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

NCT03222154 | Completed

• 1 other identifier: UFRN
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pain; Muscle Tonus

Keywords

High Energy Shock Waves; physiotherapy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

Control

NO INTERVENTION

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

Placebo

PLACEBO COMPARATOR

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

Device: Placebo - Shock wave therapy

Experimental

EXPERIMENTAL

20 volunteers who received shock wave therapy

Device: Experimental - Shock wave therapy

Interventions

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.

Also known as: High energy shock wave therapy

Experimental

Placebo - Shock wave therapy DEVICE

Simulation of shock wave therapy

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rodrigo Marcel Valentim da Silva: lead
• Universidade Federal do Rio Grande do Norte: collaborator

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 3 groups: Control (n = 20), without intervention; Placebo (n = 20), simulation of the application of shock wave therapy; And shock wave therapy (n = 20).

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Starting 6 months after publication