Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-02-27 @ 6:49 AM
Study NCT ID:
NCT06603168
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autonomic Recalibration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This pilot study design is a pretest-posttest cohort study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity (NRS Pain Scale)', 'timeFrame': 'Pre/Post for each day of treatment. 2 days total.', 'description': '0-10 Pain Rating. 0=no pain to 10=pain as intense as you can imagine'}, {'measure': 'Heart Rate Variability', 'timeFrame': 'Pre/Post for each day of treatment. 2 days total.', 'description': 'Changes in HRV (ms) pre/post and Day 1/Day 2.'}, {'measure': 'Galvanic Skin Response (GSR)', 'timeFrame': 'Pre/Post for each day of treatment. 2 days total.', 'description': 'Comparison of GSR peak counts pre/post and Day 1/Day 2.'}, {'measure': 'Muscle Stiffness using Shear Wave Elastography', 'timeFrame': 'Pre/Post for each day of treatment. 2 days total.', 'description': 'Changes in muscle stiffness (kPa) measured by Ultrasound.'}, {'measure': 'Nociceptive Trigger Points', 'timeFrame': 'Pre/Middle/Post for each day of treatment. 2 days total.', 'description': 'Log of reported trigger points during nociceptive start exam. Taken Pre, Middle, and Post ART on Day 1 and Day 2.'}, {'measure': 'Changes in mobility', 'timeFrame': 'Pre/Post for each day of treatment. 2 days total.', 'description': 'Posture/mobility changes using multivariate morphometric analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pain', 'autonomic nervous system', 'sympathetic dominance', 'myofascial pain', 'Sympathetic tone', 'dysfunctional pain', 'Primal Reflex Release Technique', 'shear wave elastography', 'heart rate variability', 'galvanic skin response', 'Rokoko', 'motion capture', 'range of motion', 'posture'], 'conditions': ['Chronic Pain (Back / Neck)', 'Autonomic Dysregulation']}, 'referencesModule': {'references': [{'pmid': '21467282', 'type': 'BACKGROUND', 'citation': 'Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR. Characteristics of opioid prescriptions in 2009. 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Compression at Myofascial Trigger Point on Chronic Neck Pain Provides Pain Relief through the Prefrontal Cortex and Autonomic Nervous System: A Pilot Study. Front Neurosci. 2017 Apr 11;11:186. doi: 10.3389/fnins.2017.00186. eCollection 2017.'}, {'pmid': '25694266', 'type': 'BACKGROUND', 'citation': 'Menendez ME, Ring D, Bateman BT. Preoperative Opioid Misuse is Associated With Increased Morbidity and Mortality After Elective Orthopaedic Surgery. Clin Orthop Relat Res. 2015 Jul;473(7):2402-12. doi: 10.1007/s11999-015-4173-5. Epub 2015 Feb 19.'}, {'pmid': '32792970', 'type': 'BACKGROUND', 'citation': 'Mejia-Mejia E, Budidha K, Abay TY, May JM, Kyriacou PA. Heart Rate Variability (HRV) and Pulse Rate Variability (PRV) for the Assessment of Autonomic Responses. Front Physiol. 2020 Jul 23;11:779. doi: 10.3389/fphys.2020.00779. eCollection 2020.'}, {'pmid': '33577359', 'type': 'BACKGROUND', 'citation': "Malliaras P, Rathi S, Burstein F, Watt L, Ridgway J, King C, Warren N. 'Physio's not going to repair a torn tendon': patient decision-making related to surgery for rotator cuff related shoulder pain. Disabil Rehabil. 2022 Jul;44(14):3686-3693. doi: 10.1080/09638288.2021.1879945. Epub 2021 Feb 12."}, {'pmid': '23684553', 'type': 'BACKGROUND', 'citation': 'Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.'}, {'pmid': '34085301', 'type': 'BACKGROUND', 'citation': 'Lok UW, Huang C, Zhou C, Yang L, Ling W, Tang S, Gong P, Madson TJ, Jensen MA, Gay RE, Chen S. Quantitative Shear Wave Speed Assessment for Muscles With the Diagnosis of Taut Bands and/or Myofascial Trigger Points Using Probe Oscillation Shear Wave Elastography: A Pilot Study. J Ultrasound Med. 2022 Apr;41(4):845-854. doi: 10.1002/jum.15764. Epub 2021 Jun 4.'}, {'pmid': '18054148', 'type': 'BACKGROUND', 'citation': 'Lavelle ED, Lavelle W, Smith HS. Myofascial trigger points. Anesthesiol Clin. 2007 Dec;25(4):841-51, vii-iii. doi: 10.1016/j.anclin.2007.07.003.'}, {'pmid': '29088586', 'type': 'BACKGROUND', 'citation': 'Lamine H, Bennour S, Laribi M, Romdhane L, Zaghloul S. Evaluation of Calibrated Kinect Gait Kinematics Using a Vicon Motion Capture System. Comput Methods Biomech Biomed Engin. 2017 Oct;20(sup1):111-112. doi: 10.1080/10255842.2017.1382886. No abstract available.'}, {'pmid': '17949906', 'type': 'BACKGROUND', 'citation': 'Kunz M, Scharmann S, Hemmeter U, Schepelmann K, Lautenbacher S. The facial expression of pain in patients with dementia. Pain. 2007 Dec 15;133(1-3):221-8. doi: 10.1016/j.pain.2007.09.007. Epub 2007 Oct 18.'}, {'pmid': '32903634', 'type': 'BACKGROUND', 'citation': 'Kisilewicz A, Madeleine P, Ignasiak Z, Ciszek B, Kawczynski A, Larsen RG. 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The ventro-medial prefrontal cortex: a major link between the autonomic nervous system, regulation of emotion, and stress reactivity? Biopsychosoc Med. 2008 Nov 5;2:21. doi: 10.1186/1751-0759-2-21.'}, {'pmid': '26491619', 'type': 'BACKGROUND', 'citation': 'Hansberger BL, Baker RT, May J, Nasypany A. A NOVEL APPROACH TO TREATING PLANTAR FASCIITIS - EFFECTS OF PRIMAL REFLEX RELEASE TECHNIQUE: A CASE SERIES. Int J Sports Phys Ther. 2015 Oct;10(5):690-9.'}, {'pmid': '32589065', 'type': 'BACKGROUND', 'citation': 'Han HJ, Labbaf S, Borelli JL, Dutt N, Rahmani AM. Objective stress monitoring based on wearable sensors in everyday settings. J Med Eng Technol. 2020 May;44(4):177-189. doi: 10.1080/03091902.2020.1759707. Epub 2020 Jun 26.'}, {'pmid': '24162088', 'type': 'BACKGROUND', 'citation': 'Hallman DM, Ekman AH, Lyskov E. Changes in physical activity and heart rate variability in chronic neck-shoulder pain: monitoring during work and leisure time. 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A systematic review of manual therapy techniques, dry cupping and dry needling in the reduction of myofascial pain and myofascial trigger points. J Bodyw Mov Ther. 2019 Jul;23(3):539-546. doi: 10.1016/j.jbmt.2019.04.001. Epub 2019 Apr 4.'}, {'pmid': '33272959', 'type': 'BACKGROUND', 'citation': 'Cederqvist S, Flinkkila T, Sormaala M, Ylinen J, Kautiainen H, Irmola T, Lehtokangas H, Liukkonen J, Pamilo K, Ridanpaa T, Sirnio K, Leppilahti J, Kiviranta I, Paloneva J. Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation. Ann Rheum Dis. 2021 Jun;80(6):796-802. doi: 10.1136/annrheumdis-2020-219099. Epub 2020 Dec 3.'}, {'pmid': '35074504', 'type': 'BACKGROUND', 'citation': 'Cauzzo S, Singh K, Stauder M, Garcia-Gomar MG, Vanello N, Passino C, Staab J, Indovina I, Bianciardi M. Functional connectome of brainstem nuclei involved in autonomic, limbic, pain and sensory processing in living humans from 7 Tesla resting state fMRI. Neuroimage. 2022 Apr 15;250:118925. doi: 10.1016/j.neuroimage.2022.118925. Epub 2022 Jan 21.'}, {'type': 'BACKGROUND', 'citation': 'Bolanos, L., Vicente, J. M., Vivas, O. A., & Sabater-Navarro, J. M. (2019). Electrodermal activity in relation to diabetes, autonomic neuropathy and aging: a preliminary study. IngenierÃa E Investigación, 39(3), 27-33.'}, {'pmid': '28640822', 'type': 'BACKGROUND', 'citation': 'Babatunde OO, Jordan JL, Van der Windt DA, Hill JC, Foster NE, Protheroe J. Effective treatment options for musculoskeletal pain in primary care: A systematic overview of current evidence. PLoS One. 2017 Jun 22;12(6):e0178621. doi: 10.1371/journal.pone.0178621. eCollection 2017.'}, {'pmid': '32269860', 'type': 'BACKGROUND', 'citation': 'Albertin ES, Walters M, May J, Baker RT, Nasypany A, Cheatham S. AN EXPLORATORY CASE SERIES ANALYSIS OF THE USE OF PRIMAL REFLEX RELEASE TECHNIQUE TO IMPROVE SIGNS AND SYMPTOMS OF HAMSTRING STRAIN. Int J Sports Phys Ther. 2020 Apr;15(2):263-273.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Autonomic Recalibration works to reduce sympathetic dominance to alleviate dysfunctional myofascial pain. The main questions it aims to answer are:\n\nHow is the Autonomic Nervous System (ANS) affected during Autonomic Recalibration Treatment (ART)? How are myofascial tissue properties impacted from ART?\n\nParticipants will:\n\nHave 2 treatments of ART on consecutive days. Wear sensors to track HRV (heart rate variability) and GSR to verify autonomic recalibration.