- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02355275
Thera-Band® HEP for LBP Secondary Prevention (TBKT_HEP)
January 11, 2016 updated by: Sport and Spine Rehab Clinical Research Foundation
Thera-Band® Based Home Exercise Program for Low Back Pain Secondary Prevention
The purpose of this study is to determine the effectiveness of a Thera-Band based home exercise program (HEP) on LBP and disability 4 weeks post treatment discharge.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The effectiveness of interventions for the treatment of acute and chronic LBP has been extensively studied, but study of the strategies for preventing the progression of acute LBP episodes into chronic back pain is still lacking.
Therefore, determining the most effective secondary prevention strategy for the prevention of recurrences of LBP is essential for the reduction of long term disability.
The purpose of this study is to determine the effectiveness of a Thera-Band based home exercise program (HEP) on LBP and disability 4 weeks post treatment discharge.
A convenience sample of 22 new patients, 18-65 years of age, with current, chronic LBP will be recruited for this study at the discharge visit from care.
Exclusionary criteria will include, current pregnancy and the presence of any red flags such as tumor or cancer, vertebral fracture, or infection.
Upon agreeing to the study, patients will sign an informed consent, complete a demographics questionnaire, and complete specific outcome measure assessments.
The outcome measures will include Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI).
Additionally, subjects will be asked to complete a secondary prevention program questionnaire.
Following the initial paperwork, all patients will be provided with a Thera-Band® Loop and Band and handout describing the HEP to be performed 3 times a week for 4 weeks.
At the conclusion of 4 weeks, a follow-up phone call or email, based on patient preference, will be conducted.
The follow-up will include pain, disability, compliance, satisfaction of program of the home program.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
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Rockville, Maryland, United States, 20852
- Sport & Spine Rehab
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- current, chronic low back pain
- discharging from care
Exclusion Criteria:
- current pregnancy
- presence of any red flags such as tumor or cancer, vertebral fracture, or infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home Exercise Program
|
All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index
Time Frame: 4 weeks
|
Patient disability was measured using the Oswestry Disability Index (OSW), a self-report outcome measure.
For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5.
The score is calculated by totaling the values marked, divided by 50 x 100.
The greater the score the greater the disability.
For example, 0% to 20% would be minimal disability and 81%-100% would be bed-bound.
This outcome measure was reported at baseline (T1) and 4 weeks later (T2).
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: 4 weeks
|
The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain.
It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.
This was measured at baseline (T1) and 4 weeks (T2)
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
January 30, 2015
First Submitted That Met QC Criteria
January 30, 2015
First Posted (Estimate)
February 4, 2015
Study Record Updates
Last Update Posted (Estimate)
February 9, 2016
Last Update Submitted That Met QC Criteria
January 11, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSR05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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