Clinical trial NCT05401903: Relationship Between Chiropractic Care and Autonomic Nervous System Regulation
Official title: Measurement of Heart Rate Variability During Chiropractic Maintenance Care: Relationship Between Chiropractic Care and Autonomic Nervous System Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chiropractic Maintenance Care and Heart Rate Variability
Keywords: chiropractic
autonomic nervous system
healthy subjects
Lead sponsor: Northeast College of Health Sciences
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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. 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.

Detailed description: The study design is a pragmatic feasibility trial comparing the effects of chiropractic maintenance care versus a control group, no chiropractic care, on heart rate variability (HRV) in healthy male adults. The subjects in both groups will be healthy controls as the purpose of the study is to determine beneficial effects, if any, of chiropractic maintenance care on physiological function as opposed to pain management. The theoretical framework suggests a potential role of chiropractic maintenance care in the prevention of segmental dysfunction in the spine and cascading neuro-endocrine responses to biomechanical stress of the spinal segments, hypomobility \[1, 2\].

Chiropractic maintenance care will be for a duration of 8 weeks with subjects scheduled for one visit per week. Control subjects will be asked to refrain from chiropractic care for 8 weeks. All subjects will be asked to maintain the current status of their lifestyle behaviors for the duration of the study period, e.g. do not change diet or exercise training schedules. Using the WHOOP wearable technology to record daily HRV, the primary outcome is the weekly average of HRV. There will be a baseline week of HRV recordings prior to starting the intervention phase of the study. An increase in HRV of at least 6.5% from baseline to 8 weeks without a concomitant change in the control group will provide preliminary insights on chiropractic maintenance care and regulation of autonomic nervous system functions. As this is a feasibility study to explore the utility of biometric devices to measure changes in HRV during chiropractic maintenance care, sample size is limited to 20 subjects.

The 20 subjects will be healthy male adults from 18 to 40 years old. Given the small sample size. females are being excluded to avoid any confounding effects of menstrual cycle on the measurement of HRV. The summary of the evidence to date indicates medium to large effects in fluctuations of HRV across the menstrual cycle \[3\]. The study design will include simple randomization of subjects into chiropractic maintenance care or control group. 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. Motion palpation of the spine will be used to identify restricted vertebrae of the cervical, thoracic and lumbar spinal segments. Subjects in the intervention group who do not attend at least four (4) scheduled chiropractic visits will be withdrawn from the study. Subjects in the control group who receive more than two (2) chiropractic treatments (visits) will be withdrawn from the study. Subjects in either group who receive more than two (2) other complementary and alternative (CAM) therapies (visits) will be withdrawn from the study.

1. 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.
2. Sampath KK, Botnmark E, Mani R, Cotter JD, Katare R, Munasinghe PE, et al. Neuroendocrine response following a thoracic spinal manipulation in healthy men. J Orthop Sports Phys Ther. 2017;47:617-27.
3. Schmalenberger KM, Eisenlohr-Moul TA, Würth L, Schneider E, Thayer JF, Ditzen B, et al. A systematic review and meta-analysis of within-person changes in cardiac vagal activity across the menstrual cycle: Implications for female health and future studies. J Clin Med. 2019;8.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Females.
2. Any diagnosed medical condition.
3. Any prescription medication use.
4. Have a pacemaker or other internal electronic device.
5. 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.).
6. 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.).
7. Any contraindications to receive high velocity-low amplitude (HVLA) chiropractic manipulations.

Primary outcomes:
measure: Heart Rate Variability
timeFrame: Nine Weeks
Secondary outcomes:
Other outcomes:
measure: Strain
timeFrame: Nine Weeks
measure: Heart Rate
timeFrame: Nine Weeks
measure: Calories Burned
timeFrame: Nine weeks
measure: Sleep
timeFrame: Nine weeks
measure: Respiratory Rate
timeFrame: Nine weeks
measure: Blood Oxygen Level
timeFrame: Nine weeks
measure: Lifestyle Behaviors
timeFrame: Nine weeks
Locations:
city: Seneca Falls
country: United States
facility: Jeanmarie R Burke
state: New York
Study officials:
affiliation: Northeast College of Health Sciences
name: Jeanmarie Burke, PhD
role: STUDY_DIRECTOR
References: