Low Back PainNCT02990585
Back School for Non-specific Low Back Pain (LBP) in an Urban Setting
A study testing Back school in people with Low Back Pain, run by Wayne State University at 1 site in United States.
Trial summary
This study will be a comparative design between 2 groups of subjects attending classes on back education in an urban setting. Participants will be randomized to either an individual one-on-one back school session or to the 8 group sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Back school
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 30 Sep 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 18 years of age or older who have been suffering from non-specific LBP for at least 3 months
Who cannot join
- Additional impairments contraindicating their safe participation in the back school program, such as evidence of spinal cord pathology, cauda equina, progressive neurological damage, infection, inflammation, malignancy, fracture or a progressive, neurodegenerative disease as well as back surgery within the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an 8-session Back School Versus a Single, Abbreviated Session When Looking at Non-specific Low Back Pain in an Urban Setting
This study will be a comparative design between 2 groups of subjects attending classes on back education in an urban setting. Participants will be randomized to either an individual one-on-one back school session or to the 8 group sessions.
- Conditions
- Low Back Pain
- Being tested
- Back school
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back schoolOther
| Study group | Role | What they receive |
|---|---|---|
| One individual back school session | Active comparator | The 1 individual session will consist of a 60 min 1-on-1 education/exercise session with an athletic trainer. Information will be an abbreviated version of the 8-session school and fill focus on the strengthening, stretching, pain control and movement re-education most needed for the individual. Receives: Other: Back school |
| 8 group session of back school | Active comparator | All sessions last 45-60 minutes. There will be up to 8 participants in each session which will be led by an athletic trainer or rehabilitation trainer. Pain management, prevention strategies, and active treatment will be covered in the 8 sessions. Active treatment includes strengthening, stretching, pain control, movement re-education, and walking. Receives: Other: Back school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Modified Oswestry Disability Index
Measured: At 4 weeks, 10 weeks, 4 months, and 7 months
Secondary outcomes (3)
Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion
Measured: At 4 weeks, 10 weeks, 4 months, and 7 months
Change in the Numeric pain rating scale
Measured: At 4 weeks, 10 weeks, 4 months, and 7 months
Change in the International Physical Activity Questionnaire
Measured: At 4 weeks, 10 weeks, 4 months, and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startOct 2016
- Primary completion1 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Eve Pepin, Wayne State University
- Investigators
- Marie Pepin, DPT, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990585
- Sponsor's protocol ID
- 041016MP4E
- Status last verified
- Oct 2018
- First submitted
- 9 Nov 2016
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an 8-session Back School Versus a Single, Abbreviated Session When Looking at Non-specific Low Back Pain in an Urban Setting
- ClinicalTrials.gov ID
- NCT02990585
- Acronym / sponsor ID
- 041016MP4E
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
This study will be a comparative design between 2 groups of subjects attending classes on back education in an urban setting. Participants will be randomized to either an individual one-on-one back school session or to the 8 group sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One individual back school session | Active comparator | Other: Back schoolThe 1 individual session will consist of a 60 min 1-on-1 education/exercise session with an athletic trainer. Information will be an abbreviated version of the 8-session school and fill focus on the strengthening, stretching, pain control and movement re-education most needed for the individual. |
| 8 group session of back school | Active comparator | Other: Back schoolAll sessions last 45-60 minutes. There will be up to 8 participants in each session which will be led by an athletic trainer or rehabilitation trainer. Pain management, prevention strategies, and active treatment will be covered in the 8 sessions. Active treatment includes strengthening, stretching, pain control, movement re-education, and walking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants 18 years of age or older who have been suffering from non-specific LBP for at least 3 months
Key exclusion criteria (1 listed)
- Additional impairments contraindicating their safe participation in the back school program, such as evidence of spinal cord pathology, cauda equina, progressive neurological damage, infection, inflammation, malignancy, fracture or a progressive, neurodegenerative disease as well as back surgery within the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Back school | Other | 8 group session of back school, One individual back school session |
Primary outcome
Change in the Modified Oswestry Disability Index
Time frame: At 4 weeks, 10 weeks, 4 months, and 7 months
3 secondary outcomes
Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion
Time frame: At 4 weeks, 10 weeks, 4 months, and 7 months
Change in the Numeric pain rating scale
Time frame: At 4 weeks, 10 weeks, 4 months, and 7 months
Change in the International Physical Activity Questionnaire
Time frame: At 4 weeks, 10 weeks, 4 months, and 7 months
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 3 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
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.
Marie Pepin, DPT principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back school in people with Low Back Pain, run by Wayne State 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 3 Oct 2018. 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?
Change in the Modified Oswestry Disability Index (time frame: At 4 weeks, 10 weeks, 4 months, and 7 months). 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 3 Oct 2018.