Non-specific Chronic Neck PainNCT05689788
High-intensity Laser Therapy for Neck Pain
A study testing High-intensity laser therapy and Stretching exercise in people with Non-specific Chronic Neck Pain, run by Quiropraxia y Equilibrio at 2 sites in Chile.
Trial summary
Chronic nonspecific neck pain is a common musculoskeletal disorder recognized for its high rates of disability and economic losses, ranking second in musculoskeletal conditions after low back pain. There are several effective physical therapy interventions to treat chronic nonspecific neck pain, such as laser therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-specific Chronic Neck Pain
- What is being tested?
- High-intensity laser therapy and Stretching exercise
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesChile
- Study dates
- 31 Mar 2024to 28 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be at least 18 years old.
- Both sexes (men and women)
- Non-specific, chronic neck pain, defined as pain or discomfort in the cervical region between the superior nuchal line and the spinous process of T1 or the shoulder girdle, with the following criteria: neck pain in the last 3 months or more; a questionnaire score of cervical disability (NDI) equal to or greater than 5; and cervical pain of 3 or greater on the numerical pain scale (NPRS).
Who cannot join
- Neck or shoulder musculoskeletal injuries in the last 3 months (fractures, sprains, tendinopathies, dislocations, or muscle tears).
- Osteosynthesis materials close to the shoulders, neck, or surrounding areas.
- Wounds or skin changes in the shoulder and/or neck region (such as psoriasis, scars, or burns).
- Analgesic, anti-inflammatory, or muscle relaxant drugs for permanent use.
- Neurological alterations such as paresthesia, loss of sensation (partial or complete), decrease in strength, or color changes in the neck, arms, forearms, or hands.
- Diagnosed photosensitivity.
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- Presence of solar urticaria or adverse reactions to sunlight.
- The presence of dermatomyositis, systemic lupus erythematosus, hepatic porphyria, cutaneous carcinoid syndrome, or pellagra.
- Cancer or tumors of some type have been diagnosed in the last 5 years.
- Epilepsy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile2 sites, 2 recruiting
- Recruiting
Universidad Andrés Bello
Santiago, Las Condes, 7591538
Hernán de la Barra, Mg., 562226618402, hdelabarra@unab.cl
Hernán Andrés HB de la Barra Ortiz, Mg., 562226618402, hdelabarra@unab.cl
- Recruiting
Hernán Andrés de la Barra
Santiago
Hernán de la Barra, PhD(C)
About this study
Official title: Effect of High-intensity Laser Therapy in Patients With Chronic Nonspecific Neck Pain. Randomized Clinical Trial
Chronic nonspecific neck pain is a common musculoskeletal disorder recognized for its high rates of disability and economic losses, ranking second in musculoskeletal conditions after low back pain. There are several effective physical therapy interventions to treat chronic nonspecific neck pain, such as laser therapy. High-intensity laser therapy (HILT) is a recent treatment proposed to reduce musculoskeletal pain; however, there are few studies that prove its effects in reducing neck pain.
The aim of this randomized clinical trial is to evaluate the effect of high-intensity laser therapy on pain intensity in patients with chronic nonspecific neck pain.
The research will be carried out in the laboratory of physical agents at the Andrés Bello University, Campus Casona de las Condes. Participants will be employers and volunteer students with non-specific chronic neck pain. Participants will be randomized and allocated into 2 study groups: group 1 (HILT and stretching exercises) and group 2 (simulated HILT and stretching exercises). Treatments will be performed twice a week for 4 weeks with 3 assessments: before treatment, at the end of treatment, and 12 weeks after treatment (follow-up). The main results will be the differences in pain pressure threshold (ΔPPT), intensity of pain at rest (ΔRPI) and intensity of pain on movement (ΔMPI). Secondary outcome measures, on the other hand, will include differences in cervical spine range (ΔCROM) and cervical disability (ΔND).
Read the detailed description
Material and Methods
Type of study: Experimental, randomized clinical trial (RCT).
- Study population: For the study, students and employees of Andrés Bello University will be considered participants.
- Randomization and sample: Participants will be evaluated according to the selection criteria through a survey with closed questions and a clinical examination that will determine the presence or absence of chronic non-specific neck pain. Participants will be divided into two study groups through a simple randomization process: group 1 (HILT) and group 2 (sham HILT). The randomization of the sample will be carried out by the study director using the simple random sampling process through the research randomizer program, who will be the only one who knows the results. All groups will receive a treatment with an exercise plan that includes passive static stretching of the upper trapezius, levator scapulae, and scalenes muscles (three sets of 30 seconds for each group bilaterally). Participants will be scheduled twice a week for four weeks to carry out the assigned treatment. The sample size was determined with the G-Power program using a power of 0.80 (1-β), a reliability of 95%, an error of 5% (α) and an effect size of 0.6 (d- Cohen) with reference to previous studies that determined differences in mean pain intensity between experimental and control groups after HILT treatment with effect sizes of 0.53. Based on the above, the sample size is 72 subjects, with at least 36 subjects per group.
- Procedures The outcomes to be measured will be: pain pressure threshold (PPT), resting pain intensity (RPI), movement pain intensity (MPI), cervical range of motion (CROM), and cervical disability (ND). Pain pressure threshold (PPT) will be evaluated with pressure algometry at six bilateral points established for the cervical region and shoulders, pain intensity at rest and on movement with VAS (RPI and MPI), cervical ROM with an inclinometer (CROM system), and cervical disability (ND) through the cervical disability index (NDI). The evaluations will be carried out by 2 independent evaluators: evaluator 1, PPT with algometry and PI with VAS (RPI and MPI); and evaluator 2, CROM with cervical inclinometry and ND with the cervical disability index. The PPT values will be evaluated in kg/cm2, the MPI will be evaluated in millimeters, the CROM will be evaluated in degrees for all movements of the cervical spine, and the ND will be evaluated as a percentage of disability. Values for the outcome measures of interest will be tabulated in an Excel® spreadsheet by each rater. The evaluations will be carried out during the study in three instances (T0-T1), including a later follow-up evaluation (T3): pretreatment (T0: baseline), end of treatment at 8 weeks (T1), and twelve weeks (T3: follow-up). The participants will be summoned twice a week to carry out their corresponding treatments. On the other hand, cervical disability will be evaluated using the Spanich version of Neck Disability Index (NDI), obtaining the percentage of disability for each of the evaluation instances. Moreover, the NDI will be applied as a self-report before and after the treatment sessions (T0 and T2). Once the study is over, the differences in cervical range of motion (ΔCFROM), pain pressure threshold (ΔPPT), pain intensity at rest (ΔRPI), pain intensity at movement (ΔMPI) and cervical disability (ΔNDI) between the evaluation sessions will be evaluated.
- Variables 4.1 Conceptual definition of the variables
- Painful pressure threshold (PPT): the magnitude of pressure described as painful by the participant when performing the six-point algometry test in the cervical and shoulder regions: 2 cm lateral to the spinous processes of C2, C5, T4, and T8, midpoint of the upper portion of the trapezius muscle belly (between the spinous process of C7 and the acromion), and levator scapula muscle (2 cm superior to the superior angle of the scapula).
- Pain intensity at rest (RPI): the magnitude of neck pain reported by participants when they are at rest.
- Movement pain intensity (MPI): magnitude of pain reported by the participants when performing movements of the cervical spine in flexion, extension, inclination, and right and left rotation.
- Cervical range of motion (CROM): range of motion of the head relative to the trunk for flexion, extension, right tilt, left tilt, right rotation, and left rotation movements.
- Neck disability (ND): lack or limitation of the functionality of the cervical region due to pain that makes it impossible or difficult to carry out normal activities of daily living.
- High Intensity Laser Therapy (HILT): laser application with powers greater than 500 milliwatts (mW) at the algometry assessment points and upper trapezius muscle belly.
- Stretching exercise (SE): Bilateral passive static stretching for the upper trapezius, levator scapulae, and scalenes muscles. 4.2 Operational definition of variables.
- Painful Pressure Threshold (PPT): The painful pressure threshold (PPT) will be quantified by pressure algometry, recording the sum of the values in kg/cm2 of pressure for the six bilateral points established to perform the measurement. Three measurements will be made for each point with an interval of 30 seconds, recording the average of the three as the final value. For the evaluation, the Baseline® brand pressure algometer will be used. The PPT exam will be performed by placing the participant in a prone position. The intra-rater reliability for the PPT measurement will be determined with the intra-class coefficient by assessing the PPT at the upper trapezius muscle belly point in 13 healthy volunteers not involved in the study with a 48-h interval between assessments.
- Pain intensity at rest (RPI): Pain intensity will be assessed using a visual analogue scale (VAS) (ICC = 0.97 (CI 95% 0.96, 0.98) [30]. The RPI The MPI exam will be carried out by the participant in a seated position, keeping the back straight and supported on a backrest.
- Movement pain intensity (MPI): Pain intensity will be assessed through the visual analogue scale (VAS) for movements of flexion, extension, inclination, and cervical rotation. The MPI value will correspond to the sum of the VAS score for all cervical movements. The MPI exam will be carried out by the participant in a seated position, keeping the back straight and supported on a backrest.
- Cervical range of motion (CROM): The range of cervical motion will be evaluated through an inclinometer, recording the degrees of movement for the movements of flexion, extension, right tilt, left tilt, right rotation, and left rotation. To measure the range of motion, the CROM device will be used (inter-evaluator reliability: Extension ICC = 0.98 (CI 95% 0.95, 0.99); Flexion ICC = 0.89 (CI 95% 0.73,0.96); Left rotation ICC = 0.95 (CI 95 % 0.87, 0.98); Rotation right ICC = 0.92 (CI 95% 0.80, 0.97); Tilt left ICC = 0.97 (CI 95% 0.91, 0.99); Tilt right ICC = 0.97 (CI 95% 0.93, 0.99). The CROM examination will be performed while seated with a straight back and supported by the chair's back.
- Neck disability (ND): Neck disability will be assessed through the Neck Disability Index (NDI), an instrument consisting of 10 sections with questions related to symptoms and life activities that may be limited by neck pain and that has been validated for the Spanish language. Each section consists of questions scored from 0-5, with greater disability being associated with a higher score (NDI; inter-rater reliability: ICC = 0.93 (95% CI 0.86, 0.97).
