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Exercise for Low Back Pain in Children (LBP)

This study has been completed.
Sponsor:
Information provided by:
University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier:
NCT00786864
First received: October 14, 2008
Last updated: November 5, 2008
Last verified: November 2008
History of Changes
  Purpose

This study aimed to determine the efficacy of an eight-week specific exercise programme in reducing self-reported episodes and intensity of LBP, as well as modifying some of the identified risk factors for LBP, in children.


Condition Intervention
Low Back Pain
 Other: exercise programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: School-Based Specific Exercise Programme Reduces the Prevalence and Intensity of Low Back Pain in 12-13 Year Old Children: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Witwatersrand, South Africa:

Primary Outcome Measures:
  • Low Back Pain Intensity [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
  • Low Back Pain Prevalence [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamstring Flexibility [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
  • Neural Mobility [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: January 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Experimental Group
Exercise Intervention Group
 Other: exercise programme
Specific low back pain exercise programme for children
No Intervention: 2. Control Group
Control group - no intervention

  Eligibility

Ages Eligible for Study:   12 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 12-13 years
  • Complained of LBP in the past three months

Exclusion Criteria:

  • Serious spinal pathologies or deformities (e.g. severe scoliosis, spinal tumours)
  • Neurological conditions which alter motor tone
  • Physical disabilities (e.g. spinal cord injuries) which prevent the child from being able to stand up on their own without an orthotic device or brace, or which prevent the child from taking part in normal physical education (PE) classes
  • Any other serious co-morbidities (e.g. cancer, severe lung pathology)
  • Provincial sports participants, or children who were currently following a specific training programme with a biokineticist or physiotherapist
  • Current orthopaedic procedures or fractures of the spine, pelvis, lower or upper limbs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786864

Locations
South Africa
Government primary schools in the Ekurhuleni West and Johannesburg East Districts of Gauteng
Johannesburg, Gauteng, South Africa
Sponsors and Collaborators
University of Witwatersrand, South Africa
Investigators
Principal Investigator: Gina L Fanucchi, MSc (Physio) University of the Witwatersrand
  More Information

No publications provided by University of Witwatersrand, South Africa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gina Lucia Fanucchi, University of the Witwatersrand, South Africa
ClinicalTrials.gov Identifier: NCT00786864     History of Changes
Other Study ID Numbers: Fanucchi et al, M060334
Study First Received: October 14, 2008
Results First Received: October 14, 2008
Last Updated: November 5, 2008
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Witwatersrand, South Africa:
Randomised controlled trial
low back pain
exercise
children
 school-based
prevalence
intensity

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 19, 2013