\n\nMeasure changes in range of motion by wearing a Rokoko motion capture suit. Measure changes in muscle stiffness through shear wave elastography.', 'detailedDescription': 'Myofascial pain contributes to opioid misuse and opioid use disorder. Alternative non-drug therapies for myofascial pain, such as osteopathic manipulative treatment, are critical areas of research. An unexplored approach in osteopathic manipulative treatment is recruiting the regulatory assistance of the autonomic nervous system (ANS) to alleviate myofascial pain. Autonomic Recalibration Technique (ART) is a manual and behavioral approach that employs osteopathic principles in addressing the neurobiological mechanisms that regulate myofascial pain. Our central hypothesis is that ART utilizes ANS regulation to restore myofascial function and alleviate chronic myofascial pain. The scientific premise of this proposal is the need to document mechanistic evidence that the ANS can be recruited to alleviate and eliminate pain by employing osteopathic principles. While elements of this approach have been employed by various practitioners, including manual and integrative clinicians including osteopaths, the innovation is to combine a manual bottom-up approach to shut down sympathetic tone, and a top-down approach to address trauma-based triggers that propagate pain. If successful, these preclinical data will be used in future grants to propose a clinical trial of ART as an additional technique in osteopathic manipulative treatment to provide an alternative to surgical or drug treatment of chronic myofascial pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* dysfunctional myofascial pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury) or known underlying condition (e.g., cancer).\n\nExclusion Criteria:\n\n* known skin allergies to gel as found in common cosmetic or household products\n* can't make treatment appointments on two consecutive days\n* myofascial pain is deemed functional (normal response to acute injury or ongoing pathology)\n* lacking a COVID-19 vaccination and a booster shot."}, 'identificationModule': {'nctId': 'NCT06603168', 'acronym': 'ART', 'briefTitle': 'Autonomic Recalibration', 'organization': {'class': 'OTHER', 'fullName': 'Edward Via Virginia College of Osteopathic Medicine'}, 'officialTitle': 'Autonomic Recalibration Approach to Myofascial Pain Elimination', 'orgStudyIdInfo': {'id': '2022-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autonomic Recalibration Treatment', 'description': 'Participant receives Autonomic Recalibration Treatment.\n\nMeasurements:\n\nPre/post shear wave elastography Pre/post myonometry Pre/post motion capture HRV/GSR during ART Pre/post pain ratings Pre/post trigger point log', 'interventionNames': ['Other: Autonomic Recalibration Treatment']}], 'interventions': [{'name': 'Autonomic Recalibration Treatment', 'type': 'OTHER', 'description': 'An initial history to r/o pathology and document a chief complaint relevant to pain is conducted. An initial head to toe assessment of withdrawal or startle reflex behavior in response to palpation is performed to identify trigger points and establish patterns of sympathetic dominance throughout the myofascial system. The pattern of sympathetic dominance (pattern of trigger point) is addressed during treatment by Primal Reflex Release Technique Protocol to inhibit somatic afferent feedback loops and rebalance the autonomic nervous system towards a state of parasympathetic dominance. The absence of a trigger point indicates that the treatment is complete.', 'armGroupLabels': ['Autonomic Recalibration Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36832', 'city': 'Auburn', 'state': 'Alabama', 'country': 'United States', 'facility': 'Edward Via College of Osteopathic Medicine, Auburn Campus', 'geoPoint': {'lat': 32.60986, 'lon': -85.48078}}], 'overallOfficials': [{'name': 'William G Pearson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edward Via College of Osteopathic Medicine, Auburn campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edward Via Virginia College of Osteopathic Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Discipline Chair for Anatomy', 'investigatorFullName': 'William Pearson', 'investigatorAffiliation': 'Edward Via Virginia College of Osteopathic Medicine'}}}}