跳至主要内容
临床试验/NCT02393352
NCT02393352已完成不适用

Benefits of Dry Needling in Trigger Points on Autonomic Nervous System, Photoelectric Plethysmography, Body Composition in Patients With Fibromyalgia Syndrome.

Universidad de Almeria2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Changes Scores on Visual Analoge Scale

研究概览

简要总结

This study evaluates the benefits of dry needling in trigger points on autonomic nervous system, photoelectric plethysmography, body composition in patients with fibromyalgia syndrome.

详细描述

Dru needling can be developed on active trigger points. Myofascial trigger points can be active or latent. An active myofascial trigger point pain causes giving a specific pathological picture. We will conduct a location of myofascial trigger points following the illustrations location myofascial trigger points that indicate Travell and Simons both left-sided and right.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fibromyalgia syndrome diagnosis.
  • Aged from 18 to 65 years.
  • No regular physical activity.
  • Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
  • Agreement to attend evening therapy sessions.

排除标准

  • Severe physical disability.
  • Comorbid conditions (eg, morbid obesity, inflammatory diseases, irritable bowel syndrome, interstitial cystitis).
  • Uncontrolled endocrine disorders (eg, hyperthyroidism or hypothyroidism, diabetes).
  • Malignancy.
  • Psychiatric.
  • Illnesses (eg, schizophrenia or substance abuse).
  • Medication usage other than as-needed analgesics (excluding long-term narcotics).
  • History of surgery.
  • History of whiplash injury.
  • Presence of a score >9 points in the Beck Depression Inventory.

研究组 & 干预措施

Dry Needling Therapy

Experimental

The dry needling therapy will be applied on active trigger points in occipital muscle, splenius capitis, sternocleidomastoid muscle, scalene muscles, trapezius, supraspinatus, infraspinatus muscle, latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourm muscles.

干预措施: Dry Needling Therapy (Other)

Electrical Stimulation Therapy

Active Comparator

Diadynamic fixed current phase in active trigger points, with pulses of 10msec, and intervals of equal duration.

干预措施: Electrical Stimulation Therapy (Other)

结局指标

主要结局

Changes Scores on Visual Analoge Scale

时间窗: At baseline and 4 weeks

Intensity of pain (within McGill questionnaire)

次要结局

  • Changes Scores on Percentage Evaluation Peripheral Capillary Oxygen saturation and photoelectric plethysmograph (Analysis of pulse wave and PANI)(At baseline and 4 weeks)
  • Change Scores on Body Composition(At baseline and 4 weeks)
  • Changes Scores on Systemic vascular resistance.(At baseline and 4 weeks)
  • Changes Scores on Heart rate variability.(At baseline and 4 weeks)
  • Changes Scores on Valsalva ratio. K30/15.(At baseline and 4 weeks)
  • Changes Scores on Assessment of autonomic nervous system(At baseline and 4 weeks)
  • Changes Scores on Cholinergic response indicators (%).(At baseline and 4 weeks)
  • Changes Scores on Systolic pressure.(At baseline and 4 weeks)
  • Changes Scores on Diastolic pressure.(At baseline and 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adelaida María Castro-Sánchez

PhD (Lecturer)

Universidad de Almeria

研究点 (2)

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