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

Primary Purpose

Low Back Pain, Mechanical

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dynamic back support
Static back support
Sponsored by
Wolfson Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring back pain, posture, lumbar support, dynamic support

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Recurrent back pain
  • use analgesics

Exclusion Criteria:

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

Sites / Locations

  • Wolfson Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dynamic

Static

Arm Description

Use of Dynamic back support

Use of static back support

Outcomes

Primary Outcome Measures

Reduction in back pain

Secondary Outcome Measures

Patient satisfaction

Full Information

First Posted
January 2, 2011
Last Updated
January 2, 2011
Sponsor
Wolfson Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01269619
Brief Title
Comparative Study of Static and Dynamic Back Supports for Lower Back Pain
Official Title
Comparative Study of Static and Dynamic Back Supports for Lower Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Wolfson Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
back pain, posture, lumbar support, dynamic support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dynamic
Arm Type
Experimental
Arm Description
Use of Dynamic back support
Arm Title
Static
Arm Type
Active Comparator
Arm Description
Use of static back support
Intervention Type
Device
Intervention Name(s)
Dynamic back support
Other Intervention Name(s)
hug by Koala
Intervention Description
A dynamic back support which provides pressure on the lumbar without pressure on the abdomen
Intervention Type
Device
Intervention Name(s)
Static back support
Other Intervention Name(s)
Oppo sacro lumbar support
Intervention Description
A standard wrap-around sacro lumbar support
Primary Outcome Measure Information:
Title
Reduction in back pain
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Patient satisfaction
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recurrent back pain use analgesics Exclusion Criteria: Pregnant women malignancy infection neurological condition surgical candidate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yigal Bronstein, M.D.
Phone
+972 3 5028453
Email
bronsteiny@wolfson.health.gov.il
Facility Information:
Facility Name
Wolfson Medical Center
City
Holon
Country
Israel

12. IPD Sharing Statement

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

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