跳至主要内容
临床试验/NCT07048366
NCT07048366招募中不适用

Art as a Therapeutic Tool in the Rehabilitation of Patients With Fibromyalgia: the University Museum as a Setting for an Integrative Medicine Program - a Randomized Controlled Trial

G. d'Annunzio University4 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年11月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
4
主要终点
Pain Reduction

研究概览

简要总结

This research study aims to investigate whether art and integrative medicine, within a unique setting like a university museum, can offer a new approach to help women suffering from fibromyalgia. Fibromyalgia is a chronic condition causing widespread pain and other symptoms such as fatigue and sleep disturbances. The question this study seeks to answer is: Is an 8-week rehabilitation program, based on mindfulness and body awareness techniques, conducted at the University Museum of the G. d'Annunzio University, effective in reducing pain and improving the quality of life (physical and mental well-being) and coping abilities in female fibromyalgia patients? Participants will be randomly assigned to either receive this program in the museum or to a control group.

详细描述

Fibromyalgia Syndrome (FM) is a complex and debilitating chronic musculoskeletal pain condition characterized by widespread pain, tenderness, and a myriad of associated symptoms including profound fatigue, sleep disturbances, cognitive impairment (often referred to as "fibro-fog"), and affective disorders such as anxiety and depression. Its prevalence is significant, affecting a substantial portion of the global population, predominantly women. Diagnosis relies on established criteria (e.g., ACR 1990, revised 2010/2011, and 2016 criteria), emphasizing the presence of widespread pain and symptom severity. The underlying pathophysiology is multifactorial, involving neuro-immuno-endocrine dysregulation, central sensitization (an amplification of pain signals in the central nervous system), and in some cases, small fiber neuropathy, leading to an altered pain perception.

Given its complex nature, a purely pharmacological approach to fibromyalgia is often insufficient. Current evidence strongly supports a multifactorial therapeutic strategy that integrates pharmacological treatments with non-pharmacological interventions, including complementary therapies and integrated medicine. This study introduces a novel, non-pharmacological integrated rehabilitation pathway designed to address the multifaceted symptoms of fibromyalgia.

This randomized controlled trial investigates the efficacy of a unique integrated rehabilitation program delivered within the evocative environment of a university museum. The program leverages the principles of art therapy and neuroaesthetics, combined with established mindfulness and body awareness techniques, to create a holistic and immersive healing experience. The rationale is rooted in the understanding that engagement with art and culturally enriching environments can positively influence brain function and emotional states. Specifically, interactions within a museum setting are hypothesized to:

  • Stimulate the brain's reward system, fostering positive emotions and reducing pain perception.
  • Modulate cortical maps, potentially normalizing altered somatosensory processing observed in fibromyalgia.
  • Provide a powerful distraction from chronic pain and discomfort, shifting focus towards aesthetic appreciation and inner experiences.
  • Enhance emotional regulation and promote self-efficacy in managing symptoms.
  • The museum itself acts as a "setting of care," providing a calming and inspiring atmosphere that can amplify the therapeutic effects of rehabilitation, reducing stress and promoting overall well-being.

The intervention consists of an 8-week program with weekly 60-minute sessions. Participants in the experimental group engage in a structured curriculum that integrates various techniques, including conscious breathing exercises, body scan meditation, mindfulness walking within the museum's exhibition spaces, specific stretching and mobilization techniques, and gratitude and recognition exercises, all framed by the artistic and cultural context of the university museum. This approach aims to cultivate body awareness, reduce pain catastrophizing, and improve emotional coping mechanisms.

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)

盲法说明

This study employs a double-blind design where both participants and outcome assessors are masked to the intervention assignment. Participants are unaware of their group allocation (treatment vs. control). Personnel collecting and analyzing outcome data will also be blinded to group assignment to minimize bias. The care providers delivering the intervention, due to the nature of the behavioral therapy, may not be fully masked.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients
  • Diagnosis of Fibromyalgia Syndrome according to 2016 criteria
  • Muscle pain Visual Analogue Scale (VAS) score greater than 5 in the last month
  • Age between 18 and 60 years
  • Absence of other chronic, widespread, or localized painful conditions
  • Absence of any other condition that might affect pain perception (e.g., diabetes)
  • Absence of neurological or psychiatric conditions that might affect study participation
  • Absence of current or past oncological diseases in the last 5 years
  • Absence of corticosteroid therapy in the last 30 days
  • Absence of NSAID (Non-Steroidal Anti-Inflammatory Drugs) and analgesic therapy in the last 4 days
  • Absence of pregnancy and breastfeeding for the entire duration of observation
  • Signed informed consent

排除标准

  • Presence of severe scoliosis or kyphoscoliosis
  • Previous spinal surgeries or sequelae of vertebral fractures
  • Presence of lumbosciatalgia (sciatica-like pain in the lower back) at the time of the visit
  • Presence of osteoporosis
  • Presence of neurological or psychiatric conditions
  • Current therapy with corticosteroids and/or NSAIDs and/or analgesics
  • Pregnancy or breastfeeding

研究组 & 干预措施

Museum-Based Integrated Rehabilitation Group

Experimental

Participants in this arm will receive an 8-week integrated rehabilitation program conducted at the University Museum. The program consists of weekly 60-minute sessions that incorporate mindfulness techniques, conscious breathing exercises, body scan meditation, mindfulness walking within the museum's exhibition spaces, specific stretching and mobilization techniques, and gratitude and recognition exercises, all framed by the artistic and cultural context of the museum.

干预措施: Integrated Rehabilitation Program at the University Museum (Behavioral)

CARES Control Group

Active Comparator

Participants in this arm will receive the same mindfulness-based integrated rehabilitation program delivered at the CARES (Center for Disability, Rehabilitation and Sports Medicine), at University. This group will serve as the control arm for comparison with the experimental museum-based intervention.

干预措施: CARES treatment (Other)

结局指标

主要结局

Pain Reduction

时间窗: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).

Reduction in musculoskeletal pain intensity, evaluated by Visual Analogue Scale (VAS) for musculoskeletal pain (0-10 cm score).

Pain Reduction

时间窗: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).

Reduction in musculoskeletal pain intensity, evaluated by Visual Analogue Scale (VAS) for musculoskeletal pain (0-10 cm score).

次要结局

  • Quality of Life Improvement(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Life Satisfaction(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Emotional Regulation Strategies(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Fibromyalgia Impact on Daily Life(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Global Symptom Severity(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Anxiety Levels(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Positive and Negative Emotions(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Depressive Symptoms(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Emotional State(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Life Satisfaction(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Quality of Life Improvement(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Depressive Symptoms(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Emotional State(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Positive and Negative Emotions(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)
  • Emotional Regulation Strategies(Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).)

研究者

发起方
G. d'Annunzio University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresa Paolucci

Associate Professor, MD, PhD, Physical and Rehabilitation Medicine

G. d'Annunzio University

研究点 (4)

Loading locations...

相似试验