NCT02823756

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
Last Updated

July 6, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

June 29, 2016

Last Update Submit

June 30, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (1)

  • Visual Analog Scale

    1 day

Study Arms (1)

Physical Therapy

EXPERIMENTAL

Treatment arm: manipulation, exercise, and education

Procedure: Physical Therapy

Interventions

Exercise, education, spinal manipulation

Physical Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patient referred to outpatient PT with a LBP related diagnosis
  • \. LBP without radiating pain distally to the knee \> 3 months in duration
  • \. Ability to read and write in English or Spanish
  • \. Age between 18 and 70 years
  • \. Able to ambulate independently without assistive devices
  • \. Access to a computer or cell phone with an email address and/or the ability to receive short text messages

You may not qualify if:

  • \. No previous diagnosis, radiological evidence, or clinical signs and symptoms of instability, spondylolysis, spondylolisthesis, fracture, tumor or metastases to the spine
  • \. 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
  • \. No surgical or biological fusion to the spine
  • \. No previous spinal surgery
  • \. No known diagnosis of osteoporosis or rheumatoid arthritis
  • \. No use of oral steroids within the past 6 months
  • \. No epidural injection over the previous 4-weeks to the lumbar spine region
  • \. No current litigation, workman's compensation or disability claim for a low back injury
  • \. No known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Low Back PainMotor ActivityChronic Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Wayne A Brewer, PhD

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 6, 2016

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 6, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share