Short-Term Effects of PT on Physical Activity

Chronic Pain Clinical Trial

Official title:

The Short-Term Effects of Manipulation and Physical Therapy on Physical Activity Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823756
• Other study ID #: 17852
• Status: Completed
• Phase: N/A
• First received: June 29, 2016
• Last updated: June 30, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Low Back Pain
• Motor Activity

Intervention

Procedure:
• Physical Therapy
Exercise, education, spinal manipulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analog Scale	A 10 cm horizontal line that the subject will use to descibe how intense their pain is before and after receiving a spinal manipulation by placing a vertical hash mark along the horizontal line to denote how intense his or her pain is.	1 day	No
Primary	Change in Physical Activity Levels	Accelerometer issued to subject at the initial data collection session and then data collected and downloaded one week later. Subject receives the intervention session, then is reissued the accelerometer. Subject returns the accelerometer one week after this intervention session with data that reflects physical activity levels that are after the intervention session	2 weeks	No