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NCT01017588 Clinical Trial

PSU Lumbar Support for Prevention of Low Back Pain in Rubber Tapper

Low Back Pain Clinical Trial

Official title:
Lumbar Support for Low Back Pain Prevention in Rubber Tapper

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01017588
Other study ID # EC52-200-11-4-2
Secondary ID
Status Completed
Phase Phase 3
First received November 17, 2009
Last updated May 12, 2012
Start date January 2010
Est. completion date June 2011

Study information
Verified date May 2012
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy of lumbar support for low back pain prevention in rubber tapper. The investigators will randomized the participants(rubber tapper) into 2 groups;lumbar support and no support.The participant will be instructed for brace use. The sample size required are 200 subjects with 100 in each group. The subject will be evaluated every 3 month for the incidence of low back pain and quality of life after using the support.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 60 Years
Eligibility Inclusion Criteria:

- current rubber tapper

Exclusion Criteria:

- underlying rheumatologic condition

- previous significant low back pain

- previous back surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• PSU lumbar back support
wear PSU back supprt during doing rubber tapper

Locations
Country Name City State
Thailand Prince of Songkla University Hat Yai Songkhla

Sponsors (1)
Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of low back pain 6 month, 1 and 2 years No
Secondary Roland Moris score 6 month, 1 and 2 years No
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