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NCT02395887 Clinical Trial

Postural Balance and Stability Among Patients With Cervical and Back Pain

Back Pain Clinical Trial

Official title:
Postural Balance and Stability Among Patients With Cervical and Back Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02395887
Other study ID # MeirMc0297-14CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 4, 2015
Last updated March 24, 2015
Start date April 2015
Est. completion date June 2016

Study information
Verified date March 2015
Source Meir Medical Center
Contact Shay Shabat, MD
Email shay.shabat@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date June 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Dynamic postural balance tests 6 months No
Primary Static postural balance tests 6 months No
Secondary Pain and quality of life questionnaires 6 months No
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