Interdisciplinary Therapeutic Intervention for People With Persistent Pain

NCT07782255 | Completed

• 2 other identifiers: Pain InterventionSocial CreaLab, SCL 03i 2025
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fybromyalgia

Keywords

Multimodal intervention; Fybromyalgia

Outcome Measures

Primary Outcomes (1)

• 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.

  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

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

• Lower body strength and functional capacity

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

• Upper limb muscle strength

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

• Functional exercise capacity

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

• Self-efficacy

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

Study Arms (1)

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.

Other: Multimodal Interdisciplinary Therapeutic Intervention

Interventions

Multimodal Interdisciplinary Therapeutic Intervention OTHER

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.

Multimodal Interdisciplinary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Playa Ancha University: lead

Study Sites (1)

University Playa Ancha

Valparaíso, Valparaiso, 2340000, Chile

Location

Related Publications (27)

• 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.

  PMID: 29218808 BACKGROUND

• Ranque 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.

  PMID: 41634061 BACKGROUND

• Sevgin 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.

  PMID: 39946182 BACKGROUND

• Fernandes 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.

  PMID: 39449056 BACKGROUND

• Kundakci 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.

  PMID: 36183478 BACKGROUND

• Carrasco-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.

  PMID: 38257075 BACKGROUND

• Rodriguez-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.

  PMID: 37123268 BACKGROUND

• Catala 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.

  PMID: 36554334 BACKGROUND

• Castel 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.

  PMID: 22899402 BACKGROUND

• Angst 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.

  PMID: 35634793 BACKGROUND

• Pagliai 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.

  PMID: 32825400 BACKGROUND

• Sanudo 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.

  PMID: 21533333 BACKGROUND

• Andrade 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.

  PMID: 32147091 BACKGROUND

• Geneen 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.

  PMID: 28436583 BACKGROUND

• Busch 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.

  PMID: 21725900 BACKGROUND

• Bidonde J, Busch AJ, Schachter CL, Overend TJ, Kim SY, Goes SM, Boden C, Foulds HJ. Aerobic exercise training for adults with fibromyalgia. Cochrane Database Syst Rev. 2017 Jun 21;6(6):CD012700. doi: 10.1002/14651858.CD012700.

  PMID: 28636204 BACKGROUND

• Jurado-Priego LN, Cueto-Urena C, Ramirez-Exposito MJ, Martinez-Martos JM. Fibromyalgia: A Review of the Pathophysiological Mechanisms and Multidisciplinary Treatment Strategies. Biomedicines. 2024 Jul 11;12(7):1543. doi: 10.3390/biomedicines12071543.

  PMID: 39062116 BACKGROUND

• Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choiniere M, Ko G, Moulin DE, Panopalis P, Proulx J, Shir Y; National Fibromyalgia Guideline Advisory Panel. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013 May-Jun;18(3):119-26. doi: 10.1155/2013/918216.

  PMID: 23748251 BACKGROUND

• Li X, Pan H, Wang L, Zhou Q, Ma Y, Wang Q, Wang M, Xie Z, Li H, Chen L, Huang L, Chen Y, Wen C. Guidelines on Treating Fibromyalgia With Nonpharmacological Therapies in China. J Evid Based Med. 2025 Jun;18(2):e70044. doi: 10.1111/jebm.70044.

  PMID: 40500865 BACKGROUND

• Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.

  PMID: 27377815 BACKGROUND

• Queiroz LP. Worldwide epidemiology of fibromyalgia. Curr Pain Headache Rep. 2013 Aug;17(8):356. doi: 10.1007/s11916-013-0356-5.

  PMID: 23801009 BACKGROUND

• D'Onghia M, Ciaffi J, Ruscitti P, Cipriani P, Giacomelli R, Ablin JN, Ursini F. The economic burden of fibromyalgia: A systematic literature review. Semin Arthritis Rheum. 2022 Oct;56:152060. doi: 10.1016/j.semarthrit.2022.152060. Epub 2022 Jul 3.

  PMID: 35849890 BACKGROUND

• Galvez-Sanchez CM, Reyes Del Paso GA. Diagnostic Criteria for Fibromyalgia: Critical Review and Future Perspectives. J Clin Med. 2020 Apr 23;9(4):1219. doi: 10.3390/jcm9041219.

  PMID: 32340369 BACKGROUND

• Hauser W, Ablin J, Fitzcharles MA, Littlejohn G, Luciano JV, Usui C, Walitt B. Fibromyalgia. Nat Rev Dis Primers. 2015 Aug 13;1:15022. doi: 10.1038/nrdp.2015.22.

  PMID: 27189527 BACKGROUND

• Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.

  PMID: 24737367 BACKGROUND

• Ablin JN, Buskila D. Fibromyalgia syndrome--novel therapeutic targets. Maturitas. 2013 Aug;75(4):335-40. doi: 10.1016/j.maturitas.2013.05.004. Epub 2013 Jun 3.

  PMID: 23742873 BACKGROUND

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 BACKGROUND

Study Officials

• Marco Higueras, Master and Bachelor

  University Playa Ancha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, Bachelor of Physical Therapy, Master of Orthopedic Manual Therapy

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: August 24, 2026
• Study Start: June 13, 2025
• Primary Completion: September 12, 2025
• Study Completion: October 31, 2025
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD will be available starting 6 months after the study results are published and will remain accessible for 5 years."
• Access Criteria: 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.

Locations

CL (1)