- High-Intensity Laser Therapy (HILT): High intensity laser therapy (HILT) will be applied with the punctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles. Dundar et al. propose the following parameters: a 3 watt average power, 60 joules per point (360 joules), and 500 joules for manual scanning (1000 joules). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used. Laser therapy will be applied with the participant in the prone position.
- Stretching exercise (SE): Three sets of bilateral passive static stretching will be performed for the upper trapezius, levator scapulae, and scalene muscles. Each series will last 30 seconds, followed by a rest interval of 30 seconds. The exercises will be carried out with the participant in a seated position in a chair with a backrest. 4.3 Variable type definition
- Painful Pressure Threshold (PPT): dependent, quantitative, continuous variable.
- Pain intensity on movement (MPI): dependent, quantitative, discrete variable.
- Cervical range of motion (CROM): dependent, quantitative, discrete variable.
- Cervical disability (ND): dependent, quantitative, continuous variable.
- High Intensity Laser Therapy (HILT): independent, quantitative, continuous variable.
- Stretching exercise (EE): independent, quantitative, discrete variable.
- Study phases Three phases have been designated for the investigation: Sampling phase, Evaluation phase and Intervention phase. The sampling phase will consist of applying the selection survey to potential participants. Participants will be chosen according to the selection criteria through a survey that will determine the presence of non-specific chronic neck pain (CNCP). The survey will be conducted online using a Microsoft Office® form. The selected participants will be divided into two study groups through a simple randomization process (research randomizer, https://www.randomizer.org/): group 1 (HILT + stretching exercise) and group 2 (sham HILT + stretching exercise). The randomization of the sample will be carried out by the study director, using the simple random sampling process through the research randomizer program, who will be the only one who knows the results. Participants will meet twice a week for four weeks to carry out the assigned treatment. The evaluation phase will consist of measuring the outcomes of interest. Pain pressure threshold (PPT) will be evaluated with pressure algometry at six established bilateral points, pain intensity at rest and on movement with VAS (RPI and MPI), cervical ROM with an inclinometer (CROM system), and the neck disability (ND) through the spanich version of Neck Disability Index. The evaluations of the interest outcome measures will be carried out in three instances; pretreatment (T0: baseline), the fourth week (T2: 8th session, end of treatment), and week 20 (T3: 12 weeks post-treatment or follow-up). The differences in pain pressure threshold (ΔPPT), pain intensity at rest (ΔRPI) and pain intensity on movement (ΔMPI) will be considered the main outcome measures. Alternatively, secondary outcome measures will include differences in cervical spine range (ΔCROM) and cervical disability (ΔND). The intervention phase will include eight treatment sessions held twice a week to carry out their corresponding treatments (4 weeks total). The sample will be treated in two study groups: the HILT group and the sham HILT group. All groups will receive, as a base treatment, a passive static cervical stretching therapeutic exercise plan focused on the upper trapezius, levator scapulae, and scalene muscles of three series for 30 seconds. The interventions will be carried out by two independent, trained therapists.The participants will be summoned twice a week to carry out their corresponding treatments.
- Statistic analysis
The descriptive statistics for the primary variables ΔPPT, ΔRPI, ΔMPI ΔCROM, and ΔND will use as analysis measures, means and standard deviation (x, SD), or median and interquartile range (mean, IQR), depending on the distribution of the data (test of normality of Kolmogorov-Smirnov). This will make it possible to build the table with the demographic data of the participants by group (Table 1 of the work). According to the data normality analysis, frequencies and means or medians will be used for the secondary variables sex and body mass index (BMI).For inferential statistical analysis of the outcome measures of interest obtained between assessments, the Kolmogorov-Smirnov normality test will be used to determine their distribution. According to the results, parametric or non-parametric tests will be selected: the T-test for independent samples if the data is normally distributed or the U-Mann Whitney test if the variables are not normally distributed. For statistical analysis, the IBM SPSS (Statistical Package for the Social Sciences) v26 program will be used.
- Conditions
- Non-specific Chronic Neck Pain
- Being tested
- High-intensity laser therapy, Stretching exercise, Sham High-intensity laser therapy
- Keywords
- Lasers, Laser therapy, Chronic pain, Neck pain, Physical Therapy Modalities, Clinical trial
- Medical subject headings
- Chronic Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity laser therapyDevice
punctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles (upper portions). The parameters proposed by Dundar et al. will be used: an average power of 3 W, 60 J per point (360 J), and 500 J for manual scanning (1000 J). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used.
Stretching exerciseProcedure or surgery
Three sets of bilateral passive static stretching will be performed for the upper trapezius, levator scapulae, and scalene muscles. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest.
