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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017588
First Posted: November 20, 2009
Last Update Posted: May 15, 2012
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.
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University
  Purpose
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 Intervention Phase
Low Back Pain Device: PSU lumbar back support Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boonsin Tangtrakulwanich, Prince of Songkla University:

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

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

Enrollment: 200
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: back exercise
strengthening back exercise
Device: PSU lumbar back support
wear PSU back supprt during doing rubber tapper

  Eligibility

Information from the National Library of Medicine

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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
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
Thailand
Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Boonsin Tangtrakulwanich, MD.,Ph.D. Department of Orthopaedic Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand
  More Information

Responsible Party: Boonsin Tangtrakulwanich, Department of Orthopaedic surgery, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01017588     History of Changes
Other Study ID Numbers: EC52-200-11-4-2
First Submitted: November 17, 2009
First Posted: November 20, 2009
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:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms