Clinical trial NCT04074798: Hyperventilation in Patients With Chronic Low Back Pain
Official title: Hyperventilation in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Recurrent
Hyperventilation Syndrome
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: ZOL
First posted: 2019-08-30
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with low back pain are compared to patients without low back pain (healthy controls).
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Nijmegen questionnaire
timeFrame: Day 1
measure: Nijmegen questionnaire
timeFrame: Day 4
measure: PetCO2
timeFrame: Day 1
measure: Postural control
timeFrame: Day 1
Secondary outcomes:
measure: Breathing frequency
timeFrame: Day 1
measure: Breathing pattern (abominal and thoracic)
timeFrame: Day 1
measure: Numerical Rating Scale for low back pain (NRS)
timeFrame: Day 1
measure: Oswestry Disability Index version 2.1a (ODI-2.1a)
timeFrame: Day 1
measure: 12-item Short form Health Survey (SF-12)
timeFrame: Day 1
measure: Fear Avoidance Component Scale (FACS)
timeFrame: Day 1
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Day 1
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Day 1
measure: Need for Controllability and Predictability Questionnaire (NCP-Q)
timeFrame: Day 1
measure: Positive And Negative Affect Schedule (PANAS)
timeFrame: Day 1
measure: Pain Solutions Questionnaire (PaSoL)
timeFrame: Day 1
measure: Toronto Alexithymia Scale 20 (TAS-20)
timeFrame: Day 1
measure: Interoceptive Awareness Questionnaire (IAQ)
timeFrame: Day 1
measure: Fremantle Back Awareness Questionnaire (FreBAQ)
timeFrame: Day 1
measure: Vragenlijst belastende ervaringen (VBE) - short version
timeFrame: Day 1
measure: Multidimensional Perfectionism Scale (MPS)
timeFrame: Day 1
measure: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
timeFrame: Day 1
Other outcomes:
measure: Heart rate
timeFrame: Day 1
measure: Skin conductance
timeFrame: Day 1
measure: Activity of abdominal muscles
timeFrame: Day 1
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Lotte Janssens, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: