Non-specific Back PainNCT04388007
Non-specific Back Pain and Spinal Manipulation
An observational study of Non-specific Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
The main purpose of this study is to identify short-term predictors of positive responses to a spinal manipulation treatment. To do this, positive responses to treatment, characterized by improvement in pain score, functional capacity, as well as the global perceived change will be evaluated using single and multiple… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-specific Back Pain
- What is being tested?
- Thoracic spinal manipulation
- How many people
- 107 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2020to 1 Jan 2022
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are patient in the chiropractic care center
Who may be able to join
- Being aged over 18 years old
- Presenting non-specific back pain (chronic >=3 months or recurrent complaint)
- Speaking French or English
Who cannot join
- Symptomatic thoracic pain
- Non-musculoskeletal disorders pain
- Pregnancy
- Not eligible to spinal manipulation (if osteoporosis, vertebral fracture history, thoracic disk herniation)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3
About this study
Official title: Predictors for Identifying Patients With Non-specific Back Pain Who Respond Favorably to Spinal Manipulation: a Prospective Cohort Study
The main purpose of this study is to identify short-term predictors of positive responses to a spinal manipulation treatment. To do this, positive responses to treatment, characterized by improvement in pain score, functional capacity, as well as the global perceived change will be evaluated using single and multiple logistic regressions in which biomechanical variables, comfort, expectation will used as potential predictors.
Read the detailed description
The main purpose of this study is to identify short-term predictors of positive responses to a spinal manipulation treatment. To do this, positive responses to treatment, characterized by improvement in pain score, functional capacity, as well as the global perceived change will be evaluated at baseline and at 7 days. Pain score will be also assessed every day with text-tracking. Global perceived change will be evaluated using single and multiple logistic regressions in which biomechanical variables, comfort, expectation will used as potential predictors. 100 individuals with a history of non-specific back pain will be recruited in a chiropractic care center.
- Conditions
- Non-specific Back Pain
- Being tested
- Thoracic spinal manipulation
- Keywords
- Back pain, Spinal manipulation, Cohort study
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic spinal manipulationOther
High velocity, low amplitude force manipulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic Back Pain (Numerical Analog Scale)
assessed by a 0-10 points scale, higher score means altered, lower score means improved
Measured: change from baseline to Day-7
Functional Disability (Quebec Back Pain Disability Scale)
assessed by 0-100 points questionary. Higher scores correlate to greater disability
Measured: change from baseline to Day-7
Global Perceived Change Scale
assessed by a 11-point score scale: higher score means improved, lower score means altered
Measured: at day-7
Secondary outcomes (6)
Dosage
assessed by a force-sensing table recording data through a computer software
Measured: during the intervention
Expectation (for improvement of pain and disability)
assessed by a 11-point score scale : higher score means improved, lower score means altered
Measured: at baseline (pre-intervention)
Socio-demographic factors
assessed with a patient history questionary
Measured: at baseline(pre-intervention)
Tampa Scale of Kinesiophobia
Questionary, Total score range from 17 to 68, Higher score indicate a worst outcome
Measured: at baseline(pre-intervention)
Level of anxiety
Assessed using the State-Trait Anxiety Inventory (STAI) (score range from 20 (minimum) to 80 (maximum) : higher score mean a worst outcome)
Measured: at baseline (pre-intervention)
Level of Comfort
Assessed with a 100mm scale : higher score means very comfortable
Measured: at baseline (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Feb 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
- Investigators
- Martin Descarreaux, DC, PhD, Study director, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388007
- Sponsor's protocol ID
- UQTR-2020-SMTdose
- Status last verified
- May 2024
- First submitted
- 7 May 2020
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Identifying Patients With Non-specific Back Pain Who Respond Favorably to Spinal Manipulation: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04388007
- Acronym / sponsor ID
- UQTR-2020-SMTdose
- Conditions
- Non-specific Back Pain
- Keywords
- Back pain, Spinal manipulation, Cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 14 May 2020 (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.
The main purpose of this study is to identify short-term predictors of positive responses to a spinal manipulation treatment. To do this, positive responses to treatment, characterized by improvement in pain score, functional capacity, as well as the global perceived change will be evaluated using single and multiple logistic regressions in which biomechanical variables, comfort, expectation will used as potential predictors.
Detailed description
The main purpose of this study is to identify short-term predictors of positive responses to a spinal manipulation treatment. To do this, positive responses to treatment, characterized by improvement in pain score, functional capacity, as well as the global perceived change will be evaluated at baseline and at 7 days. Pain score will be also assessed every day with text-tracking. Global perceived change will be evaluated using single and multiple logistic regressions in which biomechanical variables, comfort, expectation will used as potential predictors. 100 individuals with a history of non-specific back pain will be recruited in a chiropractic care center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are patient in the chiropractic care center
Key inclusion criteria (3 listed)
- Being aged over 18 years old
- Presenting non-specific back pain (chronic >=3 months or recurrent complaint)
- Speaking French or English
Key exclusion criteria (4 listed)
- Symptomatic thoracic pain
- Non-musculoskeletal disorders pain
- Pregnancy
- Not eligible to spinal manipulation (if osteoporosis, vertebral fracture history, thoracic disk herniation)
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 |
|---|---|---|
| Thoracic spinal manipulationHigh velocity, low amplitude force manipulation | Other | – |
Primary outcome
Thoracic Back Pain (Numerical Analog Scale)
Time frame: change from baseline to Day-7
assessed by a 0-10 points scale, higher score means altered, lower score means improved
Functional Disability (Quebec Back Pain Disability Scale)
Time frame: change from baseline to Day-7
assessed by 0-100 points questionary. Higher scores correlate to greater disability
Global Perceived Change Scale
Time frame: at day-7
assessed by a 11-point score scale: higher score means improved, lower score means altered
6 secondary outcomes
Dosage
Time frame: during the intervention
Expectation (for improvement of pain and disability)
Time frame: at baseline (pre-intervention)
Socio-demographic factors
Time frame: at baseline(pre-intervention)
Tampa Scale of Kinesiophobia
Time frame: at baseline(pre-intervention)
Level of anxiety
Time frame: at baseline (pre-intervention)
Level of Comfort
Time frame: at baseline (post-intervention)
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 8 May 2024.
- Individual participant dataSharing planned: No
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McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
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Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
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Hybrid mHealth for Low Back Pain
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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.
Martin Descarreaux, DC, PhD study director
Université du Québec à Trois-Rivières
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 Non-specific Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
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 3 inclusion and 4 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 8 May 2024. 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 Canada. 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?
Thoracic Back Pain (Numerical Analog Scale) (time frame: change from baseline to Day-7). The study lists 3 primary outcomes in all. 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 8 May 2024.