Hyperventilation in Patients With Chronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorHasselt University
About this trial
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
This trial accepts healthy volunteersQualifiers
Chronic primary low back pain (>12 weeks) as diagnosed by a medical doctor
No low back pain
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
assessment of hyperventilation, postural control and psychological behavior
Behavioralassessment of hyperventilation, postural control and psychological behavior
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Patients with low back painActive comparator 1 intervention
Group B: Healthy controlsSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Nijmegen questionnaire
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
Time frame
Day 12
Nijmegen questionnaire
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
Time frame
Day 43
PetCO2
End-tidal carbon dioxide pressure measured with a capnograph
Time frame
Day 14
Postural control
upright standing balance measured by center of pressure by force plate
Time frame
Day 1Secondary outcomes
1
Breathing frequency
amount of breaths per minute, inspiratory and expiratory time
Time frame
Day 12
Breathing pattern (abominal and thoracic)
abdominal or thoracic contribution to one breath measured by respiratory inductance plethysmography
Time frame
Day 13
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)
Time frame
Day 14
Oswestry Disability Index version 2.1a (ODI-2.1a)
Questionnaire evaluating disability. 10 items Total score range from 0-100
Time frame
Day 1Other outcomes
1
Heart rate
ECG measurement to determine heart rate variability
Time frame
Day 12
Skin conductance
The resistance / conductance of the skin, stress physiological measure
Time frame
Day 13
Activity of abdominal muscles
The amount of muscle activation measured by electromyography
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hasselt University
Lead sponsor
ZOL
Collaborator
Source ClinicalTrials.gov