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临床试验/NCT04238286
NCT04238286已完成不适用

Analgesic Efficacy of Dry Needling in Fibromyalgia Patients.Influence of Catastrophism in the Successful Intervention

Universitat Jaume I2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
The Pain Catastrophizing Scale (PCS) is a 13-item self-administered scale and one of the most widely used to assess pain catastrophizing

研究概览

简要总结

Background: Dry needling trigger point treatment, while painful, has been demonstrated as a useful tool in fibromyalgia patients for decreasing pain and central sensitization. However, the current biopsychosocial pain paradigm indicates that fibromyalgia subjects with high levels of catastrophizing have negative thoughts related with perceived partner responses to pain, which results in an emotional and physical stress after a painful episode.

Objective: To assess whether catastrophizing could influence the perception of pain during and after dry needling application.

Study design: A singled-blind randomized controlled trial.

Setting: Department of Medicine, Faculty of Health Sciences, Universitat Jaume I

Methods: Female fibromyalgia patients and number and age-matched female controls will be recruited and randomly assigned to either a real or a simulated dry needling group. The Spanish version of the pain catastrophizing scale will be used to assess the catastrophizing level of each participant before initiating any of the planned interventions. The perceived pain during and immediately after the dry needling procedure will be measured using the pain visual analogue scale, [VAS].

详细描述

Fibromyalgia syndrome (FS) is currently classified as chronic widespread pain with widespread allodynia (Coster et al., 2008). These symptoms are accompanied by other disorders, such as sleep disturbance, headaches, morning stiffness, irritable bowel syndrome, interstitial cystitis, dyspareunia, mood disturbances and depression (Gerwin, 2005). The World Health Organization recognized FS as a disease in 1992, basing its decision on the diagnostic criteria of the American College of Rheumatology (ACR) which has recently been criticized and updated (Wolfe et al., 2011; Wolfe et al., 2010; Wolfe and Hauser, 2011). Depending on the diagnostic criteria used, the prevalence is from 2% to 8% of the population increasing with age, with highest values attained between 60 and 70 (Stahl, 2009). In Spain, was estimated that 2.4% of the population over 20 years old presents the disease, and it is higher in females than in males (ratio 21:1) (Cordero, 2011).

A central sensitivity syndrome could be the most plausible explanation for chronic widespread pain affecting people with fibromyalgia syndrome. Although it was suggested this condition was the sole cause (Yunus, 2007), central sensitization of the nervous system causes the phenomena of hyperalgesia and allodynia in the individual suffering from chronic pain (Butler and Moseley, 2003) .

The subject with chronic pain has an altered alarm system; this alteration could be initiated by a peripheral sensitization (Sarzi-Puttini et al., 2011) activated by the release of various chemical substances such as substance P, serotonin and bradykinin (Yunus, 2007). Myofascial trigger points (MTrPs) are able to maintain this peripheral sensitization (Affaitati et al., 2011; Ge et al., 2010) by triggering the spontaneous pain patterns experienced by a patient with fibromyalgia syndrome (Ge et al., 2011).

MTrPs contain algogenic substances capable of generating changes in the intensity of pain. Differences in the concentration of these substances between healthy muscle and MTrPs (Shah et al., 2005) have been shown. One of the most effective techniques for the treatment of MTrPs is dry needling (Mayoral, 2010), because it alters the chemical environment of the MTrPs, thus decreasing their sensitization (Dommerholt, 2011). However, there are as until no few studies that have examined the effectiveness of this technique in patients with FS (Chou et al., 2008; Staud, 2006). Moreover, in these patients the perception of pain during and after treatment can be influenced not only by central sensitization, but also by psychosocial variables.

Catastrophization, considered to be the basic psychological construction concerning the perception of pain intensity, is a cognitive and emotional process encompassing magnification of pain-related stimuli, feelings of helplessness, and a generally pessimistic orientation (Labus et al., 2003; Rodero et al., 2010). This catastrophization, understood as a set of negative emotions and cognitive processes, is a risk factor in fibromyalgia and leads to an increase in symptoms, health status warning, symptoms of helplessness and pessimism (Alegre de Miquel and Sellas Fernandez, 2008; Sullivan et al., 2001).

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • A diagnosis of fibromyalgia verified by a qualified rheumatologist according to the ACR criteria
  • To have basic spanish skills (be able to understand oral and written spanish language)

排除标准

  • Belonephobia or mimicking pathologies
  • Lymphedema
  • Pregnancy
  • Neoplastic disorders

结局指标

主要结局

The Pain Catastrophizing Scale (PCS) is a 13-item self-administered scale and one of the most widely used to assess pain catastrophizing

时间窗: 48 hours

The theoretical range of the instrument is between 0 and 52, with low scores indicating low catastrophizing, and high values showing high catastrophizing. Compare to others this questionnaire is unique since the individual does not need to be in pain while completing it.

次要结局

  • Pain Intensity Measure VAS(48 hours)
  • Algometry(48 hours)

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (2)

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