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

January 2, 2011 updated by: Wolfson Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • Wolfson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recurrent back pain
  • use analgesics

Exclusion Criteria:

  • Pregnant women
  • malignancy
  • infection
  • neurological condition
  • surgical candidate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • hug by Koala
Active Comparator: Static
Use of static back support
Device: Static back support
A standard wrap-around sacro lumbar support
Other Names:
  • Oppo sacro lumbar support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in back pain
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

January 2, 2011

First Submitted That Met QC Criteria

January 2, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

January 4, 2011

Last Update Submitted That Met QC Criteria

January 2, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUG-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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