Back PainSTarT BackNCT03848988
Descriptive Analysis: STarT Back Screening Tool: Cross-sectional Survey & Chart Review
An observational study of Back Pain, run by Parker University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 4 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: New LBP patients presenting to a chiropractic teaching clinic in Dallas, TX
Who may be able to join
- Patients between the age of 18-65 years old.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain
- Keywords
- Chiropractic, Screening tool, Teaching
- Medical subject headings
- Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Low back pain self reported
Oswestry low back pain scale/ tool: 10 point scale with 0 being no pain and 10 being excruciating pain.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start5 Mar 2018
- Primary completion6 Apr 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor Scott and White Health, Private Practitioner
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848988
- Sponsor's protocol ID
- Parker19_001
- Acronym
- STarT Back
- Status last verified
- Aug 2019
- First submitted
- 18 Feb 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03848988
- Acronym / sponsor ID
- STarT Back / Parker19_001
- Conditions
- Back Pain
- Keywords
- Chiropractic, Screening tool, Teaching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Collaborators
- Baylor Scott and White Health, Private Practitioner
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New LBP patients presenting to a chiropractic teaching clinic in Dallas, TX
Key inclusion criteria (1 listed)
- Patients between the age of 18-65 years old.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Low back pain self reported
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain, run by Parker University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chiropractic care Questionnaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.