Thera-Band® HEP for LBP Secondary Prevention

Low Back Pain Clinical Trial

— TBKT_HEP  

Official title:

Thera-Band® Based Home Exercise Program for Low Back Pain Secondary Prevention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02355275
• Other study ID #: SSR05
• Status: Terminated
• Phase: N/A
• First received: January 30, 2015
• Last updated: January 11, 2016
• Start date: January 2015

Study information

• Verified date: January 2016
• Source: Sport and Spine Rehab Clinical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Sport & Spine Rehab	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sport and Spine Rehab Clinical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 weeks	No
Secondary	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)	4 weeks	No