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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.
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:
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):
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Pillastrini, PT | University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico S.Orsola-Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16274487 | Background | 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. | |
| 21289452 | Background | 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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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| At the end of the last session of physical therapy treatment (8 weeks after Time zero) |
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| 17033040 | 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. |
| 10453772 | 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. |
| 22365484 | 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. |
| 26679886 | 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. |
| 23321848 | 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. |
| 17303961 | 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. |
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