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

EFFECTS OF SHOCK WAVE THERAPY IN MIOFASCIAL PAIN: RANDOMIZED AND BLIND CLINICAL TEST

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).

Study Overview

• Status: Completed
• Conditions: Pain; Muscle Tonus
• Intervention / Treatment: Device: Placebo - Shock wave therapy; Device: Experimental - Shock wave therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 20 volunteers without intervention. At the end of the study they received an application of shock wave therapy.
Placebo Comparator: Placebo; 20 volunteers who received simulation of the application of shock wave therapy	Device: Placebo - Shock wave therapy; Simulation of shock wave therapy
Experimental: Experimental; 20 volunteers who received shock wave therapy	Device: Experimental - Shock wave therapy; Shock wave therapy was performed with the Master Plus 200® Storz Medical equipment, radial emission 2000 pulses, frequency 15 Hz and pressure 1 Bar.; Other Names: High energy shock wave therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	five minutes
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.	fifteen minutes
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"	ten minutes
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.	twenty minutes
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.	ten minutes
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.	ten minutes

Collaborators and Investigators

• Sponsor: Rodrigo Marcel Valentim da Silva
• Collaborators: Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: physiotherapy; High Energy Shock Waves
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: UFRN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No