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Clinical Trials/NCT06533345
NCT06533345
Recruiting
Not Applicable

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

Edward Via Virginia College of Osteopathic Medicine1 site in 1 country120 target enrollmentAugust 30, 2024

Overview

Phase
Not Applicable
Intervention
Osteopathic Manipulative Treatment
Conditions
Chronic Pain
Sponsor
Edward Via Virginia College of Osteopathic Medicine
Enrollment
120
Locations
1
Primary Endpoint
Pain Intensity (NRS Pain Scale)
Status
Recruiting
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2024
End Date
August 1, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William Pearson

Discipline Chair for Anatomy

Edward Via Virginia College of Osteopathic Medicine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Osteopathic Manipulative Treatment

Osteopathic Manipulative Treatment

Intervention: Osteopathic Manipulative Treatment

Dry Needling

Dry Needling

Intervention: Dry Needling

Autonomic Recalibration

Autonomic Recalibration

Intervention: Autonomic Recalibration

Nutrition

Nutrition

Intervention: Nutrition

Behavior Change Coaching

Behavior Change Coaching

Intervention: Behavior Change Coaching

Counseling Psychology

Counseling Psychology

Intervention: Counseling Psychology

Multiple

Multiple

Intervention: Osteopathic Manipulative Treatment

Multiple

Multiple

Intervention: Behavior Change Coaching

Multiple

Multiple

Intervention: Nutrition

Multiple

Multiple

Intervention: Autonomic Recalibration

Multiple

Multiple

Intervention: Dry Needling

Multiple

Multiple

Intervention: Counseling Psychology

Multiple

Multiple

Intervention: Multiple Treatments

Outcomes

Primary Outcomes

Pain Intensity (NRS Pain Scale)

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

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

PROMIS (Pain Interference, SF4a)

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

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

Use of analgesics (QAQ-Quantitative Analgesic Questionnaire)

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

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

Human Flourishing (Secure Flourishing Index)

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

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

Study Sites (1)

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