Dry Needling and Low-level Laser Therapy to Treat Myofascial Pain
Condition: Myofascial Pain; Trigger Points
MeSH terms: Myofascial Pain Syndromes
Study type: Interventional

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.
    

Intervention name(s): Dry Needling; Low-Level Laser Therapy
Intervention type(s): Other; Device
Intervention description(s): 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; 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.
Other intervention name(s): LLLT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myofascial Pain; Pain Pressure Threshold; Low-Level Laser Therapy; Dry Needling