Clinical trial NCT02823756: Short-Term Effects of PT on Physical Activity
Official title: The Short-Term Effects of Manipulation and Physical Therapy on Physical Activity Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Motor Activity
Chronic Pain
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose is to examine the impact that physical therapy (PT) interventions, including manipulations, have on physical activity levels outside of the clinical environment in persons with low back pain (LBP) as measured both objectively with an accelerometer and subjectively with questionnaires.

The secondary purpose is to determine if a relationship exists between objective physical activity, self-perceived disability pain catastrophizing thoughts, BMI, age, six-minute walk distance, lower extremity muscle endurance.

The tertiary purpose is to assess the predictive value that a standing manual lumbar unloading technique has for relief of pain following manipulation

Detailed description: At session 1: Participants are screened for eligibility. Baseline outcome measures are conducted (self-report questionnaires and physical performance tests). Accelerometer which is an instrument to measure physical activity is issued.

At session 2 (To occur at least one-week later): Accelerometer data is retrieved and downloaded to a computer. Participant numerically rates low back pain level at rest and in most painful position. Participant receives a manual distraction procedure. Participant rates pain level again. Participant starts the physical therapy intervention (manipulation of the spine, muscular strengthening and cardiovascular exercise, education). Accelerometer is reissued again.

At session 3 (At least one-week later): Accelerometer is collected and data is retrieved. Participant continues with the intervention (manipulation, exercise, education).

Eligibility criteria: Inclusion Criteria:

* 1. Patient referred to outpatient PT with a LBP related diagnosis

  2. LBP without radiating pain distally to the knee \> 3 months in duration

  3. Ability to read and write in English or Spanish

  4. Age between 18 and 70 years

  5. Able to ambulate independently without assistive devices

  6. Access to a computer or cell phone with an email address and/or the ability to receive short text messages

Exclusion Criteria:

* 1. No previous diagnosis, radiological evidence, or clinical signs and symptoms of instability, spondylolysis, spondylolisthesis, fracture, tumor or metastases to the spine

  2. No clinical indication of nerve root pathology such as: straight leg raise less than 45 degrees, asymmetric lower extremity deep tendon reflexes, lower extremity muscle strength deficits or radiating pain, numbness or tingling below the knee

  3. No surgical or biological fusion to the spine

  4. No previous spinal surgery

  5. No known diagnosis of osteoporosis or rheumatoid arthritis

  6. No use of oral steroids within the past 6 months

  7. No epidural injection over the previous 4-weeks to the lumbar spine region

  8. No current litigation, workman's compensation or disability claim for a low back injury

  9. No known pregnancy

Primary outcomes:
measure: Change in Physical Activity Levels
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
measure: Visual Analog Scale
timeFrame: 1 day
Locations:
Study officials:
affiliation: Texas Woman's University
name: Wayne A Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brewer W, Swanson BT, Roddey TS, Adewale H, Ashmore C, Frerich J, Perrin C, Ortiz A. A pilot study to determine the effect of one physical therapy session on physical activity levels for individuals with chronic low back pain. BMC Res Notes. 2017 Dec 6;10(1):691. doi: 10.1186/s13104-017-3006-x.