Hyperventilation in Patients With Chronic Low Back Pain

NCT04074798 | Recruiting DMC

• 1 other identifier: CME ZOL - CTU2019078
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Recurrent; Hyperventilation Syndrome

Outcome Measures

Primary Outcomes (4)

• Nijmegen questionnaire

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

  Day 1

• Nijmegen questionnaire

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

  Day 4

• PetCO2

  End-tidal carbon dioxide pressure measured with a capnograph

  Day 1

• Postural control

  upright standing balance measured by center of pressure by force plate

  Day 1

Secondary Outcomes (17)

• Breathing frequency

  Day 1

• Breathing pattern (abominal and thoracic)

  Day 1

• Numerical Rating Scale for low back pain (NRS)

  Day 1

• Oswestry Disability Index version 2.1a (ODI-2.1a)

  Day 1

• 12-item Short form Health Survey (SF-12)

  Day 1

Other Outcomes (3)

• Heart rate

  Day 1

• Skin conductance

  Day 1

• Activity of abdominal muscles

  Day 1

Study Arms (2)

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

Interventions

assessment of hyperventilation, postural control and psychological behavior BEHAVIORAL

assessment of hyperventilation, postural control and psychological behavior

Healthy controls; Patients with low back pain

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic primary low back pain (\>12 weeks) as diagnosed by a medical doctor
• No low back pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• ZOL: collaborator

Study Sites (1)

Hasselt University

Hasselt, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Postural Balance

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proprioception; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sensation; Nervous System Physiological Phenomena

Study Officials

• Lotte Janssens, PhD, PT

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Van Wesemael, MSc, PT

CONTACT

+32472771468; sofie.vanwesemael@uhasselt.be

Katleen Bogaerts, PhD, PT

CONTACT

Katleen.Bogaerts@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Patients with low back pain are compared to patients without low back pain (healthy controls).

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: March 1, 2020
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)