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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01017588
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Low Back Pain Device: PSU lumbar back support Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lumbar Support for Low Back Pain Prevention in Rubber Tapper
Study Start Date : January 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: back exercise
strengthening back exercise
 Device: PSU lumbar back support
wear PSU back supprt during doing rubber tapper


Outcome Measures
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Primary Outcome Measures :
  1. incidence of low back pain [ Time Frame: 6 month, 1 and 2 years ]

Secondary Outcome Measures :
  1. Roland Moris score [ Time Frame: 6 month, 1 and 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • current rubber tapper

Exclusion Criteria:

  • underlying rheumatologic condition
  • previous significant low back pain
  • previous back surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017588


Locations
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Thailand
Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
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Principal Investigator: Boonsin Tangtrakulwanich, MD.,Ph.D. Department of Orthopaedic Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand
More Information
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Responsible Party: Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01017588    
Other Study ID Numbers: EC52-200-11-4-2
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Boonsin Tangtrakulwanich, Prince of Songkla University:
lumbar support
rubber tapper
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations