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

Primary Purpose

Myofascial Pain, Trigger Points

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dry Needling
Low-Level Laser Therapy
Sponsored by
Universidade Federal de Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain focused on measuring Myofascial Pain, Pain Pressure Threshold, Low-Level Laser Therapy, Dry Needling

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Universidade Federal de Santa Catarina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group On

Group Off

Placebo group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
Muscle activity
Electromyography will be used to measure muscle activity on upper trapezius
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.
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.
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.

Full Information

First Posted
December 5, 2017
Last Updated
May 21, 2020
Sponsor
Universidade Federal de Santa Catarina
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1. Study Identification

Unique Protocol Identification Number
NCT03375229
Brief Title
Dry Needling and Low-level Laser Therapy to Treat Myofascial Pain
Official Title
Dry Needling and Photobiomodulation in the Treatment of Myofascial Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Catarina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain, Trigger Points
Keywords
Myofascial Pain, Pain Pressure Threshold, Low-Level Laser Therapy, Dry Needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group On
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group Off
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Low-Level Laser Therapy
Other Intervention Name(s)
LLLT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain through the visual analogue scale at baseline
Description
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.
Time Frame
Measure will be obtained before the intervention (baseline).
Title
Pain through the visual analogue scale after 30 minutes of intervention
Description
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.
Time Frame
Measure will be obtained 30 minutes after the intervention
Title
Pain through the visual analogue scale after one week of intervention
Description
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.
Time Frame
Measure will be obtained 1 week after the intervention
Title
Pain through the visual analogue scale after one month of intervention
Description
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.
Time Frame
Measure will be obtained 30 days after the intervention
Secondary Outcome Measure Information:
Title
Pain Pressure Threshold
Description
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.
Time Frame
This measured will be obtained before the intervention (baseline)
Title
Pain Pressure Threshold
Description
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.
Time Frame
This measured will be obtained soon after the intervention (T1)
Title
Pain Pressure Threshold
Description
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.
Time Frame
This measured will be obtained 30 minutes after the intervention (T2)
Title
Muscle activity
Description
Electromyography will be used to measure muscle activity on upper trapezius
Time Frame
Electromyographic data will be collected before the intervention and 5 minutes after the intervention.
Title
Functional Capacity
Description
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.
Time Frame
The subject will answer the NDI before the intervention
Title
Functional Capacity
Description
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.
Time Frame
The subject will answer the NDI 1 week after intervention
Title
Functional Capacity
Description
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.
Time Frame
The subject will answer the NDI 1 month after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael I Barbosa, PhD
Organizational Affiliation
Universidade Federal de Santa Catarina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Santa Catarina
City
Araranguá
State/Province
Santa Catarina
ZIP/Postal Code
88905-120
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Study protocol will be submitted for publication before the end of the study.
IPD Sharing Access Criteria
To be a principal researcher associated with a higher education institution.
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Dry Needling and Low-level Laser Therapy to Treat Myofascial Pain

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