AzTrials
AzTrials

Chronic PainMERCINCT06533345

VCOM Pain Free Research Collaborative

A study testing Behavior Change Coaching, Nutrition and Autonomic Recalibration in people with Chronic Pain, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Studies estimate that 30% of people worldwide experience chronic pain. The mechanisms causing this pain can vary: a neuropathic offender, such as nerve compression; a structural offender, such as long-term effects of soft tissue damage and repair; or nociplastic, dysfunctional offenders, such as fibromyalgia. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Chronic Pain
What is being tested?
Behavior Change Coaching, Nutrition and Autonomic Recalibration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
30 Aug 2024to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Those experiencing chronic pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury).

Who cannot join

  • Those subjects seeking pharmaceutical intervention
  • Those whose myofascial pain is deemed functional (normal response to acute injury or ongoing pathology

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bill Pearson, PhD contact

334-442-4023

wpearson01@vcom.edu

United States1 site, 1 recruiting

  • Edward Via College of Osteopathic Medicine-Auburn

    Auburn, Alabama, 36832

    Bill Pearson, PhD, 334-442-4023, wpearson01@vcom.edu

    Recruiting

Other trials in United States

About this study

Official title: MERCI Chronic Pain Research Clinic (Medical Education and Research in Compassionate Integration/Intervention)

Studies estimate that 30% of people worldwide experience chronic pain. The mechanisms causing this pain can vary: a neuropathic offender, such as nerve compression; a structural offender, such as long-term effects of soft tissue damage and repair; or nociplastic, dysfunctional offenders, such as fibromyalgia. The type of pain experienced influences diagnostic and treatment choice. In theory, there's a significant blending of these pain types within individuals and across patients, leading many specialists to view pain classification as a spectrum. Multidisciplinary pain management (MPM) is a standard model for addressing and treating different mechanisms of chronic pain using multiple interventions from different disciplines. Although many clinics employing these strategies have resulted in positive and clinically effective outcomes, the creation and implementation of such facilities have not been widespread. With increasing focus on psychosocial factors that impact pain in conjunction with structural and biomechanical offenders, a need for a whole-person, integrated approach to chronic pain management is needed. We propose an observational study to gather data that will inform the design, implementation, and operation of such a chronic pain research clinic.

Conditions
Chronic Pain
Being tested
Behavior Change Coaching, Nutrition, Autonomic Recalibration, Dry Needling, Osteopathic Manipulative Treatment
Keywords
Autonomic Dysfunction, Sympathetic Dominance, Osteopathic Manipulative Treatment, Dry Needling, Nutrition, Lifestyle, Group Therapy, Therapy, Trauma, Flourishing
Medical subject headings
Chronic Pain, Primary Dysautonomias, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavior Change CoachingBehavioural

    Done by Dr. Hollingsworth or students via consultations with participants. Participant's health behavior aspirations or target outcomes will be clarified, informed by the participant's interactions with other MERCI providers. Behaviors that move the participant towards their aspirations/outcomes will be explored to find target behaviors that the participant is motivated and able to do. Target behaviors and supporting habits will be designed into the participant's existing routine. The Fogg Behavior Model will be used 1) to find the participant's primary motivation for engaging in target behaviors and 2) to make target behaviors easier to do. Implementation intentions - When/then or If/then plans - will be used to form habits and promote behavior engagement. Adopting a growth mindset will also be discussed. Subsequent consultations will focus on troubleshooting, iterative improvements, and incorporation of new aspirations/outcomes, target behaviors, and supporting habits.

  • NutritionBehavioural

    Nutrition: The nutrition intervention will be conducted as a 12-week protocol with assessment points at baseline, 1 month, and 3 months. Following consent, eligible participants will work through a self-taught educational module detailing the anti-inflammatory dietary program. Once the module is completed, participants will be scheduled for one-on-one counseling sessions with a Registered Dietitian or a supervised Dietetic Intern or Medical Student on the research team to receive personalized guidance on implementation of the dietary intervention. A dietary recall will be conducted via the automated self-administered dietary assessment tool (ASA24®), which takes about 20 minutes to complete. This survey will be conducted on two non-consecutive days at each timepoint (baseline, 1 month, and 3 months).

  • Autonomic RecalibrationOther

    Participant will be outfitted with the Empatica wrist sensor. An initial history to rule out 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. The pattern of sympathetic dominance 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. Day 2 is the same until the initial history and r/o. Here, the history is from the previous day, asking about perception of pain, sleep, digestion, or other pertinent issues brought up on the first visit. Treatment proceeds same as Day 1. Any emotional tags to trigger points are identified and acknowledged. Subjects may be scheduled for follow-up visits if their pain persists.

