Descriptive Analysis: STarT Back Screening Tool: Cross-se... | NCT03848988

Studies
Descriptive Analysis: STarT Back Screening Tool: Cross-sectional Survey & Chart Review

NCT03848988

Sponsor

Parker University

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Back Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2018Actual

Primary Completion Date

Apr 6, 2018Actual

Completion Date

May 4, 2018Actual

First Submitted Date

Feb 18, 2019

First Submission Date that Met QC Criteria

Feb 19, 2019

First Posted Date

Feb 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2019

Last Update Posted Date

Aug 28, 2019Actual

Name	Class
Baylor Scott and White Health	OTHER
Private Practitioner	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chiropractic care Questionnaire	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 Outcomes

Measure	Description	Time Frame
Low back pain self reported	Oswestry low back pain scale/ tool: 10 point scale with 0 being no pain and 10 being excruciating pain.	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between the age of 18-65 years old.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Accepted all genders, biological and/ or self-preference.

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

New LBP patients presenting to a chiropractic teaching clinic in Dallas, TX

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parker University		Dallas	Texas	75229	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001416	Back Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided