An interventional study of High-intensity laser therapy in Chronic Non-specific Neck Pain, sponsored by Quiropraxia y Equilibrio. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Quiropraxia y Equilibrio · Not applicable, Interventional, and Treatment
Chronic non-specific neck pain (CNNP) poses a significant challenge in healthcare, sparking interest in conservative and innovative therapeutic options such as high-intensity laser therapy (HILT). While evidence of its efficacy in this specific context remains limited, there is a robust foundation supporting the use of HILT in managing chronic neck pain, demonstrating effectiveness in pain reduction and functional improvement. Therefore, the aim of this study is to evaluate the clinical response to HILT treatment in patients with CNNP, investigating its potential therapeutic benefits and adverse effects. The findings of this study will provide valuable insights into the clinical experience with HILT in this population, serving as a pivotal starting point for future research in this field.
In a clinical trial, patients with CNNP will undergo a treatment regimen consisting of two weekly sessions of HILT and stretching exercises over four weeks. The study aims to assess primary outcomes such as resting pain intensity (RPI), movement pain intensity (MPI), and pain pressure threshold (PPT), measured using the numerical pain rating scale and algometry. Secondary outcomes will include cervical range of motion (CROM) and neck disability, assessed through inclinometry and the Neck Disability Index (NDI). Evaluations will occur post-treatment, with a follow-up assessment scheduled one month later.
1.1 Study Type and Design: Experimental design for a non-controlled clinical trial.The study will be conducted in the Electrophysical Agents Laboratory (KIN 401) at the School of Physical Therapy, Faculty of Rehabilitation Sciences, Casona de las Condes Campus, Universidad Andrés Bello, located at Calle Fernández Concha Nº700, Las Condes, Santiago, Chile. The sample will be selected from the university population of the same faculty. The study group will be determined through a non-probabilistic sampling process. Participants will be recruited via a closed-ended questionnaire constructed according to selection criteria. The minimum number of participants required for the study will be calculated using the G-Power program, with a minimum of 20 participants. Subjects with CNNP pain will be recruited and will receive 8 sessions of HILT and stretching exercises over 4 weeks. Relevant outcomes will include resting pain intensity (RPI), movement pain intensity (MPI), and pressure pain threshold (PPT). Additionally, cervical range of motion (CROM) and neck disability (ND) will be assessed. Evaluations will be conducted at three time points: before treatment, at the end of treatment, and at a one-month follow-up evaluation.
1.2 Overall Objective To evaluate the effect of high-intensity laser therapy on reducing pain, increasing pain pressure threshold, improving cervical range of motion, and decreasing cervical disability in patients with non-specific chronic neck pain.
1.3 Specific Objectives - Determine the difference in cervical pain intensity before and after high-intensity laser therapy treatment.
1.4 Phases of the clinical trial
2.1 Conceptual Definition of Variables:
2.2 Operational Definition of Variables: - Pain intensity at rest: assessed using the Numeric Pain Rating Scale (NPRS) from Gymna (R). measured on a scale from 0 to 10, where 0 represents no pain and 10 represents the most pain the participant reported.
2.3 Types of Variables:
High-intensity laser therapy: independent variable, continuous quantitative.
Stretching exercise. Participants will also undergo passive bilateral static stretching exercises targeting the upper trapezius, levator scapulae, and scalene muscles. A therapist will administer these exercises, lasting 30 seconds each with a 30-second rest between sets, following the HILT treatment.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 21 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.
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Exclusion Criteria:
The BTL-6000 device, with 12W power and a wavelength of 1,064 nm, will administer laser therapy to the experimental group using the De la Barra et al. protocol. Treatment includes three phases: (Phase 1) Manual scanning 1: 12 W for 42 seconds, delivering 500 J over 100 cm2 per upper trapezius muscle (total 1,000 J). (Phase 2) Point technique: 4 W for 10 seconds per point (10 J per point), totaling 60 J per side (120 J total). (Phase 3) Manual scanning 2: 6 W for 83 seconds, delivering 500 J over 100 cm2 per upper trapezius muscle (total 1,000 J). Following the HILT treatment, we will perform three sets of 30 seconds each of passive bilateral static stretching exercises for the upper trapezius, levator scapulae, and scalene muscles.
Device: High-intensity laser therapy
High-intensity laser therapy (HILT), also referred to as Class IV laser therapy, involves the administration of collimated and monochromatic electromagnetic radiation within the infrared or red spectrum. It operates at power levels exceeding 500 milliwatts (0.5 W), leveraging both photobiomodulation and thermal effects. This distinguishes HILT from Class III lasers (low-level laser therapy, or LLLT), which lack photothermal effects when operating below 500 mW.
Also known as: Laser therapy, Power laser, Laser class IV
Pain intensity at rest (numeric pain rating scale, NPRS)
Magnitude of neck pain reported by participants at rest. The pain intensity at rest will be measured with the numeric pain rating scale (NPRS). The scale quantifies pain from 0 to 10, where 0 represents the absence of pain and 10 represents the maximum tolerable pain.
Time frame: Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)
Pain intensity at movement (numeric pain rating scale, NPRS)
Magnitude of pain reported by participants during active cervical movements, including flexion, extension, lateral bending, and rotation. The pain intensity during movement will be measured with the numeric pain rating scale (NPRS).The scale quantifies pain from 0 to 10, where 0 represents the absence of pain and 10 represents the maximum tolerable pain.
Time frame: Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)
Pain pressure threshold (algometry)
The maximum mechanical pressure tolerated by the patient was assessed using algometry. Six bilateral points were evaluated: 2 cm lateral to the spinous processes of C2, C5, T4, and T8; the midpoint of the upper trapezius muscle (between C7 and the acromion); the levator scapulae (2 cm superior to the superior angle of the scapula); and the middle third of the right tibialis anterior muscle. The pain pressure threshold will be evaluated with pressure algometry (FPX Wagner (R) equipment). The pain pressure threshold measurement unit will be evaluated in pounds per square centimeter.
Time frame: Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)
Cervical range of movement (inclinometer)
The cervical range of motion refers to the extent of movement achievable by the cervical spine in various directions, including flexion (forward bending), extension (backward bending), lateral flexion (side bending to the left and right), and rotation (turning left and right). The cervical range of motion will be assessed using an inclinometry device (CROM device). The degrees of movement are quantified for each active osteokinematic movement performed by the participant.
Time frame: Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)
Neck disability (neck disability index)
Neck disability refers to the extent or degree to which cervical pain and associated symptoms impact a person's ability to perform daily activities and participate in normal life roles. It will be assessed using the Neck Disability Index (NDI), which will evaluate the functional limitations and subjective experiences related to neck pain and its effects on a person's quality of life. Cervical disability will be quantified as a percentage (0% absence of disability and 100% maximum disability reported by the participant).
Time frame: Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)
Plan to share: No — There is currently no plan to make individual participant data (IPD) available to other researchers. There is an intention to publish the study protocol.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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