The Influence of Cardiovascular Autonomic Function on Endogenous Pain Modulation Before and After Exercise and Cognitive Task in Fibromyalgia
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
研究概览
简要总结
The study has three aims:
- To investigate the influence of cardiovascular autonomic function on pain sensitivity at rest in patients with fibromyalgia and age- and sex-matched controls
- To investigate the influence of cardiovascular autonomic function at baseline and during exercise on the pain response following submaximal isometric exercise
- To study the relation between the pain response following physical and cognitive tasks (exercise and mental math, respectively).
详细描述
Fibromyalgia (FM) affects 2 -8% of the population with a higher prevalence in women than men. People with FM report widespread pain that impacts their quality of life. Patients may also experience other symptoms besides pain such as depression, anxiety, fatigue, sleep difficulties and others. Exercise is one of the interventions that have been shown to reduce pain in chronic pain populations. The phenomenon by which exercise reduces pain sensitivity is known as exercise-induced hypoalgesia (EIH). Although exercise is strongly recommended by American Pain Society guideline for the treatment of FM, some patients with FM report an increase in pain and worsening symptoms following acute exercise. The worsening of symptoms may impact adherence to exercise training. Why some people with FM report pain exacerbation while others report pain relief following exercise is not known.
This study aims at assessing the influence of the cardiovascular autonomic nervous system on pain sensitivity at rest and following exercise in patients with fibromyalgia and pain-free individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are masked to the primary hypothesis of the study.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fibromyalgia
- •Healthy Controls without fibromyalgia
- •Stable medical management plan for four weeks prior to participation in the study.
- •Physical Activity Readiness Questionnaire
- •English proficiency
排除标准
- •Elbow arthritis
- •Carpal tunnel syndrome
- •Cardiovascular disease
- •Cervical surgery
- •Cerebrovascular accident / stroke
- •Multiple sclerosis
- •Parkinson's disease
- •Any central neurodegenerative disease
- •Traumatic brain injury
- •Peripheral neuropathy of the upper extremity
- •Myocardial infarction
- •Chronic obstructive pulmonary disease
- •Any unstable medical or psychiatric condition
- •Diabetes mellitus
- •Active cancer
- •Lymphedema of the upper extremity
- •Claustrophobia
- •Raynaud's phenomenon
- •Osteoporosis
- •Major depressive disorder
- •Bipolar disorder
- •Rheumatoid arthritis
- •Polymyalgia rheumatica
- •Pregnancy
研究组 & 干预措施
Isometric (Static) Exercise
Subjects will perform isometric (static) handgrip exercise at submaximal intensity for four minutes. The exercise will be performed while the subject is seated, and the elbow bent at around 90° and unsupported. Subjects will be asked to rate their pain using numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain), perceived exertion (RPE) from 0 (Nothing at all) to 10 (extremely strong), and perceived stress from 0 (not stressed at all) to 10 (extremely stressed). The ratings of pain intensity, RPE and perceived stress will be provided before, at the middle and at the end of the exercise.
干预措施: Exercise (Other)
Cognitive Task
The mental math task, which is also known as serial subtraction test, will be performed for four minutes. Subjects will be asked to rate their pain intensity and perceived stress before, at the middle and at the end of the mental math task.
干预措施: Cognitive Task (Other)
结局指标
主要结局
Change from Baseline Pressure Pain Threshold to immediately after performance of exercise.
时间窗: Before and immediately after exercise at session 2 or 3 which is on day 7 or day 21.
Application of a pressure stimulus to the right forearm and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Heart Rate Variability
时间窗: baseline, session1 which is day 1 of data collection
Electrocardiogram data will be recorded for ten minutes. Subjects will be instructed to relax. A two-lead configuration method will be utilized with electrodes placed at right clavicle (negative electrode), left lower rib (positive electrode), and left clavicle (ground electrode).
Change in Blood Pressure during Valsalva Maneuver
时间窗: baseline, session 1 which is day 1 of data collection
Subjects will be instructed to perform a forceful expiration at a pressure of 40 mm Hg for 15 seconds. This is done by blowing into a syringe that is connected to a pressure gauge, which will be placed in front of the subjects for visual feedback. In addition, feedback of the time will be provided. Continuous blood pressure will be collected during the test. The recovery time of blood pressure to baseline after Valsalva reflects the cardiovascular sympathetic tone. Greater recovery time indicates reduced sympathetic tone.
Temporal summation of heat assessment.
时间窗: the beginning of session 3 which day 21 of data collection
Subjects will receive ten heat pulses with ramp and return rate of 8˚C/second to the baseline temperature. The peak stimulus interval 0.6 second and the inter-stimulus interval is 0.3 seconds. The baseline temperature will be 39˚C. Subjects will be asked to rate the first, third, fifth, eighth and tenth stimuli.
Change in Heart Rate during Deep Breathing Test
时间窗: baseline, session 1 which is day 1 of data collection
The test is done by asking the participant to perform six breathing cycles with each cycle consists of a five seconds inhalation and 5 seconds exhalation (10 second-cycle). Subjects will perform practice trials until they perform respiratory cycles without sudden inhalation or exhalation or holding the breath. Continuous electrocardiogram data will be collected. The change of heart rate during deep breathing test reflects the cardiovascular parasympathetic function. Reduced heart rate variability during deep breathing test indicates reduced parasympathetic tone.
Change from Baseline Pressure Pain Threshold to immediately after cognitive task.
时间窗: Before and immediately after cognitive task at session 2 or 3 which is on day 7 or day 21.
Application of a pressure stimulus to the right forearm muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
Change from Baseline Pressure Pain Threshold to during the submersion of the foot in ice water.
时间窗: Before and during the submersion of the foot in ice water on session 2 which is day 7 of data collection
Application of a pressure stimulus to the right forearm muscle and quadriceps muscle at a rate of 50kPa per second until the pressure first becomes painful.
次要结局
- American College of Rheumatology Diagnostic Criteria for Fibromyalgia(Day 1 of data collection)
- Baseline Fat Mass(7 days after enrollment.)
- Situational Pain Catastrophizing Scale(in session 2 and 3 which are day 7 and 21 of data collection)
- Pain Catastrophizing Scale(on session 1 which is day 1 of data collection.)
- Six-Minute Walk Test(time frame: baseline, day 1 of data collection)
- The Fibromyalgia Impact Questionnaire - Revised(on session 1, 2 and 3 which are on day 1,7 and 21 of data collection.)
- Cortisol Awakening Response (CAR)(samples will be collected at home at any day between day 1 and day 7 of data collection)
- The Short-Form McGill Pain Questionnaire(on session 1, 2 and 3 which are on day 1,7 and 21 of data collection)
- Depression Anxiety and Stress Scale (DASS21)(session 3 which is day 21 of data collection)
- State Version of State-Trait Anxiety Inventory(on session 1, 2 and 3 which are on day 1,7 and 21 of data collection.)
- Total time spent in sedentary and moderate to vigorous physical activity measured by an Actigraph over the course of 7 days.(Worn continuously for a 7-day period during study enrollment.)
- Baseline Lean Mass(7 days after enrollment.)
- Composite Autonomic Symptom Score(baseline, session1 which is day 1 of data collection)
- Pain Anxiety Symptom Scale(session 3 which is day 21 of data collection)