Low Back Pain, MechanicalPhydelNCT04990518
Physical Deconditioning in COVID-19 Positive Patients and Non-Specific Low Back Pain
An observational study of Low Back Pain, Mechanical, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 to explore the relationship between physical fitness and low back pain (LBP). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- How many people
- 350 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Nov 2022to 5 Nov 2022
- 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: People with a positive COVID test during the previous year, living in Geneva Switzerland, who declare their willingness to participate in clinical studies.
Who may be able to join
- Age > 18 years, <65 years old
- Confirmed or supected COVID19 test
- Informed Consent as documented by signature
Who cannot join
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Previous enrolment into the current study.
- Any comorbidity which could impact on the physical test (6-minutes walking test), e.g hip or knee osteoarthritis, polyneuropathy, symptomatic coronary heart disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Deconditioning and Non-Specific Low Back Pain: the PHYDEL Study. A Prospective Study in a COVID-19 Positive Cohort
The purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 to explore the relationship between physical fitness and low back pain (LBP). Level of physical fitness will be measured at baseline and incidence and intensity of LBP will be recoreded over 1 year.
Read the detailed description
Non-specific low back pain (LBP) is the worldwide number one cause for disease related years lived with disability. It is frequently assumed that a low physical fitness is a major risk factor for acute LBP as well as a factor for chronic LBP. However only few prospective observational study have been conducted.
The purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 and assessing level of physical fitness and both incidence and intensity of LBP over a 1-year period.
The study aims to determine if a poor physical health, as measured by 6 minutes walk test (6MWT) and 30''seconds sit to stand test (30''STS), is a risk factor for LBP occurrence and for chronic LBP Secondary objectives aim to explore the respective weight of physical factors (i.e. physical fitness, BMI, smoking, physical activities) and psychological factors (i.e. depression, anxiety, catastrophism, fear-avoidance) on the occurrence and severity of LBP.
According to the literature, we expect that in the physically healthy population, 15% will developed back pain; whereas in the population in poor physical health the incidence at 1 year will be 30%. If alpha error is set at 0.05 then 236 patients are required to have a 80% chance to confirm our hypothesis. In order to account for drop out, and considering that the risk of drop out is high in this type of non-interventional study 350 persons will be recruited. Note that this amount of persons should yield approximately 70 persons with low back pain, which allow up to 7 independent variable in a logistic or cox regression. This is based on the rule of at least 10 events (low back pain) per variable.
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Low back pain, Physical deconditioning, Chronicity
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year incidence of LBP
Influence of baseline physical fitness on the number of participant with at least 1 episode of Low Back Pain
Measured: 1 year
1-year incidence of chronic LBP
Influence of baseline physical fitness on the number of participant with at least 3 months of LBP most of the days
Measured: 1 year
Secondary outcomes (30)
Severity of LBP according to Pain trajectories
Influence of baseline physical fitness on 1 year pain trajectories recorded at the end of the study
Measured: at least 3 months during the last year
Severity of LBP according to multiaxial evaluation
Influence of baseline physical fitness on Severity measured with COMI, multi-axial PRO specific for LBP
Measured: 1 year
Severity of LBP according to treatment use
Influence of baseline physical fitness on the number of medical and paramedical appointements during the pain period
Measured: 1 year
Influence of depression on 1-year incidence of LBP
Influence of depression as measured with HADS on the incidence of LBP
Measured: 1 year
Influence of anxiety on 1-year incidence of LBP
Influence of anxiety as measured with HADS on the incidence of LBP
Measured: 1 year
Influence of catastrophism on 1-year incidence of LBP
Influence of catastrpphism as measured with PCS on the incidence of LBP
Measured: 1 year
Influence of fear-avoidance beliefs on 1-year incidence of LBP
Influence of fear-avoidance beliefs as measured with FABQ on the incidence of LBP
Measured: 1 year
Influence of self-efficacy on 1-year incidence of LBP
Influence of self-efficacy as measured with PSEQ-2 on the incidence of LBP
Measured: 1 year
Influence of depression on 1-year incidence of chronic LBP
Influence of depression as measured with HADS on the incidence of people with LBP for more than 3 months
Measured: 1 year
Influence of anxiety on 1-year incidence of chronic LBP
Influence of anxiety as measured with HADS on the incidence of people with LBP for more than 3 months
Measured: 1 year
Influence of catastrophism on 1-year incidence of chronic LBP
Influence of catastrophisms measured with PCS on the incidence of people with LBP for more than 3 months
Measured: 1 year
Influence of fear-avoidance beliefs on 1-year incidence of chronic LBP
Influence of fear-avoidance beliefs measured with FABQ on the incidence of people with LBP for more than 3 months
Measured: 1 year
Influence of self-efficacy on 1-year incidence of chronic LBP
Influence of self-efficacy measured with PSEQ-2 on the incidence of people with LBP for more than 3 months
Measured: 1 year
Influence of depression on severity of LBP accroding to pain trajectories
Influence of depression as measured by HADS on 1 year pain trajectories recorded at the end of the study
Measured: 1 year
Influence of anxiety on severity of LBP accroding to pain trajectories
Influence of anxiety as measured by HADS on 1 year pain trajectories recorded at the end of the study
Measured: 1 year
Influence of catastrophism on severity of LBP accroding to pain trajectories
Influence of catastrophism as measured by PCS on 1 year pain trajectories recorded at the end of the study
Measured: 1 year
Influence of fear-avoidance beliefs on severity of LBP accroding to pain trajectories
Influence of fear-avoidance beliefs as measured with FABQ on 1 year pain trajectories recorded at the end of the study
Measured: 1 year
Influence of self-efficacy on severity of LBP accroding to pain trajectories
Influence of self-efficacy as measured with PSEQ-2 on 1 year pain trajectories recorded at the end of the study
Measured: 1 year
Influence of depression on severity of LBP assessed with a multiaxial tool
Influence of depression as measured by HADS on severity as assessed with COMI, multi-axial PRO specific for LBP
Measured: 1 year
Influence of anxiety on severity of LBP assessed with a multiaxial tool
Influence of anxiety as measured by HADS on severity as assessed with COMI, multi-axial PRO specific for LBP
Measured: 1 year
Influence of catastrophism on severity of LBP assessed with a multiaxial tool
Influence of catastrophism as measured by PCS on severity as assessed with COMI, multi-axial PRO specific for LBP
Measured: 1 year
Influence of fear-avoidance beliefs on severity of LBP assessed with a multiaxial tool
Influence of fear-avoidance beliefs as measured by FABQ on severity as assessed with COMI, multi-axial PRO specific for LBP
Measured: 1 year
Influence of self-efficacy on severity of LBP assessed with a multiaxial tool
Influence of self-efficacy as measured by PSEQ-2 on severity as assessed with COMI, multi-axial PRO specific for LBP
Measured: 1 year
Influence of depression on severity of LBP according to treatment use
Influence of depression as measured by HADS on the number of medical and paramedical appointements during the pain period
Measured: 1 year
Influence of anxiety on severity of LBP according to treatment use
Influence of anxiety as measured by HADS on the number of medical and paramedical appointements during the pain period
Measured: 1 year
Influence of catastrophism on severity of LBP according to treatment use
Influence of catastrophism as measured by PCS on the number of medical and paramedical appointements during the pain period
Measured: 1 year
Influence of fear-avoidance beliefs on severity of LBP according to treatment use
Influence of fear-avoidance beliefs measured by FABQ on the number of medical and paramedical appointements during the pain period
Measured: 1 year
Influence of self-efficacy on severity of LBP according to treatment use
Influence of self-efficacy measured by PSEQ-2 on the number of medical and paramedical appointements during the pain period
Measured: 1 year
Impact of regular physical activity on LBP episode
Studing the impact of the intensity of physical activity during the previous month on the length and the intensity (COMI) of LBP episode.
