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HRV Biofeedback in Pain Patients (HRVB-PP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426476
Recruitment Status : Active, not recruiting
First Posted : April 27, 2015
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
University of South Carolina
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Pain initiates a stress response that increases sympathetic output and leads to autonomic imbalance. Heart rate variability (HRV) is a easy to perform, valid measure of autonomic function. HRV biofeedback (HRV-B) is a novel biobehavioral procedure in which patients learn to restore autonomic balance by developing 'HRV Coherence'. Patients in HRV Coherence have improved mood and cognition. The investigators' pilot study showed that HRV-B alleviated chronic pain and stress among Veteran Pain Clinic patients. HRV-B thus has a pivotal role in managing pain. The proposed project is a randomized, sham-controlled, biobehavioral intervention with HRV-B to test the hypotheses that HRV-B increases HRV coherence and reduces pain, stress, fatigue, insomnia and depression and improves sleep, activity, and cognition in Veterans with chronic neuromuscular pain. The investigators hypothesize that HRV-B will (1) reduce self-reported pain and stress ratings, (2) improve objective measures of actigraphic sleep parameters (sleep latency, duration, efficiency, fragmentation), rest/activity rhythms (dichotomy index, interdaily stability) and cognitive function (reaction time, attention); and (3) alleviate self-reported fatigue and depression symptoms. Patients from two groups will be randomized to the investigators' previously established HRV-B or sham protocol (n=40 each), and will complete a baseline assessment, 6 weekly training sessions, a post-training assessment, and 4-week and 8-week follow-up evaluations post-training. Portable, hand-held, data-logging devices will be used to practice attaining HRV coherence at home by the active HRV-B training group, while those in the sham training group will get a 'stress squeeze ball'. Standard methods will quantify HRV coherence and other HRV measures, and validated instruments will be used to assess pain, stress, fatigue, insomnia, depression, and cognitive function. Wrist actigraphy will be used to objectively characterize insomnia via continuous recordings collected 24-hrs/day over three 1-week periods (pre-training, post-training, and at the 4 week follow-up assessments. Tests measuring attention and reaction time will assess changes in cognitive performance. Data analyses will apply linear models for repeated measures to evaluate the effect of HRV-B on study outcomes, and on treatment persistence, after adjusting for confounding factors. This study will be the first to examine HRV-B for pain management among Veteran chronic pain patients.

Condition or disease Intervention/treatment Phase
Chronic Neuromuscular Pain Behavioral: active heart rate variability biofeedback training Behavioral: sham HRVB training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HRV Biofeedback in Pain Patients: Pilot Intervention for Pain, Fatigue & Sleep
Actual Study Start Date : June 10, 2015
Actual Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: active HRVB training
Heart rate variability biofeedback training
Behavioral: active heart rate variability biofeedback training
resonant frequency breathing, attention focusing, positive emotional state
Other Name: a-HRVB

Sham Comparator: sham HRVB training
passive relaxation
Behavioral: sham HRVB training
passive relaxation
Other Name: s-HRVB




Primary Outcome Measures :
  1. Pain rating, measured with the Brief Pain Inventory (BPI) [ Time Frame: total time of participation is 16 weeks ]
    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.

  2. Preceived Stress Scale (PSS) [ Time Frame: total time of participation is 16 weeks ]

    It measures the degree to which situations in one's life are appraised as stressful.

    Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.


  3. HRV Coherence [ Time Frame: total time of participation is 16 weeks ]
    HRV coherence will allow for direct, quantitative assessment of participant performance and receipt of intervention.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426476


Locations
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United States, South Carolina
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, United States, 29209
Sponsors and Collaborators
VA Office of Research and Development
University of South Carolina
Investigators
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Principal Investigator: James B Burch Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02426476    
Other Study ID Numbers: CLNA-006-14F
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
heart rate variability
biofeedback
chronic pain
Veterans