Low Back Pain and Breathing Pattern Dysfunction

The purpose of the first stage of this study is to assess the association and prognostic
value of respiratory variables to low back pain presentation and outcomes with standard
physical therapy care. Thus, a prospective longitudinal cohort, observational repeated
measures (pre and post testing), design will be used for this portion of the study. Both the
treating physical therapist and the patient will be blinded to the findings of the
respiratory assessment in order to minimize the risk of treatment bias. Further, the
physical therapy plan of care and the interventions administered will be at the therapists'
discretion and will not be standardized. Typically a multimodal treatment approach is used
for LBP, which includes: patient education, therapeutic exercises to improve strength,
flexibility, and motor control deficits, manual therapy to decrease pain and improve joint
and soft tissue mobility, and physical agents for pain management. By allowing therapists to
use their clinical judgment, we are maintaining a real world environment which improves
generalizability of the results. Although this will introduce variability that may confound
results, there is no evidence that any single treatment approach is superior for addressing
all LBP patients. Thus, allowing therapists to use their clinical reasoning to subgroup and
treat accordingly maintains the standard of practice for all patient care.

A sample of convenience, consisting of 75 consecutive subjects seeking physical therapy for
low back pain, will be selected. These subjects will be measured at the initiation of their
physical therapy program and then retested 1 month later, using the procedures described
below. Subjects with unresolved BPD's at the time of reassessment will be offered the
opportunity to receive 1 month of inspiratory muscle training (IMT), which will be the
second phase of this study. Subjects that complete the IMT will be retested following the
same protocol at the end of the IMT program. All subject

recruitment and data collection will occur through UM facilities, but faculty at Nova
Southeastern University will be involved with data analysis. Thus, IRB approval will be
obtained from the University of Miami with a reliance agreement with Nova Southeastern
University. It is anticipated that data collection will last from 6/2015-6/2016.

RESEARCH DESIGN AND METHODS

Subject recruitment

Patients seeking physical therapy for LBP at the University of Miami will be contacted by
phone within 1 week of their initial examination. They will then be informed of the purpose
of the study and the study protocol. If they express interest in participating, they will
then be scheduled for a separate 90 minute session at the Kendall clinic during which all
initial data will be collected. In addition, posters (see appendix 6) will be placed in the
waiting room of 5 of the outpatient physical therapy clinics (Kendall, University of Miami
Hospital, Bascom Palmer, Pain Center in CRB, and Plantation), all owned and operated by the
University of Miami, as a recruitment tool as well. Qualifying patients from any of these
facilities may call for additional information and to request inclusion in the study as
well.

Measurement protocol

Resting Baseline Data

First subjects will be interviewed to collect data on their condition and status, as well as
to screen for inclusion/exclusion criteria. (see Appendix 1 for data collection sheet). The
subjects will then be asked to complete 3 questionnaires: the Pain Catastrophizing Scale,
the Modified Oswestry Disability Index, and the Nijmegen Questionnaire (Appendix 2, 3, and 4
respectively). These questionnaires should take less than 5 minutes each to complete. Prior
to beginning physical data collection, subjects will be informed to immediately stop any
activity that causes significant discomfort or increased symptoms during the testing
session. Then, subjects will be asked to breath forcefully into the Micro MPM (Micro Medical
Ltd, Chatham, UK) device in order to collect MEP. This will be repeated 3-5 times with a 1
minute rest in between each trial. They will then be asked to place the TIRE device in their
mouth and breathe in forcefully and sustain the breath for as long as possible in order to
collect MIP and SMIP data. This process will also be repeated 3-5 times. Finally, the
subjects will be fitted with the Cosmed K4b2 and Respitrace systems; these devices will be
described in detail later. The k4b2 consists of a rubber mask with a light nylon vest to
measure breath by breath gas analysis, and the Respitrace consists of merely 2 soft chest
straps to measure heart rate variability and chest excursion with breathing. The subjects
will then lie in the supine position for 5 minutes, sit quietly for 5 minutes, and stand
quietly for 5 minutes in order to gather baseline data in each of these positions. The first
2 minutes in each position will be used as an accommodation period and data will not be
recorded. Thus data analysis will only consist of the data from the final 3 minutes in each
of these positions.

Postural Challenge baseline data

Subjects will be seated in a stable chair, with the feet on the ground and without back
support, and asked to perform 3 rounds of resisted shoulder flexion and resisted hip flexion
on each extremity. A submaximal resistance will be applied manually by the investigator and
held for 30 seconds followed by 30 seconds of rest. After, they will be asked to lift and
hold a 25 lb weight for 30 seconds 3 times, followed by 30 seconds of rest between each
trial. Then they will lift the weight 10 times repetitively in a faster paced rhythmic
fashion set by a metronome. They will then rest in the seated position for 5 minutes to
measure recovery heart rate and respiration.

Inspiratory Muscle Training (IMT)

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 (described in detail
later). The IMT protocol uses biofeedback to train at a specific percentage of MIP and SMIP
for each inspiratory effort. The program consists of 6 breaths per level, with 6 levels, and
the ability to alter the rest time between breaths as the subject advances through each of
the levels. The training session is completed when the subject fails to achieve the selected
percentage of SMIP twice consecutively, or if they complete all 6 levels for a maximum of 36
breaths. The IMT program will be set at 60% of each subjects MIP/SMIP and breathing at this
workload will focus on full deep inhalations using diaphragmatic breathing followed by slow
prolonged exhalations with each subsequent inhalation being signaled by the RT2 software
prompt (via visual display on the computer screen) to "Please Inhale". The first level of
IMT will consist of a 40 second rest period between breaths followed by a 30 and 20 second
rest period during IMT at levels 2 and 3, respectively. The rest period during IMT at the
remaining three levels will remain at 20 seconds during which subjects will be prompted to
prolonged exhalation throughout as much of the 20 second rest period as possible. The
training session will also be stopped if the subject complains of increased back pain and if
dizziness, fatigue, or if any other adverse response is noted.

Post IMT Data Collection

After 4 weeks, or 8 sessions of IMT, the same data collection protocol will be repeated.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.