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Combined Effect of Hypnotic-Cognitive Therapy With Therapeutic Exercise on Quality of Life in Individuals With Fibromyalgia: A Randomized Controlled Trial Protocol.

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Τίτλος: Combined Effect of Hypnotic-Cognitive Therapy With Therapeutic Exercise on Quality of Life in Individuals With Fibromyalgia: A Randomized Controlled Trial Protocol.
Συγγραφείς: Behera D; Department of Physiotherapy, Manipal College of Health Professions, Bengaluru, Manipal Academy of Higher Education, Manipal, India., Jensen MP; Department of Rehabilitation Medicine, University of Washington, Seattle, Washington DC, USA., Gopalakrishna DB; Department of Rheumatology, Manipal Hospital, Bangalore, Karnataka, India., Patil A; Department of Rheumatology, Manipal Hospital, Bangalore, Karnataka, India., R VL; Department of Reproductive Science, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India., Venkatesan P; Department of Physiotherapy, Manipal College of Health Professions, Bengaluru, Manipal Academy of Higher Education, Manipal, India.
Πηγή: Musculoskeletal care [Musculoskeletal Care] 2026 Dec; Vol. 24 (4), pp. e70282.
Τύπος έκδοσης: Journal Article; Randomized Controlled Trial
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: John Wiley & Sons Ltd Country of Publication: England NLM ID: 101181344 Publication Model: Print Cited Medium: Internet ISSN: 1557-0681 (Electronic) Linking ISSN: 14782189 NLM ISO Abbreviation: Musculoskeletal Care Subsets: MEDLINE
Imprint Name(s): Publication: [Hoboken] : John Wiley & Sons Ltd.
Original Publication: London : Whurr Publishers, 2003-
Ιατρικοί όροι (MeSH): Fibromyalgia*/therapy , Fibromyalgia*/psychology , Fibromyalgia*/rehabilitation , Exercise Therapy*/methods , Cognitive Behavioral Therapy*/methods , Quality of Life* , Hypnosis*, Humans ; Female ; Adult ; Middle Aged ; Combined Modality Therapy ; Male
Περίληψη: Background: A multidisciplinary approach is viewed as the primary treatment strategy for fibromyalgia (FM). Therapeutic exercise is an important component of this approach. Hypnotic cognitive therapy (HYP-CT), a relatively new intervention strategy, has not traditionally been incorporated in FM treatment, although it has shown beneficial effects in other chronic pain conditions. This study aims to investigate the potential benefits of a combined approach that incorporates HYP-CT with therapeutic exercise in the rehabilitation of individuals with FM.
Materials and Methods: One hundred and four individuals with FM (≥ 1 year) and meeting eligibility criteria will be randomly allocated to one of two 12-week treatment groups: (1) therapeutic exercises plus HYP-CT or (2) therapeutic exercise plus patient attention. Usual pharmacological treatment will be offered to all participants. The primary outcome measure will be the quality of life (QOL) assessed by the Fibromyalgia Impact Questionnaire Revised (FIQR). Secondary outcomes will include sleep disturbance, fatigue, pressure sensitivity and muscle endurance, as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance scale-short form, PROMIS fatigue short form, Pain Pressure Threshold (PPT), and muscle endurance test, respectively. Outcomes will be assessed at baseline, at post-treatment (12 weeks following randomisation) and at 24 weeks following randomisation.
Planned Outcomes: This study explores the feasibility of a novel and holistic approach in the field of rehabilitation of individuals with FM, with the aim of informing future research and clinical practice.
Trial Registration: CTRI/2025/07/091248.
(© 2026 John Wiley & Sons Ltd. All rights reserved, including rights for text and data mining and training of artificial intelligence technologies or similar technologies.)
References: Alladin, A. 2012. “Cognitive Hypnotherapy for Major Depressive Disorder.” American Journal of Clinical Hypnosis 54, no. 4: 275–293. https://doi.org/10.1080/00029157.2012.654527.
Alladin, A. 2016. “Cognitive Hypnotherapy for Accessing and Healing Emotional Injuries for Anxiety Disorders.” American Journal of Clinical Hypnosis 59, no. 1: 24–46. https://doi.org/10.1080/00029157.2016.1163662.
Alladin, A., and A. Alibhai. 2007. “Cognitive Hypnotherapy for Depression: An Empirical Investigation.” International Journal of Clinical and Experimental Hypnosis 55, no. 2: 147–166. https://doi.org/10.1080/00207140601177897.
American College of Sports Medicine. 2018. Acsm’s Guidelines for Exercise Testing and Prescription. edited by Riebe, D., J. K. Ehrman, G. Liguori, and M. Magal. 10th ed. Wolters Kluwer.
Avichal Ughreja, R., P. Venkatesan, D. Balebail Gopalakrishna, Y. Preet Singh, and R. Vani Lakshmi. 2024. “Effectiveness of Craniosacral Therapy, Bowen Therapy, Static Touch and Standard Exercise Program on Sleep Quality in Fibromyalgia Syndrome: A Randomized Controlled Trial.” Journal of Integrative Medicine 22, no. 4: 473–483. https://doi.org/10.1016/j.joim.2024.06.003.
Bennett, R. M., R. Friend, K. D. Jones, R. Ward, B. K. Han, and R. L. Ross. 2009. “The Revised Fibromyalgia Impact Questionnaire (FIQR): Validation and Psychometric Properties.” Arthritis Research and Therapy 11, no. 4: R120. https://doi.org/10.1186/ar2783.
Bombardier, C. H., M. E. Mendoza, P. A. Thomas, J. K. Barber, and M. P. Jensen. 2026. “Hypnotic Cognitive Therapy for Chronic Pain in Spinal Cord Injury: A Randomized Controlled Trial.” Neurology 106, no. 8: e214836. https://doi.org/10.1212/WNL.0000000000214836.
Buckelew, S. P., R. Conway, J. Parker, et al. 1998. “Biofeedback/Relaxation Training and Exercise Interventions for Fibromyalgia: A Prospective Trial.” Arthritis & Rheumatism 11, no. 3: 196–209. https://doi.org/10.1002/art.1790110307.
Catella, S., R. M. Gendreau, A. C. Kraus, et al. 2024. “Self‐Guided Digital Acceptance and Commitment Therapy for Fibromyalgia Management: Results of a Randomized, Active‐Controlled, Phase II Pilot Clinical Trial.” Journal of Behavioral Medicine 47, no. 1: 27–42. https://doi.org/10.1007/s10865‐023‐00429‐3.
Chimenti, R. L., B. A. Rakel, D. L. Dailey, et al. 2021. “Test–Retest Reliability and Responsiveness of PROMIS Sleep Short Forms Within an RCT in Women With Fibromyalgia.” Frontiers in Pain Research 2: 682072. https://doi.org/10.3389/fpain.2021.682072.
Cioeta, M., M. Sitzia, M. Marelli, et al. 2026. “Perception and Lived Experience of Movement in Patients With Fibromyalgia: A Qualitative Systematic Review With Meta‐Synthesis and Meta‐Summary.” Clinical Rheumatology 45, no. 5: 2437–2462. https://doi.org/10.1007/s10067‐026‐08005‐1.
Da Costa, D., M. Abrahamowicz, I. Lowensteyn, et al. 2005. “A Randomized Clinical Trial of an Individualized Home‐Based Exercise Programme for Women With Fibromyalgia.” Rheumatology 44, no. 11: 1422–1427. https://doi.org/10.1093/rheumatology/kei032.
De La Vega, R., M. E. Mendoza, J. F. Chan, and M. P. Jensen. 2019. “Case Study: Cognitive Restructuring Hypnosis for Chronic Pain in a Quadriplegic Patient.” American Journal of Clinical Hypnosis 61, no. 4: 394–408. https://doi.org/10.1080/00029157.2018.1537973.
D’Onghia, M., J. Ciaffi, P. Ruscitti, et al. 2022. “The Economic Burden of Fibromyalgia: A Systematic Literature Review.” Seminars in Arthritis and Rheumatism 56: 152060. https://doi.org/10.1016/j.semarthrit.2022.152060.
Goldenberg, D. L. 2009. “Diagnosis and Differential Diagnosis of Fibromyalgia.” Supplement, American Journal of Medicine 122, no. 12: S14–S21. https://doi.org/10.1016/j.amjmed.2009.09.007.
Han, T., R. Xi, J. Wang, H. Yan, and L. Li. 2024. “Adherence to ACSM Exercise Guidelines and Its Influence on Fibromyalgia Treatment Outcomes: A Meta‐Analysis of Randomized Controlled Trials.” Frontiers in Physiology 15: 1413038. https://doi.org/10.3389/fphys.2024.1413038.
Heidari, F., M. Afshari, and M. Moosazadeh. 2017. “Prevalence of Fibromyalgia in General Population and Patients, a Systematic Review and Meta‐Analysis.” Rheumatology International 37, no. 9: 1527–1539. https://doi.org/10.1007/s00296‐017‐3725‐2.
Hofmann, S. G. 2021. “The Future of Cognitive Behavioral Therapy.” Cognitive Therapy and Research 45, no. 3: 383–384. https://doi.org/10.1007/s10608‐021‐10232‐6.
Izquierdo‐Alventosa, R., M. Inglés, S. Cortés‐Amador, et al. 2020. “Low‐Intensity Physical Exercise Improves Pain Catastrophizing and Other Psychological and Physical Aspects in Women With Fibromyalgia: A Randomized Controlled Trial.” International Journal of Environmental Research and Public Health 17, no. 10: 3634. https://doi.org/10.3390/ijerph17103634.
Jensen, M. P., D. M. Ehde, K. J. Gertz, et al. 2010. “Effects of Self‐Hypnosis Training and Cognitive Restructuring on Daily Pain Intensity and Catastrophizing in Individuals With Multiple Sclerosis and Chronic Pain.” International Journal of Clinical and Experimental Hypnosis 59, no. 1: 45–63. https://doi.org/10.1080/00207144.2011.522892.
Jensen, M. P., M. E. Mendoza, D. M. Ehde, et al. 2020. “Effects of Hypnosis, Cognitive Therapy, Hypnotic Cognitive Therapy, and Pain Education in Adults With Chronic Pain: A Randomized Clinical Trial.” Pain 161, no. 10: 2284–2298. https://doi.org/10.1097/j.pain.0000000000001943.
Kamudoni, P., J. Johns, K. F. Cook, et al. 2022. “A Comparison of the Measurement Properties of the PROMIS Fatigue (MS) 8a Against Legacy Fatigue Questionnaires.” Multiple Sclerosis and Related Disorders 66: 104048. https://doi.org/10.1016/j.msard.2022.104048.
Kamudoni, P., J. Johns, K. F. Cook, et al. 2021. “Standardizing Fatigue Measurement in Multiple Sclerosis: The Validity, Responsiveness and Score Interpretation of the PROMIS SF v1.0–Fatigue (MS) 8a.” Multiple Sclerosis and Related Disorders 54: 103117. https://doi.org/10.1016/j.msard.2021.103117.
Kundakci, B., J. Kaur, S. L. Goh, et al. 2022. “Efficacy of Nonpharmacological Interventions for Individual Features of Fibromyalgia: A Systematic Review and Meta‐Analysis of Randomised Controlled Trials.” Pain 163, no. 8: 1432–1445. https://doi.org/10.1097/j.pain.0000000000002500.
Macfarlane, G. J., C. Kronisch, L. E. Dean, et al. 2017. “EULAR Revised Recommendations for the Management of Fibromyalgia.” Annals of the Rheumatic Diseases 76, no. 2: 318–328. https://doi.org/10.1136/annrheumdis‐2016‐209724.
Marques, A. P., A. D. S. D. E. Santo, A. A. Berssaneti, L. A. Matsutani, and S. L. K. Yuan. 2017. “Prevalence of Fibromyalgia: Literature Review Update.” Revista Brasileira de Reumatologia 57, no. 4: 356–363. https://doi.org/10.1016/j.rbre.2017.01.005.
Ozgunay, S. E., M. Kasapoglu Aksoy, K. N. Deniz, et al. 2024. “Effect of Hypnosis on Pain, Anxiety, and Quality of Life in Female Patients With Fibromyalgia: Prospective, Randomized, Controlled Study.” International Journal of Clinical and Experimental Hypnosis 72, no. 1: 51–63. https://doi.org/10.1080/00207144.2023.2277853.
Paolucci, T., M. Vetrano, F. Zangrando, et al. 2015. “MMPI‐2 Profiles and Illness Perception in Fibromyalgia Syndrome: The Role of Therapeutic Exercise as Adapted Physical Activity.” Journal of Back and Musculoskeletal Rehabilitation 28, no. 1: 101–109. https://doi.org/10.3233/BMR‐140497.
Perrot, S., and I. J. Russell. 2014. “More Ubiquitous Effects From Non‐Pharmacologic than From Pharmacologic Treatments for Fibromyalgia Syndrome: A Meta‐Analysis Examining Six Core Symptoms.” European Journal of Pain 18, no. 8: 1067–1080. https://doi.org/10.1002/ejp.564.
Pontes‐Silva, A., A. V. Dibai‐Filho, T. S. D. Melo, et al. 2025. “Strength Training Versus Walking on the Fibromyalgia Impact: A Blinded Randomised Controlled Trial.” Musculoskeletal Care 23, no. 4: e70186. https://doi.org/10.1002/msc.70186.
Ramondo, N., G. E. Gignac, C. F. Pestell, and S. M. Byrne. 2021. “Clinical Hypnosis as an Adjunct to Cognitive Behavior Therapy: An Updated Meta‐Analysis.” International Journal of Clinical and Experimental Hypnosis 69, no. 2: 169–202. https://doi.org/10.1080/00207144.2021.1877549.
Redondo, J. R., C. M. Justo, F. V. Moraleda, et al. 2004. “Long‐Term Efficacy of Therapy in Patients With Fibromyalgia: A Physical Exercise‐Based Program and a Cognitive‐Behavioral Approach.” Arthritis Care & Research 51, no. 2: 184–192. https://doi.org/10.1002/art.20252.
Rodríguez‐Domínguez, Á.‐J., M. Rebollo‐Salas, R. Chillón‐Martínez, M. Cardellat‐González, L. Blanco‐Heras, and J.‐J. Jiménez‐Rejano. 2025. “Pain Neuroscience Education and Resistance Training in Women With Fibromyalgia: A Randomized Control Pilot Study.” Pain Research and Management 2025, no. 1: 7550108. https://doi.org/10.1155/prm/7550108.
Rutledge, T., J. H. Atkinson, T. Chircop‐Rollick, et al. 2018. “Randomized Controlled Trial of Telephone‐Delivered Cognitive Behavioral Therapy Versus Supportive Care for Chronic Back Pain.” Clinical Journal of Pain 34, no. 4: 322–327. https://doi.org/10.1097/AJP.0000000000000555.
Sañudo, B., L. Carrasco, M. De Hoyo, and J. G. McVeigh. 2012. “Effects of Exercise Training and Detraining in Patients With Fibromyalgia Syndrome: A 3‐Yr Longitudinal Study.” American Journal of Physical Medicine & Rehabilitation 91, no. 7: 561–573. https://doi.org/10.1097/PHM.0b013e31824faa03.
Schultz, N. M., A. Morga, E. Siddiqui, and S. E. Rhoten. 2023. “Psychometric Evaluation of the PROMIS SD‐SF‐8b Instrument in Individuals Experiencing Vasomotor Symptoms due to Menopause.” Health and Quality of Life Outcomes 21, no. 1: 126. https://doi.org/10.1186/s12955‐023‐02206‐x.
Şevgin, Ö., B. Buğday, R. Aydoğan Baykara, et al. 2024. “Efficacy of Different Exercises in Women With Fibromyalgia Syndrome: A Randomised Controlled Trial.” Clinical & Experimental Rheumatology. https://doi.org/10.55563/clinexprheumatol/uol8so.
Starosta, A. J., K. S. Wright, C. H. Bombardier, et al. 2023. “A Case Study of Hypnosis Enhanced Cognitive Therapy for Pain in a Ventilator Dependent Patient During Inpatient Rehabilitation for Spinal Cord Injury.” Journal of Clinical Medicine 12, no. 13: 4539. https://doi.org/10.3390/jcm12134539.
Stuifbergen, A. K., S. A. Blozis, H. Becker, et al. 2010. “A Randomized Controlled Trial of a Wellness Intervention for Women With Fibromyalgia Syndrome.” Clinical Rehabilitation 24, no. 4: 305–318. https://doi.org/10.1177/0269215509343247.
Thieme, K., H. Flor, and D. C. Turk. 2006. “Psychological Pain Treatment in Fibromyalgia Syndrome: Efficacy of Operant Behavioural and Cognitive Behavioural Treatments.” Arthritis Research and Therapy 8, no. 4: R121. https://doi.org/10.1186/ar2010.
Thorn, B. E., M. A. Day, J. Burns, et al. 2011. “Randomized Trial of Group Cognitive Behavioral Therapy Compared With a Pain Education Control for Low‐Literacy Rural People With Chronic Pain.” Pain 152, no. 12: 2710–2720. https://doi.org/10.1016/j.pain.2011.07.007.
Van Eijk‐Hustings, Y., M. Kroese, F. Tan, A. Boonen, M. Bessems‐Beks, and R. Landewé. 2013. “Challenges in Demonstrating the Effectiveness of Multidisciplinary Treatment on Quality of Life, Participation and Health Care Utilisation in Patients With Fibromyalgia: A Randomised Controlled Trial.” Clinical Rheumatology 32, no. 2: 199–209. https://doi.org/10.1007/s10067‐012‐2100‐7.
Viceconti, A., T. Geri, S. De Luca, et al. 2021. “Neuropathic Pain and Symptoms of Potential Small‐Fiber Neuropathy in Fibromyalgic Patients: A National On‐Line Survey.” Joint Bone Spine 88, no. 4: 105153. https://doi.org/10.1016/j.jbspin.2021.105153.
Wolfe, F., D. J. Clauw, M.‐A. Fitzcharles, et al. 2016. “2016 Revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria.” Seminars in Arthritis and Rheumatism 46, no. 3: 319–329. https://doi.org/10.1016/j.semarthrit.2016.08.012.
Wolfe, F., H. A. Smythe, M. B. Yunus, et al. 1990. “The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia.” Arthritis & Rheumatism 33, no. 2: 160–172. https://doi.org/10.1002/art.1780330203.
Wu, Y.‐L., C.‐J. Huang, S.‐C. Fang, L.‐H. Ko, and P.‐S. Tsai. 2018. “Cognitive Impairment in Fibromyalgia: A Meta‐Analysis of Case–Control Studies.” Psychosomatic Medicine 80, no. 5: 432–438. https://doi.org/10.1097/PSY.0000000000000575.
Zure, M., S. Arman, and A. Ketenci. 2025. “The Effect of Blood Flow Restricted Aerobic Exercise Training on Pain, Functional Status, Quality of Life and Hormonal Response to Exercise in Fibromyalgia Patients: A Randomized Double‐Blind Study.” European Journal of Physical and Rehabilitation Medicine 61, no. 3. https://doi.org/10.23736/S1973‐9087.25.08817‐3.
Contributed Indexing: Keywords: clinical hypnosis; cognitive behavioural therapy; fibromyalgia; therapeutic exercise
Entry Date(s): Date Created: 20261012 Date Completed: 20261012 Latest Revision: 20261016
Update Code: 20261016
DOI: 10.1002/msc.70282
PMID: 42863823
Βάση Δεδομένων: MEDLINE
Περιγραφή
ISSN:1557-0681
DOI:10.1002/msc.70282