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

Low Back Pain, Mechanical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01269619
• Other study ID #: HUG-001
• Status: Not yet recruiting
• Phase: N/A
• First received: January 2, 2011
• Last updated: January 2, 2011
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: December 2010
• Source: Wolfson Medical Center
• Contact: Yigal Bronstein, M.D.
• Phone: +972 3 5028453
• Email: bronsteiny[@]wolfson.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Recurrent back pain

• use analgesics

Exclusion Criteria:

• Pregnant women

• malignancy

• infection

• neurological condition

• surgical candidate

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

Device:
• Dynamic back support
A dynamic back support which provides pressure on the lumbar without pressure on the abdomen
• Static back support
A standard wrap-around sacro lumbar support

Locations

Country	Name	City	State
Israel	Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in back pain		3 weeks	No
Secondary	Patient satisfaction		3 weeks	No