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

December 18, 2019 updated by: Paolo Pillastrini, University of Bologna

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

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.

Study Overview

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

Observational

Enrollment (Actual)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Emilia Romagna
      • Bologna, Emilia Romagna, Italy, 40138
        • Policlinico S.Orsola-Malpighi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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.

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).

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paolo Pillastrini, PT, University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2019

Primary Completion (ACTUAL)

November 30, 2019

Study Completion (ACTUAL)

November 30, 2019

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (ACTUAL)

March 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 18, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/Bridge

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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