High-intensity Laser Therapy and Stretching Exercises for Chronic Non-specific Neck Pain: a Feasibility Study

NCT06465524 | Completed DMC

• 1 other identifier: 13062024
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Non-specific Neck Pain

Keywords

Laser therapy; High-intensity laser therapy; Chronic pain; Neck pain; Clinical Trial

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)

Secondary Outcomes (2)

• Cervical range of movement (inclinometer)

  Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)

• Neck disability (neck disability index)

  Baseline, 4 weeks (8 sessions) and 4 weeks (follow-up)

Study Arms (1)

High-intensity laser therapy and stretching exercise

EXPERIMENTAL

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

Interventions

High-intensity laser therapy DEVICE

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

High-intensity laser therapy and stretching exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Both sexes
• Experiencing chronic neck pain: Defined as pain or discomfort in the cervical region between the upper nuchal line and the T1 spinous process or the shoulder girdle. Lasting at least three months
• Neck Disability Index (NDI) score of 5 or higher
• Pain intensity of at least three on the Numerical Pain Rating Scale (NPRS) at rest

You may not qualify if:

• Any musculoskeletal injuries sustained in the neck or shoulders within the past three months
• The presence of osteosynthesis materials in the vicinity of the shoulders, neck, or surrounding areas
• The existence of skin wounds or changes, such as psoriasis, scars, or burns, in the neck or shoulder region.
• Continuous usage of analgesic medication, anti-inflammatories, or muscle relaxants.
• Neurological disorders, which include paresthesias, partial or total loss of sensation, decreased strength, and color changes in the neck, arms, forearms, or hands.
• Diagnosis of photosensitivity
• Skin types V and VI, as determined by the Fitzpatrick scale
• Solar urticaria or adverse reactions to sunlight are present.
• Diagnosis of autoimmune diseases (e.g., dermatomyositis, systemic lupus erythematosus, hepatic porphyria, carcinoid syndrome, pellagra)
• Diagnosis of cancer or tumors within the past five years
• Epilepsy

Sponsors & Collaborators

• Quiropraxia y Equilibrio: lead

Study Sites (1)

Universidad Andrés Bello

Santiago, Las Condes, 7591538, Chile

Location

Related Publications (35)

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Related Links

• A Randomized Comparative Study between High-Intensity Laser Therapy and Ultrasound Therapy on Chronic Neck Pain among Adult Patients

MeSH Terms

Conditions

Chronic Pain; Neck Pain

Interventions

Laser Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Phototherapy

Study Officials

• Hernán Andrés de la Barra Ortiz, PhD(c)

  Andrés Bello University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental design of a double-blind, non-controlled clinical trial

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 20, 2024
• Study Start: September 30, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 14, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)