An interventional study of Multimodal Interdisciplinary Therapeutic Intervention in Fybromyalgia, sponsored by Playa Ancha University. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Playa Ancha University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Other: Multimodal Interdisciplinary Therapeutic Intervention
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.
Health-related quality of life
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
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Playa Ancha University