Hyperventilation in Patients With Chronic Low Back Pain (HELBP)
Primary Purpose
Low Back Pain, Recurrent, Hyperventilation Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
assessment of hyperventilation, postural control and psychological behavior
Sponsored by
About this trial
This is an interventional diagnostic trial for Low Back Pain, Recurrent
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
Sites / Locations
- Hasselt UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Patients with low back pain
Healthy controls
Arm Description
Outcomes
Primary Outcome Measures
Nijmegen questionnaire
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
Nijmegen questionnaire
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
PetCO2
End-tidal carbon dioxide pressure measured with a capnograph
Postural control
upright standing balance measured by center of pressure by force plate
Secondary Outcome Measures
Breathing frequency
amount of breaths per minute, inspiratory and expiratory time
Breathing pattern (abominal and thoracic)
abdominal or thoracic contribution to one breath measured by respiratory inductance plethysmography
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)
Oswestry Disability Index version 2.1a (ODI-2.1a)
Questionnaire evaluating disability. 10 items Total score range from 0-100
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.
Fear Avoidance Component Scale (FACS)
Questionnaire evaluating fear-avoidance related to pain. 20 items Total score range from 0-100
Tampa Scale for Kinesiophobia (TSK)
Questionnaire evaluating kinesiophobia related to pain. 17 items. Total score range from 17-68
Pain Catastrophizing Scale (PCS)
Questionnaire evaluating catastrophizing. 13 items, 5 point Likert scale. Total score 0-52
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
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
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
Toronto Alexithymia Scale 20 (TAS-20)
Questionnaire evaluating characteristics linked to alexithymia. 20 items, 3 factors. Total score range 20 - 100
Interoceptive Awareness Questionnaire (IAQ)
Questionnaire evaluating adaptive and maladaptive body awareness. 19 items, 5 point Likert scale.
Fremantle Back Awareness Questionnaire (FreBAQ)
Questionnaire evaluating back specific perceptual awareness. 9 items, 5 point Likert scale. Total score range 0-36
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.
Multidimensional Perfectionism Scale (MPS)
Questionnaire evaluating adaptive and maladaptive perfectionism. 35 items, 5 point Likert scale. Total score range 35 - 175
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.
Full Information
NCT ID
NCT04074798
First Posted
August 28, 2019
Last Updated
September 26, 2023
Sponsor
Hasselt University
Collaborators
ZOL
1. Study Identification
Unique Protocol Identification Number
NCT04074798
Brief Title
Hyperventilation in Patients With Chronic Low Back Pain
Acronym
HELBP
Official Title
Hyperventilation in Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
ZOL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent, Hyperventilation Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with low back pain are compared to patients without low back pain (healthy controls).
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with low back pain
Arm Type
Active Comparator
Arm Title
Healthy controls
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
assessment of hyperventilation, postural control and psychological behavior
Intervention Description
assessment of hyperventilation, postural control and psychological behavior
Primary Outcome Measure Information:
Title
Nijmegen questionnaire
Description
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
Time Frame
Day 1
Title
Nijmegen questionnaire
Description
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
Time Frame
Day 4
Title
PetCO2
Description
End-tidal carbon dioxide pressure measured with a capnograph
Time Frame
Day 1
Title
Postural control
Description
upright standing balance measured by center of pressure by force plate
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Breathing frequency
Description
amount of breaths per minute, inspiratory and expiratory time
Time Frame
Day 1
Title
Breathing pattern (abominal and thoracic)
Description
abdominal or thoracic contribution to one breath measured by respiratory inductance plethysmography
Time Frame
Day 1
Title
Numerical Rating Scale for low back pain (NRS)
Description
11 point Likert scale evaluating severity/intensity of back pain, ranging from 0 (no pain) to 11 (worst pain imaginable)
Time Frame
Day 1
Title
Oswestry Disability Index version 2.1a (ODI-2.1a)
Description
Questionnaire evaluating disability. 10 items Total score range from 0-100
Time Frame
Day 1
Title
12-item Short form Health Survey (SF-12)
Description
Questionnaire evaluating physical and mental components of health related quality of life. 12 items. Total score range 12-56.
Time Frame
Day 1
Title
Fear Avoidance Component Scale (FACS)
Description
Questionnaire evaluating fear-avoidance related to pain. 20 items Total score range from 0-100
Time Frame
Day 1
Title
Tampa Scale for Kinesiophobia (TSK)
Description
Questionnaire evaluating kinesiophobia related to pain. 17 items. Total score range from 17-68
Time Frame
Day 1
Title
Pain Catastrophizing Scale (PCS)
Description
Questionnaire evaluating catastrophizing. 13 items, 5 point Likert scale. Total score 0-52
Time Frame
Day 1
Title
Need for Controllability and Predictability Questionnaire (NCP-Q)
Description
Questionnaire evaluating the need for being able to control and predict situations. 15 items, 5 point Likert scale. Total score range 15 - 75
Time Frame
Day 1
Title
Positive And Negative Affect Schedule (PANAS)
Description
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
Time Frame
Day 1
Title
Pain Solutions Questionnaire (PaSoL)
Description
Questionnaire evaluating assimilative and accommodative responses to problems associated with pain. 14 items, 7 point Likert scale. Total score range 0 - 84
Time Frame
Day 1
Title
Toronto Alexithymia Scale 20 (TAS-20)
Description
Questionnaire evaluating characteristics linked to alexithymia. 20 items, 3 factors. Total score range 20 - 100
Time Frame
Day 1
Title
Interoceptive Awareness Questionnaire (IAQ)
Description
Questionnaire evaluating adaptive and maladaptive body awareness. 19 items, 5 point Likert scale.
Time Frame
Day 1
Title
Fremantle Back Awareness Questionnaire (FreBAQ)
Description
Questionnaire evaluating back specific perceptual awareness. 9 items, 5 point Likert scale. Total score range 0-36
Time Frame
Day 1
Title
Vragenlijst belastende ervaringen (VBE) - short version
Description
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.
Time Frame
Day 1
Title
Multidimensional Perfectionism Scale (MPS)
Description
Questionnaire evaluating adaptive and maladaptive perfectionism. 35 items, 5 point Likert scale. Total score range 35 - 175
Time Frame
Day 1
Title
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Description
Questionnaire evaluating subjective level of physical activity. 7 questions regarding amount of time spent on certain activities.
Time Frame
Day 1
Other Pre-specified Outcome Measures:
Title
Heart rate
Description
ECG measurement to determine heart rate variability
Time Frame
Day 1
Title
Skin conductance
Description
The resistance / conductance of the skin, stress physiological measure
Time Frame
Day 1
Title
Activity of abdominal muscles
Description
The amount of muscle activation measured by electromyography
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofie Van Wesemael, MSc, PT
Phone
+32472771468
Email
sofie.vanwesemael@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Katleen Bogaerts, PhD, PT
Email
Katleen.Bogaerts@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lotte Janssens, PhD, PT
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3590
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lotte Janssens, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Hyperventilation in Patients With Chronic Low Back Pain
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