Relationship Between Chiropractic Care and Autonomic Nervous System Regulation

• ClinicalTrials.gov Identifier: NCT05401903
• Recruitment Status: Active, not recruiting
• First Posted: June 2, 2022
• Last Update Posted: September 15, 2022
• Sponsor: Northeast College of Health Sciences
• Information provided by (Responsible Party): Jeanmarie R. Burke, PhD, Northeast College of Health Sciences

Tracking Information

• First Submitted Date: May 29, 2022
• First Posted Date: June 2, 2022
• Last Update Posted Date: September 15, 2022
• Actual Study Start Date: June 1, 2022
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 29, 2022)

Heart Rate Variability [ Time Frame: Nine Weeks ]

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: May 29, 2022)

• Strain [ Time Frame: Nine Weeks ]
  Using the WHOOP, daytime Strain will be recorded daily and averaged by week
• Heart Rate [ Time Frame: Nine Weeks ]
  Using the WHOOP wearable technology, heart rate during sleep, upon waking, during activities of daily living and during exercise will be extracted from the daily heart rate profile. Average heart rate and maximum heart rate will be recorded during each defined interval on a daily basis and averaged by week.
• Calories Burned [ Time Frame: Nine weeks ]
  Using the WHOOP wearable technology, daytime calories will be recorded and averaged by week
• Sleep [ Time Frame: Nine weeks ]
  Using the WHOOP wearable technology, daily hours of sleep will be recorded and averaged by week
• Respiratory Rate [ Time Frame: Nine weeks ]
  Using the WHOOP wearable technology, daily respiratory rate (median) during sleep will be recorded and averaged by week.
• Blood Oxygen Level [ Time Frame: Nine weeks ]
  Using the WHOOP wearable technology, daily blood oxygen levels during sleep will be recorded and averaged by week.
• Lifestyle Behaviors [ Time Frame: Nine weeks ]
  Using the WHOOP Journal, self-reported changes in nutrition, activities of daily living, exercise training schedules, and the use of complementary and alternative therapies. Completed daily. Qualitative review to detect any major changes in lifestyle behaviors during the study period.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Chiropractic Maintenance Care and Heart Rate Variability

Intervention

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.

Study Arms

• Experimental: Chiropractic Maintenance Care
  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.
  Intervention: Other: Chiropractic Maintenance Care
• No Intervention: Control
  The control group will not receive any chiropractic care during study protocol.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 14, 2022): 10
• Original Estimated Enrollment (submitted: May 29, 2022): 20
• Estimated Study Completion Date: May 2023
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05401903
• Other Study ID Numbers: 22-02
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jeanmarie R. Burke, PhD, Northeast College of Health Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Northeast College of Health Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jeanmarie Burke, PhD; Northeast College of Health Sciences

• PRS Account: Northeast College of Health Sciences
• Verification Date: September 2022