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Relationship Between Chiropractic Care and Autonomic Nervous System Regulation

NCT05401903 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-18

No results posted yet for this study

Summary

The objective for this study is to explore the utility of biometric devices to measure changes in heart rate variability (HRV) during chiropractic maintenance care. The study will use WHOOP wearable technology to measure HRV. Chiropractic maintenance care refers to regular visits to manage recurrent musculoskeletal pain and dysfunction \[1\]. Beyond managing pain and dysfunction, regular chiropractic visits may also promote improvements in homeostatic regulation of internal physiological conditions, but the evidence-based is lacking for these effects \[2\]. The hypothesis of this study is that chiropractic maintenance care may lead to an increase in HRV as compared to a control group that do not receive chiropractic care.

1. Eklund A, Jensen I, Lohela-Karlsson M, Hagberg J, Leboeuf-Yde C, Kongsted A, et al. The Nordic maintenance care program: Effectiveness of chiropractic maintenance care versus symptom-guided treatment for recurrent and persistent low back pain-a pragmatic randomized controlled trial. PLoS One. 2018;13:e0203029.
2. Kovanur Sampath K, Mani R, Cotter JD, Tumilty S. Measureable changes in the neuro-endocrinal mechanism following spinal manipulation. Med Hypotheses. 2015;85:819-24.

Conditions

  • Chiropractic Maintenance Care and Heart Rate Variability

Interventions

OTHER

Chiropractic Maintenance Care

Subjects will receive high-velocity, low amplitude (HVLA) chiropractic manipulations to areas of defined restriction in the upper cervical spine, thoracic spine, lumbar spine, and pelvis. The clinician will use motion palpation to determine spinal segments with joint restrictions. Subjects will schedule weekly chiropractic visits. The clinician will not use passive care modalities. The exclusions of passive modalities include heat and cold therapies, electric stimulation, massage, acupuncture, and cupping therapies. Subjects will be encouraged to maintain normal exercise activity levels throughout the study. The clinician will provide instructions on homecare exercises as needed to promote range of motion of spinal segments between chiropractic visits. A single clinician will deliver the HVLA chiropractic manipulations to ensure consistency of chiropractic care throughout the study.

Sponsors & Collaborators

  • Northeast College of Health Sciences

    lead OTHER

Principal Investigators

  • Jeanmarie Burke, PhD · Northeast College of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05401903 on ClinicalTrials.gov