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EFFECTS OF SHOCK WAVE THERAPY IN WOMEN WITH PAIN IN TRAPÉZIO MUSCLE

Primary Purpose

Pain, Muscle Tonus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental - Shock wave therapy
Placebo - Shock wave therapy
Sponsored by
Rodrigo Marcel Valentim da Silva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring High Energy Shock Waves, physiotherapy

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with painful symptoms, compatible with the referred pain pattern of trigger points in the upper trapezius muscle.
  • Age range of 18 to 35 years.
  • No upper limb injury in the last 6 months.
  • Featuring trigger points identified in the upper trapezius muscle.
  • Present pain and / or moderate and / or severe disability after application of specific instruments.

Exclusion Criteria:

  • Present unbearable pain during the evaluation procedures.
  • Missing or not executing the solution correctly.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Placebo Comparator

    Experimental

    Arm Label

    Control

    Placebo

    Experimental

    Arm Description

    20 volunteers without intervention. At the end of the study they received an application of shock wave therapy.

    20 volunteers who received simulation of the application of shock wave therapy

    20 volunteers who received shock wave therapy

    Outcomes

    Primary Outcome Measures

    Pain assessment
    The subjective pain intensity was evaluated using the Visual Analogue Scale. Which consists of a horizontal line, 10 centimeters long, marked at one end by a rating of 0 - "No Pain" and the other by the classification "Maximum Pain". The patient had to make a line perpendicular to the line, at the point that represents the intensity of his pain.
    Evaluation of trigger points
    The presence of trigger points was investigated in the upper trapezius muscle on the side that the volunteer reported pain or bilateral. The evaluation was performed with the volunteers in the ventral decubitus, and bilaterally evaluated the presence of the trigger points in the upper trapezius. The number of trigger points was recorded according to the classification: active PMG, latent PGM and total PGM. The side that presented a larger number of trigger points was the side used to evaluate the experimental procedures. If the number of active trigger points were equal on both sides, the upper limb considered dominant by the volunteer was chosen for the evaluation.
    Evaluation of pressure pain threshold
    To evaluate the pain threshold, a WAGNER® FDM algometer was used, which is a device consisting of a 1 cm2 rubber disc connected to a pressure gauge, which shows values in N. The volunteers were previously advised on how the procedure would be performed. And that when when the pressure with the tip of the apparatus began to evoke pain / threshold it was necessary to say loudly the word "Stop"
    Electromyographic Evaluation (EMG) Electromyographic Evaluation (EMG)
    Electromyographic signal processing was performed with a TeleMyo DTS Desk Receiver® electromyography channel (Noraxon USA Inc., Scottsdale, USA) with a 20-500 Hz bandpass filter, gain of 1500 times, and a rejection rate of Common mode greater than 100 dB. The electromyographic evaluation was performed using the bipolar technique, with simple double wireless electrodes.
    Strength evaluation
    The muscle strength test was performed with a manual dynamometer (Lafayette® - model 01165), for the force in the shoulder lift movement. For this evaluation the volunteers were seated, with the shoulder in extension position, and consequently the upper limb on the side of the body. The dynamometer was placed in a fixed bulkhead and the shoulder was elevated, resisting the movement and performing an isometric contraction.
    Assessment by the Change Perception Scale
    The Patient Global Impression of Change Scale questionnaire was applied in its Portuguese version, Scale of Perception of Change, being an instrument of easy understanding and application. It becomes a useful tool to quantify the perception of change in health status and satisfaction of a treatment of chronic musculoskeletal pain.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 17, 2017
    Last Updated
    July 18, 2017
    Sponsor
    Rodrigo Marcel Valentim da Silva
    Collaborators
    Universidade Federal do Rio Grande do Norte
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03222154
    Brief Title
    EFFECTS OF SHOCK WAVE THERAPY IN WOMEN WITH PAIN IN TRAPÉZIO MUSCLE
    Official Title
    EFFECTS OF SHOCK WAVE THERAPY IN MIOFASCIAL PAIN: RANDOMIZED AND BLIND CLINICAL TEST
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    October 1, 2016 (Actual)
    Study Completion Date
    December 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Rodrigo Marcel Valentim da Silva
    Collaborators
    Universidade Federal do Rio Grande do Norte

    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
    The study consisted of 60 women who had pain-point pains in the upper fibers of the trapezius muscle. They had a medical age of 22.8 years, with a body mass index of 22.8 kg / cm2.They underwent an initial assessment, with a visual analogue pain scale, followed by an assessment of pain threshold, and manual muscle strength.Then, they were allocated into three groups: control group with 20 volunteers without intervention, placebo group with 20 volunteers with shock wave simulation and an intervention group with 20 volunteers with shock wave therapy. All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours after the intervention protocol (48 hour evaluation). A mixed ANOVA of repeated measurements was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was set at 5% (p <0.05).
    Detailed Description
    The objective was to investigate the effects of shock wave therapy on the pain of trigger points in the upper fibers of the trapezius muscle. A randomized, blinded clinical trial of 60 women (mean age 22.8 years and mean body mass index of 22.8 kg / cm2) with presence of trigger points in the upper fibers of the trapezius muscle. These were submitted to an initial evaluation (AV1), composed of the visual analogical pain scale, followed by an evaluation of the pain threshold, using algometry. Then, the evaluation of the electromyographic activity of the upper trapezius muscle was performed, as well as of its muscular strength by manual dynamometry. Then allocated randomly in 3 groups: Control (n = 20), without intervention; Placebo (n = 20), simulation of the application of shock wave therapy; And shock wave therapy (n = 20). Shock wave therapy was performed with the Master Plus 200® Storz Medical equipment, radial emission 2000 pulses, 15 Hz frequency and pressure of 1 Bar. All volunteers were evaluated immediately after the protocol (post evaluation) and 48 hours After the intervention protocol (evaluation 48 hours). A mixed ANOVA of repeated measurements was used for intra and intergroup comparisons, followed by tukey post hoc. Significance was set at 5% (p <0.05).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Muscle Tonus
    Keywords
    High Energy Shock Waves, physiotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    3 groups: Control (n = 20), without intervention; Placebo (n = 20), simulation of the application of shock wave therapy; And shock wave therapy (n = 20).
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    20 volunteers without intervention. At the end of the study they received an application of shock wave therapy.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    20 volunteers who received simulation of the application of shock wave therapy
    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    20 volunteers who received shock wave therapy
    Intervention Type
    Device
    Intervention Name(s)
    Experimental - Shock wave therapy
    Other Intervention Name(s)
    High energy shock wave therapy
    Intervention Description
    Shock wave therapy was performed with the Master Plus 200® Storz Medical equipment, radial emission 2000 pulses, frequency 15 Hz and pressure 1 Bar.
    Intervention Type
    Device
    Intervention Name(s)
    Placebo - Shock wave therapy
    Intervention Description
    Simulation of shock wave therapy
    Primary Outcome Measure Information:
    Title
    Pain assessment
    Description
    The subjective pain intensity was evaluated using the Visual Analogue Scale. Which consists of a horizontal line, 10 centimeters long, marked at one end by a rating of 0 - "No Pain" and the other by the classification "Maximum Pain". The patient had to make a line perpendicular to the line, at the point that represents the intensity of his pain.
    Time Frame
    five minutes
    Title
    Evaluation of trigger points
    Description
    The presence of trigger points was investigated in the upper trapezius muscle on the side that the volunteer reported pain or bilateral. The evaluation was performed with the volunteers in the ventral decubitus, and bilaterally evaluated the presence of the trigger points in the upper trapezius. The number of trigger points was recorded according to the classification: active PMG, latent PGM and total PGM. The side that presented a larger number of trigger points was the side used to evaluate the experimental procedures. If the number of active trigger points were equal on both sides, the upper limb considered dominant by the volunteer was chosen for the evaluation.
    Time Frame
    fifteen minutes
    Title
    Evaluation of pressure pain threshold
    Description
    To evaluate the pain threshold, a WAGNER® FDM algometer was used, which is a device consisting of a 1 cm2 rubber disc connected to a pressure gauge, which shows values in N. The volunteers were previously advised on how the procedure would be performed. And that when when the pressure with the tip of the apparatus began to evoke pain / threshold it was necessary to say loudly the word "Stop"
    Time Frame
    ten minutes
    Title
    Electromyographic Evaluation (EMG) Electromyographic Evaluation (EMG)
    Description
    Electromyographic signal processing was performed with a TeleMyo DTS Desk Receiver® electromyography channel (Noraxon USA Inc., Scottsdale, USA) with a 20-500 Hz bandpass filter, gain of 1500 times, and a rejection rate of Common mode greater than 100 dB. The electromyographic evaluation was performed using the bipolar technique, with simple double wireless electrodes.
    Time Frame
    twenty minutes
    Title
    Strength evaluation
    Description
    The muscle strength test was performed with a manual dynamometer (Lafayette® - model 01165), for the force in the shoulder lift movement. For this evaluation the volunteers were seated, with the shoulder in extension position, and consequently the upper limb on the side of the body. The dynamometer was placed in a fixed bulkhead and the shoulder was elevated, resisting the movement and performing an isometric contraction.
    Time Frame
    ten minutes
    Title
    Assessment by the Change Perception Scale
    Description
    The Patient Global Impression of Change Scale questionnaire was applied in its Portuguese version, Scale of Perception of Change, being an instrument of easy understanding and application. It becomes a useful tool to quantify the perception of change in health status and satisfaction of a treatment of chronic musculoskeletal pain.
    Time Frame
    ten minutes

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women with painful symptoms, compatible with the referred pain pattern of trigger points in the upper trapezius muscle. Age range of 18 to 35 years. No upper limb injury in the last 6 months. Featuring trigger points identified in the upper trapezius muscle. Present pain and / or moderate and / or severe disability after application of specific instruments. Exclusion Criteria: Present unbearable pain during the evaluation procedures. Missing or not executing the solution correctly.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All collected IPD
    IPD Sharing Time Frame
    Starting 6 months after publication

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    EFFECTS OF SHOCK WAVE THERAPY IN WOMEN WITH PAIN IN TRAPÉZIO MUSCLE

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