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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01269619
First received: January 2, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  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: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of Static and Dynamic Back Supports for Lower Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Reduction in back pain [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yigal Bronstein, M.D., Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01269619     History of Changes
Other Study ID Numbers: HUG-001
Study First Received: January 2, 2011
Last Updated: January 2, 2011
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013