- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03848988
Descriptive Analysis: STarT Back Screening Tool: Cross-sectional Survey & Chart Review (STarT Back)
August 26, 2019 updated by: Parker University
A Descriptive Analysis of Back Pain Patient's Seeking Care at Chiropractic Academic Teaching Clinics Using the STarT Back Screening Tool: Cross-sectional Survey and Chart Review
Keele STarT Back SCreening Tool (KSB) is a practical and validated bio-psychosocial questionnaire that stratifies lower back pain patients into 3 risk groups (low, medium, high), with suggested treatment guidelines for each grouping.
The 9-question KSB has been used in chiropractic practice to help guide medical decision making, but its use in chiropractic teaching environments has been limited.
Study Overview
Status
Completed
Conditions
Detailed Description
All new LBP patients between the ages of 18-65 years presenting to a chiropractic teaching clinic in Dallas, TX between March 05, 2018 and April 06, 2018 were asked to complete the KSB questionnaire.
No introduction of the KSB was given to students or faculty.
For all patients that completed the KSB, a chart review of the first 4 weeks of care was completed to retrieve patient follow-up information and treatment provided, including: self-reported LBP on a 10-point numerical rating scale (NRS), region of spinal manipulation therapy (SMT), and active rehabilitation provided.
Study Type
Observational
Enrollment (Actual)
87
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75229
- Parker University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
New LBP patients presenting to a chiropractic teaching clinic in Dallas, TX
Description
Inclusion Criteria:
- Patients between the age of 18-65 years old.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chiropractic care Questionnaire
Time Frame: 4 weeks
|
Nine question Keele STarT Back questionnaire to identify treatment options for individuals with low, moderate, and high risk low back pain.
A 10 point numerical rating scale (NRS) was used to with 0-4 being low risk, 5 being moderate risk, and 6-10 being high risk.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low back pain self reported
Time Frame: 4 weeks
|
Oswestry low back pain scale/ tool: 10 point scale with 0 being no pain and 10 being excruciating pain.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2018
Primary Completion (Actual)
April 6, 2018
Study Completion (Actual)
May 4, 2018
Study Registration Dates
First Submitted
February 18, 2019
First Submitted That Met QC Criteria
February 19, 2019
First Posted (Actual)
February 21, 2019
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 26, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Parker19_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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