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

Overview

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.

Full Title of Study: “Evaluation of the Responsiveness of the Bridge Tests in Subjects With Non-specific Subacute or Chronic Low Back Pain”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2019

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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).
  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Investigator Details

  • Lead Sponsor
    • University of Bologna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paolo Pillastrini, Full professor – Director of the Masters in Musculoskeletal Physiotherapy – University of Bologna – University of Bologna
  • Overall Official(s)
    • Paolo Pillastrini, PT, Principal Investigator, University of Bologna

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