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Thera-Band® HEP for LBP Secondary Prevention

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02355275
Acronym
TBKT_HEP
Enrollment
22
Registered
2015-02-04
Start date
2015-01-31
Completion date
Unknown
Last updated
2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Home Exercise, Resistance Exercise

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.

Interventions

PROCEDUREHome 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.

Sponsors

Sport and Spine Rehab Clinical Research Foundation
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oswestry Disability Index4 weeksPatient 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

MeasureTime frameDescription
Numeric Pain Rating Scale4 weeksThe 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)

Countries

United States

Participant flow

Participants by arm

ArmCount
Home Exercise Program
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.
22
Total22

Baseline characteristics

CharacteristicHome Exercise Program
Age, Continuous41.5 years
Sex: Female, Male
Female
15 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 22
serious
Total, serious adverse events
0 / 22

Outcome results

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).

Time frame: 4 weeks

ArmMeasureGroupValue (MEAN)
Home Exercise ProgramOswestry Disability IndexOSW T214.71 units on a scale
Home Exercise ProgramOswestry Disability IndexOSW T118.75 units on a scale
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)

Time frame: 4 weeks

ArmMeasureGroupValue (MEAN)
Home Exercise ProgramNumeric Pain Rating ScalePain T22.3 units on a scale
Home Exercise ProgramNumeric Pain Rating ScalePain T12.7 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026