High Intensity Laser Therapy (HILT) on Myofascial Trigger Points.

NCT04445545 | Recruiting DMC

• 1 other identifier: 60312070
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to evaluate the effects of HILT on cervical flexibility and pain reduction in myofascial trigger points. The research will be carried out in the Physiotherapy laboratory of Andrés Bello University. The participants will be civil servants and volunteer university students with the presence of latent MTrPs of the upper trapezius muscle. Participants will be randomized and divided into 3 study groups: group 1 (HILT and stretching exercises), group 2 (sham HILT and stretching exercises), and group 3 (the conventional US and stretching exercises). The treatments will be carried out twice a week for 4 weeks accompanied by 2 evaluations during the treatment and 1 post-treatment follow-up. The main result will be considered the differences in pain intensity (ΔPI), pain pressure threshold (ΔPPT), cervical spine range (ΔCROM), and cervical disability (ΔND) between the evaluation sessions.

Conditions

Myofascial Trigger Point Pain (MTrP)

Keywords

Lasers; Laser Therapy; Trigger Points; Myofascial Pain Syndromes; Analgesia; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Pain pressure thereshold (PPT)

  Comparing pain pressure threshold differences on trigger point of trapezius muscle for pre and post-treatment protocol.

  Change from Baseline pain pressure thereshold at eight treatment sessions.

• Joint Range changes (CFROM)

  Comparing maximum cervical range differences for pre and post for pre and post-treatment protocol.

  Change from Baseline joint range changes at eight treatment sessions.

Secondary Outcomes (1)

• Neck disability

  Change from Baseline meck disability at eight treatment sessions.

Study Arms (3)

Experimental group 1 (HILT + stretching exercise)

EXPERIMENTAL

The group will receive treatment of high-intensity laser therapy (HILT) with a total energy delivery of 1,060J divided into 3 phases will be achieved: phase 1, 500J; phase 2, 60J; phase 3, 500J. It will work with an average power of 3W and an energy density of 50J/cm2. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.

Device: High intensity laser therapy (HILT); Procedure: Stretching exercise

Experimental group 2 (Sham HILT + stretching exercise)

SHAM COMPARATOR

The group will receive a sham treatment of high-intensity laser therapy (HILT). At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.

Device: High intensity laser therapy (HILT); Procedure: Stretching exercise

Experimental group 3 (US + stretching exercise)

ACTIVE COMPARATOR

The group will receive treatment of therapeutic ultrasound. The US parameters will be programmed with a frequency of 1MHz, the intensity of 1.5 W/cm2, the Duty cycle of 100%, an ERA of 5cm2, and a time of 6 minutes. At the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series.

Device: Therapeutic Ultrasound (US); Procedure: Stretching exercise

Interventions

High intensity laser therapy (HILT) DEVICE

Laser application with powers greater than 500 milliwatts (mW) in the myofascial trigger point and muscle belly of the upper trapezius. Laser therapy will be applied to the upper trapezius muscle with a total energy delivery of 1,060J divided into 3 phases will be achieved (phase 1, 500J; phase 2, 60J; phase 3, 500J). It will work with an average power of 3W and an energy density of 50J/cm2. For the application of laser therapy, the 12W BTL-6000 equipment that emits infrared wavelengths of 1064nm will be used.

Experimental group 1 (HILT + stretching exercise); Experimental group 2 (Sham HILT + stretching exercise)

Therapeutic Ultrasound (US) DEVICE

Application of ultrasound therapy in the myofascial trigger point of the upper trapezius muscle. The ultrasound application will be performed with the person in a seated position. The ultrasound parameters will consist of a frequency of 1MHz, the intensity of 1.5 W/cm2, a Duty cycle of 100%, an ERA of 5cm2, and a treatment time of 6 minutes.

Experimental group 3 (US + stretching exercise)

Stretching exercise PROCEDURE

t the end of the assigned treatment will be added a treatment protocol of upper trapezius stretching exercises for the evaluated limb with shortening. The stretches will consist of 4 series of 30 seconds with an interval of 30 seconds between series

Experimental group 1 (HILT + stretching exercise); Experimental group 2 (Sham HILT + stretching exercise); Experimental group 3 (US + 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 over 18 years of age.
• Officials and students of the Casona las Condes Campus of the Andrés Bello University.
• Presence of myofascial trigger points in the shortened upper trapezius muscle evaluated (expert consensus establishing criteria for the diagnosis of MTrPs, Delphi study).25

You may not qualify if:

• Musculoskeletal problems or pathologies of the neck or shoulders in the last 3 months (fractures, sprains, tendinopathies, dislocations, or muscle tears).
• Presence of osteosynthesis materials near shoulders, neck, or surrounding areas.
• Presence of wounds or skin changes in the shoulder and/or neck region (such as psoriasis, scars, or burns).
• Use of analgesic, anti-inflammatory, or muscle relaxant medications for permanent use.
• Neurological changes such as paresthesia, loss of sensitivity (partial or complete), decreased strength, and color changes in the neck, arms, forearms, or hands.
• Diagnosed photosensitivity.
• Presence of solar urticaria or adverse reactions to sunlight.
• Presence of the following conditions: dermatomyositis, systemic lupus erythematosus, hepatic porphyria, cutaneous carcinoid syndrome or pellagra
• Cancer or tumors of any type diagnosed.
• Epilepsy.

Sponsors & Collaborators

• Quiropraxia y Equilibrio: lead

Study Sites (2)

Universidad Andrés Bello

Santiago, Las Condes, 7591538, Chile

RECRUITING

Universidad Andrés Bello

Santiago, Santiago Metropolitan, 7591538, Chile

RECRUITING

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Related Links

• BTL Company

MeSH Terms

Conditions

Myofascial Pain Syndromes; Agnosia

Interventions

Ultrasonic Therapy; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hernán A de la Barra Ortiz, Mg

  Universidad Andrés Bello

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hernán A De la Barra Ortiz, Mg.

CONTACT

984706322; hdelabarra@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: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 24, 2020
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)