Measured: 1 year
Impact of regular physical activity on chronicity
Studing the impact of the intensity of physical activity during the previous month on the risk of chronicity (3 months of pain most of the day)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start5 Nov 2022
- Primary completion5 Nov 2022
- Study completion5 Nov 2022
Why it stopped: Grant not allowed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Genevay, University Hospital, Geneva
- Investigators
- Stephane Genevay, MD, Principal investigator, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990518
- Sponsor's protocol ID
- 2020-01994
- Acronym
- Phydel
- Status last verified
- Nov 2022
- First submitted
- 22 Jul 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verbunt JA, Smeets RJ, Wittink HM. Cause or effect? Deconditioning and chronic low back pain. Pain. 2010 Jun;149(3):428-430. doi: 10.1016/j.pain.2010.01.020. Epub 2010 Feb 12. No abstract available.
PubMed 20153582Buchbinder R, Batterham R, Elsworth G, Dionne CE, Irvin E, Osborne RH. A validity-driven approach to the understanding of the personal and societal burden of low back pain: development of a conceptual and measurement model. Arthritis Res Ther. 2011;13(5):R152. doi: 10.1186/ar3468. Epub 2011 Sep 20.
PubMed 21933393Maetzel A, Li L. The economic burden of low back pain: a review of studies published between 1996 and 2001. Best Pract Res Clin Rheumatol. 2002 Jan;16(1):23-30. doi: 10.1053/berh.2001.0204.
PubMed 11987929Choi BK, Verbeek JH, Tam WW, Jiang JY. Exercises for prevention of recurrences of low-back pain. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006555. doi: 10.1002/14651858.CD006555.pub2.
PubMed 20091596Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
PubMed 22231424Bohannon RW, Crouch R. Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review. J Eval Clin Pract. 2017 Apr;23(2):377-381. doi: 10.1111/jep.12629. Epub 2016 Sep 4.
PubMed 27592691Kongsted A, Hestbaek L, Kent P. How can latent trajectories of back pain be translated into defined subgroups? BMC Musculoskelet Disord. 2017 Jul 3;18(1):285. doi: 10.1186/s12891-017-1644-8.
PubMed 28673341Genevay S, Marty M, Courvoisier DS, Foltz V, Mahieu G, Demoulin C, Fontana AG, Norberg M, de Goumoens P, Cedraschi C, Rozenberg S; Section Rachisde la Societe Francaise de Rhumatologie. Validity of the French version of the Core Outcome Measures Index for low back pain patients: a prospective cohort study. Eur Spine J. 2014 Oct;23(10):2097-104. doi: 10.1007/s00586-014-3325-8. Epub 2014 Jul 15.
PubMed 25022859Dionne CE, Dunn KM, Croft PR, Nachemson AL, Buchbinder R, Walker BF, Wyatt M, Cassidy JD, Rossignol M, Leboeuf-Yde C, Hartvigsen J, Leino-Arjas P, Latza U, Reis S, Gil Del Real MT, Kovacs FM, Oberg B, Cedraschi C, Bouter LM, Koes BW, Picavet HS, van Tulder MW, Burton K, Foster NE, Macfarlane GJ, Thomas E, Underwood M, Waddell G, Shekelle P, Volinn E, Von Korff M. A consensus approach toward the standardization of back pain definitions for use in prevalence studies. Spine (Phila Pa 1976). 2008 Jan 1;33(1):95-103. doi: 10.1097/BRS.0b013e31815e7f94.
PubMed 18165754
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Deconditioning and Non-Specific Low Back Pain: the PHYDEL Study. A Prospective Study in a COVID-19 Positive Cohort
- ClinicalTrials.gov ID
- NCT04990518
- Acronym / sponsor ID
- Phydel / 2020-01994
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Low back pain, Physical deconditioning, Chronicity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Grant not allowed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 4 Aug 2021 (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 purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 to explore the relationship between physical fitness and low back pain (LBP). Level of physical fitness will be measured at baseline and incidence and intensity of LBP will be recoreded over 1 year.
Detailed description
Non-specific low back pain (LBP) is the worldwide number one cause for disease related years lived with disability. It is frequently assumed that a low physical fitness is a major risk factor for acute LBP as well as a factor for chronic LBP. However only few prospective observational study have been conducted.
The purpose of this study is to take advantage of cohorts of patients followed for Coronavirus Disease 2019 (COVID19) expected to present poor physical fitness as the consequence of COVID19 and assessing level of physical fitness and both incidence and intensity of LBP over a 1-year period.
The study aims to determine if a poor physical health, as measured by 6 minutes walk test (6MWT) and 30''seconds sit to stand test (30''STS), is a risk factor for LBP occurrence and for chronic LBP Secondary objectives aim to explore the respective weight of physical factors (i.e. physical fitness, BMI, smoking, physical activities) and psychological factors (i.e. depression, anxiety, catastrophism, fear-avoidance) on the occurrence and severity of LBP.
According to the literature, we expect that in the physically healthy population, 15% will developed back pain; whereas in the population in poor physical health the incidence at 1 year will be 30%. If alpha error is set at 0.05 then 236 patients are required to have a 80% chance to confirm our hypothesis. In order to account for drop out, and considering that the risk of drop out is high in this type of non-interventional study 350 persons will be recruited. Note that this amount of persons should yield approximately 70 persons with low back pain, which allow up to 7 independent variable in a logistic or cox regression. This is based on the rule of at least 10 events (low back pain) per variable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with a positive COVID test during the previous year, living in Geneva Switzerland, who declare their willingness to participate in clinical studies.
Key inclusion criteria (3 listed)
- Age > 18 years, <65 years old
- Confirmed or supected COVID19 test
- Informed Consent as documented by signature
Key exclusion criteria (3 listed)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Previous enrolment into the current study.
- Any comorbidity which could impact on the physical test (6-minutes walking test), e.g hip or knee osteoarthritis, polyneuropathy, symptomatic coronary heart disease.
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
1-year incidence of LBP
Time frame: 1 year
Influence of baseline physical fitness on the number of participant with at least 1 episode of Low Back Pain
1-year incidence of chronic LBP
Time frame: 1 year
Influence of baseline physical fitness on the number of participant with at least 3 months of LBP most of the days
30 secondary outcomes
Severity of LBP according to Pain trajectories
Time frame: at least 3 months during the last year
Severity of LBP according to multiaxial evaluation
Time frame: 1 year
Severity of LBP according to treatment use
Time frame: 1 year
Influence of depression on 1-year incidence of LBP
Time frame: 1 year
Influence of anxiety on 1-year incidence of LBP
Time frame: 1 year
Influence of catastrophism on 1-year incidence of LBP
Time frame: 1 year
Influence of fear-avoidance beliefs on 1-year incidence of LBP
Time frame: 1 year
Influence of self-efficacy on 1-year incidence of LBP
Time frame: 1 year
Influence of depression on 1-year incidence of chronic LBP
Time frame: 1 year
Influence of anxiety on 1-year incidence of chronic LBP
Time frame: 1 year
Influence of catastrophism on 1-year incidence of chronic LBP
Time frame: 1 year
Influence of fear-avoidance beliefs on 1-year incidence of chronic LBP
Time frame: 1 year
Influence of self-efficacy on 1-year incidence of chronic LBP
Time frame: 1 year
Influence of depression on severity of LBP accroding to pain trajectories
Time frame: 1 year
Influence of anxiety on severity of LBP accroding to pain trajectories
Time frame: 1 year
Influence of catastrophism on severity of LBP accroding to pain trajectories
Time frame: 1 year
Influence of fear-avoidance beliefs on severity of LBP accroding to pain trajectories
Time frame: 1 year
Influence of self-efficacy on severity of LBP accroding to pain trajectories
Time frame: 1 year
Influence of depression on severity of LBP assessed with a multiaxial tool
Time frame: 1 year
Influence of anxiety on severity of LBP assessed with a multiaxial tool
Time frame: 1 year
Influence of catastrophism on severity of LBP assessed with a multiaxial tool
Time frame: 1 year
Influence of fear-avoidance beliefs on severity of LBP assessed with a multiaxial tool
Time frame: 1 year
Influence of self-efficacy on severity of LBP assessed with a multiaxial tool
Time frame: 1 year
Influence of depression on severity of LBP according to treatment use
Time frame: 1 year
Influence of anxiety on severity of LBP according to treatment use
Time frame: 1 year
Influence of catastrophism on severity of LBP according to treatment use
Time frame: 1 year
Influence of fear-avoidance beliefs on severity of LBP according to treatment use
Time frame: 1 year
Influence of self-efficacy on severity of LBP according to treatment use
Time frame: 1 year
Impact of regular physical activity on LBP episode
Time frame: 1 year
Impact of regular physical activity on chronicity
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Grant not allowed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Results publication: PubMed 20153582Verbunt JA, Smeets RJ, Wittink HM. Cause or effect? Deconditioning and chronic low back pain. Pain. 2010 Jun;149(3):428-430. doi: 10.1016/j.pain.2010.01.020. Epub 2010 Feb 12. No abstract available.
- Results publication: PubMed 21933393Buchbinder R, Batterham R, Elsworth G, Dionne CE, Irvin E, Osborne RH. A validity-driven approach to the understanding of the personal and societal burden of low back pain: development of a conceptual and measurement model. Arthritis Res Ther. 2011;13(5):R152. doi: 10.1186/ar3468. Epub 2011 Sep 20.
- Results publication: PubMed 11987929Maetzel A, Li L. The economic burden of low back pain: a review of studies published between 1996 and 2001. Best Pract Res Clin Rheumatol. 2002 Jan;16(1):23-30. doi: 10.1053/berh.2001.0204.
- Results publication: PubMed 20091596Choi BK, Verbeek JH, Tam WW, Jiang JY. Exercises for prevention of recurrences of low-back pain. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006555. doi: 10.1002/14651858.CD006555.pub2.
- Results publication: PubMed 22231424Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
- Results publication: PubMed 27592691Bohannon RW, Crouch R. Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review. J Eval Clin Pract. 2017 Apr;23(2):377-381. doi: 10.1111/jep.12629. Epub 2016 Sep 4.
- Results publication: PubMed 28673341Kongsted A, Hestbaek L, Kent P. How can latent trajectories of back pain be translated into defined subgroups? BMC Musculoskelet Disord. 2017 Jul 3;18(1):285. doi: 10.1186/s12891-017-1644-8.
- Results publication: PubMed 25022859Genevay S, Marty M, Courvoisier DS, Foltz V, Mahieu G, Demoulin C, Fontana AG, Norberg M, de Goumoens P, Cedraschi C, Rozenberg S; Section Rachisde la Societe Francaise de Rhumatologie. Validity of the French version of the Core Outcome Measures Index for low back pain patients: a prospective cohort study. Eur Spine J. 2014 Oct;23(10):2097-104. doi: 10.1007/s00586-014-3325-8. Epub 2014 Jul 15.
- Results publication: PubMed 18165754Dionne CE, Dunn KM, Croft PR, Nachemson AL, Buchbinder R, Walker BF, Wyatt M, Cassidy JD, Rossignol M, Leboeuf-Yde C, Hartvigsen J, Leino-Arjas P, Latza U, Reis S, Gil Del Real MT, Kovacs FM, Oberg B, Cedraschi C, Bouter LM, Koes BW, Picavet HS, van Tulder MW, Burton K, Foster NE, Macfarlane GJ, Thomas E, Underwood M, Waddell G, Shekelle P, Volinn E, Von Korff M. A consensus approach toward the standardization of back pain definitions for use in prevalence studies. Spine (Phila Pa 1976). 2008 Jan 1;33(1):95-103. doi: 10.1097/BRS.0b013e31815e7f94.
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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.
Stephane Genevay, MD principal investigator
University Hospitals of Geneva
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 Low Back Pain, Mechanical, run by University Hospital, Geneva at 1 site in Switzerland.
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 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: stopped early, as of the sponsor's last update on 9 Nov 2022. 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 Switzerland. 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 was stopped early (reason given: Grant not allowed). Results are not available in the source record.
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?
1-year incidence of LBP (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT04990518, which also lists 9 linked publications.
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 9 Nov 2022.