  • Dry NeedlingProcedure or surgery

    An initial history to document a chief complaint relevant to pain is conducted and to identify and potential contraindications (infection of overlying skin, patient on anticoagulation drugs, 1st trimester of pregnancy, etc.) A physical exam is performed to identify the trigger points causing pain. The subject is educated about the risks/benefits/indications and alternative treatments. The subject is also educated about dry needling aftercare. The skin over the trigger points is cleaned with 70% isopropyl alcohol. The pertinent trigger points are treated with dry needling (95% of time), direct inhibition (2 - 3% of time) or injection of 1% lidocaine in a fan-like fashion (1 - 2 % of the time). Subject is assessed for any bleeding. An office note, including a procedure note, is documented in the subject's record. Subject is scheduled for additional follow-up meeting.

  • Osteopathic Manipulative TreatmentOther

    Osteopathic Manipulative Treatment: After inform and consent process, the subject will enter patient room and meet with Dr. Hayes, who will conduct a brief history of patient pain, injuries, and procedures. Subjects will be asked to wear, or change into, athletic shorts or a tank top or loose-fitting T-shirt to facilitate treatment. Subject will undergo a brief somatic dysfunction screen, which involves light tough and manipulation. Once Hayes has diagnosed potential dysfunctions, he will proceed with osteopathic manipulative treatment. Treatment will last anywhere from 15 minutes to 1 hour. At the end of the treatment, subjects will be scheduled for a follow-up visit.

  • Counseling PsychologyBehavioural

    Psychoeducation Workshop and Counseling: The psychoeducational group intervention will be done according to the standardized Empowered Relief (Darnall et al., 2024) protocol. Empowered Relief is a single-session, 2-hour group workshop (online or in person) that teaches participants pain neuroscience education, mindfulness principles, and cognitive-behavioral skills. During the program, participants will complete a personalized plan to work toward pain relief. This program requires a certified instructor; Marilyn Cornish (Co-I), a licensed psychologist, is certified. After completion, participants can attend up to 4 individual counseling sessions with a counseling psychology doctoral student (supervised by Marilyn Cornish). Sessions will be approximately 50-60 minutes and will occur every other week. Specific in-session interventions will be tailored to the participant's unique needs but will focus on participants' pain relief plan and overall psychological wellbeing of participants.

  • Multiple TreatmentsOther

    Subjects receiving multiple treatment interventions over the same period of time.

    Example: A subject joins the Osteopathic Manipulative Treatment group and meets with Dr. Hayes for treatment visits. At the same time, they are meeting with Dr. Kirby in a separate visit (or at the same time, if scheduling allows) to discuss Nutrition. Any subjects who were in multiple/overlapping treatment groups will fit this description.

Study groups in NCT06533345
Study groupRoleWhat they receive
Osteopathic Manipulative TreatmentExperimentalOsteopathic Manipulative Treatment
Receives: Other: Osteopathic Manipulative Treatment
Dry NeedlingExperimentalDry Needling
Receives: Procedure: Dry Needling
Autonomic RecalibrationExperimentalAutonomic Recalibration
Receives: Other: Autonomic Recalibration
NutritionExperimentalNutrition
Receives: Behavioral: Nutrition
Behavior Change CoachingExperimentalBehavior Change Coaching
Receives: Behavioral: Behavior Change Coaching
Counseling PsychologyExperimentalCounseling Psychology
Receives: Behavioral: Counseling Psychology
MultipleExperimentalMultiple
Receives: Behavioral: Behavior Change Coaching; Behavioral: Nutrition; Other: Autonomic Recalibration; Procedure: Dry Needling; Other: Osteopathic Manipulative Treatment; Behavioral: Counseling Psychology; Other: Multiple Treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity (NRS Pain Scale)

    0-10 Pain Rating. 0=no pain to 10=pain as intense as you can imagine

    Measured: Beginning of each Visit through study completion, an average (anticipated) of 6 months

  2. PROMIS (Pain Interference, SF4a)

    Pain interference survey. Answers range from "Not at all" to "Very Much" when relating to the impact of pain on daily life.

    Measured: Beginning of each Visit through study completion, an average (anticipated) of 6 months

  3. Use of analgesics (QAQ-Quantitative Analgesic Questionnaire)

    Survey listing all medications taken for pain. All types are converted in equivalent doses of morphine and scored.

    Measured: Beginning of each Visit through study completion, an average (anticipated) of 6 months

  4. Human Flourishing (Secure Flourishing Index)

    Measure of Human Flourishing across 6 Domains. Scores range from 0-10 with lower scores indicating lower flourishing and higher scores indicating higher flourishing.

