- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00786864
Exercise for Low Back Pain in Children (LBP)
November 5, 2008 updated by: University of Witwatersrand, South Africa
School-Based Specific Exercise Programme Reduces the Prevalence and Intensity of Low Back Pain in 12-13 Year Old Children: a Randomized Controlled Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gauteng
-
Johannesburg, Gauteng, South Africa
- Government primary schools in the Ekurhuleni West and Johannesburg East Districts of Gauteng
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1. Experimental Group
Exercise Intervention Group
|
Specific low back pain exercise programme for children
|
No Intervention: 2. Control Group
Control group - no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low Back Pain Prevalence
Time Frame: 3 months post-intervention
|
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.
|
3 months post-intervention
|
Low Back Pain Intensity
Time Frame: 3 months post-intervention
|
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.
|
3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neural Mobility
Time Frame: 3 months post-intervention
|
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.
|
3 months post-intervention
|
Hamstring Flexibility
Time Frame: 3 months post-intervention
|
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).
|
3 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gina L Fanucchi, MSc (Physio), University of Witwatersrand, South Africa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
October 14, 2008
First Submitted That Met QC Criteria
November 5, 2008
First Posted (Estimate)
November 6, 2008
Study Record Updates
Last Update Posted (Estimate)
November 6, 2008
Last Update Submitted That Met QC Criteria
November 5, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fanucchi et al
- M060334
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
-
Universidade Federal do PiauíFoundation for Research Support of the State of PiauíCompletedLow Back Pain, Recurrent | Chronic Low Back PainBrazil
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedChronic Low Back Pain | Mechanical Low Back PainUnited States
-
University of ExtremaduraCompletedChronic Low Back Pain | Postural Low Back PainSpain
-
Université du Québec à Trois-RivièresCompletedChronic Low Back Pain | Mechanical Low Back PainCanada
Clinical Trials on exercise programme
-
University of GlasgowRecruiting
-
Hacettepe UniversityCompleted
-
NHS Greater Glasgow and ClydeUniversity of GlasgowCompletedGluteal TendinitisUnited Kingdom
-
Instituto Sexológico MurcianoUniversidad Miguel Hernandez de ElcheCompletedPremature Ejaculation | Cognitive-Behavior Treatment | Masturbation Aid DeviceSpain
-
Aarhus University HospitalCompletedArthritis, RheumatoidDenmark
-
University of British ColumbiaSimon Fraser University; Vancouver Coastal Health Research Institute; Vancouver... and other collaboratorsRecruitingFall | Old Age; DebilityCanada
-
Margarita Pino JusteEnrolling by invitationCervical and Mandibular Pain and Disorders in Wind PlayersSpain
-
University of CagliariSuspendedHemorrhagic StrokeItaly
-
Oxford Brookes UniversityNational Institute for Health Research, United Kingdom; Royal Berkshire NHS... and other collaboratorsCompleted
-
University of East AngliaUnknownOesophageal Adenocarcinoma | Postoperative Complications (Cardiopulmonary)United Kingdom