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

NCT ID: NCT01269619

Last Updated: 2011-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain, Mechanical

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dynamic

Use of Dynamic back support

Group Type EXPERIMENTAL

Dynamic back support

Intervention Type DEVICE

A dynamic back support which provides pressure on the lumbar without pressure on the abdomen

Static

Use of static back support

Group Type ACTIVE_COMPARATOR

Static back support

Intervention Type DEVICE

A standard wrap-around sacro lumbar support

Interventions

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Dynamic back support

A dynamic back support which provides pressure on the lumbar without pressure on the abdomen

Intervention Type DEVICE

Static back support

A standard wrap-around sacro lumbar support

Intervention Type DEVICE

Other Intervention Names

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hug by Koala Oppo sacro lumbar support

Eligibility Criteria

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Inclusion Criteria

* Recurrent back pain
* use analgesics

Exclusion Criteria

* Pregnant women
* malignancy
* infection
* neurological condition
* surgical candidate
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wolfson Medical Center

Locations

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Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yigal Bronstein, M.D.

Role: CONTACT

+972 3 5028453

Other Identifiers

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HUG-001

Identifier Type: -

Identifier Source: org_study_id

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