VCOM Pain Free Research Collaborative

NCT06533345 | Recruiting

• 1 other identifier: 2024--061
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Autonomic Dysfunction; Sympathetic Dominance; Osteopathic Manipulative Treatment; Dry Needling; Nutrition; Lifestyle; Group Therapy; Therapy; Trauma; Flourishing

Outcome Measures

Primary Outcomes (4)

• Pain Intensity (NRS Pain Scale)

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

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

• 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.

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

• 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.

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

• 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.

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

Study Arms (7)

Osteopathic Manipulative Treatment

EXPERIMENTAL

Osteopathic Manipulative Treatment

Other: Osteopathic Manipulative Treatment

Dry Needling

EXPERIMENTAL

Dry Needling

Procedure: Dry Needling

Autonomic Recalibration

EXPERIMENTAL

Autonomic Recalibration

Other: Autonomic Recalibration

Nutrition

EXPERIMENTAL

Nutrition

Behavioral: Nutrition

Behavior Change Coaching

EXPERIMENTAL

Behavior Change Coaching

Behavioral: Behavior Change Coaching

Counseling Psychology

EXPERIMENTAL

Counseling Psychology

Behavioral: Counseling Psychology

Multiple

EXPERIMENTAL

Multiple

Behavioral: Behavior Change Coaching; Behavioral: Nutrition; Other: Autonomic Recalibration; Procedure: Dry Needling; Other: Osteopathic Manipulative Treatment; Behavioral: Counseling Psychology; Other: Multiple Treatments

Interventions

Behavior Change Coaching BEHAVIORAL

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.

Behavior Change Coaching; Multiple

Nutrition BEHAVIORAL

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).

Multiple; Nutrition

Autonomic Recalibration OTHER

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.

Autonomic Recalibration; Multiple

Dry Needling PROCEDURE

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.

Dry Needling; Multiple

Osteopathic Manipulative Treatment OTHER

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.

Multiple; Osteopathic Manipulative Treatment

Counseling Psychology BEHAVIORAL

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.

Counseling Psychology; Multiple

Multiple Treatments OTHER

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.

Multiple

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead

Study Sites (1)

Edward Via College of Osteopathic Medicine-Auburn

Auburn, Alabama, 36832, United States

RECRUITING

Related Publications (22)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Primary Dysautonomias; Wounds and Injuries

Interventions

Nutritional Status; Dry Needling; Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Musculoskeletal Manipulations; Rehabilitation

Central Study Contacts

Bill Pearson, PhD

CONTACT

334-442-4023; wpearson01@vcom.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Discipline Chair for Anatomy

Model Details: This research is a prospective longitudinal observational study to gather preliminary data for a future Sequential Multiple Assignment Randomized Trial (SMART).

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 1, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)