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Postural Balance and Stability Among Patients With Cervical and Back Pain

Sponsor
Meir Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02395887
Collaborator
(none)
80
Enrollment
14
Duration (Months)

Study Details

Study Description

Brief Summary

High percentage of chronic back pain is due to spinal stenosis. The clinical picture is of 'neurogenic claudication' which effects postural balance and stability. If conservative treatment fail to improve symptoms, an invasive treatment which includes spinal decompression can be done.

The research is an observational prospective one, pre and post operational intervention. The aim is to examine whether an operational intervention improves quality of life, pain, postural balance an stability among patients.

It's important to clarify, that although there is operational intervention, the research is observational. The decision weather to operate or not, is not a part of the research. The investigators assume that since there is a population that independently going through an operation, the investigators can observe this population and evaluate different aspects of the operation outcomes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Postural Balance and Stability Among Patients With Cervical and Back Pain
    Study Start Date :
    Apr 1, 2015
    Anticipated Primary Completion Date :
    Apr 1, 2016
    Anticipated Study Completion Date :
    Jun 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Intervational

    Patients with back or neck pain who are a candidates for operational intervention.
    Control

    Men or women who haven't seek for spine surgery consultation.

    Outcome Measures

    Primary Outcome Measures

    1. Dynamic postural balance tests [6 months]

    2. Static postural balance tests [6 months]

    Secondary Outcome Measures

    1. Pain and quality of life questionnaires [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients suffering from back or neck pain

    • Patients that are candidates for operational intervention

    Exclusion Criteria:

    • Pregnant women

    • Patients who had a spinal operation in the past.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Meir Medical Center

    Investigators

    • Principal Investigator: Shay Shabat, MD, Meir Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    shay shabat, Prof. Shay Shabat, Meir Medical Center
    ClinicalTrials.gov Identifier:
    NCT02395887
    Other Study ID Numbers:
    • MeirMc0297-14CTIL
    First Posted:
    Mar 24, 2015
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by shay shabat, Prof. Shay Shabat, Meir Medical Center
    Spinal stenosis
    Spinal decompression
    Postural balance
    Neurogenic claudication
    Additional relevant MeSH terms:
    Spinal Stenosis
    Back Pain

    Study Results

    No Results Posted as of Mar 25, 2015