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Interdisciplinary Therapeutic Intervention for People With Persistent Pain

20 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

15

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Valparaiso
      • Valparaíso, Valparaiso, Chile, 2340000
        • University Playa Ancha

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Health-related quality of life
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional mobility
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: Marco Higueras, Master and Bachelor, University Playa Ancha

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

13 juni 2025

Primärt slutförande (Faktisk)

12 september 2025

Avslutad studie (Faktisk)

31 oktober 2025

Studieregistreringsdatum

Först inskickad

18 juli 2026

Först inskickad som uppfyllde QC-kriterierna

20 augusti 2026

Första postat (Faktisk)

24 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • Pain Intervention
  • Social CreaLab, SCL 03i 2025 (Annat bidrag/finansieringsnummer: Playa Ancha University)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

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Nej

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