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
Information provided by:
Wolfson Medical Center Identifier:
First received: January 2, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted

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:

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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recurrent back pain
  • use analgesics

Exclusion Criteria:

  • Pregnant women
  • malignancy
  • infection
  • neurological condition
  • surgical candidate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01269619

Contact: Yigal Bronstein, M.D. +972 3 5028453

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 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
lumbar support
dynamic support

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on October 08, 2015