Chronic Pain (Back / Neck)ARTNCT06603168
Autonomic Recalibration
A study testing Autonomic Recalibration Treatment in people with Chronic Pain (Back / Neck) and Autonomic Dysregulation, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial summary
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: How is the Autonomic Nervous System (ANS) affected during Autonomic Recalibration Treatment (ART)? How are myofascial tissue… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Chronic Pain (Back / Neck), Autonomic Dysregulation
- What is being tested?
- Autonomic Recalibration Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2023to 27 Feb 2024
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dysfunctional myofascial pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury) or known underlying condition (e.g., cancer).
Who cannot join
- known skin allergies to gel as found in common cosmetic or household products
- can't make treatment appointments on two consecutive days
- myofascial pain is deemed functional (normal response to acute injury or ongoing pathology)
- lacking a COVID-19 vaccination and a booster shot.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Via College of Osteopathic Medicine, Auburn Campus
Auburn, Alabama, 36832
About this study
Official title: Autonomic Recalibration Approach to Myofascial Pain Elimination
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:
How is the Autonomic Nervous System (ANS) affected during Autonomic Recalibration Treatment (ART)? How are myofascial tissue properties impacted from ART?
Participants will:
Have 2 treatments of ART on consecutive days. Wear sensors to track HRV (heart rate variability) and GSR to verify autonomic recalibration.
Measure changes in range of motion by wearing a Rokoko motion capture suit. Measure changes in muscle stiffness through shear wave elastography.
Read the detailed description
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.
- Being tested
- Autonomic Recalibration Treatment
- 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
- Medical subject headings
- Chronic Pain, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic Recalibration TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Autonomic Recalibration Treatment | Experimental | Participant receives Autonomic Recalibration Treatment.
Measurements:
Pre/post shear wave elastography Pre/post myonometry Pre/post motion capture HRV/GSR during ART Pre/post pain ratings Pre/post trigger point log Receives: Other: Autonomic Recalibration Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (NRS Pain Scale)
0-10 Pain Rating. 0=no pain to 10=pain as intense as you can imagine
Measured: Pre/Post for each day of treatment. 2 days total.
Heart Rate Variability
Changes in HRV (ms) pre/post and Day 1/Day 2.
Measured: Pre/Post for each day of treatment. 2 days total.
Galvanic Skin Response (GSR)
Comparison of GSR peak counts pre/post and Day 1/Day 2.
Measured: Pre/Post for each day of treatment. 2 days total.
Muscle Stiffness using Shear Wave Elastography
Changes in muscle stiffness (kPa) measured by Ultrasound.
Measured: Pre/Post for each day of treatment. 2 days total.
Nociceptive Trigger Points
Log of reported trigger points during nociceptive start exam. Taken Pre, Middle, and Post ART on Day 1 and Day 2.
Measured: Pre/Middle/Post for each day of treatment. 2 days total.
Changes in mobility
Posture/mobility changes using multivariate morphometric analysis.
Measured: Pre/Post for each day of treatment. 2 days total.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Apr 2023
- Primary completion24 Aug 2023
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain (Back / Neck)Studies 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
- Model description
- This pilot study design is a pretest-posttest cohort study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Pearson, Edward Via Virginia College of Osteopathic Medicine
- Investigators
- William G Pearson, PhD, Principal investigator, Edward Via College of Osteopathic Medicine, Auburn campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603168
- Sponsor's protocol ID
- 2022-058
- Acronym
- ART
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR. Characteristics of opioid prescriptions in 2009. JAMA. 2011 Apr 6;305(13):1299-301. doi: 10.1001/jama.2011.401. No abstract available.
PubMed 21467282Vattigunta S, Weiner S, Nayar SK, Jenkins S, Srikumaran U. Opioid consumption following orthopedic shoulder surgery: a retrospective analysis. J Shoulder Elbow Surg. 2021 Jul;30(7S):S153-S158. doi: 10.1016/j.jse.2021.04.005. Epub 2021 Apr 21.
