Low Back PainNCT02932163
Predictors of Chronic Non-specific Low Back Pain
An observational study of Low Back Pain, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the lower back for at least three months with no known causes. The CNSLBP prevalence is estimated of 90% among all types of the LBP. The LBP imposes high direct and indirect costs on the patients and the society. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2016
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic non-specific LBP were recruited from five hospitals in Ahvaz, Iran.
Who may be able to join
- Patients with chronic non-specific LBP,
- LBP duration ≥ 6 months.
Who cannot join
- spinal osteoarthritis,
- spondylolisthesis,
- history of vertebral fractures.
About this study
Official title: Relationships Between Muscular Impairments, Pain, and Disability in Patients With Chronic Non-specific Low Back Pain: a Cross Sectional Study
Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the lower back for at least three months with no known causes. The CNSLBP prevalence is estimated of 90% among all types of the LBP. The LBP imposes high direct and indirect costs on the patients and the society. Whereas a specific pathology has not been identified for CNSLBP, mechanical factors (e.g. changes in muscle length, strength, or endurance) may contribute to the pain and disability.
- Conditions
- Low Back Pain
- Keywords
- Chronic low back pain, disability, endurance
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain intensity
Visual Analogue Scale
Measured: Baseline
Change of Disability
Oswestry disability index
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionAug 2016
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.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JORGE H VILLAFAÑE, PhD, Principal investigator, IRCCS Don Gnocchi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932163
- Sponsor's protocol ID
- chronic non-specific LBP
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 13 Oct 2016
- 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 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Between Muscular Impairments, Pain, and Disability in Patients With Chronic Non-specific Low Back Pain: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT02932163
- Acronym / sponsor ID
- chronic non-specific LBP
- Conditions
- Low Back Pain
- Keywords
- Chronic low back pain, disability, endurance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Oct 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.
Chronic non-specific low back pain (CNSLBP) has been defined as a persistent pain in the lower back for at least three months with no known causes. The CNSLBP prevalence is estimated of 90% among all types of the LBP. The LBP imposes high direct and indirect costs on the patients and the society. Whereas a specific pathology has not been identified for CNSLBP, mechanical factors (e.g. changes in muscle length, strength, or endurance) may contribute to the pain and disability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic non-specific LBP were recruited from five hospitals in Ahvaz, Iran.
Key inclusion criteria (2 listed)
- Patients with chronic non-specific LBP,
- LBP duration ≥ 6 months.
Key exclusion criteria (3 listed)
- spinal osteoarthritis,
- spondylolisthesis,
- history of vertebral fractures.
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
Change of Pain intensity
Time frame: Baseline
Visual Analogue Scale
Change of Disability
Time frame: Baseline
Oswestry disability index
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 13 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific 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.
JORGE H VILLAFAÑE, PhD principal investigator
IRCCS Don Gnocchi Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Fondazione Don Carlo Gnocchi ETS.
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 2 inclusion and 3 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 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 of Pain intensity (time frame: Baseline). The study lists 2 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 13 Oct 2016.