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Hyperventilation in Patients With Chronic Low Back Pain (HELBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074798
Recruitment Status : Not yet recruiting
First Posted : August 30, 2019
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
ZOL
Information provided by (Responsible Party):
Lotte Janssens, Hasselt University

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.

Condition or disease Intervention/treatment Phase
Low Back Pain, Recurrent Hyperventilation Syndrome Behavioral: assessment of hyperventilation, postural control and psychological behavior Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with low back pain are compared to patients without low back pain (healthy controls).
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Hyperventilation in Patients With Chronic Low Back Pain
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Patients with low back pain Behavioral: assessment of hyperventilation, postural control and psychological behavior
assessment of hyperventilation, postural control and psychological behavior

Sham Comparator: Healthy controls Behavioral: assessment of hyperventilation, postural control and psychological behavior
assessment of hyperventilation, postural control and psychological behavior




Primary Outcome Measures :
  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 Outcome Measures :
  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. Diaphragmatic thickness and thickening [ Time Frame: Day 1 ]
    The thickness of the diaphragm at Total Lung Capacity and Residual Volume, and the difference between thicknesses

  4. Diaphragmatic motion [ Time Frame: Day 1 ]
    amount of displacement of the diaphragm between Total Lung Capacity and Residual Volume

  5. 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)

  6. Oswestry Disability Index version 2.1a (ODI-2.1a) [ Time Frame: Day 1 ]
    Questionnaire evaluating disability. 10 items Total score range from 0-100

  7. 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.

  8. Fear Avoidance Component Scale (FACS) [ Time Frame: Day 1 ]
    Questionnaire evaluating fear-avoidance related to pain. 20 items Total score range from 0-100

  9. Tampa Scale for Kinesiophobia (TSK) [ Time Frame: Day 1 ]
    Questionnaire evaluating kinesiophobia related to pain. 17 items. Total score range from 17-68

  10. Pain Catastrophizing Scale (PCS) [ Time Frame: Day 1 ]
    Questionnaire evaluating catastrophizing. 13 items, 5 point Likert scale. Total score 0-52

  11. 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

  12. 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

  13. 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

  14. 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

  15. Interoceptive Awareness Questionnaire (IAQ) [ Time Frame: Day 1 ]
    Questionnaire evaluating adaptive and maladaptive body awareness. 19 items, 5 point Likert scale.

  16. 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

  17. 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.

  18. 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

  19. 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 Outcome Measures:
  1. Heart rate [ Time Frame: Day 1 ]
    ECG measurement to determine heart rate variability

  2. Skin temperature [ Time Frame: Day 1 ]
    The temperature measured at the level of the skin, stress physiological measure

  3. Skin conductance [ Time Frame: Day 1 ]
    The resistance / conductance of the skin, stress physiological measure

  4. Activity of abdominal muscles [ Time Frame: Day 1 ]
    The amount of muscle activation measured by electromyography



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074798


Contacts
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Contact: Charlotte Amerijckx, MSc, PT +3211 26 92 10 Charlotte.Amerijckx@uhasselt.be
Contact: Katleen Bogaerts, PhD, PT Katleen.Bogaerts@uhasselt.be

Sponsors and Collaborators
Hasselt University
ZOL
Investigators
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Principal Investigator: Lotte Janssens, PhD, PT Hasselt University
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Responsible Party: Lotte Janssens, Prof. dr., Hasselt University
ClinicalTrials.gov Identifier: NCT04074798    
Other Study ID Numbers: CME ZOL - CTU2019078
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperventilation
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory