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

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ClinicalTrials.gov Identifier: NCT04445545
Recruitment Status : Not yet recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Quiropraxia y Equilibrio

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.

Condition or disease Intervention/treatment Phase
Myofascial Trigger Point Pain (MTrP) Device: High intensity laser therapy (HILT) Device: Therapeutic Ultrasound (US) Procedure: Stretching exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of High Intensity Laser Therapy (HILT) and Stretching Exercises on Cervical Flexibility and Pain Reduction in Myofascial Trigger Points. Randomized Clinical Trial (RCT).
Estimated Study Start Date : March 1, 2023
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group 1 (HILT + stretching exercise)
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)
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.

Procedure: Stretching exercise
Active static stretching for the upper trapezius muscle with the presence of myofascial trigger points 4 sets of active static stretching of the upper trapezius muscle will be performed. Each set will last 30 seconds followed by a 30-second rest interval.

Sham Comparator: Experimental group 2 (Sham HILT + stretching exercise)
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)
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.

Procedure: Stretching exercise
Active static stretching for the upper trapezius muscle with the presence of myofascial trigger points 4 sets of active static stretching of the upper trapezius muscle will be performed. Each set will last 30 seconds followed by a 30-second rest interval.

Active Comparator: Experimental group 3 (US + stretching exercise)
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)
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.

Procedure: Stretching exercise
Active static stretching for the upper trapezius muscle with the presence of myofascial trigger points 4 sets of active static stretching of the upper trapezius muscle will be performed. Each set will last 30 seconds followed by a 30-second rest interval.




Primary Outcome Measures :
  1. Pain pressure thereshold (PPT) [ Time Frame: Change from Baseline pain pressure thereshold at eight treatment sessions. ]
    Comparing pain pressure threshold differences on trigger point of trapezius muscle for pre and post-treatment protocol.

  2. Joint Range changes (CFROM) [ Time Frame: Change from Baseline joint range changes at eight treatment sessions. ]
    Comparing maximum cervical range differences for pre and post for pre and post-treatment protocol.


Secondary Outcome Measures :
  1. Neck disability [ Time Frame: Change from Baseline meck disability at eight treatment sessions. ]
    Comparing neck disability for pre and post treatment protocol.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445545


Contacts
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Contact: Hernán A De la Barra Ortiz, Mg. 984706322 ext +56 hdelabarra@unab.cl

Locations
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Chile
Universidad Andrés Bello
Santiago de Chile, Las Condes, Chile, 7591538
Contact: Hernán de la Barra, Mg.    562226618402    hdelabarra@unab.cl   
Contact: Hernán Andrés HB de la Barra Ortiz, Mg.    562226618402    quiropraxiayequilibrio@gmail.com   
Principal Investigator: Hernán A de la Barra Ortiz, Mg.         
Sub-Investigator: Richard Liebano, PhD         
Universidad Andrés Bello
Santiago, Región Metropolitana, Chile, 7591538
Sponsors and Collaborators
Quiropraxia y Equilibrio
Investigators
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Principal Investigator: Hernán A de la Barra Ortiz, Mg Universidad Andrés Bello
Additional Information:
Publications:

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Responsible Party: Quiropraxia y Equilibrio
ClinicalTrials.gov Identifier: NCT04445545    
Other Study ID Numbers: 60312070
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quiropraxia y Equilibrio:
Lasers
Laser Therapy
Trigger Points
Myofascial Pain Syndromes
Analgesia
Clinical Trial
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases