Short-Term Effects of PT on Physical Activity

NCT ID: NCT02823756

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-04-30

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).

Conditions

Low Back Pain; Motor Activity; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical Therapy

Treatment arm: manipulation, exercise, and education

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: PROCEDURE

Exercise, education, spinal manipulation

Interventions

Physical Therapy

Exercise, education, spinal manipulation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Brewer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne A Brewer, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

References

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.

Reference Type: DERIVED

PMID: 29208007 (View on PubMed)

Other Identifiers

17852

Identifier Type: -

Identifier Source: org_study_id