Clinical trial NCT03222154: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Muscle Tonus
Keywords: High Energy Shock Waves
physiotherapy
Lead sponsor: Estácio Ponta Negra
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio Grande do Norte
First posted: 2017-07-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Pain assessment
timeFrame: five minutes
measure: Evaluation of trigger points
timeFrame: fifteen minutes
measure: Evaluation of pressure pain threshold
timeFrame: ten minutes
measure: Electromyographic Evaluation (EMG) Electromyographic Evaluation (EMG)
timeFrame: twenty minutes
measure: Strength evaluation
timeFrame: ten minutes
measure: Assessment by the Change Perception Scale
timeFrame: ten minutes
Secondary outcomes:
Other outcomes:
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