NCT01269619

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 4, 2011

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

January 2, 2011

Last Update Submit

January 2, 2011

Conditions

Low Back Pain, Mechanical

Keywords

back painposturelumbar supportdynamic support

Outcome Measures

Primary Outcomes (1)

  • Reduction in back pain

    3 weeks

Secondary Outcomes (1)

  • Patient satisfaction

    3 weeks

Study Arms (2)

Dynamic

EXPERIMENTAL

Use of Dynamic back support

Device: Dynamic back support

Static

ACTIVE COMPARATOR

Use of static back support

Device: Static back support

Interventions

Dynamic back supportDEVICE

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

Also known as: hug by Koala
Dynamic
Static back supportDEVICE

A standard wrap-around sacro lumbar support

Also known as: Oppo sacro lumbar support
Static

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrent back pain
  • use analgesics

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Medical Center

Holon, Israel

Location

MeSH Terms

Conditions

Low Back PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yigal Bronstein, M.D.

CONTACT

+972 3 5028453bronsteiny@wolfson.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 2, 2011

First Posted

January 4, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

January 4, 2011

Record last verified: 2010-12

Locations

IL(1)