Relationship Between Chiropractic Care and Autonomic Nervous System Regulation

NCT05401903 | Completed

• 1 other identifier: 22-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

chiropractic; autonomic nervous system; healthy subjects

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  Using the WHOOP wearable technology, daily Heart Rate Variability calculated during sleep will be recorded and averaged by week

  Nine Weeks

Other Outcomes (7)

• Strain

  Nine Weeks

• Heart Rate

  Nine Weeks

• Calories Burned

  Nine weeks

Study Arms (2)

Chiropractic Maintenance Care

EXPERIMENTAL

The intervention group will receive weekly chiropractic care, in the form of high-velocity, low amplitude (HVLA) chiropractic adjustments delivered to restricted vertebrae of the cervical, thoracic and lumbar spinal segments. The intervention duration is 8 weeks. Subjects in the intervention group who do not attend at least four (4) scheduled chiropractic visits will be withdrawn from the study.

Other: Chiropractic Maintenance Care

Control

NO INTERVENTION

The control group will not receive any chiropractic care during study protocol.

Interventions

Chiropractic Maintenance Care OTHER

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.

Chiropractic Maintenance Care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males, Minimum age of 18 years and Maximum age of 40 years
• Subjects with access to a smart phone for use with the WHOOP app to allow for data tracking throughout the study.
• Subjects are willing to be randomized to either the experimental group, maintenance chiropractic care, or control group, no chiropractic care.
• Subjects are willing to not participate in other complementary and alternative medicine (CAM) therapies during the study period.

You may not qualify if:

• Females.
• Any diagnosed medical condition.
• Any prescription medication use.
• Have a pacemaker or other internal electronic device.
• Any acute musculoskeletal (MSK) injuries involving the back and upper and lower extremities (e.g., neck, mid-back, lower back, shoulder, elbow, wrist, hand, hip, knee, ankle, foot etc.).
• Any chronic MSK injuries involving the back and upper and lower extremities, (e.g., neck, mid-back, lower back, shoulder, elbow, wrist, hand, hip, knee, ankle, foot etc.).
• Any contraindications to receive high velocity-low amplitude (HVLA) chiropractic manipulations.

Sponsors & Collaborators

• Northeast College of Health Sciences: lead

Study Sites (1)

Jeanmarie R Burke

Seneca Falls, New York, 13148, United States

Location

Study Officials

• Jeanmarie Burke, PhD

  Northeast College of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Research and Faculty

Model Details: Pragmatic feasibility trial comparing the effects of chiropractic maintenance care versus a control group, no chiropractic care, on heart rate variability in healthy male adults.

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)