Impact of Auditory Environments on the Functioning of Pain Mechanisms in Fibromyalgia Syndrome: a Randomized, Triple-blind, Placebo-controlled 4×4 Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This study examines whether different types of sounds can help reduce pain in people with fibromyalgia, a chronic condition that causes widespread pain and increased sensitivity to sensory experiences. Fibromyalgia affects approximately 2-3% of the global population and has limited treatment options. Recent research suggests that environmental sounds might have the capacity to influence pain perception, but their effects in chronic pain conditions remain largely unexplored. Such research could lead to new, non-invasive, sound-based approaches for managing fibromyalgia pain and inform the design of healthier acoustic environments for people with chronic pain conditions.
The study will compare four different sound environments: natural soundscapes (like birdsong and rainfall), urban soundscapes (like traffic and background conversation), broadband sounds (white or pink noise), and silence (as a neutral/control condition with intended placebo effect). Researchers want to know if these different sound environments can change how people with fibromyalgia experience pain and if some environmental sounds might be more helpful than others.
Each participant will experience all four sound conditions in a random order, with one session per week over four weeks. With this study design, each participant acts as their own control, which reduces differences between individuals and increases the reliability of the results. During each 20-minute session, participants will listen to the assigned sounds through a high-fidelity sound reproduction setup using headphones while lying comfortably on a padded therapy table in a controlled laboratory setting. Before and after each sound exposure, researchers measure pain intensity and sensitivity using standardized assessments to determine whether and how different sound environments, if any, might offer pain relief.
详细描述
This protocol investigates the potential modulatory effects of distinct auditory environments on pain processing mechanisms in individuals with fibromyalgia syndrome. The study is grounded in emerging neuroscientific evidence suggesting that auditory stimuli can influence pain perception through direct neural pathways between the auditory cortex and pain-processing regions.
Soundscapes-defined as acoustic environments perceived, experienced, and interpreted within specific contexts-are categorized as natural or anthropogenic based on their origin for research purposes. Natural soundscapes comprise elements such as biophonies (non-human animal sounds) and geophonies (non-living natural elements), while urban soundscapes feature anthropophonies (human-generated sounds) and technophonies (mechanical sources). Recent neuroimaging research has demonstrated that these different soundscape categories elicit distinct neural signatures and may differentially shape intrinsic brain dynamics.
Fibromyalgia syndrome presents a particularly relevant clinical model for investigating auditory-pain interactions due to its characteristic heightened sensitivity to non-noxious sensory input. Preclinical evidence has identified direct neural pathways between the auditory cortex and pain-processing regions, with rodent studies showing that 20-minute broadband sound exposure significantly increases mechanical pain thresholds through mechanisms involving reduced thalamic activity. Human studies have similarly documented analgesic effects of auditory stimulation across both acute experimental pain and chronic pain conditions.
The general objective of this study is to:
GO1. Investigate the differential effects of controlled auditory environmental exposures-natural soundscapes, urban soundscapes, broadband sound, and silence-on the functioning of altered pain mechanisms in individuals with fibromyalgia syndrome, evaluated through clinical outcomes (pain intensity and perceived improvement) and experimental indices of pain processing (quantitative sensory testing measures).
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study employs a triple-blind design: intervention administrator, outcome assessor, and data analyst will be fully masked, while participants will remain unaware (masked, not blinded) of the study hypotheses. The intervention administrator will be blinded to the audio content being delivered, as stimuli will be labeled with non-descriptive codes by a separate investigator. The outcome assessor will not be involved in the intervention and will be blinded to group allocation. Participants will be instructed not to disclose any intervention-related information. Any potentially unblinding data that could reveal group allocation will be masked before it reaches the outcome assessor. The data analyst will receive fully de-identified datasets, with groups labeled only as "Group A/B/C/D"; unblinding will occur only after all analyses have been completed and verified.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of fibromyalgia syndrome, documented in the medical record provided by the participant prior to enrollment.
- •Moderate or greater pain intensity during the preceding week, defined as a score higher than 3 on an 11-point Numeric Rating Scale.
- •Normal hearing confirmed by a hearing test, defined as a mean threshold of ≤ 20 dB HL at 0.125, 0.25, 0.5, 1, 2, 4, 6, and 8 kHz.
- •Ability to communicate in Spanish.
- •Provision of signed written informed consent to participate in the research.
排除标准
- •A diagnosis of misophonia or auditory processing disorders, as documented in the participant's medical record.
- •Concurrent neuropathic or acute pain.
- •Severe cognitive impairment, defined as a Mini-Mental State Examination score ≤
- •Severe psychiatric disorders in the symptomatic phase.
- •History of substance abuse in the past 12 months or current substance use disorder as reported by the participant.
- •Changes in ongoing therapy during or within one month prior to study enrollment per participant self-reports.
- •Central nervous system disorders.
- •Any other serious or unstable medical condition that could interfere with study participation.
- •Known allergies or hypersensitivity to study materials.
- •Pregnancy, lactation, or being within three months postpartum at the time of study enrollment.
