Clinical trial NCT06533345: VCOM Pain Free Research
Official title: MERCI Chronic Pain Research Clinic (Medical Education and Research in Compassionate Integration/Intervention)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Autonomic Dysfunction
Sympathetic Dominance
Osteopathic Manipulative Treatment
Dry Needling
Nutrition
Lifestyle
Group Therapy
Therapy
Trauma
Flourishing
Lead sponsor: Edward Via Virginia College of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This research is a prospective longitudinal observational study to gather preliminary data for a future Sequential Multiple Assignment Randomized Trial (SMART).
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain Intensity (NRS Pain Scale)
timeFrame: Beginning of each Visit through study completion, an average (anticipated) of 6 months
measure: PROMIS (Pain Interference, SF4a)
timeFrame: Beginning of each Visit through study completion, an average (anticipated) of 6 months
measure: Use of analgesics (QAQ-Quantitative Analgesic Questionnaire)
timeFrame: Beginning of each Visit through study completion, an average (anticipated) of 6 months
measure: Human Flourishing (Secure Flourishing Index)
timeFrame: Beginning of each Visit through study completion, an average (anticipated) of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Edward Via College of Osteopathic Medicine-Auburn
state: Alabama
Study officials:
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