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临床试验/NCT07782255
NCT07782255已完成不适用

Interdisciplinary Therapeutic Intervention for People With Persistent Pain

Playa Ancha University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Health-related quality of life

研究概览

简要总结

Study Objective The project aims to implement an interdisciplinary therapeutic program for people suffering from persistent pain (specifically fibromyalgia) to optimize their quality of life through a comprehensive approach that addresses physical, psychological, social, and nutritional dimensions.

What does the intervention consist of?

The initiative is a social innovation proposal structured around four fundamental pillars, carried out by a team of physical therapists (kinesiologists), nutritionists, and psychologists:

Adapted physical activity: Low-to-moderate intensity in-person sessions to improve cardiovascular capacity, reduce pain sensitivity, and promote general well-being.

Therapeutic education: Talks (online/in-person) to improve understanding of the condition and foster self-care.

Nutritional counseling: Assessment of nutritional status and guidance on anti-inflammatory nutrition, healthy habits, and key micronutrients.

Mental health workshops: Strategies such as cognitive-behavioral therapy, mindfulness, and stress management to improve emotional regulation and resilience.

Methodology and Participation Population: The study is aimed at individuals over 18 years old diagnosed with fibromyalgia who are members of the Fibromyalgia Corporation of the Valparaíso Region.

Procedure: It includes an initial assessment (pre-test), the implementation of the interdisciplinary program, and a final assessment (post-test) to measure functional, nutritional, and psychosocial changes.

Safety: The procedures are non-invasive. To minimize any physical or emotional discomfort, the team will implement a gradual progression in exercises and provide emotional support spaces in a safe and supportive environment.

Expected Benefits For participants: A significant improvement in their functional and nutritional status and psychosocial well-being is expected, positively impacting their quality of life and perceived pain levels.

For the community: The project seeks to make the needs of people with fibromyalgia visible, strengthen the local health network, and foster a more resilient and supportive community.

For professional training: By working under a service-learning model, Physical Therapy and Nutrition students will acquire practical skills by working in real contexts alongside professionals.

Ethical Commitments Confidentiality: All information will be treated with strict confidentiality protocols, using alphanumeric codes to anonymize user data.

Voluntariness: Participation is entirely voluntary. Interested individuals will receive clear information, will be able to resolve any doubts, and must sign an informed consent form before beginning.

Transparency: The study does not involve monetary incentives and has no conflicts of interest with external institutions.

This project is led by the principal investigator Marco Antonio Higueras Contreras, in collaboration with co-investigator Natalia María Muñoz Palma, both from the Department of Rehabilitation, Intervention, and Therapeutic Approach at the University of Playa Ancha.

详细描述

Introduction and Social Justification The project "Interdisciplinary Therapeutic Intervention for People with Persistent Pain" emerges as an innovative response to the complex problem of chronic pain, a condition that transcends physical limitation to deeply affect people's psychological, social, and economic well-being. This proposal is framed within a social innovation model, integrating professional knowledge with community expertise to offer a comprehensive, person-centered approach.

Project Objectives The general objective of this research is to implement an interdisciplinary therapeutic intervention that addresses the physical, psychological, social, and nutritional dimensions of people with persistent pain to optimize their quality of life. To achieve this, specific objectives have been established, including the design and execution of a therapeutic plan that combines physical activity, health education, nutritional counseling, and psychological support. Furthermore, the project seeks to promote self-management of the persistent pain condition, evaluate the functional, nutritional, and psychosocial impact associated with pain, and strengthen local health networks through the linkage between territorial actors, community organizations, and academia.

Intervention Components The intervention is structured around four key components. First, aerobic physical activity is included, which consists of low-to-moderate intensity therapeutic exercises that are progressive and adapted; these will be performed by physical therapists (kinesiologists) and include between 12 and 16 sessions distributed over two months. Second, therapeutic education will be provided through talks on the pathophysiology of pain, coping strategies, and healthy habits, all executed in an online format. Third, the nutritional approach will include an assessment of nutritional status, considering weight and body composition, as well as personalized counseling on anti-inflammatory nutrition, hydration, and key micronutrients. Finally, the mental health component will integrate the use of cognitive-behavioral therapy, mindfulness, and stress management techniques to strengthen the participants' resilience and emotional regulation.

Methodology and Study Design The study is defined as descriptive-associative with a quantitative, longitudinal approach. The research focuses on members of the Fibromyalgia Corporation of the Valparaíso Region, with a non-probabilistic convenience sample composed of 20 people.

Among the evaluations performed, nutritional status is measured through the calculation of BMI, fat mass, and muscle mass, using an Omron HBF514 scale and a Seca 213 stadiometer, in addition to applying food frequency questionnaires. To evaluate functionality and physical capacity, instruments such as the Timed Up and Go (TUG) test, hand dynamometry, the 6-minute walk test, and the SF-36 quality of life questionnaire are applied. Finally, for psychosocial perception, various validated scales are used, such as the VAS (Visual Analog Scale), the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale, and the Tampa Scale for Kinesiophobia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis: Individuals with a medical diagnosis of fibromyalgia.
  • Membership: Members of the Fibromyalgia Corporation of the Valparaíso Region.
  • Age: Adults aged 18 years or older.
  • Voluntary Participation: Individuals who provide informed consent to participate in the study.

排除标准

  • Severe Comorbidities: Individuals with severe uncontrolled medical or psychiatric conditions that prevent physical activity or participation in the intervention.
  • Inability to Follow Instructions: Individuals unable to follow the online or in-person instructions provided during the therapeutic sessions.
  • Recent Surgery or Acute Injury: Individuals with acute physical injuries or recent surgeries that contraindicate exercise.
  • Pregnancy: Women who are currently pregnant.

结局指标

主要结局

Health-related quality of life

时间窗: Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.

The score is based on the 36-Item Short Form Health Survey version 2 (SF-36v2). The scores are transformed to a scale ranging from a minimum value of 0 to a maximum value of 100. Higher scores indicate a better outcome, representing a better state of health and quality of life.

次要结局

  • Functional mobility(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)
  • Lower body strength and functional capacity(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)
  • Upper limb muscle strength(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)
  • Functional exercise capacity(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)
  • Self-efficacy(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)
  • Anxiety and depression(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)
  • Pain characteristics and intensity(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)
  • Pain-related catastrophic thinking(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)
  • Sleep quality(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)
  • Kinesiophobia(Baseline (before the start of the 2-month interdisciplinary program) and at 2 months post-intervention, immediately following the completion of the 12 to 16 therapeutic sessions.)

研究者

发起方
Playa Ancha University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Higueras Contreras

Physical Therapist, Bachelor of Physical Therapy, Master of Orthopedic Manual Therapy

Playa Ancha University

研究点 (1)

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