Inspiratory Muscle Training and Low Back Pain

Low Back Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505582
• Other study ID #: 2012_SBrumagne_IMT-LBP
• Secondary ID: 1.5.104.03, G.06
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: December 10, 2013
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2012
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. Deficits in proprioception are found in a subgroup of patients with low back pain. In addition, disorders of respiration have been identified as strongly related to low back pain.

The aim of the study is to clarify whether inspiratory muscle training has a positive effect on proprioceptive postural control in individuals with recurrent low back pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria individuals with low back pain:

• Age: 18-45 years old

• At least 1 year of low back pain with/without referred pain in buttock/thigh

• At least 3 episodes of disabling low back pain

• At least a score of 20% on the Oswestry Disability Index

• Willingness to sign the informed consent

Exclusion Criteria:

• History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant

• One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy

• Radicular symptoms

• Not Dutch-speaking

• Strong opioids

• Neck pain

• Smoking history

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Inspiratory Muscle Training
• Low Back Pain
• Respiration Disorders
• Respiratory Aspiration
• Respiratory Disorders
• Respiratory Tract Diseases

Intervention

Other:
• Inspiratory muscle training
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 60% Pi,max
• Sham inspiratory muscle training
Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proprioceptive postural control	Center of pressure displacement (force plate) in standing in response to local muscle vibration on ankle and back muscles to specifically detect the role of proprioception in postural control.	8 weeks	No