PubMed 33892118Turo D, Otto P, Hossain M, Gebreab T, Armstrong K, Rosenberger WF, Shao H, Shah JP, Gerber LH, Sikdar S. Novel Use of Ultrasound Elastography to Quantify Muscle Tissue Changes After Dry Needling of Myofascial Trigger Points in Patients With Chronic Myofascial Pain. J Ultrasound Med. 2015 Dec;34(12):2149-61. doi: 10.7863/ultra.14.08033. Epub 2015 Oct 21.
PubMed 26491094Reddan MC, Wager TD. Modeling Pain Using fMRI: From Regions to Biomarkers. Neurosci Bull. 2018 Feb;34(1):208-215. doi: 10.1007/s12264-017-0150-1. Epub 2017 Jun 23.
PubMed 28646349Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
PubMed 22506152Oliveira-Campelo NM, de Melo CA, Alburquerque-Sendin F, Machado JP. Short- and medium-term effects of manual therapy on cervical active range of motion and pressure pain sensitivity in latent myofascial pain of the upper trapezius muscle: a randomized controlled trial. J Manipulative Physiol Ther. 2013 Jun;36(5):300-9. doi: 10.1016/j.jmpt.2013.04.008. Epub 2013 Jun 12.
PubMed 23769263Morikawa Y, Takamoto K, Nishimaru H, Taguchi T, Urakawa S, Sakai S, Ono T, Nishijo H. 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.
PubMed 28442987Menendez 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.
PubMed 25694266Mejia-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.
PubMed 32792970Malliaras 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.
PubMed 33577359Maher 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.
PubMed 23684553Lok 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.
PubMed 34085301Lavelle 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.
PubMed 18054148Lamine 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.
PubMed 29088586Kunz 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.
PubMed 17949906
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Recalibration Approach to Myofascial Pain Elimination
- ClinicalTrials.gov ID
- NCT06603168
- Acronym / sponsor ID
- ART / 2022-058
- Keywords
- chronic pain, autonomic nervous system, sympathetic dominance, myofascial pain, Sympathetic tone, dysfunctional pain, Primal Reflex Release Technique, shear wave elastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 19 Sep 2024 (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.
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:
How is the Autonomic Nervous System (ANS) affected during Autonomic Recalibration Treatment (ART)? How are myofascial tissue properties impacted from ART?
Participants will:
Have 2 treatments of ART on consecutive days. Wear sensors to track HRV (heart rate variability) and GSR to verify autonomic recalibration.
Measure changes in range of motion by wearing a Rokoko motion capture suit. Measure changes in muscle stiffness through shear wave elastography.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot study design is a pretest-posttest cohort study.
| Arm | Type | Receives |
|---|---|---|
| Autonomic Recalibration Treatment | Experimental | Other: Autonomic Recalibration TreatmentParticipant receives Autonomic Recalibration Treatment. Measurements: Pre/post shear wave elastography Pre/post myonometry Pre/post motion capture HRV/GSR during ART Pre/post pain ratings Pre/post trigger point log |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- dysfunctional myofascial pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury) or known underlying condition (e.g., cancer).
Key exclusion criteria (4 listed)
- known skin allergies to gel as found in common cosmetic or household products
- can't make treatment appointments on two consecutive days
- myofascial pain is deemed functional (normal response to acute injury or ongoing pathology)
- lacking a COVID-19 vaccination and a booster shot.
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 |
|---|---|---|
| Autonomic Recalibration TreatmentAn 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. | Other | Autonomic Recalibration Treatment |
Primary outcome
Pain Intensity (NRS Pain Scale)
Time frame: Pre/Post for each day of treatment. 2 days total.
0-10 Pain Rating. 0=no pain to 10=pain as intense as you can imagine
Heart Rate Variability
Time frame: Pre/Post for each day of treatment. 2 days total.
Changes in HRV (ms) pre/post and Day 1/Day 2.
Galvanic Skin Response (GSR)
Time frame: Pre/Post for each day of treatment. 2 days total.
Comparison of GSR peak counts pre/post and Day 1/Day 2.
Muscle Stiffness using Shear Wave Elastography
Time frame: Pre/Post for each day of treatment. 2 days total.
Changes in muscle stiffness (kPa) measured by Ultrasound.
Nociceptive Trigger Points
Time frame: Pre/Middle/Post for each day of treatment. 2 days total.
Log of reported trigger points during nociceptive start exam. Taken Pre, Middle, and Post ART on Day 1 and Day 2.
Changes in mobility
Time frame: Pre/Post for each day of treatment. 2 days total.
Posture/mobility changes using multivariate morphometric analysis.
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 19 Sep 2024.
- Background: PubMed 21467282Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR. Characteristics of opioid prescriptions in 2009. JAMA. 2011 Apr 6;305(13):1299-301. doi: 10.1001/jama.2011.401. No abstract available.
- Background: PubMed 33892118Vattigunta S, Weiner S, Nayar SK, Jenkins S, Srikumaran U. Opioid consumption following orthopedic shoulder surgery: a retrospective analysis. J Shoulder Elbow Surg. 2021 Jul;30(7S):S153-S158. doi: 10.1016/j.jse.2021.04.005. Epub 2021 Apr 21.
- Background: PubMed 26491094Turo D, Otto P, Hossain M, Gebreab T, Armstrong K, Rosenberger WF, Shao H, Shah JP, Gerber LH, Sikdar S. Novel Use of Ultrasound Elastography to Quantify Muscle Tissue Changes After Dry Needling of Myofascial Trigger Points in Patients With Chronic Myofascial Pain. J Ultrasound Med. 2015 Dec;34(12):2149-61. doi: 10.7863/ultra.14.08033. Epub 2015 Oct 21.
- Background: PubMed 28646349Reddan MC, Wager TD. Modeling Pain Using fMRI: From Regions to Biomarkers. Neurosci Bull. 2018 Feb;34(1):208-215. doi: 10.1007/s12264-017-0150-1. Epub 2017 Jun 23.
- Background: PubMed 22506152Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.
- Background: PubMed 23769263Oliveira-Campelo NM, de Melo CA, Alburquerque-Sendin F, Machado JP. Short- and medium-term effects of manual therapy on cervical active range of motion and pressure pain sensitivity in latent myofascial pain of the upper trapezius muscle: a randomized controlled trial. J Manipulative Physiol Ther. 2013 Jun;36(5):300-9. doi: 10.1016/j.jmpt.2013.04.008. Epub 2013 Jun 12.
- Background: PubMed 28442987Morikawa Y, Takamoto K, Nishimaru H, Taguchi T, Urakawa S, Sakai S, Ono T, Nishijo H. 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.
- Background: PubMed 25694266Menendez 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.
- Background: PubMed 32792970Mejia-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.
- Background: PubMed 33577359Malliaras 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.
- Background: PubMed 23684553Maher 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.
- Background: PubMed 34085301Lok 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain (Back / Neck)
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Not yet recruiting
Differences in Mechanistic Measures (Oxytocin and Cortisol) of Therapeutic Alliance Between A Talk-Based Therapy and Soft-Tissue Mobilization in Individuals With Chronic Spinal Pain
Spine, Low Back Pain
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
Lumbosacral Radiculopathy, Sciatica
Recruiting
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
Chronic Back Pain, Chronic Pain (Back / Neck)
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.
William G Pearson, PhD principal investigator
Edward Via College of Osteopathic Medicine, Auburn campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autonomic Recalibration Treatment in people with Chronic Pain (Back / Neck) and Autonomic Dysregulation, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
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 1 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 19 Sep 2024. 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 United States. 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?
Pain Intensity (NRS Pain Scale) (time frame: Pre/Post for each day of treatment. 2 days total.). The study lists 6 primary outcomes in all. 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 NCT06603168, which also lists 33 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 19 Sep 2024.