Back to resultsPSU Lumbar Support for Prevention of Low Back Pain in Rubber Tapper
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
PSU lumbar back support
Sponsored by
About this trial
This is an interventional prevention trial for Low Back Pain focused on measuring lumbar support, rubber tapper
Eligibility Criteria
Inclusion Criteria:
- current rubber tapper
Exclusion Criteria:
- underlying rheumatologic condition
- previous significant low back pain
- previous back surgery
Sites / Locations
- Prince of Songkla University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
back exercise
Arm Description
strengthening back exercise
Outcomes
Primary Outcome Measures
incidence of low back pain
Secondary Outcome Measures
Roland Moris score
Full Information
NCT ID
NCT01017588
First Posted
November 17, 2009
Last Updated
May 12, 2012
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01017588
Brief Title
PSU Lumbar Support for Prevention of Low Back Pain in Rubber Tapper
Official Title
Lumbar Support for Low Back Pain Prevention in Rubber Tapper
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
lumbar support, rubber tapper
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
back exercise
Arm Type
Experimental
Arm Description
strengthening back exercise
Intervention Type
Device
Intervention Name(s)
PSU lumbar back support
Intervention Description
wear PSU back supprt during doing rubber tapper
Primary Outcome Measure Information:
Title
incidence of low back pain
Time Frame
6 month, 1 and 2 years
Secondary Outcome Measure Information:
Title
Roland Moris score
Time Frame
6 month, 1 and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
current rubber tapper
Exclusion Criteria:
underlying rheumatologic condition
previous significant low back pain
previous back surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boonsin Tangtrakulwanich, MD.,Ph.D.
Organizational Affiliation
Department of Orthopaedic Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
PSU Lumbar Support for Prevention of Low Back Pain in Rubber Tapper
We'll reach out to this number within 24 hrs