- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02426476
HRV Biofeedback in Pain Patients (HRVB-PP)
HRV Biofeedback in Pain Patients: Pilot Intervention for Pain, Fatigue & Sleep
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study fulfills the national Veterans Health Administration/Department of Defense (VHA/DoD) Task Force recommendation that complementary, integrative therapies for pain management be provided to Veterans. Chronic pain elicits stress which increases sympathetic output fostering autonomic nervous system imbalance, an overextended stress response, fatigue, depression and insomnia. Heart Rate Variability (HRV) is a measure of the interplay between the sympathetic and parasympathetic nervous systems, and thus is a useful and easily-measured index of autonomic balance that has a relationship to chronic pain effects. HRV biofeedback (HRV-B) is a novel, biobehavioral procedure that restores normal autonomic balance. Through HRV-B, patients increase parasympathetic cardiac output and restore autonomic balance via induction of 'HRV coherence'. The investigators' pilot study indicated that HRV-B produced coherence and alleviated self-reported ratings of chronic pain and stress among Veterans attending the investigators' Pain Clinic. The proposed clinical intervention will further test hypotheses that HRV-B increases HRV coherence, reduces self-reported pain, stress, depression, fatigue, and insomnia, and improves cognition among Veterans with chronic pain.
The specific aims are to: (1) conduct a randomized, sham-controlled, pilot intervention trial to determine whether HRV-B increases HRV coherence among chronic pain patients (n=40 each for the HRV-B and sham treatment groups; total N=80 patients); (2) determine whether HRV-B reduces self-reported pain and stress among chronic pain patients. The primary endpoints include HRV coherence, pain (Brief Pain Inventory or BPI),and stress (Perceived Stress Scale or PSS)
Outcomes will be measured at 4 time points. pre-training; post-training, one week after the 6 weekly treatments are over; at 4 weeks follow-up after post-training, and at an 8-week post-training follow-up (total time of participation is 16 weeks from pre-training to 8 week follow-up).
Furthermore, chronic stress is associated with disrupted circadian rest/activity rhythms and domains of quality of life (QoL) including fatigue, insomnia, and reduced physical and social functioning. Interventions that relieve pain thus represent a novel therapeutic target for normalizing dysfunctional rest/activity rhythms and these QoL domains among pain patients. The investigators are also interested in assessing the effects of HRV-B on cognitive function in pain patients. Thus, the investigators' secondary exploratory objectives are to determine if HRV-B: (1) improves sleep and rest/activity rhythms; (2) alleviates self-reported fatigue and depression; and (3) improves cognitive function (reaction time, attention). Circadian endpoints will be measured as actigraphic parameters of sleep (e.g., duration, efficiency), and rest/activity (e.g., dichotomy index, interdaily stability), and with the Insomnia Symptom Questionnaire (ISQ); fatigue will be assessed using the Multi-Dimensional Fatigue Inventory (MFI), which assesses general physical and mental fatigue and motivation. Depression will be assessed via the Beck Depression Inventory II (BDI-II). Cognitive function will be measured with a cognitive battery comprised of the Paced Auditory Serial Addition Test (PASAT), the Rey Auditory Verbal Learning Test (RAVLT), and the Psychomotor Vigilance Test (PVT).
Proposed Intervention. HRV-B training will follow a previously established, standardized protocol. The primary (HRV coherence, pain, stress) and exploratory outcomes (insomnia, fatigue, depression, cognition). Outcomes will be assessed at 4 time points: pre-training; post-training, one week after the 6 weekly treatments are over; at 4 weeks follow-up after post-training, and at an 8-week post-training follow-up (total time of participation is 16 weeks from pre-training to 8 week follow-up). There will be no HRV-B training at the 8 week follow-up, only assessment. Standardized procedures will characterize HRV coherence and other frequency- or time-domain HRV measures, and validated instruments will be used to assess pain and stress. Wrist actigraphy will characterize insomnia via continuous, 24-hour/day personal monitoring of rest/activity rhythms at 1-week intervals coinciding with the baseline pre-training (baseline), post-training, and 8-week follow-up assessments. The investigators will provide portable data-logging devices for practicing HRV-B at home. Sham intervention subjects will have pulse and respiration monitored but not receive active training; instead they will view a static, relaxing nature picture on a computer screen.
The investigators will control false discovery rates at 5%. Analyses will be based on intent to treat with two-sided tests. The effect of HRV-B on coherence and other HRV variables will be analyzed using linear mixed models for repeated measures data from sequential time assessments, and a between-subjects factor to evaluate the intervention after adjusting for potential confounding factors (e.g., age, standard therapy, medications, co-morbid disease). Baseline relationships between HRV and endpoints will be examined using multiple regression models. Few studies have examined the multivariate relationship between pain, autonomic dysfunction, stress, depression, sleep, rest/activity rhythms, fatigue, and cognition.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
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Columbia, South Carolina, United States, 29209
- Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- are a Veteran between age 18 or older
- have chronic, non-malignant, neuro-musculoskeletal pain
Exclusion Criteria:
- a history of arrhythmia requiring medication or hospitalization
- a pacemaker or automatic implantable cardioverter-defibrillator
- a history of ischemic heart disease, heart transplant, cardiovascular surgery within 1 year
- congestive heart failure
- uncontrolled hypertension
- an active prescription for certain heart medications
- a history of seizures or use of antiseizure or anticonvulsant medication
- moderate or severe head injury or stroke
- evidence of active substance abuse or dependence (alcohol or tobacco use is not be an exclusion, participants will be asked to provide information about these behaviors in the investigators' questionnaire)
- a history of bipolar, psychotic, panic or obsessive-compulsive disorder (note: depression is an exclusion)
- cognitive impairment (dementia), neurocognitive deficits, or a central nervous system or neurological disorder (e.g., Gulf War Syndrome)
- a current or pending worker compensation claim or personal injury litigation related to the participants' symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: active HRVB training
Heart rate variability biofeedback training
|
resonant frequency breathing, attention focusing, positive emotional state
Other Names:
|
Sham Comparator: sham HRVB training
passive relaxation
|
passive relaxation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Interference Rating, Measured With the Brief Pain Inventory (BPI)
Time Frame: Baseline, Week 15 (Follow-up Assessment)
|
The BPI was developed by the World Health Organization (WHO) specifically for use among cancer patients, and it has since been widely adopted for assessment of clinical pain and pain treatment effectiveness in a variety of clinical and research settings.
The possible range is 0 to 10; higher scores represent more pain interference.
|
Baseline, Week 15 (Follow-up Assessment)
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Perceived Stress Scale (PSS)
Time Frame: Baseline, Week 15 (Follow-up Assessment)
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The perceived stress scale measures the degree to which situations in one's life are appraised as stressful.
Higher values correspond to more stress.
Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives.
The possible range is 0-40; higher values represent more stress.
|
Baseline, Week 15 (Follow-up Assessment)
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Heart Rate Variability Coherence Ratio
Time Frame: Baseline, Week 15 (Follow-up Assessment)
|
Heart rate variability coherence will allow for direct, quantitative assessment of participant performance and receipt of intervention.
The HRV Coherence Ratio is obtained by identifying the maximum peak in the 0.04-0.26
Hz range of the fast Fourier transformation of heart rate interbeat intervals, then calculating the integral in a window 0.030 Hz wide centered on the highest peak in that region ('peak power', usually ~0.1 Hz), then calculating the total power of the entire spectrum.
The HRV Coherence Ratio is then quantified as: peak power / (total power - peak power).
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Baseline, Week 15 (Follow-up Assessment)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James B Burch, Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CLNA-006-14F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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