Clinical Outcomes After Dry Needling on Cervical Muscles, Quality of Life, Fatigue, Quality of Sleep, Anxiety and Depression in Patients With Fibromyalgia Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Active and Latent Myofascial Trigger Points (Number of trigger Points)
研究概览
简要总结
Objectives: The purpose of the current randomized clinical trial is to compare the effectiveness of dry needling versus myofascial release therapy on myofascial trigger points (MTrPs) in cervical muscles, quality of life, fatigue, quality of sleep, anxiety and depression in patients with fibromyalgia syndrome (FMS).
详细描述
Design: A single-blind randomized controlled trial will be conducted on patients with FMS.
Methods: Sixty-four subjects with FMS will be randomly assigned to an experimental group receiving dry needling therapy, or to a control group for myofascial release therapy in the trigger points active or latent in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus. Myofascial trigger points, quality of life, impact of fibromyalgia symptoms, quality of sleep, intensity of pain, anxiety levels, state of depression, impact of fatigue will be recorded at baseline and after four weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia syndrome diagnosis.
- •Aged from 18 to 60 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
- •Receipt of any no pharmacologic therapies.
- •Presence of cardiac, renal or hepatic insufficiency.
- •Severe physical disability.
- •Comorbid condition (eg, inflammatory disease).
- •Infection fever.
- •Hypotension.
- •Skin alterations.
- •Psychiatric illness.
- •Previous history of surgery.
研究组 & 干预措施
Dry Needling Therapy
Active or latent MTrPs (myofascial trigger points) will be remarked in black or red, respectively. Active or latent MTrPs will be needled in the same position employed by the blinded examiner for diagnosis. All dry needling procedures will be performed by the same investigator, and the technique used will be similar to the Hong method, using sterile Ener-Qi needles (EQ 1661) for the punction of TrPs (trigger points).
干预措施: Dry Needling Therapy (Other)
Myofascial Release Therapy
Patients will develope a myofascial therapy protocol, administered in the following order: deep fascia release in temporal region, suboccipital release, compression-decompression of temporomandibular joint, global release of cervicodorsal fascia, release of pectoral region, diaphragm release (transverse slide), and transverse diaphragmatic plane.
干预措施: Myofascial Release Therapy (Other)
结局指标
主要结局
Active and Latent Myofascial Trigger Points (Number of trigger Points)
时间窗: Change from baseline myofascial trigger points at four weeks
Myofascial Trigger Points will be explored in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus.
次要结局
- Quality of Life (SF-36 quality of life questionnaire)(Change from baseline quality of life at four weeks)
- Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire)(Change from baseline impact of fibromyalgia symptoms at four weeks)
- Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)(Change from baseline quality of life at four weeks)
- Pain (Visual Analog Scale)(Change from baseline pain intensity at four weeks)
- Anxiety levels (State-Trait Anxiety Inventory )(Change from baseline anxiety levels at four weeks)
- State of depression (Beck Depression Inventory)(Change from state of depression at four weeks)
- Impact of fatigue (Fatigue Impact Scale )(Change from impact of fatigue at four weeks)
研究者
Adelaida María Castro-Sánchez
PhD, Full Professor
Universidad de Almeria