Use of heart rate variability biofeedback to predict and improve pain expectations and experiences in patients with chronic low back pain

Autonomic imbalance as a predictor of pain expectations and experience in chronic low back pain: a pilot study on the application of heart rate variability biofeedback in a mixed-methods design

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19147367

Enrollment

Registered

2024-11-25

Start date

2025-05-01

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic back pain Musculoskeletal Diseases

Interventions

All included study participants wear a study smartwatch that records their heart rate variability (HRV) and other health parameters (sleep quality, number of steps, heart rate) continuously for 24 hou

the participants do not receive any feedback on their measured health data. In addition, the study participants indicate their expected pain intensity in the morning and their subjectively experienced

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Minimum age of 18 years old 2. Back pain that has persisted for at least 12 weeks 3. Suffering due to back pain, operationalized by an SSD-12 sum score = 15 and a mean sum score of the visual analogue scales recommended by EURONET-SOMA on pain intensity and limitations =5 4. Provision of written informed consent to participate

Exclusion criteria

Exclusion criteria: 1. Insufficient knowledge of German 2. Acute need for treatment due to other comorbid mental disorders (inpatient treatment required) 2. Severe acute somatic back injury or a known cardiovascular (e.g. pacemaker) or pulmonary disease (e.g. COPD) 3. Presence of acute danger to oneself or others

Design outcomes

Primary

Measure	Time frame
Feasibility and acceptability of the intervention and study procedures throughout the study, measured using data on the recruitment rate, retention rate, adherence to HRV biofeedback sessions, compliance with smartwatch wear and daily pain assessments, and completeness of physiological and self-reported data, collected at the end of the study;Heart rate variability measured using the standard deviation of all NN intervals (SDNN), the root mean square of successive differences between normal heartbeats (RMSSD), the natural logarithm of high frequency (lnHF) and the natural logarithm of low frequency (lnLF) at baseline, two-week follow-up (T1), three-week follow-up (T2), four-week follow-up (T3), and five-week follow-up (T4);Previous primary outcomes as of 01/07/2026: Heart rate variability measured using the standard deviation of all NN intervals (SDNN), the root mean square of successive differences between normal heartbeats (RMSSD), the natural logarithm of high frequency (lnHF) and the natural logarithm of low frequency (lnLF) at baseline, two-week follow-up (T1), three-week follow-up (T2), four-week follow-up (T3), and five-week follow-up (T4)	—

Measure

Time frame

Feasibility and acceptability of the intervention and study procedures throughout the study, measured using data on the recruitment rate, retention rate, adherence to HRV biofeedback sessions, compliance with smartwatch wear and daily pain assessments, and completeness of physiological and self-reported data, collected at the end of the study;Heart rate variability measured using the standard deviation of all NN intervals (SDNN), the root mean square of successive differences between normal heartbeats (RMSSD), the natural logarithm of high frequency (lnHF) and the natural logarithm of low frequency (lnLF) at baseline, two-week follow-up (T1), three-week follow-up (T2), four-week follow-up (T3), and five-week follow-up (T4);Previous primary outcomes as of 01/07/2026: Heart rate variability measured using the standard deviation of all NN intervals (SDNN), the root mean square of successive differences between normal heartbeats (RMSSD), the natural logarithm of high frequency (lnHF) and the natural logarithm of low frequency (lnLF) at baseline, two-week follow-up (T1), three-week follow-up (T2), four-week follow-up (T3), and five-week follow-up (T4)

—

Secondary

Measure	Time frame
1. Pain expectancy measured using a numeric rating scale (0-10) daily in the morning for 5 weeks 2. Pain intensity measured using a numeric rating scale (0-10) daily in the evening for 5 weeks 3. Conceptualization of symptoms measured using the Bodily Symptoms Concepts Questionnaire post-study follow-up (one week after T4)	—

Countries

Germany

Contacts

Public ContactPaul Hüsing

p.huesing@uke.de+49 40 7410 53543

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026