研究组 & 干预措施
Sequence NBPU
Participants assigned to this sequence receive natural soundscape exposure in Week 1, broadband sound exposure in Week 2, placebo control (blank tape) in Week 3, and urban soundscape exposure in Week 4. Each session lasts 20 minutes, with one-week washout intervals between sessions.
干预措施: Broadband sound exposure (Other)
Sequence NBPU
Participants assigned to this sequence receive natural soundscape exposure in Week 1, broadband sound exposure in Week 2, placebo control (blank tape) in Week 3, and urban soundscape exposure in Week 4. Each session lasts 20 minutes, with one-week washout intervals between sessions.
干预措施: Blank tape attention placebo control (Other)
Sequence NBPU
Participants assigned to this sequence receive natural soundscape exposure in Week 1, broadband sound exposure in Week 2, placebo control (blank tape) in Week 3, and urban soundscape exposure in Week 4. Each session lasts 20 minutes, with one-week washout intervals between sessions.
干预措施: Natural soundscape exposure (Other)
Sequence NBPU
Participants assigned to this sequence receive natural soundscape exposure in Week 1, broadband sound exposure in Week 2, placebo control (blank tape) in Week 3, and urban soundscape exposure in Week 4. Each session lasts 20 minutes, with one-week washout intervals between sessions.
干预措施: Urban soundscape exposure (Other)
Sequence UPBN
Participants assigned to this sequence receive urban soundscape exposure in Week 1, placebo control (blank tape) in Week 2, broadband sound exposure in Week 3, and natural soundscape exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Natural soundscape exposure (Other)
Sequence UPBN
Participants assigned to this sequence receive urban soundscape exposure in Week 1, placebo control (blank tape) in Week 2, broadband sound exposure in Week 3, and natural soundscape exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Urban soundscape exposure (Other)
Sequence UPBN
Participants assigned to this sequence receive urban soundscape exposure in Week 1, placebo control (blank tape) in Week 2, broadband sound exposure in Week 3, and natural soundscape exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Broadband sound exposure (Other)
Sequence UPBN
Participants assigned to this sequence receive urban soundscape exposure in Week 1, placebo control (blank tape) in Week 2, broadband sound exposure in Week 3, and natural soundscape exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Blank tape attention placebo control (Other)
Sequence BUNP
Participants assigned to this sequence receive broadband sound exposure in Week 1, urban soundscape exposure in Week 2, natural soundscape exposure in Week 3, and placebo control (blank tape) in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Natural soundscape exposure (Other)
Sequence BUNP
Participants assigned to this sequence receive broadband sound exposure in Week 1, urban soundscape exposure in Week 2, natural soundscape exposure in Week 3, and placebo control (blank tape) in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Urban soundscape exposure (Other)
Sequence BUNP
Participants assigned to this sequence receive broadband sound exposure in Week 1, urban soundscape exposure in Week 2, natural soundscape exposure in Week 3, and placebo control (blank tape) in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Broadband sound exposure (Other)
Sequence BUNP
Participants assigned to this sequence receive broadband sound exposure in Week 1, urban soundscape exposure in Week 2, natural soundscape exposure in Week 3, and placebo control (blank tape) in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Blank tape attention placebo control (Other)
Sequence PNUB
Participants assigned to this sequence receive placebo control (blank tape) in Week 1, natural soundscape exposure in Week 2, urban soundscape exposure in Week 3, and broadband sound exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Natural soundscape exposure (Other)
Sequence PNUB
Participants assigned to this sequence receive placebo control (blank tape) in Week 1, natural soundscape exposure in Week 2, urban soundscape exposure in Week 3, and broadband sound exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Urban soundscape exposure (Other)
Sequence PNUB
Participants assigned to this sequence receive placebo control (blank tape) in Week 1, natural soundscape exposure in Week 2, urban soundscape exposure in Week 3, and broadband sound exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Broadband sound exposure (Other)
Sequence PNUB
Participants assigned to this sequence receive placebo control (blank tape) in Week 1, natural soundscape exposure in Week 2, urban soundscape exposure in Week 3, and broadband sound exposure in Week 4. Each session lasts 20 minutes, with one week washout intervals between sessions.
干预措施: Blank tape attention placebo control (Other)
结局指标
主要结局
Pain intensity
时间窗: Change from immediately before to immediately after each 20-minute intervention session during each of the four crossover periods
The primary outcome measure assesses acute changes in subjective pain intensity following each auditory intervention. Participants mark their current pain level on a 100-mm Visual Analog Scale anchored from "no pain" to "the worst pain imaginable". The scale is scored as the distance in millimeters from the left end, with lower scores corresponding to lower perceived pain.
次要结局
- Patient global impression of change(Assessed immediately after each 20-minute intervention session during each of the four crossover periods)
- Mechanical pain sensitivity(Change from immediately before to immediately after each 20-minute intervention session during each of the four crossover periods)
- Temporal summation of pain(Change from immediately before to immediately after each 20-minute intervention session during each of the four crossover periods)
- Pressure pain detection thresholds and intensity ratings(Change from immediately before to immediately after each 20-minute intervention session during each of the four crossover periods)
研究者
José Manuel Pérez Mármol
Associate Professor
Universidad de Granada