Dry Needling and Low-level Laser Therapy to Treat Myofascial Pain

NCT03375229 | Completed

• 1 other identifier: U1111-1205-4687
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Myofascial Pain is a clinical condition of myalgic pain characterized mainly by the presence of Myofascial Trigger Points. Trigger points can be active or latent and they are described as a hypersensitive spot within a taut band in the muscle. The use of a computer for long periods has been shown as a trigger the trigger points. Dry Needling and Low-Level Laser Therapy (LLLT) has been described as good resources to treat myofascial pain. The hypothesis is that the association of the purposed interventions will have greater effects than only the dry needling intervention. The objective is to evaluate the effects of the dry needling and the laser in the treatment of upper trapezius trigger point on women. This study is composed of an evaluation and an intervention proposal with dry needling and LLLT to treat myofascial trigger points. The sample will be composed of 60 women, with 18 to 65 years old, divided into three groups. Twenty individuals will be in group Dry-On that will receive dry needling intervention on the trigger point, followed by LLLT intervention on. Twenty individuals will be in group Dry-Off that will receive dry needling intervention on the trigger point, followed by LLLT intervention turned off. Twenty individuals will be in group Control that will receive dry needling intervention at 1.5 cm from the trigger point, followed by LLLT intervention turned off. All interventions will be performed in one session. Outcome measures for pain, pressure pain threshold, functionality, and muscle activity will be collected.

Conditions

Myofascial Pain; Trigger Points

Keywords

Myofascial Pain; Pain Pressure Threshold; Low-Level Laser Therapy; Dry Needling

Outcome Measures

Primary Outcomes (4)

• Pain through the visual analogue scale at baseline

  The Visual Analogue Scale (VAS) will be used so the subjects can graduate their pain in shoulder and neck regions. The scale range goes from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

  Measure will be obtained before the intervention (baseline).

• Pain through the visual analogue scale after 30 minutes of intervention

  The Visual Analogue Scale (VAS) will be used so the subjects can graduate their pain in shoulder and neck regions. The scale range goes from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

  Measure will be obtained 30 minutes after the intervention

• Pain through the visual analogue scale after one week of intervention

  The Visual Analogue Scale (VAS) will be used so the subjects can graduate their pain in shoulder and neck regions. The scale range goes from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

  Measure will be obtained 1 week after the intervention

• Pain through the visual analogue scale after one month of intervention

  The Visual Analogue Scale (VAS) will be used so the subjects can graduate their pain in shoulder and neck regions. The scale range goes from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

  Measure will be obtained 30 days after the intervention

Secondary Outcomes (7)

• Pain Pressure Threshold

  This measured will be obtained before the intervention (baseline)

• Pain Pressure Threshold

  This measured will be obtained soon after the intervention (T1)

• Pain Pressure Threshold

  This measured will be obtained 30 minutes after the intervention (T2)

• Muscle activity

  Electromyographic data will be collected before the intervention and 5 minutes after the intervention.

• Functional Capacity

  The subject will answer the NDI before the intervention

Study Arms (3)

Group On

ACTIVE COMPARATOR

This group was composed of 15 subjects. The application of dry needling and Low-Level Laser Therapy (LLLT) turned on will be directly on the trigger point. The intervention will be administered one time.

Other: Dry Needling; Device: Low-Level Laser Therapy

Group Off

ACTIVE COMPARATOR

This group was composed of 14 subjects. The application of dry needling and LLLT turned off will be directly on the trigger point. The intervention will be administered one time.

Other: Dry Needling; Device: Low-Level Laser Therapy

Placebo group

PLACEBO COMPARATOR

This group was composed of 14 subjects. The application of dry needling and LLLT turned off will be 1.5 cm medially from the trigger point. The intervention will be administered one time.

Other: Dry Needling; Device: Low-Level Laser Therapy

Interventions

Dry Needling OTHER

It will be used acupuncture needles, individually packaged and sterilized, with 0.25 mm of thickness and 0.40 mm of length. The therapist will perform the grip in upper trapezius on the site of one of the two previously marked locations, according to the subject group allocation, and will insert the needle in the skin with help of a guide tube and will deepen the needle approximately 10 to 15 mm inside the trigger point. The needle will be moved up and down as in the "fast-in and fast-out" technique described by Hong and the movement will be repeated during 30 seconds in a cadence of approximately 1 Hz. The protocol will be the same for the groups that will receive the application directly on the trigger point and for the group that will receive the application away from the trigger point

Group Off; Group On; Placebo group

Low-Level Laser Therapy DEVICE

The laser protocol used the PainAway Laser™ cluster equipment composed of one pulsed infrared laser of 905 nm, four red LEDs of 640 nm, and four infrared LEDs of 875 nm, with full device aperture of 4 cm2, total delivered energy of 39,8 J, a magnetic field of 35 Mt and treatment time of 300 seconds. The equipment was turned on only for the DNP group and it remained in slight contact with the skin during 300 s for all groups.

Also known as: LLLT

Group Off; Group On; Placebo group

Eligibility Criteria

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

You may qualify if:

• Presence of active trigger point in upper trapezius.
• Use of computer for typing activities for, at least, 20 hours per week.
• Presence of mechanic pain in cervical region for less than three months.
• Pain level higher than 3 and lower than 8 on the Visual Analogue Scale (VAS) for neck and cervical regions in the last 30 days.

You may not qualify if:

• Body Mass Index (BMI) higher than 30
• Presence of whiplash injury or other cervical pathologies such as herniated disc and
• Thoracic Gorge Syndrome;
• Presence of contraindication to the treatment with low-level laser therapy or with dry needling
• Fear of needles
• To be receiving treatment for the pain in neck and/or shoulder regions
• Make use of analgesic drugs, anti-inflammatory and/or muscle relaxants and anticoagulant medications.

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (1)

Universidade Federal de Santa Catarina

Araranguá, Santa Catarina, 88905-120, Brazil

Location

Related Publications (14)

• Boyles R, Fowler R, Ramsey D, Burrows E. Effectiveness of trigger point dry needling for multiple body regions: a systematic review. J Man Manip Ther. 2015 Dec;23(5):276-93. doi: 10.1179/2042618615Y.0000000014.

  PMID: 26955257 BACKGROUND

• Kamanli A, Kaya A, Ardicoglu O, Ozgocmen S, Zengin FO, Bayik Y. Comparison of lidocaine injection, botulinum toxin injection, and dry needling to trigger points in myofascial pain syndrome. Rheumatol Int. 2005 Oct;25(8):604-11. doi: 10.1007/s00296-004-0485-6. Epub 2004 Sep 15.

  PMID: 15372199 BACKGROUND

• Ge HY, Arendt-Nielsen L, Farina D, Madeleine P. Gender-specific differences in electromyographic changes and perceived pain induced by experimental muscle pain during sustained contractions of the upper trapezius muscle. Muscle Nerve. 2005 Dec;32(6):726-33. doi: 10.1002/mus.20410.

  PMID: 16136601 BACKGROUND

• Mata Diz JB, de Souza JR, Leopoldino AA, Oliveira VC. Exercise, especially combined stretching and strengthening exercise, reduces myofascial pain: a systematic review. J Physiother. 2017 Jan;63(1):17-22. doi: 10.1016/j.jphys.2016.11.008. Epub 2016 Dec 3.

  PMID: 27989732 BACKGROUND

• Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.

  PMID: 25143704 BACKGROUND

• Espejo-Antunez L, Tejeda JF, Albornoz-Cabello M, Rodriguez-Mansilla J, de la Cruz-Torres B, Ribeiro F, Silva AG. Dry needling in the management of myofascial trigger points: A systematic review of randomized controlled trials. Complement Ther Med. 2017 Aug;33:46-57. doi: 10.1016/j.ctim.2017.06.003. Epub 2017 Jun 15.

  PMID: 28735825 BACKGROUND

• Ilbuldu E, Cakmak A, Disci R, Aydin R. Comparison of laser, dry needling, and placebo laser treatments in myofascial pain syndrome. Photomed Laser Surg. 2004 Aug;22(4):306-11. doi: 10.1089/pho.2004.22.306.

  PMID: 15345173 BACKGROUND

• Manca A, Limonta E, Pilurzi G, Ginatempo F, De Natale ER, Mercante B, Tolu E, Deriu F. Ultrasound and laser as stand-alone therapies for myofascial trigger points: a randomized, double-blind, placebo-controlled study. Physiother Res Int. 2014 Sep;19(3):166-75. doi: 10.1002/pri.1580. Epub 2014 Jan 2.

  PMID: 24382836 BACKGROUND

• Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.

  PMID: 16945250 BACKGROUND

• Pecos-Martin D, Montanez-Aguilera FJ, Gallego-Izquierdo T, Urraca-Gesto A, Gomez-Conesa A, Romero-Franco N, Plaza-Manzano G. Effectiveness of dry needling on the lower trapezius in patients with mechanical neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2015 May;96(5):775-81. doi: 10.1016/j.apmr.2014.12.016. Epub 2015 Jan 9.

  PMID: 25582412 BACKGROUND

• Uemoto L, Nascimento de Azevedo R, Almeida Alfaya T, Nunes Jardim Reis R, Depes de Gouvea CV, Cavalcanti Garcia MA. Myofascial trigger point therapy: laser therapy and dry needling. Curr Pain Headache Rep. 2013 Sep;17(9):357. doi: 10.1007/s11916-013-0357-4.

  PMID: 23904202 BACKGROUND

• Cotler HB, Chow RT, Hamblin MR, Carroll J. The Use of Low Level Laser Therapy (LLLT) For Musculoskeletal Pain. MOJ Orthop Rheumatol. 2015;2(5):00068. doi: 10.15406/mojor.2015.02.00068. Epub 2015 Jun 9.

  PMID: 26858986 BACKGROUND

• De Meulemeester K, Calders P, Dewitte V, Barbe T, Danneels L, Cagnie B. Surface Electromyographic Activity of the Upper Trapezius Before and After a Single Dry Needling Session in Female Office Workers With Trapezius Myalgia. Am J Phys Med Rehabil. 2017 Dec;96(12):861-868. doi: 10.1097/PHM.0000000000000761.

  PMID: 28644247 BACKGROUND

• Mejuto-Vazquez MJ, Salom-Moreno J, Ortega-Santiago R, Truyols-Dominguez S, Fernandez-de-Las-Penas C. Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):252-60. doi: 10.2519/jospt.2014.5108. Epub 2014 Feb 25.

  PMID: 24568260 BACKGROUND

MeSH Terms

Interventions

Dry Needling; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Laser Therapy; Phototherapy

Study Officials

• Rafael I Barbosa, PhD

  Universidade Federal de Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 18, 2017
• Study Start: April 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: July 31, 2019
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study protocol will be submitted for publication before the end of the study.
• Access Criteria: To be a principal researcher associated with a higher education institution.

Locations

BR (1)