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High-intensity Laser Therapy for Neck Pain

ConditionNon-specific Chronic Neck Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQuiropraxia y Equilibrio

About this 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Stretching exercise

    Procedure/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 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: HILT + stretching exerciseExperimental treatment 2 interventions
Group B: Sham HILT + stretching exerciseSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)
2

Pain intensity at rest (RPI)

Magnitude of neck pain reported by participants at rest evaluated with visual anologue scale (VAS)

Time frame
Baseline, 4 weeks (8 sessions) and 12 weeks (follow-up)
3

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).

Time frame
Baseline and 4 weeks (8 sessions)

Secondary outcomes

1

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).

Time frame
Baseline and 4 weeks (8 sessions)
2

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)

Time frame
Baseline and 4 weeks (8 sessions)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Quiropraxia y Equilibrio

Lead sponsor

Universidad Nacional Andres Bello

Sponsor institution

Source ClinicalTrials.gov
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