Low Back Pain, RecurrentHELBPNCT04074798
Hyperventilation in Patients With Chronic Low Back Pain
A study of Low Back Pain, Recurrent and Hyperventilation Syndrome, run by Hasselt University at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Recurrent, Hyperventilation Syndrome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2020to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chronic primary low back pain (>12 weeks) as diagnosed by a medical doctor
- No low back pain
Who cannot join
- 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
Show all 10Show fewer
- Pregnant and lactating women
- Major psychiatric conditions
- Acute lower limb problems
- Vestibular disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- assessment of hyperventilation, postural control and psychological behavior
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of hyperventilation, postural control and psychological behaviorBehavioural
assessment of hyperventilation, postural control and psychological behavior
| Study group | Role | What they receive |
|---|---|---|
| Patients with low back pain | Active comparator | Not described Receives: Behavioral: assessment of hyperventilation, postural control and psychological behavior |
| Healthy controls | Sham comparator | Not described Receives: Behavioral: assessment of hyperventilation, postural control and psychological behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nijmegen questionnaire
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
Measured: Day 1
Nijmegen questionnaire
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
Measured: Day 4
PetCO2
End-tidal carbon dioxide pressure measured with a capnograph
Measured: Day 1
Postural control
upright standing balance measured by center of pressure by force plate
Measured: Day 1
Secondary outcomes (17)
Breathing frequency
amount of breaths per minute, inspiratory and expiratory time
Measured: Day 1
Breathing pattern (abominal and thoracic)
abdominal or thoracic contribution to one breath measured by respiratory inductance plethysmography
Measured: Day 1
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)
Measured: Day 1
Oswestry Disability Index version 2.1a (ODI-2.1a)
Questionnaire evaluating disability. 10 items Total score range from 0-100
Measured: Day 1
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.
Measured: Day 1
Fear Avoidance Component Scale (FACS)
Questionnaire evaluating fear-avoidance related to pain. 20 items Total score range from 0-100
Measured: Day 1
Tampa Scale for Kinesiophobia (TSK)
Questionnaire evaluating kinesiophobia related to pain. 17 items. Total score range from 17-68
Measured: Day 1
Pain Catastrophizing Scale (PCS)
Questionnaire evaluating catastrophizing. 13 items, 5 point Likert scale. Total score 0-52
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
Toronto Alexithymia Scale 20 (TAS-20)
Questionnaire evaluating characteristics linked to alexithymia. 20 items, 3 factors. Total score range 20 - 100
Measured: Day 1
Interoceptive Awareness Questionnaire (IAQ)
Questionnaire evaluating adaptive and maladaptive body awareness. 19 items, 5 point Likert scale.
Measured: Day 1
Fremantle Back Awareness Questionnaire (FreBAQ)
Questionnaire evaluating back specific perceptual awareness. 9 items, 5 point Likert scale. Total score range 0-36
Measured: Day 1
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.
Measured: Day 1
Multidimensional Perfectionism Scale (MPS)
Questionnaire evaluating adaptive and maladaptive perfectionism. 35 items, 5 point Likert scale. Total score range 35 - 175
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Mar 2020
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with low back pain are compared to patients without low back pain (healthy controls).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- ZOL
- Responsible party
- Principal investigator, Lotte Janssens, Hasselt University
- Investigators
- Lotte Janssens, PhD, PT, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074798
- Sponsor's protocol ID
- CME ZOL - CTU2019078
- Acronym
- HELBP
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2019
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperventilation in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04074798
- Acronym / sponsor ID
- HELBP / CME ZOL - CTU2019078
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- ZOL
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with low back pain are compared to patients without low back pain (healthy controls).
| Arm | Type | Receives |
|---|---|---|
| Patients with low back pain | Active comparator | Behavioral: assessment of hyperventilation, postural control and psychological behavior |
| Healthy controls | Sham comparator | Behavioral: assessment of hyperventilation, postural control and psychological behavior |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic primary low back pain (>12 weeks) as diagnosed by a medical doctor
- No low back pain
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of hyperventilation, postural control and psychological behaviorassessment of hyperventilation, postural control and psychological behavior | Behavioural | Healthy controls, Patients with low back pain |
Primary outcome
Nijmegen questionnaire
Time frame: Day 1
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
Nijmegen questionnaire
Time frame: Day 4
Questionnaire evaluating hyperventilation symptoms, 16 items, total score range 0-64
PetCO2
Time frame: Day 1
End-tidal carbon dioxide pressure measured with a capnograph
Postural control
Time frame: Day 1
upright standing balance measured by center of pressure by force plate
17 secondary outcomes
Breathing frequency
Time frame: Day 1
Breathing pattern (abominal and thoracic)
Time frame: Day 1
Numerical Rating Scale for low back pain (NRS)
Time frame: Day 1
Oswestry Disability Index version 2.1a (ODI-2.1a)
Time frame: Day 1
12-item Short form Health Survey (SF-12)
Time frame: Day 1
Fear Avoidance Component Scale (FACS)
Time frame: Day 1
Tampa Scale for Kinesiophobia (TSK)
Time frame: Day 1
Pain Catastrophizing Scale (PCS)
Time frame: Day 1
Need for Controllability and Predictability Questionnaire (NCP-Q)
Time frame: Day 1
Positive And Negative Affect Schedule (PANAS)
Time frame: Day 1
Pain Solutions Questionnaire (PaSoL)
Time frame: Day 1
Toronto Alexithymia Scale 20 (TAS-20)
Time frame: Day 1
Interoceptive Awareness Questionnaire (IAQ)
Time frame: Day 1
Fremantle Back Awareness Questionnaire (FreBAQ)
Time frame: Day 1
Vragenlijst belastende ervaringen (VBE) - short version
Time frame: Day 1
Multidimensional Perfectionism Scale (MPS)
Time frame: Day 1
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain, Recurrent
Not yet recruiting
Effects of Motor Control Exercises With and Without Pressure Biofeedback in Recurrent Low Back Pain (MCE)
Low Back Pain
RecruitingObservational study
The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
Low Back Pain, Back Pain Lower Back Chronic
Not yet recruiting
Magnetic Resonance Elastography Of Chronic Low Back Pain Before And After Therapy
Low Back Pain, Recurrent, Chronic Low Back Pain (CLBP)
Active, not recruiting
Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care
Low Back Pain
RecruitingPhase 2
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
Chronic Low Back Pain, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lotte Janssens, PhD, PT principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Low Back Pain, Recurrent and Hyperventilation Syndrome, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nijmegen questionnaire (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.