Low Back Pain and Breathing Pattern Dysfunction

NCT02429752 | Completed

• 1 other identifier: 20140764
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to identify if there is a significant prevalence of abnormal respiratory patterns in a sample of patients with low back pain (LBP), and if the presence of abnormal respiratory patterns are predictive of rehabilitation outcomes in this population. In addition, the investigators will assess the response to inspiratory muscle training (IMT) for a subgroup of subjects that maintain abnormal breathing patterns after 1 month of physical therapy. Patients seeking physical therapy for LBP within the Uhealth system will be recruited. The first phase of this study will be observational. A comprehensive assessment of their respiratory function will be performed at the beginning of their therapy and after 1 month of therapy. Subjects that demonstrate abnormal respiratory patterns after 1 month of therapy will be offered the opportunity to participate in the second phase of the study in which they will receive 1 month of inspiratory muscle training (IMT). The respiratory assessment will then be repeated at the end of the IMT training program.

Conditions

Low Back Pain

Keywords

inspiratory muscle training; low back pain; respiration; breathing

Outcome Measures

Primary Outcomes (1)

• Change in baseline value of breath-by-breath gas analysis

  Measure of breathing pattern and respiratory gases at rest and with activity

  baseline, after 1 month of therapy, after 2 months of IMT

Secondary Outcomes (5)

• Number of Participants improved on the Oswestry Disability Index

  baseline, after 1 month of therapy, after 2 months of IMT

• Number of Participants improved on the Numeric Pain Rating Scale

  baseline, after 1 month of therapy, after 2 months of IMT

• Change in baseline value of Maximal inspiratory pressure

  baseline, after 1 month of therapy, after 2 months

• Change in baseline value of sustained maximal inspiratory pressure

  baseline, after 1 month of therapy, after 2 months

• Change in baseline value of maximal expiratory pressure

  baseline, after 1 month of therapy, after 2 months

Study Arms (1)

Inspiratory Muscle Training

EXPERIMENTAL

Subjects will receive 8 weeks of IMT

Other: Inspiratory muscle training

Interventions

Inspiratory muscle training OTHER

Subjects that demonstrate unresolved BPD's upon reassessment after PT treatment, will have the option to participate in the second phase of the study. These subjects will be scheduled twice a week to receive IMT using the RT2 device and software program. The IMT protocol uses biofeedback to train at a specific percentage of MIP and SMIP for each inspiratory effort.

Inspiratory Muscle Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65,
• seeking physical therapy services for lumbar or pelvic pain will be recruited for this study.
• Subjects must intend to complete their prescribed physical therapy plan of care.

You may not qualify if:

• Patients unable to consent, complete questionnaires independently, or fulfill all testing requirements will be excluded from the study.
• All vulnerable populations will be excluded including:
• prisoners,
• children,
• terminally ill patients, and
• individuals with cognitive, emotional, or communication impairments that require them to have a guardian.

Sponsors & Collaborators

• University of Miami: lead
• Nova Southeastern University: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33176, United States

Location

MeSH Terms

Conditions

Low Back Pain; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Marlon L Wong, DPT

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 29, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

US (1)