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Comparative Study of Static and Dynamic Back Supports for Lower Back Pain

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269619
First Posted: January 4, 2011
Last Update Posted: January 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wolfson Medical Center
  Purpose
Lower back pain is one of the most common conditions affecting humans. Lower back supports are a common device used in order to alleviate the pain. All the available back supports are wrapped around the lower back and abdomen and act as static support devices. "The hug" is a new dynamic back support where the participant actively improves his/her posture and strengthens the muscle of the lower back. This trial compares both devices and their effect on reducing lower back pain.

Condition Intervention
Low Back Pain, Mechanical Device: Dynamic back support Device: Static back support

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Static and Dynamic Back Supports for Lower Back Pain

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Reduction in back pain [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 3 weeks ]

Estimated Enrollment: 20
Study Start Date: February 2011
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dynamic
Use of Dynamic back support
Device: Dynamic back support
A dynamic back support which provides pressure on the lumbar without pressure on the abdomen
Other Name: hug by Koala
Active Comparator: Static
Use of static back support
Device: Static back support
A standard wrap-around sacro lumbar support
Other Name: Oppo sacro lumbar support

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent back pain
  • use analgesics

Exclusion Criteria:

  • Pregnant women
  • malignancy
  • infection
  • neurological condition
  • surgical candidate
  Contacts and Locations
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): NCT01269619


Contacts
Contact: Yigal Bronstein, M.D. +972 3 5028453 bronsteiny@wolfson.health.gov.il

Locations
Israel
Wolfson Medical Center Not yet recruiting
Holon, Israel
Sponsors and Collaborators
Wolfson Medical Center
  More Information

Responsible Party: Yigal Bronstein, M.D., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01269619     History of Changes
Other Study ID Numbers: HUG-001
First Submitted: January 2, 2011
First Posted: January 4, 2011
Last Update Posted: January 4, 2011
Last Verified: December 2010

Keywords provided by Wolfson Medical Center:
back pain
posture
lumbar support
dynamic support

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms