Effectiveness of Electro Neuro Adaptive Regulator on Pain, Disability and Central Sensitization in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Numerical pain ranting Scale
研究概览
简要总结
Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, Evidence shows that different physical therapies could activation situations of chronic pain there is no activation of CPM.
Objectives: The purpose of this study is to measure the CPM response and determine whether Electro Neuro Adaptative Regulator in patients with Fibromyalgia is effective in the improvement of CPM, TS, pain intensity, disability.
Design: Double-blind, randomized placebo clinical trial. Methods: Patients with fibromyalgia will be randomly allocated into two groups: the Electro Neuro Adaptative Regulator group (SCENAR) or the sham technique (ST) group.
Main outcomes measures: Pain intensity (with visual analogue scale, Conditioned Pain Modulation (CPM), Temporal Summation (TS) and Pressure Pain Thresholds (PPT´s) were the primary outcomes and will be assessed at baseline and at 3-months follow-up. Secondary outcome measures were the Fibromyalgia Impact Questionnaire to measure disability, Pain Catastrophizing Scale and the Pain Anxiety Symptoms Scale, Beck Depression Inventory, Jenkins Sleep Scale. Questionnaire of quality of life SF36.
Participants will be selected if they met the following inclusion criteria: (a) fulfilled the 1990 and 2010 American College of Rheumatology classification criteria for FM; (b) reported an average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale during the previous week to study commencement; (c) were on stable doses of medication for FM ≥ 4 weeks; and (d) were aged between 18 and 65 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •. American College of Rheumatology classification criteria for Fibromyalgia.
- •. reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries;
- •on stable doses of medications for FM ≥ 4 weeks.
排除标准
- •Patients will be excluded from enrolment if: (1) they suffer from an inflammatory rheumatic conditions; (2) have a planned elective surgery during the study period; (3) have ongoing unresolved disability claims; (4) experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis; (5) do not speak Spanish fluently.
结局指标
主要结局
Numerical pain ranting Scale
时间窗: Change from Baseline of pain intensity at 3 months
The patients will be asked to assess the subjective pain intensity of the painful in whole body by to marking the level of pain on the scale. Pain intensity was measured with the NRS of 11 points (interval from 0 to 10), where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable.
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: Change from Baseline of Fibromyalgia impact questionnaire at 3 months
The FIQ, which is a validated self-reported questionnaire to measure multidimensional function/health-related quality of life, will be used.Scores in the FIQ range from 0 to 100, An improvement greater than 30% in the FIQ total score has been identified in clinical trials as sensitive to identify a positive response to treatment.
次要结局
- Conditioned pain modulation(Change from Baseline of CPM at 3 months)
- State Trait Anxiety Inventory(Change from Baseline of Anxiety at 3 months)
- Beck Depression Inventory (BDI)(Change from Baseline of Depression symptoms at 3 months)
- Mechanical Hyperalgesia(Change from Baseline of PPT at 3 months)
- Temporal Summation(Change from Baseline of TS at 3 months)
- Pain Catastrophizing(Change from Baseline of pain catastrophizing at 3 months)
- Tampa Scale for Kinesiophobia(Change from Baseline of kinesiophobia at 3 months)
- Jenkins Sleep Scale(Change from Baseline of sleep scale at 3 months)
- SF-36. Short Form-36 Health Survey(Change from Baseline of quality of life at 3 months)
研究者
Josue Fernandez Carnero
Professor
Universidad Rey Juan Carlos