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
  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:


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 April 15, 2014