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Trial record 50 of 633 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

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

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ClinicalTrials.gov Identifier: NCT03375229
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Rafael Inácio Barbosa, Universidade Federal de Santa Catarina

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.

Condition or disease Intervention/treatment Phase
Myofascial Pain Trigger Points Other: Dry Needling Device: Low-Level Laser Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dry Needling and Photobiomodulation in the Treatment of Myofascial Pain
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group On
This group will be composed of 20 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
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

Device: Low-Level Laser Therapy
The laser 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 mW, beam area of 0.116 cm², energy of 2,3 J per point, continuous beam (22). The low-level laser therapy (LLLT) will be applied for 30 seconds at the marked point on upper trapezius, right after the dry needling application.
Other Name: LLLT

Active Comparator: Group Off
This group will be composed of 20 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
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

Device: Low-Level Laser Therapy
The laser 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 mW, beam area of 0.116 cm², energy of 2,3 J per point, continuous beam (22). The low-level laser therapy (LLLT) will be applied for 30 seconds at the marked point on upper trapezius, right after the dry needling application.
Other Name: LLLT

Placebo Comparator: Placebo group
This group will be composed of 20 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
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

Device: Low-Level Laser Therapy
The laser 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 mW, beam area of 0.116 cm², energy of 2,3 J per point, continuous beam (22). The low-level laser therapy (LLLT) will be applied for 30 seconds at the marked point on upper trapezius, right after the dry needling application.
Other Name: LLLT




Primary Outcome Measures :
  1. Pain [ 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.

  2. Pain [ 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.

  3. Pain [ 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.

  4. Pain [ 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.


Secondary Outcome Measures :
  1. Pain Pressure Threshold [ Time Frame: This measured will be obtained before the intervention (baseline) ]
    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.

  2. Pain Pressure Threshold [ Time Frame: This measured will be obtained soon after the intervention (T1) ]
    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.

  3. Pain Pressure Threshold [ Time Frame: This measured will be obtained 30 minutes after the intervention (T2) ]
    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.

  4. Muscle activity [ Time Frame: Electromyographic data will be collected before the intervention and 5 minutes after the intervention. ]
    Electromyography will be used to measure muscle activity on upper trapezius

  5. Functional Capacity [ Time Frame: The subject will answer the NDI before the intervention ]
    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.

  6. Functional Capacity [ Time Frame: The subject will answer the NDI 1 week after intervention ]
    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.

  7. Functional Capacity [ Time Frame: The subject will answer the NDI 1 month after intervention ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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): NCT03375229


Contacts
Contact: Rafael I Barbosa, PhD +55 (48) 3721-6250 rafael.barbosa@ufsc.br
Contact: Ameg Dalpiaz +55 (51) 995470829 dalpiaz.ameg@gmail.com

Locations
Brazil
Universidade Federal de Santa Catarina Recruiting
Araranguá, Santa Catarina, Brazil, 88905-120
Contact: Ameg Dalpiaz    +55 51 995470829    dalpiaz.ameg@gmail.com   
Contact: Rafael I Barbosa, PhD    +55 (48) 3721-6250    ppgcr@contato.ufsc.br   
Sponsors and Collaborators
Universidade Federal de Santa Catarina
Investigators
Principal Investigator: Rafael I Barbosa, PhD Universidade Federal de Santa Catarina
  Study Documents (Full-Text)

Documents provided by Rafael Inácio Barbosa, Universidade Federal de Santa Catarina:

Publications:

Responsible Party: Rafael Inácio Barbosa, Principal Investigator, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier: NCT03375229     History of Changes
Other Study ID Numbers: U1111-1205-4687
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rafael Inácio Barbosa, Universidade Federal de Santa Catarina:
Myofascial Pain
Pain Pressure Threshold
Low-Level Laser Therapy
Dry Needling

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases