NCT01017588

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 low-back-pain

Timeline
Completed

Started Jan 2010

Typical duration for phase_3 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

November 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

1.4 years

First QC Date

November 17, 2009

Last Update Submit

May 12, 2012

Conditions

Low Back Pain

Keywords

lumbar supportrubber tapper

Outcome Measures

Primary Outcomes (1)

  • incidence of low back pain

    6 month, 1 and 2 years

Secondary Outcomes (1)

  • Roland Moris score

    6 month, 1 and 2 years

Study Arms (1)

back exercise

EXPERIMENTAL

strengthening back exercise

Device: PSU lumbar back support

Interventions

PSU lumbar back supportDEVICE

wear PSU back supprt during doing rubber tapper

back exercise

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • current rubber tapper

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Boonsin Tangtrakulwanich, MD.,Ph.D.

    Department of Orthopaedic Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Orthopaedic surgery

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 20, 2009

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

TH(1)