NCT02355275

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Results Posted

Study results publicly available

February 9, 2016

Completed
Last Updated

February 9, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 30, 2015

Results QC Date

January 11, 2016

Last Update Submit

January 11, 2016

Conditions

Low Back Pain

Keywords

Home ExerciseResistance Exercise

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Numeric Pain Rating Scale

    4 weeks

Study Arms (1)

Home Exercise Program

EXPERIMENTAL
Procedure: Home Exercise Program

Interventions

Home Exercise ProgramPROCEDURE

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.

Home Exercise Program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current, chronic low back pain
  • discharging from care

You may not qualify if:

  • current pregnancy
  • presence of any red flags such as tumor or cancer, vertebral fracture, or infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport & Spine Rehab

Rockville, Maryland, 20852, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jena Slaski
Organization
Sport & Spine Rehab Clinical Research Foundation
jslaski@gmail.com
301-251-2777

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Last Updated

February 9, 2016

Results First Posted

February 9, 2016

Record last verified: 2016-01

Locations

US(1)