Myofascial PainNCT03375229
Dry Needling and Low-level Laser Therapy to Treat Myofascial Pain
A study testing Dry Needling and Low-Level Laser Therapy in people with Myofascial Pain and Trigger Points, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain, Trigger Points
- What is being tested?
- Dry Needling and Low-Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Santa Catarina
Araranguá, Santa Catarina, 88905-120
About this study
Official title: Dry Needling and Photobiomodulation in the Treatment of Myofascial Pain
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.
Read the detailed description
The present study has the objective to evaluate the effects of dry needling and photobiomodulation application in the treatment of trigger points in upper trapezius on women with myofascial pain. The specific objectives are: 1) To evaluate the pain level before, during, and after the dry needling and photobiomodulation applications on the trigger point; 2) To identify the pain pressure threshold before and after dry needling and photobiomodulation applications on the trigger point; 3) To verify the electromyographic activity of upper trapezius before and after the proposed treatments; and 4) To compare the effects fond intra and inter-groups for the applications of dry needling, dry needling and photobiomodulation, and control protocol.
The sample will be composed by 20 subjects in each group, a total of 60 subjects, according to a convenience sample based on review studies of Cagnie at al., 2015, and Espejo-Antúnez et al., 2017.
The study will be performed at the Laboratory of Evaluation and Rehabilitation of the Locomotor Apparatus (LARAL), located at Universidade Federal de Santa Catarina, Campus Araranguá, Santa Catarina, Brazil. Women, with age between 18 and 65 years old, students, workers, and professors at Universidade Federal de Santa Catarina (UFSC) will be invited to participate in the research. The invitation of subjects to participate in the study will be done through digital and printed folders that will be delivered at UFSC and on the social media. Those subjects that show interest to participate will be forwarded to an evaluation selection where it will be identified if the participant fits the inclusion criteria and where the Consent Form will be presented.
The active trigger point in upper trapezius will be localized through manual palpation and the location will be marked with a special pen for the skin. A second mark located 1.5 centimeters medially from the trigger point will be made in all subjects. The trigger point identification will follow Simons et al. criteria, featuring 3 of 4itens: (1) presence of palpable taut band in the muscle; (2) presence of hypersensitive spot inside the taut band; (3) subject recognize the familiar pain; and (4) painful limitation of the range of motion during total stretch.
The surface electromyography (EMG) will be used to evaluate the muscle recruitment pattern. Disposable electrodes, made with polyethylene foam and with hypoallergenic adhesive, solid gel adherent, bipolar contact of Silver/Silver Chloride (Ag/AgCl), will be used and positioned with 20mm of distance between poles. The Medtrace® reference electrode will be positioned in the ipsilateral wrist of the data collection. The electrodes will be positioned in the upper trapezius muscle as recommended by Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM).
The Visual Analogue Scale (VAS) will be used so the subjects can graduate their pain in shoulder and neck regions. The VAS level of pain will be acquired before the intervention, soon after the intervention, 30 minutes after the intervention, one week and one month after the intervention.
Pressure algometry will be used to evaluate the pain pressure threshold (PPT). This measured will be obtained before the intervention (baseline), soon after the intervention, and 30 minutes after the intervention. The equipment will be positioned on the trigger point mark and the subject will be instructed to report when the sensation changes from pressure to pain. The force measured in kilograms per square centimeter (kg / cm²) will correspond to the quantity of pressure needed so the subject report change in pressure pain sensation.
The Neck Disability Index (NDI) is a unidimensional questionnaire composed of 10 items that have the aim to evaluate the limitation caused by pain and disability on the neck (30). This questionnaire will be self-applied and the subject will answer it before the intervention, one week and one month after intervention.
The Dry Needling (DN) protocol will be performed in one session. It will be used acupuncture needles, individually packaged and sterilized, with 0.25 mm of thickness and 0.40 mm of length. The therapist, then, 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. 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.
The photobiomodulation protocol will be performed using an equipment from Ibramed Equipamentos Médicos® of Aluminized Gallium Arsenide (AsGaAl) laser diode, with a wavelength of 830 nm, fluency of 20 J/cm², 30 milliwatts (mW), beam area of 0.116 cm², energy of 2,3 J per point, continuous beam. The low-level laser therapy (LLLT) will be applied for 30 seconds at one point on the trigger point in upper trapezius, right after the dry needling application.
The placebo/control group will receive the DN application 1.5 cm away from the trigger point and will follow the application protocol described above. The LLLT equipment will be turned off during the intervention. As the other groups, it will be performed one session of the dry needling followed by the intervention with the laser turned off.
The present study is grounded on the ethical principles, with base on the Resolution no 466 of December 12th, 2012, of the National Health Council, which incorporates under the individual and collectivities optics, the four basic references of the bioethics: autonomy, non-maleficence, beneficence, and justice, among others, aiming to ensure the rights and duties which concern the scientific community, the research subjects, and the State.
Data analysis will be performed through the GraphPad Prisma® software, version 6.01 (GraphPad Software, La Jolla, California, USA). The Shapiro-Wilk test will be run to verify sample normality distribution. The Two-Way ANOVA test will be used for comparative analysis inter and intra-groups. The P value (p<0.05) will be used to establish the significance of the results, in addition to the 95% Confidence Interval (95% CI). The values will be described as a mean ± standard deviation.
- Conditions
- Myofascial Pain, Trigger Points
- Being tested
- Dry Needling, Low-Level Laser Therapy
- Keywords
- Myofascial Pain, Pain Pressure Threshold, Low-Level Laser Therapy, Dry Needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
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
Low-Level Laser TherapyDevice
Also called LLLT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Dry Needling; Device: Low-Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measure will be obtained 30 days after the intervention
Secondary outcomes (7)
Pain Pressure Threshold
Measured through Pressure Algometry. The force measured in kilograms per square centimeter (kg / cm²) will correspond to the quantity of pressure needed so the subject report change in pressure pain sensation.
Measured: This measured will be obtained before the intervention (baseline)
Pain Pressure Threshold
Measured through Pressure Algometry. The force measured in kilograms per square centimeter (kg / cm²) will correspond to the quantity of pressure needed so the subject report change in pressure pain sensation.
Measured: This measured will be obtained soon after the intervention (T1)
Pain Pressure Threshold
Measured through Pressure Algometry. The force measured in kilograms per square centimeter (kg / cm²) will correspond to the quantity of pressure needed so the subject report change in pressure pain sensation.
Measured: This measured will be obtained 30 minutes after the intervention (T2)
Muscle activity
Electromyography will be used to measure muscle activity on upper trapezius
Measured: Electromyographic data will be collected before the intervention and 5 minutes after the intervention.
Functional Capacity
Neck Disability Index (NDI) will be used to access the functional capacity. Its score ranges from 0 to 50, where 0 to 4 is considered total capacity, 5 to 14 is mild incapacity, 15 to 24 is moderate incapacity, 25 to 34 is serious incapacity, and >35 is severe incapacity.
Measured: The subject will answer the NDI before the intervention
Functional Capacity
Neck Disability Index (NDI) will be used to access the functional capacity. Its score ranges from 0 to 50, where 0 to 4 is considered total capacity, 5 to 14 is mild incapacity, 15 to 24 is moderate incapacity, 25 to 34 is serious incapacity, and >35 is severe incapacity.
Measured: The subject will answer the NDI 1 week after intervention
Functional Capacity
Neck Disability Index (NDI) will be used to access the functional capacity. Its score ranges from 0 to 50, where 0 to 4 is considered total capacity, 5 to 14 is mild incapacity, 15 to 24 is moderate incapacity, 25 to 34 is serious incapacity, and >35 is severe incapacity.
Measured: The subject will answer the NDI 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Apr 2018
- Primary completion31 May 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Inácio Barbosa, Universidade Federal de Santa Catarina
- Investigators
- Rafael I Barbosa, PhD, Principal investigator, Universidade Federal de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375229
- Sponsor's protocol ID
- U1111-1205-4687
- Status last verified
- May 2020
- First submitted
- 5 Dec 2017
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data that underlie results in a publication will be available after the end of the study for researchers that have doubts about it.
Publications
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.
PubMed 26955257Kamanli 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.
PubMed 15372199Ge 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.
PubMed 16136601Mata 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.
PubMed 27989732Dunning 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.
PubMed 25143704Espejo-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.
PubMed 28735825Ilbuldu 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.
PubMed 15345173Manca 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.
PubMed 24382836Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.
PubMed 16945250Pecos-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.
PubMed 25582412Uemoto 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.
PubMed 23904202Cotler 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.
PubMed 26858986De 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.
PubMed 28644247Mejuto-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.
PubMed 24568260
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling and Photobiomodulation in the Treatment of Myofascial Pain
- ClinicalTrials.gov ID
- NCT03375229
- Acronym / sponsor ID
- U1111-1205-4687
- Conditions
- Myofascial Pain, Trigger Points
- Keywords
- Myofascial Pain, Pain Pressure Threshold, Low-Level Laser Therapy, Dry Needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The present study has the objective to evaluate the effects of dry needling and photobiomodulation application in the treatment of trigger points in upper trapezius on women with myofascial pain. The specific objectives are: 1) To evaluate the pain level before, during, and after the dry needling and photobiomodulation applications on the trigger point; 2) To identify the pain pressure threshold before and after dry needling and photobiomodulation applications on the trigger point; 3) To verify the electromyographic activity of upper trapezius before and after the proposed treatments; and 4) To compare the effects fond intra and inter-groups for the applications of dry needling, dry needling and photobiomodulation, and control protocol.
The sample will be composed by 20 subjects in each group, a total of 60 subjects, according to a convenience sample based on review studies of Cagnie at al., 2015, and Espejo-Antúnez et al., 2017.
The study will be performed at the Laboratory of Evaluation and Rehabilitation of the Locomotor Apparatus (LARAL), located at Universidade Federal de Santa Catarina, Campus Araranguá, Santa Catarina, Brazil. Women, with age between 18 and 65 years old, students, workers, and professors at Universidade Federal de Santa Catarina (UFSC) will be invited to participate in the research. The invitation of subjects to participate in the study will be done through digital and printed folders that will be delivered at UFSC and on the social media. Those subjects that show interest to participate will be forwarded to an evaluation selection where it will be identified if the participant fits the inclusion criteria and where the Consent Form will be presented.
The active trigger point in upper trapezius will be localized through manual palpation and the location will be marked with a special pen for the skin. A second mark located 1.5 centimeters medially from the trigger point will be made in all subjects. The trigger point identification will follow Simons et al. criteria, featuring 3 of 4itens: (1) presence of palpable taut band in the muscle; (2) presence of hypersensitive spot inside the taut band; (3) subject recognize the familiar pain; and (4) painful limitation of the range of motion during total stretch.
The surface electromyography (EMG) will be used to evaluate the muscle recruitment pattern. Disposable electrodes, made with polyethylene foam and with hypoallergenic adhesive, solid gel adherent, bipolar contact of Silver/Silver Chloride (Ag/AgCl), will be used and positioned with 20mm of distance between poles. The Medtrace® reference electrode will be positioned in the ipsilateral wrist of the data collection. The electrodes will be positioned in the upper trapezius muscle as recommended by Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM).
The Visual Analogue Scale (VAS) will be used so the subjects can graduate their pain in shoulder and neck regions. The VAS level of pain will be acquired before the intervention, soon after the intervention, 30 minutes after the intervention, one week and one month after the intervention.
Pressure algometry will be used to evaluate the pain pressure threshold (PPT). This measured will be obtained before the intervention (baseline), soon after the intervention, and 30 minutes after the intervention. The equipment will be positioned on the trigger point mark and the subject will be instructed to report when the sensation changes from pressure to pain. The force measured in kilograms per square centimeter (kg / cm²) will correspond to the quantity of pressure needed so the subject report change in pressure pain sensation.
The Neck Disability Index (NDI) is a unidimensional questionnaire composed of 10 items that have the aim to evaluate the limitation caused by pain and disability on the neck (30). This questionnaire will be self-applied and the subject will answer it before the intervention, one week and one month after intervention.
The Dry Needling (DN) protocol will be performed in one session. It will be used acupuncture needles, individually packaged and sterilized, with 0.25 mm of thickness and 0.40 mm of length. The therapist, then, 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. 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.
The photobiomodulation protocol will be performed using an equipment from Ibramed Equipamentos Médicos® of Aluminized Gallium Arsenide (AsGaAl) laser diode, with a wavelength of 830 nm, fluency of 20 J/cm², 30 milliwatts (mW), beam area of 0.116 cm², energy of 2,3 J per point, continuous beam. The low-level laser therapy (LLLT) will be applied for 30 seconds at one point on the trigger point in upper trapezius, right after the dry needling application.
The placebo/control group will receive the DN application 1.5 cm away from the trigger point and will follow the application protocol described above. The LLLT equipment will be turned off during the intervention. As the other groups, it will be performed one session of the dry needling followed by the intervention with the laser turned off.
The present study is grounded on the ethical principles, with base on the Resolution no 466 of December 12th, 2012, of the National Health Council, which incorporates under the individual and collectivities optics, the four basic references of the bioethics: autonomy, non-maleficence, beneficence, and justice, among others, aiming to ensure the rights and duties which concern the scientific community, the research subjects, and the State.
Data analysis will be performed through the GraphPad Prisma® software, version 6.01 (GraphPad Software, La Jolla, California, USA). The Shapiro-Wilk test will be run to verify sample normality distribution. The Two-Way ANOVA test will be used for comparative analysis inter and intra-groups. The P value (p<0.05) will be used to establish the significance of the results, in addition to the 95% Confidence Interval (95% CI). The values will be described as a mean ± standard deviation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group On | Active comparator | Other: Dry Needling, Device: Low-Level Laser TherapyThis 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. |
| Group Off | Active comparator | Other: Dry Needling, Device: Low-Level Laser TherapyThis 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. |
| Placebo group | Placebo comparator | Other: Dry Needling, Device: Low-Level Laser TherapyThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingIt 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 | Other | Group Off, Group On, Placebo group |
| Low-Level Laser TherapyAlso: LLLTThe 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. | Device | Group Off, Group On, Placebo group |
Primary outcome
Pain through the visual analogue scale at baseline
Time frame: Measure will be obtained before the intervention (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.
Pain through the visual analogue scale after 30 minutes of intervention
Time frame: Measure will be obtained 30 minutes after the 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.
Pain through the visual analogue scale after one week of intervention
Time frame: Measure will be obtained 1 week after the 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.
Pain through the visual analogue scale after one month of intervention
Time frame: Measure will be obtained 30 days after the 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.
7 secondary outcomes
Pain Pressure Threshold
Time frame: This measured will be obtained before the intervention (baseline)
Pain Pressure Threshold
Time frame: This measured will be obtained soon after the intervention (T1)
Pain Pressure Threshold
Time frame: This measured will be obtained 30 minutes after the intervention (T2)
Muscle activity
Time frame: Electromyographic data will be collected before the intervention and 5 minutes after the intervention.
Functional Capacity
Time frame: The subject will answer the NDI before the intervention
Functional Capacity
Time frame: The subject will answer the NDI 1 week after intervention
Functional Capacity
Time frame: The subject will answer the NDI 1 month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Background: PubMed 26955257Boyles 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.
- Background: PubMed 15372199Kamanli 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.
- Background: PubMed 16136601Ge 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.
- Background: PubMed 27989732Mata 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.
- Background: PubMed 25143704Dunning 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.
- Background: PubMed 28735825Espejo-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.
- Background: PubMed 15345173Ilbuldu 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.
- Background: PubMed 24382836Manca 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.
- Background: PubMed 16945250Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.
- Background: PubMed 25582412Pecos-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.
- Background: PubMed 23904202Uemoto 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.
- Background: PubMed 26858986Cotler 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.
- Individual participant dataSharing planned: Yes. Individual Participant Data that underlie results in a publication will be available after the end of the study for researchers that have doubts about it.
Related trials for Myofascial Pain
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Not yet recruiting
Effects of Myofascial Techniques on Chronic Low Back Pain
Chronic Low-back Pain (cLBP)
Recruiting
Comparing Myofascial Exercise and Trigger Point Therapy for Non-Specific Low Back Pain
Non-specific Low Back Pain
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael I Barbosa, PhD principal investigator
Universidade Federal de Santa Catarina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Low-Level Laser Therapy in people with Myofascial Pain and Trigger Points, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain through the visual analogue scale at baseline (time frame: Measure will be obtained before the intervention (baseline).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03375229, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.