Development of a Pain Neuroscience Education Intervention to Analyze Conditioned Pain Modulation Mechanisms and the Emotional Processes Underlying Centralized Pain in Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Endogenous pain modulation mechanisms_Pressure Pain Hyperalgesia
研究概览
简要总结
Chronic pain represents a significant public health concern worldwide and is a primary reason why patients seek specialized medical care. Fibromyalgia (FM) is a highly prevalent chronic condition, affecting approximately 2% to 5% of the global population. Its main symptom is widespread, diffuse pain, often accompanied by joint stiffness, persistent fatigue, paresthesia, hyperalgesia, non-restorative sleep, anxiety, cognitive difficulties, and sensory hypersensitivity.
Although the exact pathophysiology of FM remains incompletely understood, alterations in central nervous system (CNS) nociceptive processing are believed to play a fundamental role in the development, propagation, and persistence of pain associated with this condition. Increased sensitivity to both painful and non-painful stimuli-known as central sensitization-may result from changes in neural function and activity, which also impact the emotional and affective regulation of pain perception and experience.
Pain neuroscience education (PNE) is an emerging therapeutic approach that focuses on helping patients reconceptualize and understand their pain through education about the neurophysiology, neuroanatomy, and neurobiology of pain. This intervention aims to promote patient awareness of the origins of their symptoms, reduce hyperactivity within the nervous system, and modify maladaptive beliefs and attitudes related to their pain experience. PNE seeks to enhance patients' capacity to manage emotional, psychological, and environmental factors that influence pain perception-such as beliefs, cultural background, motivation, and body awareness-in order to improve coping strategies in daily activities.
In this study, the investigators aim to analyze the effects of a PNE program on nociceptive processing and emotional-affective modulation in patients with FM. The hypothesis is that the intervention will lead to improvements in markers of nociceptive processing, such as pressure hyperalgesia, conditioned pain modulation (CPM), and temporal summation (TS), all of which are related to descending inhibitory pain pathways. Furthermore, the researchers anticipate enhancements in the emotional and affective mechanisms that underlie centralized pain in this population.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Fibromyalgia in accordance with the American College of Rheumatology criteria for classifying Fibromyalgia (2016 revision) by a rheumatologist of the Public Health System of Andalusia (Spain)
排除标准
- •Presence of liver, cardiac, or renal disease.
- •Presence of previous inflammatory rheumatic disease or neurological disorders.
- •Presence of infectious processes, fever, hypotension, or respiratory alterations.
- •Severe physical disability or severe psychiatric illness.
- •Previous surgical intervention prior to the study period.
- •Presence of associated comorbidities (chemical hypersensitivity syndrome, chronic fatigue syndrome, interstitial cystitis, etc.).
- •Receiving any other non-pharmacological therapy.
结局指标
主要结局
Endogenous pain modulation mechanisms_Pressure Pain Hyperalgesia
时间窗: Six weeks
Change from baseline in pressure pain hyperalgesia. Pressure pain thresholds (PPTs) will be assessed at the right trapezius and gastrocnemius muscles using a digital algometer. Force will be increased at a rate of 1 kg/s until the participant reports pain. Three measurements will be taken at each site to calculate the mean value.
Endogenous pain modulation mechanisms_Deep Hyperalgesia
时间窗: Six Weeks
Change from baseline in deep hyperalgesia. To quantify the level of deep hyperalgesia, the pressure occlusion threshold will be calculated. An occlusion cuff on the left arm will be inflated at 20 mmHg/s until the subject reports pain. After 30 seconds, pain is rated on a verbal numerical rating scale (VNSR) from 0 to 10 to obtain the VNRS1 value. The cuff pressure is then adjusted until the subject reports level 3 pain on the VNRS, obtaining the VNRS3 value.
Endogenous pain modulation mechanisms_ Temporal Summation of pain
时间窗: Six Weeks
Change from baseline in the temporal summation (TS) variable of pain, or endogenous pain facilitation. Will be assessed two minutes after the last quantified Pressure pain thresholds (PPT) at both levels (shoulder and calf). Participants will receive 10 pressure pulses perceived as painful, starting at the previously determined mean PPT intensity. Pressure will be increased at a rate of approximately 2 kg/s for each pulse, with 1-second rest intervals between pulses. For each pulse, the pressure will be maintained for 1 second before being released. After the first, fifth, and tenth pulse, participants will be asked to verbally rate their pain on a verbal numerical rating scale (VNRS). The TS measurement variable will be defined as the difference between the VNRS score after the tenth pulse and that after the first pulse
Endogenous pain modulation mechanisms_Conditioned pain modulation
时间窗: Six Weeks
change from baseline in Conditioned pain modulation (CPM) or endogenous pain inhibition. To assess CPM, the sequence previously described for the temporal summation of pain will be repeated while a so-called 'heterotopic noxious conditioning stimulus' is applied to the patient. This painful stimulus will consist of placing an occlusion cuff on the left arm. The cuff will be inflated to the pressure previously determined to correspond to a verbal numerical rating scale (VNRS) score of 3, representing a moderate pain intensity stimulus. The CPM measurement variable will be defined as the difference between the initial VNRS score before inflating the cuff and the initial VNRS score during cuff occlusion.
Endogenous pain modulation mechanisms_Pressure Pain Hyperalgesia
时间窗: Six weeks
Change from baseline in pressure pain hyperalgesia. Pressure pain thresholds (PPTs) will be assessed at the right trapezius and gastrocnemius muscles using a digital algometer. Force will be increased at a rate of 1 kg/s until the participant reports pain. Three measurements will be taken at each site to calculate the mean value.
Endogenous pain modulation mechanisms_Deep Hyperalgesia
时间窗: Six Weeks
Change from baseline in deep hyperalgesia. To quantify the level of deep hyperalgesia, the pressure occlusion threshold will be calculated. An occlusion cuff on the left arm will be inflated at 20 mmHg/s until the subject reports pain. After 30 seconds, pain is rated on a verbal numerical rating scale (VNSR) from 0 to 10 to obtain the VNRS1 value. The cuff pressure is then adjusted until the subject reports level 3 pain on the VNRS, obtaining the VNRS3 value.
Endogenous pain modulation mechanisms_ Temporal Summation of pain
时间窗: Six Weeks
Change from baseline in the temporal summation (TS) variable of pain, or endogenous pain facilitation. Will be assessed two minutes after the last quantified Pressure pain thresholds (PPT) at both levels (shoulder and calf). Participants will receive 10 pressure pulses perceived as painful, starting at the previously determined mean PPT intensity. Pressure will be increased at a rate of approximately 2 kg/s for each pulse, with 1-second rest intervals between pulses. For each pulse, the pressure will be maintained for 1 second before being released. After the first, fifth, and tenth pulse, participants will be asked to verbally rate their pain on a verbal numerical rating scale (VNRS). The TS measurement variable will be defined as the difference between the VNRS score after the tenth pulse and that after the first pulse
Endogenous pain modulation mechanisms_Conditioned pain modulation
时间窗: Six Weeks
change from baseline in Conditioned pain modulation (CPM) or endogenous pain inhibition. To assess CPM, the sequence previously described for the temporal summation of pain will be repeated while a so-called 'heterotopic noxious conditioning stimulus' is applied to the patient. This painful stimulus will consist of placing an occlusion cuff on the left arm. The cuff will be inflated to the pressure previously determined to correspond to a verbal numerical rating scale (VNRS) score of 3, representing a moderate pain intensity stimulus. The CPM measurement variable will be defined as the difference between the initial VNRS score before inflating the cuff and the initial VNRS score during cuff occlusion.
次要结局
- Pain Intensity: Visual Analog Scale(Baseline and 18 weeks)
- Pressure Pain Threshold(Baseline and 18 weeks)
- Central Sensitization(Baseline and 18 weeks)
- Severity of Fibromyalgia_perceived disability(Baseline and 18 weeks)
- Fatigue severity(Baseline and 18 weeks)
- Quality of sleep(Baseline and 18 weeks)
- Psychological aspects and common symptoms of anxiety(Baseline and 18 weeks)
- Fear of movement_ Kinesiophobia(Baseline and 18 weeks)
- Pain Catastrophizing(Baseline and 18 weeks)
- Perceived Emotional Intelligence(Baseline and 18 weeks)
- Global Level of Empathy(Baseline and 18 weeks)
- Cognitive and Affective Levels of Empathy(Baseline and 18 weeks)
- Positive and Negative Affect of Emotions and Feelings(Baseline and 18 weeks)
- Emotional Well-being(Baseline and 18 weeks)
- Patients' knowledge levels regarding the neurophysiology of pain(Baseline and 18 weeks)
- Pain vigilance and awareness(Baseline and 18 weeks)
- Quality of sleep(Baseline and 18 weeks)
- Psychological aspects and common symptoms of anxiety(Baseline and 18 weeks)
- Fear of movement_ Kinesiophobia(Baseline and 18 weeks)
- Pain Catastrophizing(Baseline and 18 weeks)
- Fatigue severity(Baseline and 18 weeks)
- Central Sensitization(Baseline and 18 weeks)
- Severity of Fibromyalgia_perceived disability(Baseline and 18 weeks)
- Pain Intensity: Visual Analog Scale(Baseline and 18 weeks)
- Pressure Pain Threshold(Baseline and 18 weeks)
- Perceived Emotional Intelligence(Baseline and 18 weeks)
- Global Level of Empathy(Baseline and 18 weeks)
- Cognitive and Affective Levels of Empathy(Baseline and 18 weeks)
- Positive and Negative Affect of Emotions and Feelings(Baseline and 18 weeks)
- Emotional Well-being(Baseline and 18 weeks)
- Patients' knowledge levels regarding the neurophysiology of pain(Baseline and 18 weeks)
- Pain vigilance and awareness(Baseline and 18 weeks)
研究者
Antonio Casas
Principal Investigator, PhD research and teaching staff of the University of Granada
Universidad de Granada