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Interdisciplinary Therapeutic Intervention for People With Persistent Pain

2026年8月20日 更新者:Marco Higueras Contreras、Playa Ancha University

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.

研究概览

详细说明

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.

Safety, Ethics, and Confidentiality The project guarantees professional and ethical treatment at all times. In the event of any potential physical or emotional discomfort that may arise, effective mitigation measures have been planned, such as the gradual progression of physical activities and the provision of emotional containment spaces during psychological interventions. All data collected from participants will be anonymized through the assignment of alphanumeric codes and will be guarded under strict confidentiality protocols for a period of three years. Participation in this study is entirely voluntary and will be formalized through an informed consent process that is clear and understandable to all involved.

Research Team The project is led by physical therapist (kinesiologist) Marco Antonio Higueras Contreras, Master in Orthopedic Manual Therapy, together with nutritionist Natalia María Muñoz Palma, Master in Pedagogy and Nutrition. Both are professors at the University of Playa Ancha and have extensive academic and professional experience in the areas of rehabilitation, diet therapy, and the management of chronic conditions.

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Valparaiso
      • Valparaíso、Valparaiso、智利、2340000
        • University Playa Ancha

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Multimodal Interdisciplinary Intervention
Participants in this study group receive an interdisciplinary intervention consisting of: 1) adapted aerobic physical activity (two sessions per week for two months); 2) online therapeutic education sessions regarding the pathophysiology of pain and coping strategies; 3) mental health counseling focused on cognitive-behavioral techniques, mindfulness, and stress management; and 4) personalized nutritional counseling including assessment and dietary guidance to manage symptoms.

Participants receive an interdisciplinary program over two months, consisting of: 1) Adapted aerobic physical activity: two weekly sessions focusing on low-to-moderate intensity exercises. 2) Therapeutic education: online sessions covering pain pathophysiology and self-management strategies. 3) Mental health counseling: interventions based on cognitive-behavioral techniques, mindfulness, and stress management. 4) Nutritional counseling: personalized assessment and dietary guidance focused on anti-inflammatory habits and symptom management.

This intervention distinguishes itself from other studies through its unique social innovation model, which integrates professional healthcare with community-based agents. It utilizes a service-learning framework, where students provide care under expert supervision to foster mutual learning. Additionally, it targets a specific population-the Valparaíso Fibromyalgia Corporation-synchronizing four pillars for holistic patient empowerment.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Health-related quality of life
大体时间: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.
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.

次要结果测量

结果测量
措施说明
大体时间
Functional mobility
大体时间: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 mobility was assessed using the Timed Up and Go (TUG) test, which is measured in seconds. The theoretical minimum value is 0 seconds, and there is no defined maximum value. Higher scores (greater time taken to complete the test) mean a worse outcome.
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
大体时间: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 were assessed using the 30-Second Chair Stand Test (30-CST). The score represents the number of full stands completed within 30 seconds. The theoretical minimum value is 0, and there is no defined maximum value. Higher scores mean a better outcome.
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
大体时间: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 was assessed using the Handgrip Strength Test, typically measured in kilograms (kg) using a hand-held Jamar's dynamometer. The theoretical minimum value is 0 kg, and there is no defined maximum value. Higher scores mean a better outcome.
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
大体时间: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 were assessed using the 6-Minute Walk Test (6MWT), with the total distance measured in meters. The theoretical minimum value is 0 meters, and there is no defined maximum value. Higher scores (greater distance walked) mean a better outcome.
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
大体时间: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 was assessed using the General Self-Efficacy Scale by Baessler and Schwarzer. The scale consists of 10 items, each scored from 1 to 4. Total scores range from a minimum value of 10 to a maximum value of 40. Higher scores mean a better outcome, representing a higher level of perceived 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
大体时间: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 were assessed using the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 items divided into two 7-item subscales: Anxiety (HADS-A) and Depression (HADS-D). Each item is scored from 0 to 3. The score for each subscale ranges from a minimum value of 0 to a maximum value of 21, yielding a total score range of 0 to 42. Higher scores mean a worse outcome, indicating greater levels of anxiety and/or 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
大体时间: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 were assessed using the McGill Pain Questionnaire (MPQ). The MPQ provides multiple scoring components, most commonly the Total Pain Rating Index (PRI, derived from pain descriptors with scores typically ranging from 0 to 78), Present Pain Intensity (PPI, categorical scale ranging from 0 to 5), and a Visual Analogue Scale (VAS, typically ranging from 0 to 100). For all measurement components, the theoretical minimum value is 0. Higher scores mean a worse outcome, indicating greater pain severity and complexity.
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
大体时间: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 was assessed using the Pain Catastrophizing Scale. The questionnaire consists of 13 items, each rated on a 5-point scale (scored from 0 to 4). Total scores range from a minimum value of 0 to a maximum value of 52. Higher scores mean a worse outcome, indicating a higher degree of pain catastrophizing.
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
大体时间: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 was assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score is calculated by summing 7 component scores. The total score ranges from a minimum value of 0 to a maximum value of 21. Higher scores mean a worse outcome, indicating poorer sleep quality and severe sleep difficulties.
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
大体时间: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.
Fear of movement or kinesiophobia was assessed using the 11-item Tampa Scale for Kinesiophobia (TSK-11SV). The questionnaire consists of 11 items, each rated on a 4-point scale ranging from 1 to 4. Total scores range from a minimum value of 11 to a maximum value of 44. Higher scores mean a worse outcome, indicating a greater fear of movement and re-injury.
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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Marco Higueras, Master and Bachelor、University Playa Ancha

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月13日

初级完成 (实际的)

2025年9月12日

研究完成 (实际的)

2025年10月31日

研究注册日期

首次提交

2026年7月18日

首先提交符合 QC 标准的

2026年8月20日

首次发布 (实际的)

2026年8月24日

研究记录更新

最后更新发布 (实际的)

2026年8月24日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pain Intervention
  • Social CreaLab, SCL 03i 2025 (其他赠款/资助编号:Playa Ancha University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Individual participant data (IPD) that underlie the results reported in this study, after de-identification (text, tables, and figures), will be made available to other researchers upon reasonable request. Access to the data will be provided for study-related purposes, subject to institutional ethical board approval and a formal data-sharing agreement.

IPD 共享时间框架

IPD will be available starting 6 months after the study results are published and will remain accessible for 5 years."

IPD 共享访问标准

Access is limited to bona fide researchers affiliated with academic or clinical institutions who submit a scientifically sound proposal. Access includes the de-identified individual participant data (IPD), data dictionary, and statistical analysis plan. Requests must be sent to the principal investigator via email, including a formal research protocol and a signed data-sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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