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Postural Balance and Stability Among Patients With Cervical and Back Pain

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ClinicalTrials.gov Identifier: NCT02395887
Recruitment Status : Unknown
Verified March 2015 by shay shabat, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2015
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
shay shabat, Meir Medical Center

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
Spinal Stenosis Back Pain

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Study Type : Observational
Estimated 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 : April 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Dynamic postural balance tests [ Time Frame: 6 months ]
  2. Static postural balance tests [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pain and quality of life questionnaires [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
80 patients, men and women above 18, which suffer from back or neck pain and are candidates for an operational intervention.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395887


Contacts
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Contact: Shay Shabat, MD shay.shabat@clalit.org.il
Contact: Yisrael Tauber, MD yisraeltauber@gmail.com

Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Shay Shabat, MD Meir Medical Center

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Responsible Party: shay shabat, Prof. Shay Shabat, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02395887     History of Changes
Other Study ID Numbers: MeirMc0297-14CTIL
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by shay shabat, Meir Medical Center:
Spinal stenosis
Spinal decompression
Postural balance
Neurogenic claudication

Additional relevant MeSH terms:
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Back Pain
Spinal Stenosis
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases