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Exercise for Low Back Pain in Children (LBP)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
exercise programme
Sponsored by
University of Witwatersrand, South Africa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Back Pain focused on measuring Randomised controlled trial, low back pain, exercise, children, school-based, prevalence, intensity

Eligibility Criteria

12 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Government primary schools in the Ekurhuleni West and Johannesburg East Districts of Gauteng

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1. Experimental Group

2. Control Group

Arm Description

Exercise Intervention Group

Control group - no intervention

Outcomes

Primary Outcome Measures

Low Back Pain Prevalence
All of the children complained of low back pain at baseline. Low back pain prevalence post-intervention was determined by the number of children still complaining of low back pain post-intervention.
Low Back Pain Intensity
The visual analogue scale (standardised 100mm, non-hatched line) was used to determine pain intensity. Scores can range between 0 and 10, with the worst possible pain/score = 10 and no pain/best score = 0. Visual analogue scale is continuous.

Secondary Outcome Measures

Neural Mobility
Straight leg raise test was used to measure neural mobility. The amount of hip flexion (angle between the plinth and femur of the raised leg) was measured using a digital inclinometer. Scores ranged between 3 (worst score) and 90.5 (best score). Continuous data.
Hamstring Flexibility
Standardised hamstring muscle length test. The child was positioned in supine, with the hip flexed at 90 degrees. The knee was then extended passively. The angle of knee extension [from horizontal plane (level to plinth) to fibula] was measured using a digital inclinometer. Continuous data. Scores ranged from -20 (worst score) to 82 (best score).

Full Information

First Posted
October 14, 2008
Last Updated
November 5, 2008
Sponsor
University of Witwatersrand, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT00786864
Brief Title
Exercise for Low Back Pain in Children
Acronym
LBP
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Witwatersrand, South Africa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Randomised controlled trial, low back pain, exercise, children, school-based, prevalence, intensity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Experimental Group
Arm Type
Experimental
Arm Description
Exercise Intervention Group
Arm Title
2. Control Group
Arm Type
No Intervention
Arm Description
Control group - no intervention
Intervention Type
Other
Intervention Name(s)
exercise programme
Intervention Description
Specific low back pain exercise programme for children
Primary Outcome Measure Information:
Title
Low Back Pain Prevalence
Description
All of the children complained of low back pain at baseline. Low back pain prevalence post-intervention was determined by the number of children still complaining of low back pain post-intervention.
Time Frame
3 months post-intervention
Title
Low Back Pain Intensity
Description
The visual analogue scale (standardised 100mm, non-hatched line) was used to determine pain intensity. Scores can range between 0 and 10, with the worst possible pain/score = 10 and no pain/best score = 0. Visual analogue scale is continuous.
Time Frame
3 months post-intervention
Secondary Outcome Measure Information:
Title
Neural Mobility
Description
Straight leg raise test was used to measure neural mobility. The amount of hip flexion (angle between the plinth and femur of the raised leg) was measured using a digital inclinometer. Scores ranged between 3 (worst score) and 90.5 (best score). Continuous data.
Time Frame
3 months post-intervention
Title
Hamstring Flexibility
Description
Standardised hamstring muscle length test. The child was positioned in supine, with the hip flexed at 90 degrees. The knee was then extended passively. The angle of knee extension [from horizontal plane (level to plinth) to fibula] was measured using a digital inclinometer. Continuous data. Scores ranged from -20 (worst score) to 82 (best score).
Time Frame
3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina L Fanucchi, MSc (Physio)
Organizational Affiliation
University of Witwatersrand, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Government primary schools in the Ekurhuleni West and Johannesburg East Districts of Gauteng
City
Johannesburg
State/Province
Gauteng
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
19463080
Citation
Fanucchi GL, Stewart A, Jordaan R, Becker P. Exercise reduces the intensity and prevalence of low back pain in 12-13 year old children: a randomised trial. Aust J Physiother. 2009;55(2):97-104. doi: 10.1016/s0004-9514(09)70039-x.
Results Reference
derived

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Exercise for Low Back Pain in Children

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