The Effects of Chiropractic Care on Inflammation and Quality of Life in People Living With HIV

N/AActive Not RecruitingNCT07466836

Tyson Perez, DC, PhD10 enrolled

Overview

The main aim of this pilot trial is to investigate the feasibility of undertaking a randomized controlled trial involving adults living with HIV. Additionally, this trial will explore potential change differences in self-reported quality of life and blood-derived immune markers between a chiropractic care group and no treatment controls.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Human Immunodeficiency Virus (HIV)

Interventions

Chiropractic CarePROCEDURE

Full-spine Chiropractic Care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 or older * Medically confirmed HIV diagnosis * Willing to complete online surveys * Willing to share lab results * Willing to be randomized to either once weekly chiropractic care or a no treatment control condition Exclusion Criteria: * Participating in another clinical/behavioral trial related to HIV * Receiving chiropractic care elsewhere * Involved in litigation related to a physical, health-related injury * Has severe osteoporosis or recent spinal fracture

Locations (1)

Life University

Marietta, Georgia, United States

Outcomes

Primary Outcomes

Proportion of eligible individuals enrolled

The number of eligible individuals (i.e., people who pass the online screen) who enroll (i.e., sign the consent form), divided by the total number of eligible individuals. This assesses 'Enrollment'.

Time frame: From online screen submission to enrollment (up to 2 weeks).

Proportion of trial participants complying with instructions

The number of trial participants submitting the online assessments within the submission window, divided by the total number of trial participants. This assesses 'Compliance'.

Time frame: From enrollment to the end of participation (up to 6 months).

Proportion of chiropractic participants adhering to the care plan

The number of trial participants randomized to chiropractic care attending at least 90% of their scheduled chiropractic sessions, divided by the total number of trial participants randomized to chiropractic care. This assesses 'Adherence'.

Time frame: From enrollment to the end of participation (up to 6 months)

Proportion of chiropractic participants retained

The number of trial participants randomized to chiropractic care who complete the 3rd and final assessments, divided by the total number of trial participants randomized to chiropractic care.

Time frame: From enrollment to the end of the 6 month trial period

Proportion of control participants retained

The number of trial participants randomized to the control group who complete the 3rd and final assessments, divided by the total number of trial participants randomized to the control group.

Time frame: From enrollment to the end of the 6 month trial period

Secondary Outcomes

Change difference in the Short Form 12 Health Survey (SF-12)

Data from ClinicalTrials.gov

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Change difference in SF-12 scores between the chiropractic and control groups. The SF-12 is a validated, 12-item self-report designed to measure health-related quality of life (HRQoL). The SF-12 uses T-scores with a score of 50 representing the population mean.

Time frame: Baseline, 12 weeks, 24 weeks

Change difference in the General Pain Index (GPI)

Change difference in GPI scores between the chiropractic and control groups. The GPI is a validated, 6-item self-report that asks patients to rate how much pain has interfered with functioning across various aspects of life on a scale of 0 (completely able to function) to 10 (totally unable to function)

Time frame: Baseline, 12 weeks, 24 weeks

Change difference in CD4 count

Change difference in CD4 counts between the chiropractic and control groups. CD4 count is a lab test that measures the number of CD4 T-lymphocytes (also called "helper T-cells") in a cubic millimeter of blood.

Time frame: Baseline; 12 weeks; 24 weeks

Change difference in CD4/CD8 ratio

Change difference in CD4/CD8 ratios between the chiropractic and control groups. CD4/CD8 ratio is calculated by dividing the number of CD4 cells ("helper T-cells") in a cubic millimeter of blood by the number of CD8 cells ("killer T-cells") in a cubic millimeter of blood.

Time frame: Baseline; 12 weeks; 24 weeks

Change difference in C-Reactive Protein (CRP)

Change difference in CRP levels between the chiropractic and control groups. CRP is a marker of inflammation and a measure of the weight of a specific liver-produced protein found in a liter of blood (expressed as mg/L). Its levels rise significantly in the bloodstream in response to IL-6 signaling during infection, tissue injury, or chronic disease.

Time frame: Baseline; 12 weeks; 24 weeks

Change difference in Interleukin-6 (IL-6)

Change difference in IL-6 between chiropractic and control groups. IL-6 is a pro-inflammatory cytokine and a measure of the weight of a specific signaling protein found in a milliliter of blood (expressed as pg/mL). It acts as a primary messenger that triggers the liver to produce CRP and is used as an early marker of systemic immune activation, chronic inflammation, or "cytokine storms."

Time frame: Baseline; 12 weeks; 24 weeks