Thera-Band® HEP for LBP Secondary Prevention

NCT ID: NCT02355275

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Home Exercise Program

Group Type: EXPERIMENTAL

Home Exercise Program

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sport and Spine Rehab Clinical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sport & Spine Rehab

Rockville, Maryland, United States

Countries

United States

Other Identifiers

SSR05

Identifier Type: -

Identifier Source: org_study_id