    Measured: Beginning of each Visit through study completion, an average (anticipated) of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start30 Aug 2024
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Crossover
Model description
This research is a prospective longitudinal observational study to gather preliminary data for a future Sequential Multiple Assignment Randomized Trial (SMART).
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06533345
Sponsor's protocol ID
2024--061
Acronym
MERCI
Status last verified
Feb 2026
First submitted
19 Jul 2024
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuntz JL, Young DR, Saelens BE, Frank LD, Meenan RT, Dickerson JF, Keast EM, Fortmann SP. Validity of the Exercise Vital Sign Tool to Assess Physical Activity. Am J Prev Med. 2021 Jun;60(6):866-872. doi: 10.1016/j.amepre.2021.01.012. Epub 2021 Mar 27.

    PubMed 33781618

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • Barkham, Michael, Bewick, Bridgette, Mullin, Tracy, Gilbody, Simon, Connell, Janice, Cahill, Jane, Mellor-Clark, John, Richards, David, Unsworth, Gisela, Evans, Chris, (2013), The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research, 13 doi: 10.1080/14733145.2012.729069.

  • Sullivan, M. J. L., Bishop, S. R., & Pivik, J. (1995). The Pain Catastrophizing Scale: Development and validation. Psychological Assessment, 7(4), 524-532. https://doi.org/10.1037/1040-3590.7.4.524

  • Hooper, L. M., Stockton, P., Krupnick, J., & Green, B. L. (2011). The development, use, and psychometric properties of the Trauma History Questionnaire. Journal of Loss and Trauma, 16, 258-283.

  • Jensen, Mark P., Hypnosis for Chronic Pain Management: Therapist Guide, Treatments That Work (New York, 2011; online edn, Oxford Academic, 1 Apr. 2015), https://doi.org/10.1093/med:psych/9780199772377.001.0001, accessed 12 Mar. 2024.

  • Robinson-Papp J, George MC, Wongmek A, Nmashie A, Merlin JS, Ali Y, Epstein L, Green M, Serban S, Sheth P, Simpson DM. The Quantitative Analgesic Questionnaire: A Tool to Capture Patient-Reported Chronic Pain Medication Use. J Pain Symptom Manage. 2015 Sep;50(3):381-6. doi: 10.1016/j.jpainsymman.2015.03.013. Epub 2015 Apr 23.

    PubMed 25912277

  • Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.

    PubMed 20554116

  • Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.

    PubMed 9635069

  • Edwards LC, Pearce SA, Turner-Stokes L, Jones A. The Pain Beliefs Questionnaire: an investigation of beliefs in the causes and consequences of pain. Pain. 1992 Dec;51(3):267-272. doi: 10.1016/0304-3959(92)90209-T.

    PubMed 1491853

  • Vartiainen P, Heiskanen T, Sintonen H, Roine RP, Kalso E. Health-related quality of life change in patients treated at a multidisciplinary pain clinic. Eur J Pain. 2019 Aug;23(7):1318-1328. doi: 10.1002/ejp.1398. Epub 2019 May 3.

    PubMed 30980782

  • Kress HG, Aldington D, Alon E, Coaccioli S, Collett B, Coluzzi F, Huygen F, Jaksch W, Kalso E, Kocot-Kepska M, Mangas AC, Ferri CM, Mavrocordatos P, Morlion B, Muller-Schwefe G, Nicolaou A, Hernandez CP, Sichere P. A holistic approach to chronic pain management that involves all stakeholders: change is needed. Curr Med Res Opin. 2015;31(9):1743-54. doi: 10.1185/03007995.2015.1072088. Epub 2015 Aug 20.

    PubMed 26172982

  • Asmundson GJ, Katz J. Understanding the co-occurrence of anxiety disorders and chronic pain: state-of-the-art. Depress Anxiety. 2009;26(10):888-901. doi: 10.1002/da.20600.

    PubMed 19691031

  • Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. Lancet. 2021 May 29;397(10289):2082-2097. doi: 10.1016/S0140-6736(21)00393-7.

    PubMed 34062143

Questions about this trial

What is this clinical trial studying?

A study testing Behavior Change Coaching, Nutrition and Autonomic Recalibration in people with Chronic Pain, 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 2 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bill Pearson, PhD (334-442-4023, wpearson01@vcom.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (NRS Pain Scale) (time frame: Beginning of each Visit through study completion, an average (anticipated) of 6 months). The study lists 4 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 NCT06533345, which also lists 22 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 20 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
VCOM Pain Free Research Collaborative (NCT06533345) | AzTrials