Low Back PainNCT03879031
Responsiveness of the Bridge Tests in Non-specific Low Back Pain
An observational study of Low Back Pain, run by University of Bologna at 1 site in Italy.
Trial summary
This observational study aims to investigate the internal responsiveness and external responsiveness of the Bridge Tests (supine bridge test, prone bridge test, and side bridge test) in relation to pain and disability, in subjects with subacute and chronic non-specific low back pain submitted to a physical therapy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Cluster of Clinical tests to measure lumbar stability
- How many people
- 139 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2019to 30 Nov 2019
- 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 80 years
- All sexes
- Adult, Older adult
Study population: All outpatients entering the conservative physical therapy treatment for subacute or chronic non-specific low back pain in a Occupational Medicine Unit are considered eligible.
Who may be able to join
- Non-specific subacute or chronic low back pain (low back pain from 1 month or more, not related to specific pathologies);
- Low back pain, with or without irradiation to the lower limb, noted as ≥2 on a scale of 0-10;
- Good comprehension of written and spoken Italian Language;
- Informed consent.
Who cannot join
- Acute low back pain;
- Specific causes of low back pain (truma, herniated disc, vertebral deformity, fractures, dislocations);
- Central or peripheral neurologic signs;
- Systemic pathologies;
- Rheumatic disorders;
- Neuromuscular pathologies;
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- Tumors;
- Cognitive deficits;
- Surgical interventions in the last six months prior to the study;
- Osteoporosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Responsiveness of the Bridge Tests in Subjects With Non-specific Subacute or Chronic Low Back Pain
This observational study aims to investigate the internal responsiveness and external responsiveness of the Bridge Tests (supine bridge test, prone bridge test, and side bridge test) in relation to pain and disability, in subjects with subacute and chronic non-specific low back pain submitted to a physical therapy program.
Read the detailed description
Time 0 (first session of the physical therapy treatment program)
The physical therapist will explain to each patient the purpose of the study and request informed consent and data processing consent. In the informed consent form will be specified that the study will concern some diagnostic tests and the study protocol will not influence the physical therapy treatment strategy in any way. Only those who give their consent will be included in the study and will fill in a booklet containing:
- socio-demographical, anthropometric and pain data;
- the Italian version of the Oswestry Disability Index (ODI-I);
- the Italian version of the 0-100 Numerical Rating Scale (NRS). Once completed, the questionnaires will be placed in a sealed envelope and delivered to the examiner.
The physical therapist will perform the following tests, without being aware of the results collected during the initial clinical evaluation and will record the tests results on a pre-printed sheet, which will then be inserted in the same envelope as well.
The tests performed are (in order of execution):
- Aberrant Movements (AM) Test,
- Active Straight Leg Raise (ASLR) Test,
- Supine Bridge Test (SuBT),
- Right Side Bridge Test (RBT),
- Left Side Bridge Test (LBT),
- Prone Bridge Test (PrBT),
- Passive Lumbar Extension (PLE) Test,
- Prone Instability Test (PIT).
The envelope containing the patient's data and the results of the tests will be sent to an independent subject, who will take care of the data collection and their insertion into the electronic database, assigning to each patient a numerical code as the only identification element.
The patients will be submitted to a physical therapy treatment for eight 30-minutes sessions, once a week.
Time 1 (at the end of the last session of the physical therapy treatment)
Those who have completed the physical therapy treatment will receive a final booklet containing the Italian version of the Oswestry Disability Index (ODI-I), the Numerical Rating Scale (NRS) and the Global Perceived Effect (GPE) Questionnaire. Once completed, these questionnaires will be placed in a sealed envelope and delivered to the examiner.
Without being aware of the outcome of the questionnaires contained in the final booklet, the same tests will be repeated:
- Aberrant Movements (AM) Test,
- Active Straight Leg Raise (ASLR) Test,
- Supine Bridge Test (SuBT),
- Right Side Bridge Test (RBT),
- Left Side Bridge Test (LBT),
- Prone Bridge Test (PrBT),
- Passive Lumbar Extension (PLE) Test,
- Prone Instability Test (PIT).
Test results will be recorded on a pre-printed sheet, which will then be inserted in the same envelope and send to the independent subject who is responsible for data collection.
- Conditions
- Low Back Pain
- Being tested
- Cluster of Clinical tests to measure lumbar stability
- Keywords
- lumbar, physical endurance, pain, disability, assessment
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cluster of Clinical tests to measure lumbar stabilityDiagnostic test
All subjects will be submitted to a cluster of clinical test before the starting of the first session, and at the ending of the last session of the physical therapy program. This cluster will include:
- Aberrant Movements (AM) Test,
- Active Straight Leg Raise Test (ASLR) Test,
- Supine Bridge Test (SuBT),
- Right Side Bridge Test (RBT),
- Left Side Bridge Test (LBT),
- Prone Bridge Test (PrBT),
- Passive Lumbar Extension (PLE) Test,
- Prone Instability Test (PIT).
| Study group | Role | What they receive |
|---|---|---|
| Outpatients with low back pain | All outpatients with non-specific subacute or chronic low back pain will be submitted to a physical therapy program including:
* information on pain mechanisms and the favorable nature of non-specific low back pain;
* advice on positions, movements and activities recommended or advised against in people with low back pain, both at work and during leisure time;
* active postural correction exercises, overactive muscles lengthening and weak musculature strengthening;
* passive manual techniques, aimed at muscle relaxation and recovery of lumbar joint mobility.
A cluster of Clinical tests to measure lumbar stability will be administrated before the starting of the first session and at the ending of the last session of the physical therapy program. Receives: Diagnostic Test: Cluster of Clinical tests to measure lumbar stability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in low back pain over time
0-100 Numerical Rating Scale (NRS) for low back pain. This scale is arranged to measure the amount of perceived lumbar pain, from 0 (= no pain) to 100 (=maximum pain).
Measured: Time zero: at baseline - Time one: at the end of the last session of physical therapy treatment (8 weeks after Time zero)
Changes in lumbar disability over time
Oswestry Disability Index - Italian version (ODI-I). This questionnaire measures disability related to low back pain in 10 different domains (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, and Traveling). The patients are asked to identify which of six statements in each domain applies to them at the time of evaluation. The sentences are arranged from no impairment (0) to maximum impairment (5). The scores for each domain are added together (range from 0 to 50) and multiplied by 2 which yields a Disability Index Score percent. If not all items are completed, the score is prorated by averaging the items completed and then multiplying it by 10. A Disability Index Score of 0% to 20% corresponds to minimal disability, 21% to 40% to moderate disability, 41% to 60% to severe disability, 61% to 80% crippled, and 81% to 100% indicates a patient that is either bed-bound or exaggerating their symptoms.
Measured: Time zero: at baseline - Time one: at the end of the last session of physical therapy treatment (8 weeks after Time zero)
Secondary outcomes (1)
Changes in Global Perceived Effect (GPS) questionnaire (Italian version) over time
The GPE is composed of one question on a 7-point Likert-type scale, evaluating the subjective self-reported improvement or deterioration after the intervention, from "fully improved" (score 1) to "fully worsened" (score 7). More specificaly, 1=fully improved; 2=much improved; 3=a little improved; 4=no change; 5= a little deterioration; 6=much deterioration; 7=fully worsened. GPE is widely used in the physical therapy literature.
Measured: At the end of the last session of physical therapy treatment (8 weeks after Time zero)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start20 Mar 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pillastrini, University of Bologna
- Investigators
- Paolo Pillastrini, PT, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879031
- Sponsor's protocol ID
- 1/Bridge
- Status last verified
- Dec 2019
- First submitted
- 8 Mar 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbott JH, McCane B, Herbison P, Moginie G, Chapple C, Hogarty T. Lumbar segmental instability: a criterion-related validity study of manual therapy assessment. BMC Musculoskelet Disord. 2005 Nov 7;6:56. doi: 10.1186/1471-2474-6-56.
PubMed 16274487Alqarni AM, Schneiders AG, Hendrick PA. Clinical tests to diagnose lumbar segmental instability: a systematic review. J Orthop Sports Phys Ther. 2011 Mar;41(3):130-40. doi: 10.2519/jospt.2011.3457. Epub 2011 Feb 2.
PubMed 21289452Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
PubMed 22466247Durall CJ, Greene PF, Kernozek TW. A comparison of two isometric tests of trunk flexor endurance. J Strength Cond Res. 2012 Jul;26(7):1939-44. doi: 10.1519/JSC.0b013e318237ea1c.
PubMed 22728944Ferrari S, Manni T, Bonetti F, Villafane JH, Vanti C. A literature review of clinical tests for lumbar instability in low back pain: validity and applicability in clinical practice. Chiropr Man Therap. 2015 Apr 8;23:14. doi: 10.1186/s12998-015-0058-7. eCollection 2015.
PubMed 25866618Fritz JM, Whitman JM, Childs JD. Lumbar spine segmental mobility assessment: an examination of validity for determining intervention strategies in patients with low back pain. Arch Phys Med Rehabil. 2005 Sep;86(9):1745-52. doi: 10.1016/j.apmr.2005.03.028.
PubMed 16181937Frymoyer JW, Selby DK. Segmental instability. Rationale for treatment. Spine (Phila Pa 1976). 1985 Apr;10(3):280-6. doi: 10.1097/00007632-198504000-00017.
PubMed 3992349Habets B, van Cingel RE, Ostelo RW. Reproducibility of a battery of commonly used clinical tests to evaluate lumbopelvic motor control. Phys Ther Sport. 2015 Nov;16(4):331-9. doi: 10.1016/j.ptsp.2015.02.004. Epub 2015 Mar 7.
PubMed 26254503Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
PubMed 16181938Kasai Y, Morishita K, Kawakita E, Kondo T, Uchida A. A new evaluation method for lumbar spinal instability: passive lumbar extension test. Phys Ther. 2006 Dec;86(12):1661-7. doi: 10.2522/ptj.20050281. Epub 2006 Oct 10.
PubMed 17033040McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
PubMed 10453772Mens JM, Huis In 't Veld YH, Pool-Goudzwaard A. The Active Straight Leg Raise test in lumbopelvic pain during pregnancy. Man Ther. 2012 Aug;17(4):364-8. doi: 10.1016/j.math.2012.01.007. Epub 2012 Feb 22.
PubMed 22365484Ozcan Kahraman B, Salik Sengul Y, Kahraman T, Kalemci O. Developing a Reliable Core Stability Assessment Battery for Patients with Nonspecific Low Back Pain. Spine (Phila Pa 1976). 2016 Jul 15;41(14):E844-E850. doi: 10.1097/BRS.0000000000001403.
PubMed 26679886Rabin A, Shashua A, Pizem K, Dar G. The interrater reliability of physical examination tests that may predict the outcome or suggest the need for lumbar stabilization exercises. J Orthop Sports Phys Ther. 2013 Feb;43(2):83-90. doi: 10.2519/jospt.2013.4310. Epub 2013 Jan 14.
PubMed 23321848Schellenberg KL, Lang JM, Chan KM, Burnham RS. A clinical tool for office assessment of lumbar spine stabilization endurance: prone and supine bridge maneuvers. Am J Phys Med Rehabil. 2007 May;86(5):380-386. doi: 10.1097/PHM.0b013e318032156a.
PubMed 17303961
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Responsiveness of the Bridge Tests in Subjects With Non-specific Subacute or Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03879031
- Acronym / sponsor ID
- 1/Bridge
- Conditions
- Low Back Pain
- Keywords
- lumbar, physical endurance, pain, disability, assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 18 Mar 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.
This observational study aims to investigate the internal responsiveness and external responsiveness of the Bridge Tests (supine bridge test, prone bridge test, and side bridge test) in relation to pain and disability, in subjects with subacute and chronic non-specific low back pain submitted to a physical therapy program.
Detailed description
Time 0 (first session of the physical therapy treatment program)
The physical therapist will explain to each patient the purpose of the study and request informed consent and data processing consent. In the informed consent form will be specified that the study will concern some diagnostic tests and the study protocol will not influence the physical therapy treatment strategy in any way. Only those who give their consent will be included in the study and will fill in a booklet containing:
- socio-demographical, anthropometric and pain data;
- the Italian version of the Oswestry Disability Index (ODI-I);
- the Italian version of the 0-100 Numerical Rating Scale (NRS). Once completed, the questionnaires will be placed in a sealed envelope and delivered to the examiner.
The physical therapist will perform the following tests, without being aware of the results collected during the initial clinical evaluation and will record the tests results on a pre-printed sheet, which will then be inserted in the same envelope as well.
The tests performed are (in order of execution):
- Aberrant Movements (AM) Test,
- Active Straight Leg Raise (ASLR) Test,
- Supine Bridge Test (SuBT),
- Right Side Bridge Test (RBT),
- Left Side Bridge Test (LBT),
- Prone Bridge Test (PrBT),
- Passive Lumbar Extension (PLE) Test,
- Prone Instability Test (PIT).
The envelope containing the patient's data and the results of the tests will be sent to an independent subject, who will take care of the data collection and their insertion into the electronic database, assigning to each patient a numerical code as the only identification element.
The patients will be submitted to a physical therapy treatment for eight 30-minutes sessions, once a week.
Time 1 (at the end of the last session of the physical therapy treatment)
Those who have completed the physical therapy treatment will receive a final booklet containing the Italian version of the Oswestry Disability Index (ODI-I), the Numerical Rating Scale (NRS) and the Global Perceived Effect (GPE) Questionnaire. Once completed, these questionnaires will be placed in a sealed envelope and delivered to the examiner.
Without being aware of the outcome of the questionnaires contained in the final booklet, the same tests will be repeated:
- Aberrant Movements (AM) Test,
- Active Straight Leg Raise (ASLR) Test,
- Supine Bridge Test (SuBT),
- Right Side Bridge Test (RBT),
- Left Side Bridge Test (LBT),
- Prone Bridge Test (PrBT),
- Passive Lumbar Extension (PLE) Test,
- Prone Instability Test (PIT).
Test results will be recorded on a pre-printed sheet, which will then be inserted in the same envelope and send to the independent subject who is responsible for data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients with low back pain | – | Diagnostic Test: Cluster of Clinical tests to measure lumbar stabilityAll outpatients with non-specific subacute or chronic low back pain will be submitted to a physical therapy program including: * information on pain mechanisms and the favorable nature of non-specific low back pain; * advice on positions, movements and activities recommended or advised against in people with low back pain, both at work and during leisure time; * active postural correction exercises, overactive muscles lengthening and weak musculature strengthening; * passive manual techniques, aimed at muscle relaxation and recovery of lumbar joint mobility. A cluster of Clinical tests to measure lumbar stability will be administrated before the starting of the first session and at the ending of the last session of the physical therapy program. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All outpatients entering the conservative physical therapy treatment for subacute or chronic non-specific low back pain in a Occupational Medicine Unit are considered eligible.
Key inclusion criteria (4 listed)
- Non-specific subacute or chronic low back pain (low back pain from 1 month or more, not related to specific pathologies);
- Low back pain, with or without irradiation to the lower limb, noted as ≥2 on a scale of 0-10;
- Good comprehension of written and spoken Italian Language;
- Informed consent.
Key exclusion criteria (10 listed)
- Acute low back pain;
- Specific causes of low back pain (truma, herniated disc, vertebral deformity, fractures, dislocations);
- Central or peripheral neurologic signs;
- Systemic pathologies;
- Rheumatic disorders;
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 |
|---|---|---|
| Cluster of Clinical tests to measure lumbar stabilityAll subjects will be submitted to a cluster of clinical test before the starting of the first session, and at the ending of the last session of the physical therapy program. This cluster will include: * Aberrant Movements (AM) Test, * Active Straight Leg Raise Test (ASLR) Test, * Supine Bridge Test (SuBT), * Right Side Bridge Test (RBT), * Left Side Bridge Test (LBT), * Prone Bridge Test (PrBT), * Passive Lumbar Extension (PLE) Test, * Prone Instability Test (PIT). | Diagnostic test | Outpatients with low back pain |
Primary outcome
Changes in low back pain over time
Time frame: Time zero: at baseline - Time one: at the end of the last session of physical therapy treatment (8 weeks after Time zero)
0-100 Numerical Rating Scale (NRS) for low back pain. This scale is arranged to measure the amount of perceived lumbar pain, from 0 (= no pain) to 100 (=maximum pain).
