Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT04855851
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2021-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Self-report Pain Intensity', 'timeFrame': 'at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week).', 'description': 'Evaluated by the visual analogue scale (VAS). The total VAS score is between 0-10 cm. A higher score indicates greater pain intensity'}, {'measure': 'Change from Central Sensitization symptoms', 'timeFrame': 'at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week)', 'description': 'Measured by the Central Sensitization Inventory (CSI). The total CSI score is between 0-100 points. Scores equal to or greater than 40 points are considered positive for Central Sensitization.'}, {'measure': 'Change from Disability', 'timeFrame': 'at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week)', 'description': 'Measured by the Fibromyalgia Impact Questionnaire (FIQ). The total FIQ score is between 0-100. Thus, 0 represents the highest functional capacity and quality of life and 100 the worst state.'}], 'secondaryOutcomes': [{'measure': 'Change from viscoelastic properties.', 'timeFrame': 'at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]', 'description': 'Measured by the Myoton®.'}, {'measure': 'Change from Autonomic Disfunction symptoms', 'timeFrame': 'at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]', 'description': 'Measured by the Heart Rate Variability.'}, {'measure': 'Change from Nerve Conduction Velocity', 'timeFrame': 'at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]', 'description': 'Measured by the Sensory Nerve Action Potential (SNAP).'}, {'measure': 'Change from grip strength', 'timeFrame': 'at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]', 'description': 'Measure by the dynamometer.'}, {'measure': 'Change from the pressure pain threshold', 'timeFrame': 'at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]', 'description': 'Measure by the pressure algometer.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Education', 'Strength training'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '30657077', 'type': 'BACKGROUND', 'citation': 'Andrade A, de Azevedo Klumb Steffens R, Sieczkowska SM, Peyre Tartaruga LA, Torres Vilarino G. A systematic review of the effects of strength training in patients with fibromyalgia: clinical outcomes and design considerations. Adv Rheumatol. 2018 Oct 22;58(1):36. doi: 10.1186/s42358-018-0033-9.'}, {'pmid': '31963773', 'type': 'BACKGROUND', 'citation': 'Serrat M, Sanabria-Mazo JP, Garcia-Troiteiro E, Fontcuberta A, Mateo-Canedo C, Almirall M, Feliu-Soler A, Mendez-Ulrich JL, Sanz A, Luciano JV. Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Jan 19;17(2):634. doi: 10.3390/ijerph17020634.'}, {'pmid': '25892394', 'type': 'BACKGROUND', 'citation': 'Nelson NL. Muscle strengthening activities and fibromyalgia: a review of pain and strength outcomes. J Bodyw Mov Ther. 2015 Apr;19(2):370-6. doi: 10.1016/j.jbmt.2014.08.007. Epub 2014 Aug 19.'}, {'pmid': '32033824', 'type': 'BACKGROUND', 'citation': 'Barrenengoa-Cuadra MJ, Angon-Puras LA, Moscosio-Cuevas JI, Gonzalez-Lama J, Fernandez-Luco M, Gracia-Ballarin R. [Effectiveness of pain neuroscience education in patients with fibromyalgia: Structured group intervention in Primary Care]. Aten Primaria. 2021 Jan;53(1):19-26. doi: 10.1016/j.aprim.2019.10.007. Epub 2020 Feb 6. Spanish.'}, {'pmid': '22133255', 'type': 'BACKGROUND', 'citation': 'Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.'}, {'pmid': '27377815', 'type': 'BACKGROUND', 'citation': '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': '33024295', 'type': 'BACKGROUND', 'citation': 'Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.'}, {'pmid': '28743363', 'type': 'BACKGROUND', 'citation': 'Marques AP, Santo ASDE, Berssaneti AA, Matsutani LA, Yuan SLK. Prevalence of fibromyalgia: literature review update. Rev Bras Reumatol Engl Ed. 2017 Jul-Aug;57(4):356-363. doi: 10.1016/j.rbre.2017.01.005. Epub 2017 Feb 8. English, Portuguese.'}, {'pmid': '28734619', 'type': 'BACKGROUND', 'citation': 'Cabo-Meseguer A, Cerda-Olmedo G, Trillo-Mata JL. Fibromyalgia: Prevalence, epidemiologic profiles and economic costs. Med Clin (Barc). 2017 Nov 22;149(10):441-448. doi: 10.1016/j.medcli.2017.06.008. Epub 2017 Jul 19. English, Spanish.'}, {'pmid': '18191990', 'type': 'BACKGROUND', 'citation': 'Yunus MB. Central sensitivity syndromes: a new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Semin Arthritis Rheum. 2008 Jun;37(6):339-52. doi: 10.1016/j.semarthrit.2007.09.003. Epub 2008 Jan 14.'}, {'pmid': '18511329', 'type': 'BACKGROUND', 'citation': 'Nijs J, Van Houdenhove B. From acute musculoskeletal pain to chronic widespread pain and fibromyalgia: application of pain neurophysiology in manual therapy practice. Man Ther. 2009 Feb;14(1):3-12. doi: 10.1016/j.math.2008.03.001. Epub 2008 Jun 3.'}, {'pmid': '24508406', 'type': 'BACKGROUND', 'citation': 'Cagnie B, Coppieters I, Denecker S, Six J, Danneels L, Meeus M. Central sensitization in fibromyalgia? A systematic review on structural and functional brain MRI. Semin Arthritis Rheum. 2014 Aug;44(1):68-75. doi: 10.1016/j.semarthrit.2014.01.001. Epub 2014 Jan 8.'}, {'pmid': '26921267', 'type': 'BACKGROUND', 'citation': "Feliu-Soler A, Borras X, Penarrubia-Maria MT, Rozadilla-Sacanell A, D'Amico F, Moss-Morris R, Howard MA, Fayed N, Soriano-Mas C, Puebla-Guedea M, Serrano-Blanco A, Perez-Aranda A, Tuccillo R, Luciano JV. Cost-utility and biological underpinnings of Mindfulness-Based Stress Reduction (MBSR) versus a psychoeducational programme (FibroQoL) for fibromyalgia: a 12-month randomised controlled trial (EUDAIMON study). BMC Complement Altern Med. 2016 Feb 27;16:81. doi: 10.1186/s12906-016-1068-2."}, {'pmid': '29185675', 'type': 'BACKGROUND', 'citation': 'Assumpcao A, Matsutani LA, Yuan SL, Santo AS, Sauer J, Mango P, Marques AP. Muscle stretching exercises and resistance training in fibromyalgia: which is better? A three-arm randomized controlled trial. Eur J Phys Rehabil Med. 2018 Oct;54(5):663-670. doi: 10.23736/S1973-9087.17.04876-6. Epub 2017 Nov 29.'}, {'pmid': '9624661', 'type': 'BACKGROUND', 'citation': 'American College of Sports Medicine Position Stand. The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness, and flexibility in healthy adults. Med Sci Sports Exerc. 1998 Jun;30(6):975-91. doi: 10.1097/00005768-199806000-00032.'}, {'pmid': '40686548', 'type': 'DERIVED', 'citation': 'Rodriguez-Dominguez AJ, Rebollo-Salas M, Chillon-Martinez R, Cardellat-Gonzalez M, Blanco-Heras L, Jimenez-Rejano JJ. Pain Neuroscience Education and Resistance Training in Women With Fibromyalgia: A Randomized Control Pilot Study. Pain Res Manag. 2025 Jul 10;2025:7550108. doi: 10.1155/prm/7550108. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The main goal of this study is to get to know if applying both, pain neuroscience education (PNE) plus strength training (ST) will reduce the pain of fibromyalgia (FM). Both therapies have shown evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their efficacy in combination.', 'detailedDescription': 'At present, the increase in knowledge about the neuroscience of pain has led to the integration of psychological factors, such as cognitions and beliefs about pain, fear-avoidance behaviors or catastrophism within the integrative perception of the concept . This has led to the development of therapeutic strategies aimed at the reconceptualization of pain through a treatment method called Pain Neuroscience Education (PNE), having shown evidence in the treatment of pain, disability, catastrophism and physical performance.\n\nBut despite current advances in pain neuroscience, there are still pain syndromes, such as fibromyalgia, that are the subject of debate and controversy. Fibromyalgia is a syndrome that causes generalized musculoskeletal pain, fatigue, sleep disorders, and physical disability. It is the main cause of chronic generalized musculoskeletal pain, with a prevalence of 1-5% of the world population. Scientific research has provided new insight for the diagnosis of fibromyalgia patients, who are characterized by a central sensitization process.\n\nObjectives:\n\nTo assess the effectiveness of Pain Neuroscience Education and Strength Training to decrease pain and disability; and increasing quality of life and functionality in patients with Fibromyalgia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women diagnosed with fibromyalgia.\n* Duration of pain greater than one year.\n* Generalized or present pain in more than two body regions.\n* Not having participated in pain neuroscience education program.\n* Not having participated in physical exercise programs in the last three months.\n\nExclusion Criteria:\n\n* Presence of other diseases not related to the musculoskeletal system.\n* Being under medical treatment not related to pain.\n* being under physiotherapeutic treatment related to pain.\n* Unavailability to carry out a physical exercise program.\n* Pregnant or puerperium women.\n* Inability to perform or complete the necessary tests to measure the study variables.'}, 'identificationModule': {'nctId': 'NCT04855851', 'acronym': 'PNE-ST-FM', 'briefTitle': 'Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Effectiveness of Pain Neuroscience Education and Strength Training Program in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'USeville-AJRD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING', 'description': 'Subjects will receive 6 PAIN NEUROSCIENCE EDUCATION (PNE) sessions and 12 weeks (3 times/week) of STRENGTH TRAINING (ST)', 'interventionNames': ['Procedure: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'USUAL CARE', 'description': 'The subjects of this group will receive Usual Care. In Spain, the treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients, and recommendation of aerobic and flexibility exercise', 'interventionNames': ['Procedure: USUAL CARE']}], 'interventions': [{'name': 'PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING', 'type': 'PROCEDURE', 'description': 'The subjects of this group will receive an amount of six sessions that will be applied within 12 weeks. Every 15 days, the subjects will come for a consultation to receive a PNE session and review of the exercise program, which will be carried out 3 times a week for 12 weeks.', 'armGroupLabels': ['PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING']}, {'name': 'USUAL CARE', 'type': 'PROCEDURE', 'description': 'Aerobic exercises will consist of a standard table of low intensity stretching exercises, commonly prescribed to fibromyalgia patients. There will be three series of 30 seconds of each stretch, having a total duration of approximately 40 minutes. Each session will be held twice a week, following the recommendations of the "American College of Sport Medicine". Monitoring will be performed every 15 days by a physiotherapist.', 'armGroupLabels': ['USUAL CARE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'state': 'Spain', 'country': 'Spain', 'facility': 'Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manuel Rebollo Salas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Manuel Rebollo Salas', 'investigatorAffiliation': 'University of Seville'}}}}