Hyperventilation in Patients With Chronic Low Back Pain

Low Back Pain, Recurrent Clinical Trial

— HELBP  

Official title:

Hyperventilation in Patients With Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04074798
• Other study ID #: CME ZOL - CTU2019078
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: July 2024

Study information

• Verified date: September 2023
• Source: Hasselt University
• Contact: Sofie Van Wesemael, MSc, PT
• Phone: +32472771468
• Email: sofie.vanwesemael[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Hyperventilation
• Hyperventilation Syndrome
• Low Back Pain
• Low Back Pain, Recurrent

Intervention

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

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	ZOL

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart rate	ECG measurement to determine heart rate variability	Day 1
Other	Skin conductance	The resistance / conductance of the skin, stress physiological measure	Day 1
Other	Activity of abdominal muscles	The amount of muscle activation measured by electromyography	Day 1
Primary	Nijmegen questionnaire	Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64	Day 1
Primary	Nijmegen questionnaire	Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64	Day 4
Primary	PetCO2	End-tidal carbon dioxide pressure measured with a capnograph	Day 1
Primary	Postural control	upright standing balance measured by center of pressure by force plate	Day 1
Secondary	Breathing frequency	amount of breaths per minute, inspiratory and expiratory time	Day 1
Secondary	Breathing pattern (abominal and thoracic)	abdominal or thoracic contribution to one breath measured by respiratory inductance plethysmography	Day 1
Secondary	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
Secondary	Oswestry Disability Index version 2.1a (ODI-2.1a)	Questionnaire evaluating disability. 10 items Total score range from 0-100	Day 1
Secondary	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
Secondary	Fear Avoidance Component Scale (FACS)	Questionnaire evaluating fear-avoidance related to pain. 20 items Total score range from 0-100	Day 1
Secondary	Tampa Scale for Kinesiophobia (TSK)	Questionnaire evaluating kinesiophobia related to pain. 17 items. Total score range from 17-68	Day 1
Secondary	Pain Catastrophizing Scale (PCS)	Questionnaire evaluating catastrophizing. 13 items, 5 point Likert scale. Total score 0-52	Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	Toronto Alexithymia Scale 20 (TAS-20)	Questionnaire evaluating characteristics linked to alexithymia. 20 items, 3 factors. Total score range 20 - 100	Day 1
Secondary	Interoceptive Awareness Questionnaire (IAQ)	Questionnaire evaluating adaptive and maladaptive body awareness. 19 items, 5 point Likert scale.	Day 1
Secondary	Fremantle Back Awareness Questionnaire (FreBAQ)	Questionnaire evaluating back specific perceptual awareness. 9 items, 5 point Likert scale. Total score range 0-36	Day 1
Secondary	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
Secondary	Multidimensional Perfectionism Scale (MPS)	Questionnaire evaluating adaptive and maladaptive perfectionism. 35 items, 5 point Likert scale. Total score range 35 - 175	Day 1
Secondary	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