Responsiveness of the Bridge Tests in Non-specific Low Back Pain
NCT ID: NCT03879031
Last Updated: 2019-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
139 participants
OBSERVATIONAL
2019-03-20
2019-11-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Cluster of Clinical tests to measure lumbar stability
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).
Interventions
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Cluster of Clinical tests to measure lumbar stability
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).
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Specific causes of low back pain (truma, herniated disc, vertebral deformity, fractures, dislocations);
* Central or peripheral neurologic signs;
* Systemic pathologies;
* Rheumatic disorders;
* Neuromuscular pathologies;
* Tumors;
* Cognitive deficits;
* Surgical interventions in the last six months prior to the study;
* Osteoporosis.
18 Years
80 Years
ALL
No
Sponsors
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University of Bologna
OTHER
Responsible Party
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Paolo Pillastrini
Full professor - Director of the Masters in Musculoskeletal Physiotherapy - University of Bologna
Principal Investigators
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Paolo Pillastrini, PT
Role: PRINCIPAL_INVESTIGATOR
University of Bologna
Locations
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Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, Italy
Countries
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References
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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.
Alqarni 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.
Delitto 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.
Durall 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.
Ferrari 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.
Fritz 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.
Frymoyer JW, Selby DK. Segmental instability. Rationale for treatment. Spine (Phila Pa 1976). 1985 Apr;10(3):280-6. doi: 10.1097/00007632-198504000-00017.
Habets 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.
Hicks 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.
Kasai 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.
McGill 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.
Mens 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.
Ozcan 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.
Rabin 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.
Schellenberg 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.
Stuge B, Veierod MB, Laerum E, Vollestad N. The efficacy of a treatment program focusing on specific stabilizing exercises for pelvic girdle pain after pregnancy: a two-year follow-up of a randomized clinical trial. Spine (Phila Pa 1976). 2004 May 15;29(10):E197-203. doi: 10.1097/00007632-200405150-00021.
Vanti C, Conti C, Faresin F, Ferrari S, Piccarreta R. The Relationship Between Clinical Instability and Endurance Tests, Pain, and Disability in Nonspecific Low Back Pain. J Manipulative Physiol Ther. 2016 Jun;39(5):359-368. doi: 10.1016/j.jmpt.2016.04.003. Epub 2016 May 7.
Vanti C, Ferrari S, Berjano P, Villafane JH, Monticone M. Responsiveness of the bridge maneuvers in subjects with symptomatic lumbar spondylolisthesis: A prospective cohort study. Physiother Res Int. 2017 Oct;22(4). doi: 10.1002/pri.1682. Epub 2017 Jan 6.
Weir A, Darby J, Inklaar H, Koes B, Bakker E, Tol JL. Core stability: inter- and intraobserver reliability of 6 clinical tests. Clin J Sport Med. 2010 Jan;20(1):34-8. doi: 10.1097/JSM.0b013e3181cae924.
Other Identifiers
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1/Bridge
Identifier Type: -
Identifier Source: org_study_id