Hyperventilation in Patients With Chronic Low Back Pain (HELBP)

Low back pain (LBP) is the leading cause of disability worldwide. Impaired postural control is a key factor in the development and maintenance of LBP. Moreover, the prevalence of LBP is associated with impairments in diaphragm function, symptoms of dyspnea, and dysfunctional breathing. However, the association between LBP (and more specifically postural control) and hyperventilation remains unknown. The main objective of this project is to investigate whether the presence of recurrent non-specific LBP is related to the presence of hyperventilation, when classified either objectively by decreased carbon dioxide values (demonstrating hypocapnia) or by symptoms while showing normal carbon dioxide values. Moreover, the investigators will explore whether psychosocial factors play a role in this relation. Subsequently, the investigators will examine whether hyperventilation in LBP patients is related to impaired postural control, and more specifically to a decreased postural contribution of the diaphragm.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain, Recurrent; Hyperventilation Syndrome
• Intervention / Treatment: Behavioral: assessment of hyperventilation, postural control and psychological behavior

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katleen Bogaerts, PhD, PT; Email: Katleen.Bogaerts@uhasselt.be
• Study Contact Backup: Name: Sofie Van Wesemael, MSc, PT; Phone Number: +32472771468; Email: sofie.vanwesemael@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3590
    • Recruiting
    • Hasselt University
    • Contact: Lotte Janssens, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria Patients:

• Chronic primary low back pain (>12 weeks) as diagnosed by a medical doctor

Inclusion Criteria Healthy controls:

• No low back pain

Exclusion Criteria:

• Insufficient understanding of Dutch language
• Previous spinal surgery
• Chronic Obstructive Lung Disease, Interstitial Lung Disease, pulmonary vascular disease, asthma except for exertional asthma
• Acute cardiovascular or gastrointestinal disorders
• Neuromuscular disease interfering with normal lower limb or trunk functioning
• Acute pain or secondary chronic pain
• Pregnant and lactating women
• Major psychiatric conditions
• Acute lower limb problems
• Vestibular disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Healthy controls	Behavioral: assessment of hyperventilation, postural control and psychological behavior; assessment of hyperventilation, postural control and psychological behavior
Active Comparator: Patients with low back pain	Behavioral: assessment of hyperventilation, postural control and psychological behavior; assessment of hyperventilation, postural control and psychological behavior

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nijmegen questionnaire	Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64	Day 1
Nijmegen questionnaire	Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64	Day 4
PetCO2	End-tidal carbon dioxide pressure measured with a capnograph	Day 1
Postural control	upright standing balance measured by center of pressure by force plate	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing frequency	amount of breaths per minute, inspiratory and expiratory time	Day 1
Breathing pattern (abominal and thoracic)	abdominal or thoracic contribution to one breath measured by respiratory inductance plethysmography	Day 1
Numerical Rating Scale for low back pain (NRS)	11 point Likert scale evaluating severity/intensity of back pain, ranging from 0 (no pain) to 11 (worst pain imaginable)	Day 1
Oswestry Disability Index version 2.1a (ODI-2.1a)	Questionnaire evaluating disability. 10 items Total score range from 0-100	Day 1
12-item Short form Health Survey (SF-12)	Questionnaire evaluating physical and mental components of health related quality of life. 12 items. Total score range 12-56.	Day 1
Fear Avoidance Component Scale (FACS)	Questionnaire evaluating fear-avoidance related to pain. 20 items Total score range from 0-100	Day 1
Tampa Scale for Kinesiophobia (TSK)	Questionnaire evaluating kinesiophobia related to pain. 17 items. Total score range from 17-68	Day 1
Pain Catastrophizing Scale (PCS)	Questionnaire evaluating catastrophizing. 13 items, 5 point Likert scale. Total score 0-52	Day 1
Need for Controllability and Predictability Questionnaire (NCP-Q)	Questionnaire evaluating the need for being able to control and predict situations. 15 items, 5 point Likert scale. Total score range 15 - 75	Day 1
Positive And Negative Affect Schedule (PANAS)	Questionnaire evaluating positive and negative affect. 10 items positive affect, 10 items negative affect, 5 point Likert scale. Total score range per affect: 10 - 50	Day 1
Pain Solutions Questionnaire (PaSoL)	Questionnaire evaluating assimilative and accommodative responses to problems associated with pain. 14 items, 7 point Likert scale. Total score range 0 - 84	Day 1
Toronto Alexithymia Scale 20 (TAS-20)	Questionnaire evaluating characteristics linked to alexithymia. 20 items, 3 factors. Total score range 20 - 100	Day 1
Interoceptive Awareness Questionnaire (IAQ)	Questionnaire evaluating adaptive and maladaptive body awareness. 19 items, 5 point Likert scale.	Day 1
Fremantle Back Awareness Questionnaire (FreBAQ)	Questionnaire evaluating back specific perceptual awareness. 9 items, 5 point Likert scale. Total score range 0-36	Day 1
Vragenlijst belastende ervaringen (VBE) - short version	Questionnaire evaluating aversive experiences in adult life. 11 items should be scored with yes or no. If yes a score on a 5 point Likert scale should be given.	Day 1
Multidimensional Perfectionism Scale (MPS)	Questionnaire evaluating adaptive and maladaptive perfectionism. 35 items, 5 point Likert scale. Total score range 35 - 175	Day 1
International Physical Activity Questionnaire - Short Form (IPAQ-SF)	Questionnaire evaluating subjective level of physical activity. 7 questions regarding amount of time spent on certain activities.	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	ECG measurement to determine heart rate variability	Day 1
Skin conductance	The resistance / conductance of the skin, stress physiological measure	Day 1
Activity of abdominal muscles	The amount of muscle activation measured by electromyography	Day 1

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: ZOL
• Investigators: Principal Investigator: Lotte Janssens, PhD, PT, Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Pain; Neurologic Manifestations; Signs and Symptoms, Respiratory; Back Pain; Low Back Pain; Hyperventilation
• Other Study ID Numbers: CME ZOL - CTU2019078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No