes, with an energy dose of 2 J/cm² applied to each point (20). |
| CONTROL | Active comparator | Other: CONTROLThe home program involved stretching exercises for levator scapulae and upper trapezius, strengthening exercises for neck extensors, and scapular stabilizer exercises. Each exercise was executed with a 5-second hold and 10 repetitions per set, for a total of three sets repeated three times per week for 10 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- chonic neck pain lasting more than 30 days with no evidence of foraminal compression;
- age 18 years or older;
- experiencing considerable pain, stiffness, or discomfort localized to the neck area, without associated numbness or radiation of pain to the upper limbs;
- a visual analog scale (VAS) pain rating of 3 or above;
- no therapeutic intervention within the last month
Key exclusion criteria (3 listed)
- Previous cervical spine trauma or surgery;
- significant cervical disc prolapse, cervical nerve root compression or spinal cord manifestations;
- history of severe and frequent migraines, fibromyalgia, shoulder diseases, rheumatic or rheumatoid diseases, severe osteoporosis, mental illnesses, significant spinal deformities, or serious cardiovascular, pulmonary, or neurological diseases.
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 |
|---|---|---|
| HILTAlso: Home programThe first phase consisted of rapid manual scanning, delivering a total energy of 1000 J/cm². During the second phase, HILT was applied to eight trigger points, with four applications per point, continuing until pain reduction reached approximately 70-80%; a total of 200 J was delivered in this phase. The final phase was performed with slow manual scanning with the same parameters as the initial phase. The complete HILT procedure lasted around 30 minutes, with a total energy dose of approximately 2050 J (19). | Other | HILT |
| LLLTAlso: HOME PROGRAMThe laser probe was positioned directly on specific points along the cervical spine while the participant's head remained in a neutral position. Each point was treated for 2 minutes. A total of eight points were marked bilaterally over the trapezius and sternocleidomastoid muscles, covering an area of 24 cm². The total treatment duration was 18 minutes, with an energy dose of 2 J/cm² applied to each point (20). | Other | LLLT |
| CONTROLThe home program involved stretching exercises for levator scapulae and upper trapezius, strengthening exercises for neck extensors, and scapular stabilizer exercises. Each exercise was executed with a 5-second hold and 10 repetitions per set, for a total of three sets repeated three times per week for 10 weeks. | Other | CONTROL, HILT, LLLT |
Primary outcome
Pain intensity
Time frame: 10 weeks
VAS is a reliable tool for measuring pain intensity. Each participant was asked to mark a point on a 10 cm line corresponding to the severity of their pain, with scores ranging from 0 to 10-where 0 indicates no pain and 10 represents the most severe pain. Previous research has demonstrated that the VAS is a reliable and valid tool for assessing the intensity of neck pain
3 secondary outcomes
Active ROM of the cervical spine
Time frame: 10 weeks
Functional disability
Time frame: 10 weeks
SF-36 Quality of life
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 31742366Ezzati K, Laakso EL, Saberi A, Yousefzadeh Chabok S, Nasiri E, Bakhshayesh Eghbali B. A comparative study of the dose-dependent effects of low level and high intensity photobiomodulation (laser) therapy on pain and electrophysiological parameters in patients with carpal tunnel syndrome. Eur J Phys Rehabil Med. 2020 Dec;56(6):733-740. doi: 10.23736/S1973-9087.19.05835-0. Epub 2019 Nov 18.
- Background: PubMed 30932879Alayat MSM, Alshehri MA, Shousha TM, Abdelgalil AA, Alhasan H, Khayyat OK, Al-Attar WS. The effectiveness of high intensity laser therapy in the management of spinal disorders: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2019;32(6):869-884. doi: 10.3233/BMR-181341.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HILT and LLLT in people with Neck Pain and Non Specific Neck Pain, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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 5 inclusion and 3 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 4 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 Saudi Arabia. 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. 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?
Pain intensity (time frame: 10 weeks). 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 NCT07262697, which also lists 2 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 4 Dec 2025.