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

NCT ID: NCT03222154

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2016-12-01

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).

Conditions

Pain; Muscle Tonus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo - Shock wave therapy

Intervention Type: DEVICE

Simulation of shock wave therapy

Experimental

20 volunteers who received shock wave therapy

Group Type: EXPERIMENTAL

Experimental - Shock wave therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Placebo - Shock wave therapy

Simulation of shock wave therapy

Intervention Type: DEVICE

Other Intervention Names

High energy shock wave therapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: collaborator

Rodrigo Marcel Valentim da Silva

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Marcel Valentim da Silva

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

UFRN

Identifier Type: -

Identifier Source: org_study_id