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Completed

NCT Number: NCT03222154

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

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).

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Key information

Conditions

Pain Muscle Tonus Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental - Shock wave therapy

Device

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

Placebo - Shock wave therapy

Device

Simulation of shock wave therapy

Primary outcomes

  1. Pain assessment

    Time frame: five minutes

    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.

  2. Evaluation of trigger points

    Time frame: fifteen minutes

    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.

  3. Evaluation of pressure pain threshold

    Time frame: ten minutes

    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"

  4. Electromyographic Evaluation (EMG) Electromyographic Evaluation (EMG)

    Time frame: twenty minutes

    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.

  5. Strength evaluation

    Time frame: ten minutes

    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.

  6. Assessment by the Change Perception Scale

    Time frame: ten minutes

    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.

Sponsors and collaborators

Lead sponsor

Rodrigo Marcel Valentim da Silva

Other

Collaborators

  • Universidade Federal do Rio Grande do Norte

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 19, 2017
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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