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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boonsin Tangtrakulwanich, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01017588
First received: November 17, 2009
Last updated: May 12, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lumbar Support for Low Back Pain Prevention in Rubber Tapper

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • incidence of low back pain [ Time Frame: 6 month, 1 and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Roland Moris score [ Time Frame: 6 month, 1 and 2 years ] [ Designated as safety issue: No ]

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
Other Name: PSU lumbar back support

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 17, 2009
Last Updated: May 12, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 23, 2013