Responsiveness of the Bridge Tests in Non-specific Low Back Pain

NCT03879031 | Completed

• 1 other identifier: 1/Bridge
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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 program.

Conditions

Low Back Pain

Keywords

lumbar; physical endurance; pain; disability; assessment

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  At the end of the last session of physical therapy treatment (8 weeks after Time zero)

Study Arms (1)

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.

Diagnostic Test: Cluster of Clinical tests to measure lumbar stability

Interventions

Cluster of Clinical tests to measure lumbar stability DIAGNOSTIC_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).

Outpatients with low back pain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

Related Publications (19)

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• 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.

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• 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.

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• 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.

  PMID: 22728944 BACKGROUND

• 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.

  PMID: 25866618 BACKGROUND

• 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.

  PMID: 16181937 BACKGROUND

• 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.

  PMID: 3992349 BACKGROUND

• 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.

  PMID: 26254503 BACKGROUND

• 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.

  PMID: 16181938 BACKGROUND

• 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.

  PMID: 17033040 BACKGROUND

• 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.

  PMID: 10453772 BACKGROUND

• 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.

  PMID: 22365484 BACKGROUND

• 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.

  PMID: 26679886 BACKGROUND

• 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.

  PMID: 23321848 BACKGROUND

• 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.

  PMID: 17303961 BACKGROUND

• 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.

  PMID: 15131454 BACKGROUND

• 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.

  PMID: 27167368 BACKGROUND

• 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.

  PMID: 28060461 BACKGROUND

• 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.

  PMID: 20051732 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Pillastrini, PT

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor - Director of the Masters in Musculoskeletal Physiotherapy - University of Bologna

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 18, 2019
• Study Start: March 20, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)