Thera-Band® HEP for LBP Secondary Prevention (TBKT_HEP)
Primary Purpose
Low Back Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Exercise Program
Sponsored by
About this trial
This is an interventional prevention trial for Low Back Pain focused on measuring Home Exercise, Resistance Exercise
Eligibility Criteria
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
Sites / Locations
- Sport & Spine Rehab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home Exercise Program
Arm Description
Outcomes
Primary Outcome Measures
Oswestry Disability Index
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).
Secondary Outcome Measures
Numeric Pain Rating Scale
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)
Full Information
NCT ID
NCT02355275
First Posted
January 30, 2015
Last Updated
January 11, 2016
Sponsor
Sport and Spine Rehab Clinical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02355275
Brief Title
Thera-Band® HEP for LBP Secondary Prevention
Acronym
TBKT_HEP
Official Title
Thera-Band® Based Home Exercise Program for Low Back Pain Secondary Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
large non-response rate
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sport and Spine Rehab Clinical Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Home Exercise, Resistance Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Exercise Program
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Home Exercise Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sport & Spine Rehab
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Thera-Band® HEP for LBP Secondary Prevention
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