MedPath

VCOM Pain Free Research

Not Applicable
Recruiting
Conditions
Chronic Pain
Interventions
Other: Osteopathic Manipulative Treatment
Procedure: Dry Needling
Other: Autonomic Recalibration
Behavioral: Nutrition
Behavioral: Behavior Change Coaching
Behavioral: Counseling Psychology
Other: Multiple Treatments
Registration Number
NCT06533345
Lead Sponsor
Edward Via Virginia College of Osteopathic Medicine
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
120
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
MultipleMultiple TreatmentsMultiple
Osteopathic Manipulative TreatmentOsteopathic Manipulative TreatmentOsteopathic Manipulative Treatment
Dry NeedlingDry NeedlingDry Needling
Autonomic RecalibrationAutonomic RecalibrationAutonomic Recalibration
NutritionNutritionNutrition
Behavior Change CoachingBehavior Change CoachingBehavior Change Coaching
Counseling PsychologyCounseling PsychologyCounseling Psychology
MultipleBehavior Change CoachingMultiple
MultipleNutritionMultiple
MultipleAutonomic RecalibrationMultiple
MultipleDry NeedlingMultiple
MultipleOsteopathic Manipulative TreatmentMultiple
MultipleCounseling PsychologyMultiple
Primary Outcome Measures
NameTimeMethod
Pain Intensity (NRS Pain Scale)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)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)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)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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Edward Via College of Osteopathic Medicine-Auburn

🇺🇸

Auburn, Alabama, United States

© Copyright 2025. All Rights Reserved by MedPath