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

Phase 3

Completed

• Conditions: Low Back Pain
• Interventions: Device: PSU lumbar back support

• Registration Number: NCT01017588
• Lead Sponsor: Prince of Songkla University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2010-01
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-12
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• current rubber tapper

Exclusion Criteria

• underlying rheumatologic condition
• previous significant low back pain
• previous back surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
back exercise	PSU lumbar back support	strengthening back exercise

Primary Outcome Measures

Name	Time	Method
incidence of low back pain	6 month, 1 and 2 years

Secondary Outcome Measures

Name	Time	Method
Roland Moris score	6 month, 1 and 2 years

Trial Locations

Locations (1)

Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand