PSU Lumbar Support for Prevention of Low Back Pain in Rub... | NCT01017588

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

NCT01017588

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

May 15, 2012Estimated

Enrollment

200Actual

Phase

Phase 3

Conditions

Low Back Pain

Interventions

PSU lumbar back support

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 19, 2009

First Posted Date

Nov 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2012

Last Update Posted Date

May 15, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla UniversityPrincipal Investigator

Lead Sponsor

Prince of Songkla UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
back exercise	Experimental	strengthening back exercise	Device: PSU lumbar back support

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PSU lumbar back support	Device	wear PSU back supprt during doing rubber tapper	back exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of low back pain		6 month, 1 and 2 years

Secondary Outcomes

Measure	Description	Time Frame
Roland Moris score		6 month, 1 and 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

current rubber tapper

Exclusion Criteria:

underlying rheumatologic condition
previous significant low back pain
previous back surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boonsin Tangtrakulwanich, MD.,Ph.D.	Department of Orthopaedic Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided