High-intensity Laser Therapy for Neck Pain

NCT05689788 | Recruiting DMC

• 1 other identifier: 26122022
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Non-specific Chronic Neck Pain

Keywords

Lasers; Laser therapy; Chronic pain; Neck pain; Physical Therapy Modalities; Clinical trial

Outcome Measures

Primary Outcomes (3)

• 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).

  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)

  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).

  Baseline and 4 weeks (8 sessions)

Secondary Outcomes (2)

• Cervical range of motion (CROM)

  Baseline and 4 weeks (8 sessions)

• Neck disability (ND)

  Baseline and 4 weeks (8 sessions)

Study Arms (2)

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.

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.

Procedure: Stretching exercise; Device: Sham High-intensity laser therapy

Interventions

High-intensity laser therapy DEVICE

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.

HILT + stretching exercise

Stretching exercise PROCEDURE

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.

HILT + stretching exercise; Sham HILT + stretching exercise

Sham High-intensity laser therapy DEVICE

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.

Sham HILT + stretching exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Quiropraxia y Equilibrio: lead

Study Sites (2)

Universidad Andrés Bello

Santiago, Las Condes, 7591538, Chile

RECRUITING

Hernán Andrés de la Barra

Santiago, Chile

RECRUITING

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MeSH Terms

Conditions

Chronic Pain; Neck Pain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hernán de la Barra Ortiz, MSc

  Universidad Andrés Bello

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hernán A de la Barra Ortiz, MSc

CONTACT

56984706322; hdelabarra@unab.cl

Luis A Gomez Miranda, MSc

CONTACT

56984706322; lgomez@unab.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 19, 2023
• Study Start: March 31, 2024
• Primary Completion: May 30, 2024
• Study Completion: December 28, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)