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
About this trial
This is an interventional treatment trial for Pain focused on measuring High Energy Shock Waves, physiotherapy
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.
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
NCT ID
NCT03222154
First Posted
July 17, 2017
Last Updated
July 18, 2017
Sponsor
Rodrigo Marcel Valentim da Silva
Collaborators
Universidade Federal do Rio Grande do Norte
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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