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NCT Number: NCT04074798

Hyperventilation in Patients With Chronic Low Back Pain

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.

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Key information

Conditions

Low Back Pain, Recurrent Back Pain Hyperventilation Syndrome Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Hasselt, 3590, Belgium

Location status: Recruiting

Location contact

Lotte Janssens, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

assessment of hyperventilation, postural control and psychological behavior

Behavioral

assessment of hyperventilation, postural control and psychological behavior

Primary outcomes

  1. Nijmegen questionnaire

    Time frame: Day 1

    Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64

  2. Nijmegen questionnaire

    Time frame: Day 4

    Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64

  3. PetCO2

    Time frame: Day 1

    End-tidal carbon dioxide pressure measured with a capnograph

  4. Postural control

    Time frame: Day 1

    upright standing balance measured by center of pressure by force plate

Secondary outcomes

  1. Breathing frequency

    Time frame: Day 1

    amount of breaths per minute, inspiratory and expiratory time

  2. Breathing pattern (abominal and thoracic)

    Time frame: Day 1

    abdominal or thoracic contribution to one breath measured by respiratory inductance plethysmography

  3. Numerical Rating Scale for low back pain (NRS)

    Time frame: Day 1

    11 point Likert scale evaluating severity/intensity of back pain, ranging from 0 (no pain) to 11 (worst pain imaginable)

  4. Oswestry Disability Index version 2.1a (ODI-2.1a)

    Time frame: Day 1

    Questionnaire evaluating disability. 10 items Total score range from 0-100

  5. 12-item Short form Health Survey (SF-12)

    Time frame: Day 1

    Questionnaire evaluating physical and mental components of health related quality of life. 12 items. Total score range 12-56.

  6. Fear Avoidance Component Scale (FACS)

    Time frame: Day 1

    Questionnaire evaluating fear-avoidance related to pain. 20 items Total score range from 0-100

  7. Tampa Scale for Kinesiophobia (TSK)

    Time frame: Day 1

    Questionnaire evaluating kinesiophobia related to pain. 17 items. Total score range from 17-68

  8. Pain Catastrophizing Scale (PCS)

    Time frame: Day 1

    Questionnaire evaluating catastrophizing. 13 items, 5 point Likert scale. Total score 0-52

  9. Need for Controllability and Predictability Questionnaire (NCP-Q)

    Time frame: Day 1

    Questionnaire evaluating the need for being able to control and predict situations. 15 items, 5 point Likert scale. Total score range 15 - 75

  10. Positive And Negative Affect Schedule (PANAS)

    Time frame: Day 1

    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

  11. Pain Solutions Questionnaire (PaSoL)

    Time frame: Day 1

    Questionnaire evaluating assimilative and accommodative responses to problems associated with pain. 14 items, 7 point Likert scale. Total score range 0 - 84

  12. Toronto Alexithymia Scale 20 (TAS-20)

    Time frame: Day 1

    Questionnaire evaluating characteristics linked to alexithymia. 20 items, 3 factors. Total score range 20 - 100

  13. Interoceptive Awareness Questionnaire (IAQ)

    Time frame: Day 1

    Questionnaire evaluating adaptive and maladaptive body awareness. 19 items, 5 point Likert scale.

  14. Fremantle Back Awareness Questionnaire (FreBAQ)

    Time frame: Day 1

    Questionnaire evaluating back specific perceptual awareness. 9 items, 5 point Likert scale. Total score range 0-36

  15. Vragenlijst belastende ervaringen (VBE) - short version

    Time frame: Day 1

    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.

  16. Multidimensional Perfectionism Scale (MPS)

    Time frame: Day 1

    Questionnaire evaluating adaptive and maladaptive perfectionism. 35 items, 5 point Likert scale. Total score range 35 - 175

  17. International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    Time frame: Day 1

    Questionnaire evaluating subjective level of physical activity. 7 questions regarding amount of time spent on certain activities.

Other outcomes

  1. Heart rate

    Time frame: Day 1

    ECG measurement to determine heart rate variability

  2. Skin conductance

    Time frame: Day 1

    The resistance / conductance of the skin, stress physiological measure

  3. Activity of abdominal muscles

    Time frame: Day 1

    The amount of muscle activation measured by electromyography

Study contacts

Contact information is provided by the study sponsor or research team.

Katleen Bogaerts, PhD, PT

CONTACT

[email protected]

Sofie Van Wesemael, MSc, PT

CONTACT

[email protected]

+32472771468

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • ZOL

Registry information

Acronym: HELBP

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2019
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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