Changes in lumbar disability over time
Time frame: Time zero: at baseline - Time one: at the end of the last session of physical therapy treatment (8 weeks after Time zero)
Oswestry Disability Index - Italian version (ODI-I). This questionnaire measures disability related to low back pain in 10 different domains (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, and Traveling). The patients are asked to identify which of six statements in each domain applies to them at the time of evaluation. The sentences are arranged from no impairment (0) to maximum impairment (5). The scores for each domain are added together (range from 0 to 50) and multiplied by 2 which yields a Disability Index Score percent. If not all items are completed, the score is prorated by averaging the items completed and then multiplying it by 10. A Disability Index Score of 0% to 20% corresponds to minimal disability, 21% to 40% to moderate disability, 41% to 60% to severe disability, 61% to 80% crippled, and 81% to 100% indicates a patient that is either bed-bound or exaggerating their symptoms.
1 secondary outcome
Changes in Global Perceived Effect (GPS) questionnaire (Italian version) over time
Time frame: At the end of the last session of physical therapy treatment (8 weeks after Time zero)
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 19 Dec 2019.
- Background: PubMed 16274487Abbott JH, McCane B, Herbison P, Moginie G, Chapple C, Hogarty T. Lumbar segmental instability: a criterion-related validity study of manual therapy assessment. BMC Musculoskelet Disord. 2005 Nov 7;6:56. doi: 10.1186/1471-2474-6-56.
- Background: PubMed 21289452Alqarni AM, Schneiders AG, Hendrick PA. Clinical tests to diagnose lumbar segmental instability: a systematic review. J Orthop Sports Phys Ther. 2011 Mar;41(3):130-40. doi: 10.2519/jospt.2011.3457. Epub 2011 Feb 2.
- Background: PubMed 22466247Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
- Background: PubMed 22728944Durall CJ, Greene PF, Kernozek TW. A comparison of two isometric tests of trunk flexor endurance. J Strength Cond Res. 2012 Jul;26(7):1939-44. doi: 10.1519/JSC.0b013e318237ea1c.
- Background: PubMed 25866618Ferrari S, Manni T, Bonetti F, Villafane JH, Vanti C. A literature review of clinical tests for lumbar instability in low back pain: validity and applicability in clinical practice. Chiropr Man Therap. 2015 Apr 8;23:14. doi: 10.1186/s12998-015-0058-7. eCollection 2015.
- Background: PubMed 16181937Fritz JM, Whitman JM, Childs JD. Lumbar spine segmental mobility assessment: an examination of validity for determining intervention strategies in patients with low back pain. Arch Phys Med Rehabil. 2005 Sep;86(9):1745-52. doi: 10.1016/j.apmr.2005.03.028.
- Background: PubMed 3992349Frymoyer JW, Selby DK. Segmental instability. Rationale for treatment. Spine (Phila Pa 1976). 1985 Apr;10(3):280-6. doi: 10.1097/00007632-198504000-00017.
- Background: PubMed 26254503Habets B, van Cingel RE, Ostelo RW. Reproducibility of a battery of commonly used clinical tests to evaluate lumbopelvic motor control. Phys Ther Sport. 2015 Nov;16(4):331-9. doi: 10.1016/j.ptsp.2015.02.004. Epub 2015 Mar 7.
- Background: PubMed 16181938Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
- Background: PubMed 17033040Kasai Y, Morishita K, Kawakita E, Kondo T, Uchida A. A new evaluation method for lumbar spinal instability: passive lumbar extension test. Phys Ther. 2006 Dec;86(12):1661-7. doi: 10.2522/ptj.20050281. Epub 2006 Oct 10.
- Background: PubMed 10453772McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
- Background: PubMed 22365484Mens JM, Huis In 't Veld YH, Pool-Goudzwaard A. The Active Straight Leg Raise test in lumbopelvic pain during pregnancy. Man Ther. 2012 Aug;17(4):364-8. doi: 10.1016/j.math.2012.01.007. Epub 2012 Feb 22.
- Individual participant dataSharing planned: No
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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.
Paolo Pillastrini, PT principal investigator
University of Bologna
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, run by University of Bologna at 1 site in Italy.
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 4 inclusion and 10 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 19 Dec 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 Italy. 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?
Changes in low back pain over time (time frame: Time zero: at baseline - Time one: at the end of the last session of physical therapy treatment (8 weeks after Time zero)). 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 NCT03879031, which also lists 19 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 19 Dec 2019.