FybromyalgiaNCT07782255
Interdisciplinary Therapeutic Intervention for People With Persistent Pain
A study testing Multimodal Interdisciplinary Therapeutic Intervention in people with Fybromyalgia, run by Playa Ancha University at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fybromyalgia
- What is being tested?
- Multimodal Interdisciplinary Therapeutic Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChile
- Study dates
- 13 Jun 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Fybromyalgia
- Being tested
- Multimodal Interdisciplinary Therapeutic Intervention
- Keywords
- Multimodal intervention, Fybromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Interdisciplinary Therapeutic InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Interdisciplinary Intervention | Experimental | 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. Receives: Other: Multimodal Interdisciplinary Therapeutic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start13 Jun 2025
- Primary completion12 Sep 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for FybromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Playa Ancha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Higueras Contreras, Playa Ancha University
- Investigators
- Marco Higueras, Master and Bachelor, Principal investigator, University Playa Ancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782255
- Sponsor's protocol ID
- Pain Intervention
- Other IDs
- Social CreaLab, SCL 03i 2025
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Healey EL, Jinks C, Foster NE, Chew-Graham CA, Pincus T, Hartshorne L, Cooke K, Nicholls E, Proctor J, Lewis M, Dent S, Wathall S, Hay EM, McBeth J. The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol. Musculoskeletal Care. 2018 Mar;16(1):118-132. doi: 10.1002/msc.1222. Epub 2017 Dec 8.
PubMed 29218808Ranque S, Laurin J, Linguraru MG, Jiang Z, Loundou A, Boyer L, Guieu R, Boucraut J, Sault C, Simon J, Barthelemy F, Donnet A, Guedj E. Efficacy and mechanism of supervised adapted physical activity on quality of life for patients with fibromyalgia: single-center, prospective, randomised clinical and neuroimaging study. Sci Rep. 2026 Feb 3;16(1):5398. doi: 10.1038/s41598-025-33433-5.
PubMed 41634061Sevgin O, Bugday B, Aydogan Baykara R, Gunendi G, Akkurt B, Atasoy H, Dikmen Hosbas B, Akkurt MF, Karamancioglu B. Efficacy of different exercises in women with fibromyalgia syndrome: a randomised controlled trial. Clin Exp Rheumatol. 2025 Jun;43(6):1010-1018. doi: 10.55563/clinexprheumatol/uol8so. Epub 2025 Feb 12.
PubMed 39946182Fernandes G, Nery M, Meireles SM, Santos R, Natour J, Jennings F. A functional exercise program improves pain and health related quality of life in patients with fibromyalgia: a randomized controlled trial. Adv Rheumatol. 2024 Oct 24;64(1):81. doi: 10.1186/s42358-024-00422-7.
PubMed 39449056Kundakci B, Hall M, Atzeni F, Branco J, Buskila D, Clauw D, Crofford LJ, Fitzcharles MA, Georgopoulos V, Gerwin RD, Kosek E, Macfarlane GJ, Neal C, Rudin NJ, Ryan S, da Silva JAP, Taylor AM, Turk DC, Whibley D, Doherty M, Zhang W, Abhishek A. International, multidisciplinary Delphi consensus recommendations on non-pharmacological interventions for fibromyalgia. Semin Arthritis Rheum. 2022 Dec;57:152101. doi: 10.1016/j.semarthrit.2022.152101. Epub 2022 Sep 24.
PubMed 36183478Carrasco-Querol N, Cabricano-Canga L, Bueno Hernandez N, Goncalves AQ, Caballol Angelats R, Pozo Ariza M, Martin-Borras C, Monteso-Curto P, Castro Blanco E, Dalmau Llorca MR, Aguilar Martin C. Nutrition and Chronobiology as Key Components of Multidisciplinary Therapeutic Interventions for Fibromyalgia and Associated Chronic Fatigue Syndrome: A Narrative and Critical Review. Nutrients. 2024 Jan 5;16(2):182. doi: 10.3390/nu16020182.
PubMed 38257075Rodriguez-Almagro D, Del Moral-Garcia M, Lopez-Ruiz MDC, Cortes-Perez I, Obrero-Gaitan E, Lomas-Vega R. Optimal dose and type of exercise to reduce pain, anxiety and increase quality of life in patients with fibromyalgia. A systematic review with meta-analysis. Front Physiol. 2023 Apr 12;14:1170621. doi: 10.3389/fphys.2023.1170621. eCollection 2023.
PubMed 37123268Catala P, Ecija C, Serrano Del Moral A, Perez Viejo E, Penacoba C. Predicting Adherence to Walking from Anxiety, Depression, Disease Impact, Catastrophizing, and Cognitive Fusion in Patients with Fibromyalgia: Does Pain Severity Matter? Int J Environ Res Public Health. 2022 Dec 8;19(24):16453. doi: 10.3390/ijerph192416453.
PubMed 36554334Castel A, Fontova R, Montull S, Perinan R, Poveda MJ, Miralles I, Cascon-Pereira R, Hernandez P, Aragones N, Salvat I, Castro S, Monterde S, Padrol A, Sala J, Anez C, Rull M. Efficacy of a multidisciplinary fibromyalgia treatment adapted for women with low educational levels: a randomized controlled trial. Arthritis Care Res (Hoboken). 2013 Mar;65(3):421-31. doi: 10.1002/acr.21818.
PubMed 22899402Angst F, Lehmann S, Sandor PS, Benz T. Catastrophizing as a prognostic factor for pain and physical function in the multidisciplinary rehabilitation of fibromyalgia and low back pain. Eur J Pain. 2022 Aug;26(7):1569-1580. doi: 10.1002/ejp.1983. Epub 2022 Jun 11.
PubMed 35634793Pagliai G, Giangrandi I, Dinu M, Sofi F, Colombini B. Nutritional Interventions in the Management of Fibromyalgia Syndrome. Nutrients. 2020 Aug 20;12(9):2525. doi: 10.3390/nu12092525.
PubMed 32825400Sanudo B, Galiano D, Carrasco L, de Hoyo M, McVeigh JG. Effects of a prolonged exercise program on key health outcomes in women with fibromyalgia: a randomized controlled trial. J Rehabil Med. 2011 May;43(6):521-6. doi: 10.2340/16501977-0814.
PubMed 21533333Andrade A, Dominski FH, Sieczkowska SM. What we already know about the effects of exercise in patients with fibromyalgia: An umbrella review. Semin Arthritis Rheum. 2020 Dec;50(6):1465-1480. doi: 10.1016/j.semarthrit.2020.02.003. Epub 2020 Feb 14.
PubMed 32147091Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.
PubMed 28436583Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2.
PubMed 21725900
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Therapeutic Intervention for People With Persistent Pain
- ClinicalTrials.gov ID
- NCT07782255
- Acronym / sponsor ID
- Pain Intervention
- Conditions
- Fybromyalgia
- Keywords
- Multimodal intervention, Fybromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Playa Ancha UniversityUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Interdisciplinary Intervention | Experimental | Other: Multimodal Interdisciplinary Therapeutic InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Interdisciplinary Therapeutic InterventionParticipants 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. | Other | Multimodal Interdisciplinary Intervention |
Primary outcome
Health-related 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.
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.
10 secondary outcomes
Functional mobility
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
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
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
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
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
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
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 29218808Healey EL, Jinks C, Foster NE, Chew-Graham CA, Pincus T, Hartshorne L, Cooke K, Nicholls E, Proctor J, Lewis M, Dent S, Wathall S, Hay EM, McBeth J. The feasibility and acceptability of a physical activity intervention for older people with chronic musculoskeletal pain: The iPOPP pilot trial protocol. Musculoskeletal Care. 2018 Mar;16(1):118-132. doi: 10.1002/msc.1222. Epub 2017 Dec 8.
- Background: PubMed 41634061Ranque S, Laurin J, Linguraru MG, Jiang Z, Loundou A, Boyer L, Guieu R, Boucraut J, Sault C, Simon J, Barthelemy F, Donnet A, Guedj E. Efficacy and mechanism of supervised adapted physical activity on quality of life for patients with fibromyalgia: single-center, prospective, randomised clinical and neuroimaging study. Sci Rep. 2026 Feb 3;16(1):5398. doi: 10.1038/s41598-025-33433-5.
- Background: PubMed 39946182Sevgin O, Bugday B, Aydogan Baykara R, Gunendi G, Akkurt B, Atasoy H, Dikmen Hosbas B, Akkurt MF, Karamancioglu B. Efficacy of different exercises in women with fibromyalgia syndrome: a randomised controlled trial. Clin Exp Rheumatol. 2025 Jun;43(6):1010-1018. doi: 10.55563/clinexprheumatol/uol8so. Epub 2025 Feb 12.
- Background: PubMed 39449056Fernandes G, Nery M, Meireles SM, Santos R, Natour J, Jennings F. A functional exercise program improves pain and health related quality of life in patients with fibromyalgia: a randomized controlled trial. Adv Rheumatol. 2024 Oct 24;64(1):81. doi: 10.1186/s42358-024-00422-7.
- Background: PubMed 36183478Kundakci B, Hall M, Atzeni F, Branco J, Buskila D, Clauw D, Crofford LJ, Fitzcharles MA, Georgopoulos V, Gerwin RD, Kosek E, Macfarlane GJ, Neal C, Rudin NJ, Ryan S, da Silva JAP, Taylor AM, Turk DC, Whibley D, Doherty M, Zhang W, Abhishek A. International, multidisciplinary Delphi consensus recommendations on non-pharmacological interventions for fibromyalgia. Semin Arthritis Rheum. 2022 Dec;57:152101. doi: 10.1016/j.semarthrit.2022.152101. Epub 2022 Sep 24.
- Background: PubMed 38257075Carrasco-Querol N, Cabricano-Canga L, Bueno Hernandez N, Goncalves AQ, Caballol Angelats R, Pozo Ariza M, Martin-Borras C, Monteso-Curto P, Castro Blanco E, Dalmau Llorca MR, Aguilar Martin C. Nutrition and Chronobiology as Key Components of Multidisciplinary Therapeutic Interventions for Fibromyalgia and Associated Chronic Fatigue Syndrome: A Narrative and Critical Review. Nutrients. 2024 Jan 5;16(2):182. doi: 10.3390/nu16020182.
- Background: PubMed 37123268Rodriguez-Almagro D, Del Moral-Garcia M, Lopez-Ruiz MDC, Cortes-Perez I, Obrero-Gaitan E, Lomas-Vega R. Optimal dose and type of exercise to reduce pain, anxiety and increase quality of life in patients with fibromyalgia. A systematic review with meta-analysis. Front Physiol. 2023 Apr 12;14:1170621. doi: 10.3389/fphys.2023.1170621. eCollection 2023.
- Background: PubMed 36554334Catala P, Ecija C, Serrano Del Moral A, Perez Viejo E, Penacoba C. Predicting Adherence to Walking from Anxiety, Depression, Disease Impact, Catastrophizing, and Cognitive Fusion in Patients with Fibromyalgia: Does Pain Severity Matter? Int J Environ Res Public Health. 2022 Dec 8;19(24):16453. doi: 10.3390/ijerph192416453.
- Background: PubMed 22899402Castel A, Fontova R, Montull S, Perinan R, Poveda MJ, Miralles I, Cascon-Pereira R, Hernandez P, Aragones N, Salvat I, Castro S, Monterde S, Padrol A, Sala J, Anez C, Rull M. Efficacy of a multidisciplinary fibromyalgia treatment adapted for women with low educational levels: a randomized controlled trial. Arthritis Care Res (Hoboken). 2013 Mar;65(3):421-31. doi: 10.1002/acr.21818.
- Background: PubMed 35634793Angst F, Lehmann S, Sandor PS, Benz T. Catastrophizing as a prognostic factor for pain and physical function in the multidisciplinary rehabilitation of fibromyalgia and low back pain. Eur J Pain. 2022 Aug;26(7):1569-1580. doi: 10.1002/ejp.1983. Epub 2022 Jun 11.
- Background: PubMed 32825400Pagliai G, Giangrandi I, Dinu M, Sofi F, Colombini B. Nutritional Interventions in the Management of Fibromyalgia Syndrome. Nutrients. 2020 Aug 20;12(9):2525. doi: 10.3390/nu12092525.
- Background: PubMed 21533333Sanudo B, Galiano D, Carrasco L, de Hoyo M, McVeigh JG. Effects of a prolonged exercise program on key health outcomes in women with fibromyalgia: a randomized controlled trial. J Rehabil Med. 2011 May;43(6):521-6. doi: 10.2340/16501977-0814.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Higueras, Master and Bachelor principal investigator
University Playa Ancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Interdisciplinary Therapeutic Intervention in people with Fybromyalgia, run by Playa Ancha University at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07782255, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.