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

Low Back Pain Clinical Trial

Official title:

Evaluation of the Responsiveness of the Bridge Tests in Subjects With Non-specific Subacute or Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879031
• Other study ID #: 1/Bridge
• Status: Completed
• Start date: March 20, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 program.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola-Malpighi	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (19)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Ferrari S, Manni T, Bonetti F, Villafañe 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. — View Citation

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. — View Citation

Frymoyer JW, Selby DK. Segmental instability. Rationale for treatment. Spine (Phila Pa 1976). 1985 Apr;10(3):280-6. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Oct 10. — View Citation

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. — View Citation

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. — View Citation

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):E844-50. doi: 10.1097/BRS.0000000000001403. — View Citation

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. — View Citation

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. — View Citation

Stuge B, Veierød MB, Laerum E, Vøllestad 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. — View Citation

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. — View Citation

Vanti C, Ferrari S, Berjano P, Villafañe 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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	At the end of the last session of physical therapy treatment (8 weeks after Time zero)