- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879031
Responsiveness of the Bridge Tests in Non-specific Low Back Pain
Evaluation of the Responsiveness of the Bridge Tests in Subjects With Non-specific Subacute or Chronic Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Emilia Romagna
-
Bologna, Emilia Romagna, Italy, 40138
- Policlinico S.Orsola-Malpighi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Tumors;
- Cognitive deficits;
- Surgical interventions in the last six months prior to the study;
- Osteoporosis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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:
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. |
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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
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.
|
Time zero: at baseline - Time one: at the end of the last session of physical therapy treatment (8 weeks after Time zero)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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.
|
At the end of the last session of physical therapy treatment (8 weeks after Time zero)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paolo Pillastrini, PT, University of Bologna
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1/Bridge
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Ache Laboratorios Farmaceuticos S.A.Unknown
-
Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
-
Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on Cluster of Clinical tests to measure lumbar stability
-
Cambridge University Hospitals NHS Foundation TrustCompleted
-
Prof. Dr. Matthis SynofzikRecruitingAtaxiaGermany, Italy, Australia, Brazil, France, New Zealand, Turkey
-
Instituto de Investigacion Sanitaria La FeSociedad Española de Neumología y Cirugía Torácica; Sociedad Valenciana de... and other collaboratorsRecruitingCommunity-acquired PneumoniaSpain
-
Dr. Rebecca SchuleGerman Research Foundation; German Center for Neurodegenerative Diseases (DZNE)RecruitingSpastic AtaxiaCanada, France, Germany, Italy, Netherlands, Turkey, United Kingdom
-
Gazi UniversityCompleted
-
Royal Brompton & Harefield NHS Foundation TrustUnknown
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of Medicine; PharmaHempCompletedQuality of Life | Cannabis | Physical Disability | Spastic Cerebral Palsy | Children, AdultSlovenia
-
Fundacion para la Investigacion Biomedica del Hospital...University of Alcala; Hospital Universitario Ramon y Cajal; Instituto de Salud... and other collaboratorsRecruitingPolycystic Ovary Syndrome | Hyperandrogenism | Type 1 Diabetes | Hirsutism | Oligomenorrhea | Ovulation DisorderSpain