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Recruiting NCT04074798

Hyperventilation in Patients With Chronic Low Back Pain

No phase Interventional Low Back Pain, Recurrent Hyperventilation Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: assessment of hyperventilation, postural control and psychological behavior.
Who it may be relevant to
Registry conditions: Low Back Pain, Recurrent, Hyperventilation Syndrome. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral assessment of hyperventilation, postural control and psychological behavior
    assessment of hyperventilation, postural control and psychological behavior

Primary outcome measures

  • Nijmegen questionnaire [Time frame: Day 1]
  • Nijmegen questionnaire [Time frame: Day 4]
  • PetCO2 [Time frame: Day 1]
  • Postural control [Time frame: Day 1]
Secondary outcome measures (12)
  • Breathing frequency [Time frame: Day 1]
  • Breathing pattern (abominal and thoracic) [Time frame: Day 1]
  • Numerical Rating Scale for low back pain (NRS) [Time frame: Day 1]
  • Oswestry Disability Index version 2.1a (ODI-2.1a) [Time frame: Day 1]
  • 12-item Short form Health Survey (SF-12) [Time frame: Day 1]
  • Fear Avoidance Component Scale (FACS) [Time frame: Day 1]
  • Tampa Scale for Kinesiophobia (TSK) [Time frame: Day 1]
  • Pain Catastrophizing Scale (PCS) [Time frame: Day 1]
  • Need for Controllability and Predictability Questionnaire (NCP-Q) [Time frame: Day 1]
  • Positive And Negative Affect Schedule (PANAS) [Time frame: Day 1]
  • Pain Solutions Questionnaire (PaSoL) [Time frame: Day 1]
  • Toronto Alexithymia Scale 20 (TAS-20) [Time frame: Day 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Belgium · 1 center
  • Hasselt University — Hasselt

Identifiers

NCT: NCT04074798 · CME ZOL - CTU2019078

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