Sham High-intensity laser therapyDevice
Intervention in which the therapist performs a HILT simulation application, performing all of the steps and movements for an administration without actually receiving the treatment.
| Study group | Role | What they receive |
|---|---|---|
| HILT + stretching exercise | Experimental | High-intensity laser therapy (HILT) will be applied with the punctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles (upper portions). The parameters proposed by Dundar et al. will be used: an average power of 3 W, 60 J per point (360 J), and 500 J for manual scanning (1000 J). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used. Laser therapy will be applied with the participant in the prone position.The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest. Receives: Device: High-intensity laser therapy; Procedure: Stretching exercise |
| Sham HILT + stretching exercise | Sham comparator | The group will receive a sham treatment of high-intensity laser therapy (HILT). The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest. Receives: Procedure: Stretching exercise; Device: Sham High-intensity laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure thereshold (PPT)
Pain pressure threshold differences evaluated with algometry at six neck and shoulder locations: 2 cm lateral to the spinous processes of C2, C5, T4, and T8, midpoint of the upper trapezius muscle belly (between the spinous process of C7 and the acromion), and the levator scapula muscle (2 cm superior to the superior angle of the scapula).
Measured: Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)
Pain intensity at rest (RPI)
Magnitude of neck pain reported by participants at rest evaluated with visual anologue scale (VAS)
Measured: Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)
Pain intensity at movement (MPI)
Magnitude of pain reported by the participants when performing movements of the cervical spine in flexion, extension, inclination, and right and left rotation evaluated with visual anologue scale (VAS).
Measured: Baseline and 4 weeks (8 sessions)
Secondary outcomes (2)
Cervical range of motion (CROM)
Range of motion of the head relative to the trunk in flexion, extension, right tilt, left tilt, right rotation, and left rotation movements evalluated with goniometry (cervical ROM device).
Measured: Baseline and 4 weeks (8 sessions)
Neck disability (ND)
Lack or limitation of the functionality of the cervical region due to pain makes it impossible or difficult to carry out normal activities of daily living evaluated with the Neck Disability Index (NDI)
Measured: Baseline and 4 weeks (8 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start31 Mar 2024
- Primary completion30 May 2024
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Non-specific Chronic 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quiropraxia y Equilibrio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hernán Andrés de la Barra Ortiz, Universidad Nacional Andres Bello
- Investigators
- Hernán de la Barra Ortiz, MSc, Principal investigator, Universidad Nacional Andres Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689788
- Sponsor's protocol ID
- 26122022
- Status last verified
- Aug 2025
- First submitted
- 26 Dec 2022
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
PubMed 25659245Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
PubMed 34980079Fandim JV, Nitzsche R, Michaleff ZA, Pena Costa LO, Saragiotto B. The contemporary management of neck pain in adults. Pain Manag. 2021 Jan;11(1):75-87. doi: 10.2217/pmt-2020-0046. Epub 2020 Nov 25.
PubMed 33234017Hoy DG, Protani M, De R, Buchbinder R. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):783-92. doi: 10.1016/j.berh.2011.01.019.
PubMed 21665126Peron R, Rampazo EP, Liebano RE. Traditional acupuncture and laser acupuncture in chronic nonspecific neck pain: study protocol for a randomized controlled trial. Trials. 2022 May 16;23(1):408. doi: 10.1186/s13063-022-06349-y.
PubMed 35578302Alayat MS, Mohamed AA, Helal OF, Khaled OA. Efficacy of high-intensity laser therapy in the treatment of chronic neck pain: a randomized double-blind placebo-control trial. Lasers Med Sci. 2016 May;31(4):687-94. doi: 10.1007/s10103-016-1910-2. Epub 2016 Feb 25.
PubMed 26914684Matre D, Knardahl S. 'Central sensitization' in chronic neck/shoulder pain. Scand J Pain. 2012 Oct 1;3(4):230-235. doi: 10.1016/j.sjpain.2012.04.003.
PubMed 29913871Diwan S, Manchikanti L, Benyamin RM, Bryce DA, Geffert S, Hameed H, Sharma ML, Abdi S, Falco FJ. Effectiveness of cervical epidural injections in the management of chronic neck and upper extremity pain. Pain Physician. 2012 Jul-Aug;15(4):E405-34.
PubMed 22828692Cotler HB, Chow RT, Hamblin MR, Carroll J. The Use of Low Level Laser Therapy (LLLT) For Musculoskeletal Pain. MOJ Orthop Rheumatol. 2015;2(5):00068. doi: 10.15406/mojor.2015.02.00068. Epub 2015 Jun 9.
PubMed 26858986Hadis MA, Zainal SA, Holder MJ, Carroll JD, Cooper PR, Milward MR, Palin WM. The dark art of light measurement: accurate radiometry for low-level light therapy. Lasers Med Sci. 2016 May;31(4):789-809. doi: 10.1007/s10103-016-1914-y. Epub 2016 Mar 10.
PubMed 26964800Khalkhal E, Razzaghi M, Rostami-Nejad M, Rezaei-Tavirani M, Heidari Beigvand H, Rezaei Tavirani M. Evaluation of Laser Effects on the Human Body After Laser Therapy. J Lasers Med Sci. 2020 Winter;11(1):91-97. doi: 10.15171/jlms.2020.15. Epub 2020 Jan 18.
PubMed 32099633Stewart N, Lim AC, Lowe PM, Goodman G. Lasers and laser-like devices: part one. Australas J Dermatol. 2013 Aug;54(3):173-83. doi: 10.1111/ajd.12034. Epub 2013 Apr 10.
PubMed 23573909de Freitas LF, Hamblin MR. Proposed Mechanisms of Photobiomodulation or Low-Level Light Therapy. IEEE J Sel Top Quantum Electron. 2016 May-Jun;22(3):7000417. doi: 10.1109/JSTQE.2016.2561201.
PubMed 28070154Karu T. Mitochondrial mechanisms of photobiomodulation in context of new data about multiple roles of ATP. Photomed Laser Surg. 2010 Apr;28(2):159-60. doi: 10.1089/pho.2010.2789. No abstract available.
PubMed 20374017Clijsen R, Brunner A, Barbero M, Clarys P, Taeymans J. Effects of low-level laser therapy on pain in patients with musculoskeletal disorders: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2017 Aug;53(4):603-610. doi: 10.23736/S1973-9087.17.04432-X. Epub 2017 Jan 30.
PubMed 28145397
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-intensity Laser Therapy in Patients With Chronic Nonspecific Neck Pain. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05689788
- Acronym / sponsor ID
- 26122022
- Conditions
- Non-specific Chronic Neck Pain
- Keywords
- Lasers, Laser therapy, Chronic pain, Neck pain, Physical Therapy Modalities, Clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Quiropraxia y EquilibrioUniversity, hospital or other
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 19 Jan 2023 (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.
Chronic nonspecific neck pain is a common musculoskeletal disorder recognized for its high rates of disability and economic losses, ranking second in musculoskeletal conditions after low back pain. There are several effective physical therapy interventions to treat chronic nonspecific neck pain, such as laser therapy. High-intensity laser therapy (HILT) is a recent treatment proposed to reduce musculoskeletal pain; however, there are few studies that prove its effects in reducing neck pain.
The aim of this randomized clinical trial is to evaluate the effect of high-intensity laser therapy on pain intensity in patients with chronic nonspecific neck pain.
The research will be carried out in the laboratory of physical agents at the Andrés Bello University, Campus Casona de las Condes. Participants will be employers and volunteer students with non-specific chronic neck pain. Participants will be randomized and allocated into 2 study groups: group 1 (HILT and stretching exercises) and group 2 (simulated HILT and stretching exercises). Treatments will be performed twice a week for 4 weeks with 3 assessments: before treatment, at the end of treatment, and 12 weeks after treatment (follow-up). The main results will be the differences in pain pressure threshold (ΔPPT), intensity of pain at rest (ΔRPI) and intensity of pain on movement (ΔMPI). Secondary outcome measures, on the other hand, will include differences in cervical spine range (ΔCROM) and cervical disability (ΔND).
Detailed description
Material and Methods
Type of study: Experimental, randomized clinical trial (RCT).
- Study population: For the study, students and employees of Andrés Bello University will be considered participants.
- Randomization and sample: Participants will be evaluated according to the selection criteria through a survey with closed questions and a clinical examination that will determine the presence or absence of chronic non-specific neck pain. Participants will be divided into two study groups through a simple randomization process: group 1 (HILT) and group 2 (sham HILT). The randomization of the sample will be carried out by the study director using the simple random sampling process through the research randomizer program, who will be the only one who knows the results. All groups will receive a treatment with an exercise plan that includes passive static stretching of the upper trapezius, levator scapulae, and scalenes muscles (three sets of 30 seconds for each group bilaterally). Participants will be scheduled twice a week for four weeks to carry out the assigned treatment. The sample size was determined with the G-Power program using a power of 0.80 (1-β), a reliability of 95%, an error of 5% (α) and an effect size of 0.6 (d- Cohen) with reference to previous studies that determined differences in mean pain intensity between experimental and control groups after HILT treatment with effect sizes of 0.53. Based on the above, the sample size is 72 subjects, with at least 36 subjects per group.
- Procedures The outcomes to be measured will be: pain pressure threshold (PPT), resting pain intensity (RPI), movement pain intensity (MPI), cervical range of motion (CROM), and cervical disability (ND). Pain pressure threshold (PPT) will be evaluated with pressure algometry at six bilateral points established for the cervical region and shoulders, pain intensity at rest and on movement with VAS (RPI and MPI), cervical ROM with an inclinometer (CROM system), and cervical disability (ND) through the cervical disability index (NDI). The evaluations will be carried out by 2 independent evaluators: evaluator 1, PPT with algometry and PI with VAS (RPI and MPI); and evaluator 2, CROM with cervical inclinometry and ND with the cervical disability index. The PPT values will be evaluated in kg/cm2, the MPI will be evaluated in millimeters, the CROM will be evaluated in degrees for all movements of the cervical spine, and the ND will be evaluated as a percentage of disability. Values for the outcome measures of interest will be tabulated in an Excel® spreadsheet by each rater. The evaluations will be carried out during the study in three instances (T0-T1), including a later follow-up evaluation (T3): pretreatment (T0: baseline), end of treatment at 8 weeks (T1), and twelve weeks (T3: follow-up). The participants will be summoned twice a week to carry out their corresponding treatments. On the other hand, cervical disability will be evaluated using the Spanich version of Neck Disability Index (NDI), obtaining the percentage of disability for each of the evaluation instances. Moreover, the NDI will be applied as a self-report before and after the treatment sessions (T0 and T2). Once the study is over, the differences in cervical range of motion (ΔCFROM), pain pressure threshold (ΔPPT), pain intensity at rest (ΔRPI), pain intensity at movement (ΔMPI) and cervical disability (ΔNDI) between the evaluation sessions will be evaluated.
- Variables 4.1 Conceptual definition of the variables
- Painful pressure threshold (PPT): the magnitude of pressure described as painful by the participant when performing the six-point algometry test in the cervical and shoulder regions: 2 cm lateral to the spinous processes of C2, C5, T4, and T8, midpoint of the upper portion of the trapezius muscle belly (between the spinous process of C7 and the acromion), and levator scapula muscle (2 cm superior to the superior angle of the scapula).
- Pain intensity at rest (RPI): the magnitude of neck pain reported by participants when they are at rest.
- Movement pain intensity (MPI): magnitude of pain reported by the participants when performing movements of the cervical spine in flexion, extension, inclination, and right and left rotation.
- Cervical range of motion (CROM): range of motion of the head relative to the trunk for flexion, extension, right tilt, left tilt, right rotation, and left rotation movements.
- Neck disability (ND): lack or limitation of the functionality of the cervical region due to pain that makes it impossible or difficult to carry out normal activities of daily living.
- High Intensity Laser Therapy (HILT): laser application with powers greater than 500 milliwatts (mW) at the algometry assessment points and upper trapezius muscle belly.
- Stretching exercise (SE): Bilateral passive static stretching for the upper trapezius, levator scapulae, and scalenes muscles. 4.2 Operational definition of variables.
- Painful Pressure Threshold (PPT): The painful pressure threshold (PPT) will be quantified by pressure algometry, recording the sum of the values in kg/cm2 of pressure for the six bilateral points established to perform the measurement. Three measurements will be made for each point with an interval of 30 seconds, recording the average of the three as the final value. For the evaluation, the Baseline® brand pressure algometer will be used. The PPT exam will be performed by placing the participant in a prone position. The intra-rater reliability for the PPT measurement will be determined with the intra-class coefficient by assessing the PPT at the upper trapezius muscle belly point in 13 healthy volunteers not involved in the study with a 48-h interval between assessments.
- Pain intensity at rest (RPI): Pain intensity will be assessed using a visual analogue scale (VAS) (ICC = 0.97 (CI 95% 0.96, 0.98) [30]. The RPI The MPI exam will be carried out by the participant in a seated position, keeping the back straight and supported on a backrest.
- Movement pain intensity (MPI): Pain intensity will be assessed through the visual analogue scale (VAS) for movements of flexion, extension, inclination, and cervical rotation. The MPI value will correspond to the sum of the VAS score for all cervical movements. The MPI exam will be carried out by the participant in a seated position, keeping the back straight and supported on a backrest.
- Cervical range of motion (CROM): The range of cervical motion will be evaluated through an inclinometer, recording the degrees of movement for the movements of flexion, extension, right tilt, left tilt, right rotation, and left rotation. To measure the range of motion, the CROM device will be used (inter-evaluator reliability: Extension ICC = 0.98 (CI 95% 0.95, 0.99); Flexion ICC = 0.89 (CI 95% 0.73,0.96); Left rotation ICC = 0.95 (CI 95 % 0.87, 0.98); Rotation right ICC = 0.92 (CI 95% 0.80, 0.97); Tilt left ICC = 0.97 (CI 95% 0.91, 0.99); Tilt right ICC = 0.97 (CI 95% 0.93, 0.99). The CROM examination will be performed while seated with a straight back and supported by the chair's back.
- Neck disability (ND): Neck disability will be assessed through the Neck Disability Index (NDI), an instrument consisting of 10 sections with questions related to symptoms and life activities that may be limited by neck pain and that has been validated for the Spanish language. Each section consists of questions scored from 0-5, with greater disability being associated with a higher score (NDI; inter-rater reliability: ICC = 0.93 (95% CI 0.86, 0.97).
- High-Intensity Laser Therapy (HILT): High intensity laser therapy (HILT) will be applied with the punctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles. Dundar et al. propose the following parameters: a 3 watt average power, 60 joules per point (360 joules), and 500 joules for manual scanning (1000 joules). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used. Laser therapy will be applied with the participant in the prone position.
- Stretching exercise (SE): Three sets of bilateral passive static stretching will be performed for the upper trapezius, levator scapulae, and scalene muscles. Each series will last 30 seconds, followed by a rest interval of 30 seconds. The exercises will be carried out with the participant in a seated position in a chair with a backrest. 4.3 Variable type definition
- Painful Pressure Threshold (PPT): dependent, quantitative, continuous variable.
- Pain intensity on movement (MPI): dependent, quantitative, discrete variable.
- Cervical range of motion (CROM): dependent, quantitative, discrete variable.
- Cervical disability (ND): dependent, quantitative, continuous variable.
- High Intensity Laser Therapy (HILT): independent, quantitative, continuous variable.
- Stretching exercise (EE): independent, quantitative, discrete variable.
- Study phases Three phases have been designated for the investigation: Sampling phase, Evaluation phase and Intervention phase. The sampling phase will consist of applying the selection survey to potential participants. Participants will be chosen according to the selection criteria through a survey that will determine the presence of non-specific chronic neck pain (CNCP). The survey will be conducted online using a Microsoft Office® form. The selected participants will be divided into two study groups through a simple randomization process (research randomizer, https://www.randomizer.org/): group 1 (HILT + stretching exercise) and group 2 (sham HILT + stretching exercise). The randomization of the sample will be carried out by the study director, using the simple random sampling process through the research randomizer program, who will be the only one who knows the results. Participants will meet twice a week for four weeks to carry out the assigned treatment. The evaluation phase will consist of measuring the outcomes of interest. Pain pressure threshold (PPT) will be evaluated with pressure algometry at six established bilateral points, pain intensity at rest and on movement with VAS (RPI and MPI), cervical ROM with an inclinometer (CROM system), and the neck disability (ND) through the spanich version of Neck Disability Index. The evaluations of the interest outcome measures will be carried out in three instances; pretreatment (T0: baseline), the fourth week (T2: 8th session, end of treatment), and week 20 (T3: 12 weeks post-treatment or follow-up). The differences in pain pressure threshold (ΔPPT), pain intensity at rest (ΔRPI) and pain intensity on movement (ΔMPI) will be considered the main outcome measures. Alternatively, secondary outcome measures will include differences in cervical spine range (ΔCROM) and cervical disability (ΔND). The intervention phase will include eight treatment sessions held twice a week to carry out their corresponding treatments (4 weeks total). The sample will be treated in two study groups: the HILT group and the sham HILT group. All groups will receive, as a base treatment, a passive static cervical stretching therapeutic exercise plan focused on the upper trapezius, levator scapulae, and scalene muscles of three series for 30 seconds. The interventions will be carried out by two independent, trained therapists.The participants will be summoned twice a week to carry out their corresponding treatments.
- Statistic analysis
The descriptive statistics for the primary variables ΔPPT, ΔRPI, ΔMPI ΔCROM, and ΔND will use as analysis measures, means and standard deviation (x, SD), or median and interquartile range (mean, IQR), depending on the distribution of the data (test of normality of Kolmogorov-Smirnov). This will make it possible to build the table with the demographic data of the participants by group (Table 1 of the work). According to the data normality analysis, frequencies and means or medians will be used for the secondary variables sex and body mass index (BMI).For inferential statistical analysis of the outcome measures of interest obtained between assessments, the Kolmogorov-Smirnov normality test will be used to determine their distribution. According to the results, parametric or non-parametric tests will be selected: the T-test for independent samples if the data is normally distributed or the U-Mann Whitney test if the variables are not normally distributed. For statistical analysis, the IBM SPSS (Statistical Package for the Social Sciences) v26 program will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HILT + stretching exercise | Experimental | Device: High-intensity laser therapy, Procedure: Stretching exerciseHigh-intensity laser therapy (HILT) will be applied with the punctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles (upper portions). The parameters proposed by Dundar et al. will be used: an average power of 3 W, 60 J per point (360 J), and 500 J for manual scanning (1000 J). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used. Laser therapy will be applied with the participant in the prone position.The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest. |
| Sham HILT + stretching exercise | Sham comparator | Procedure: Stretching exercise, Device: Sham High-intensity laser therapyThe group will receive a sham treatment of high-intensity laser therapy (HILT). The treatment will be complemented with passive static stretching for the upper trapezius, levator scapulae, and scalene muscles (bilaterally) in three series. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be at least 18 years old.
- Both sexes (men and women)
- Non-specific, chronic neck pain, defined as pain or discomfort in the cervical region between the superior nuchal line and the spinous process of T1 or the shoulder girdle, with the following criteria: neck pain in the last 3 months or more; a questionnaire score of cervical disability (NDI) equal to or greater than 5; and cervical pain of 3 or greater on the numerical pain scale (NPRS).
Key exclusion criteria (10 listed)
- Neck or shoulder musculoskeletal injuries in the last 3 months (fractures, sprains, tendinopathies, dislocations, or muscle tears).
- Osteosynthesis materials close to the shoulders, neck, or surrounding areas.
- Wounds or skin changes in the shoulder and/or neck region (such as psoriasis, scars, or burns).
- Analgesic, anti-inflammatory, or muscle relaxant drugs for permanent use.
- Neurological alterations such as paresthesia, loss of sensation (partial or complete), decrease in strength, or color changes in the neck, arms, forearms, or hands.
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 therapypunctual technique on the 6 bilateral points of the cervical region and shoulder girdle, to be followed by a sweep technique on both trapezius muscles (upper portions). The parameters proposed by Dundar et al. will be used: an average power of 3 W, 60 J per point (360 J), and 500 J for manual scanning (1000 J). For the application of laser therapy, the 12 W BTL-6000 equipment that emits at 1064 nm wavelengths will be used. | Device | HILT + stretching exercise |
| Stretching exerciseThree sets of bilateral passive static stretching will be performed for the upper trapezius, levator scapulae, and scalene muscles. Each series will last 30 seconds, followed by a 30-second rest interval. The exercises will be carried out with the participant in a seated position in a chair with a backrest. | Procedure or surgery | HILT + stretching exercise, Sham HILT + stretching exercise |
| Sham High-intensity laser therapyIntervention in which the therapist performs a HILT simulation application, performing all of the steps and movements for an administration without actually receiving the treatment. | Device | Sham HILT + stretching exercise |
Primary outcome
Pain pressure thereshold (PPT)
Time frame: Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)
Pain pressure threshold differences evaluated with algometry at six neck and shoulder locations: 2 cm lateral to the spinous processes of C2, C5, T4, and T8, midpoint of the upper trapezius muscle belly (between the spinous process of C7 and the acromion), and the levator scapula muscle (2 cm superior to the superior angle of the scapula).
Pain intensity at rest (RPI)
Time frame: Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)
Magnitude of neck pain reported by participants at rest evaluated with visual anologue scale (VAS)
Pain intensity at movement (MPI)
Time frame: Baseline and 4 weeks (8 sessions)
Magnitude of pain reported by the participants when performing movements of the cervical spine in flexion, extension, inclination, and right and left rotation evaluated with visual anologue scale (VAS).
2 secondary outcomes
Cervical range of motion (CROM)
Time frame: Baseline and 4 weeks (8 sessions)
Neck disability (ND)
Time frame: Baseline and 4 weeks (8 sessions)
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 7 Aug 2025.
- Background: PubMed 25659245Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
- Background: PubMed 34980079Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
- Background: PubMed 33234017Fandim JV, Nitzsche R, Michaleff ZA, Pena Costa LO, Saragiotto B. The contemporary management of neck pain in adults. Pain Manag. 2021 Jan;11(1):75-87. doi: 10.2217/pmt-2020-0046. Epub 2020 Nov 25.
- Background: PubMed 21665126Hoy DG, Protani M, De R, Buchbinder R. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):783-92. doi: 10.1016/j.berh.2011.01.019.
- Background: PubMed 35578302Peron R, Rampazo EP, Liebano RE. Traditional acupuncture and laser acupuncture in chronic nonspecific neck pain: study protocol for a randomized controlled trial. Trials. 2022 May 16;23(1):408. doi: 10.1186/s13063-022-06349-y.
- Background: PubMed 26914684Alayat MS, Mohamed AA, Helal OF, Khaled OA. Efficacy of high-intensity laser therapy in the treatment of chronic neck pain: a randomized double-blind placebo-control trial. Lasers Med Sci. 2016 May;31(4):687-94. doi: 10.1007/s10103-016-1910-2. Epub 2016 Feb 25.
- Background: PubMed 29913871Matre D, Knardahl S. 'Central sensitization' in chronic neck/shoulder pain. Scand J Pain. 2012 Oct 1;3(4):230-235. doi: 10.1016/j.sjpain.2012.04.003.
- Background: PubMed 22828692Diwan S, Manchikanti L, Benyamin RM, Bryce DA, Geffert S, Hameed H, Sharma ML, Abdi S, Falco FJ. Effectiveness of cervical epidural injections in the management of chronic neck and upper extremity pain. Pain Physician. 2012 Jul-Aug;15(4):E405-34.
- Background: PubMed 26858986Cotler HB, Chow RT, Hamblin MR, Carroll J. The Use of Low Level Laser Therapy (LLLT) For Musculoskeletal Pain. MOJ Orthop Rheumatol. 2015;2(5):00068. doi: 10.15406/mojor.2015.02.00068. Epub 2015 Jun 9.
- Background: PubMed 26964800Hadis MA, Zainal SA, Holder MJ, Carroll JD, Cooper PR, Milward MR, Palin WM. The dark art of light measurement: accurate radiometry for low-level light therapy. Lasers Med Sci. 2016 May;31(4):789-809. doi: 10.1007/s10103-016-1914-y. Epub 2016 Mar 10.
- Background: PubMed 32099633Khalkhal E, Razzaghi M, Rostami-Nejad M, Rezaei-Tavirani M, Heidari Beigvand H, Rezaei Tavirani M. Evaluation of Laser Effects on the Human Body After Laser Therapy. J Lasers Med Sci. 2020 Winter;11(1):91-97. doi: 10.15171/jlms.2020.15. Epub 2020 Jan 18.
- Background: PubMed 23573909Stewart N, Lim AC, Lowe PM, Goodman G. Lasers and laser-like devices: part one. Australas J Dermatol. 2013 Aug;54(3):173-83. doi: 10.1111/ajd.12034. Epub 2013 Apr 10.
- 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.
Hernán de la Barra Ortiz, MSc principal investigator
Universidad Nacional Andres Bello
2 sites 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 Stretching exercise in people with Non-specific Chronic Neck Pain, run by Quiropraxia y Equilibrio at 2 sites in Chile.
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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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 Hernán A de la Barra Ortiz, MSc (56984706322, hdelabarra@unab.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure thereshold (PPT) (time frame: Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)). The study lists 3 primary outcomes in all. 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 NCT05689788, which also lists 37 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 7 Aug 2025.