Low Back PainLBPNCT00786864

Exercise for Low Back Pain in Children

A study testing exercise programme in people with Low Back Pain, run by University of Witwatersrand, South Africa at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 13 years
Conditions the study is for: Low Back Pain
What is being tested?: exercise programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteSouth Africa
Study dates: Jan 2007to Oct 2007
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 13 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

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

Other trials in South Africa

About this study

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

Conditions: Low Back Pain
Being tested: exercise programme
Keywords: Randomised controlled trial, low back pain, exercise, children, school-based, prevalence, intensity
Medical subject headings: Low Back Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

exercise programmeOther
Specific low back pain exercise programme for children

Study groups in NCT00786864
Study group	Role	What they receive
1. Experimental Group	Experimental	Exercise Intervention Group Receives: Other: exercise programme
2. Control Group	No intervention	Control group - no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months 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.
Measured: 3 months post-intervention

Secondary outcomes (2)

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.
Measured: 3 months post-intervention
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).
Measured: 3 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Oct 2007

First posted6 Nov 2008 (estimated)
Study startJan 2007
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00786864
Sponsor's protocol ID: Fanucchi et al
Other IDs: M060334
Acronym: LBP
Status last verified: Nov 2008
First submitted: 14 Oct 2008
Last updated: 6 Nov 2008
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19463080

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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Hybrid mHealth for Low Back Pain
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McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
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Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00786864
Acronym / sponsor ID: LBP / Fanucchi et al
Conditions: Low Back Pain
Keywords: Randomised controlled trial, low back pain, exercise, children, school-based, prevalence, intensity
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: University of Witwatersrand, South AfricaUniversity, hospital or other
Study start: Jan 2007
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 6 Nov 2008 (estimated)
Results: Posted 6 Nov 2008

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1. Experimental Group	Experimental	Other: exercise programmeExercise Intervention Group
2. Control Group	No intervention	–Control group - no intervention

Who may qualify

Ages: 12 to 13 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
exercise programmeSpecific low back pain exercise programme for children	Other	1. Experimental Group

Primary outcome

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.
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.

2 secondary outcomes

Neural Mobility
Time frame: 3 months post-intervention
Hamstring Flexibility
Time frame: 3 months post-intervention

Results and safety

Results posted to the registry on 6 Nov 2008, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exercise Intervention Group	39	38
Control Group	33	32

Primary outcome: Low Back Pain Prevalence

Time frame: 3 months post-intervention. Number. Unit: participants

Measure	Exercise Intervention Group n = 38	Control Group n = 32
Value	16	26

Exercise Intervention Group vs Control Group: p = p=0.001, ANCOVA

Population analysed: Intention to treat analysis

Primary outcome: Low Back Pain Intensity

Time frame: 3 months post-intervention. Mean (Standard Deviation). Unit: units on a scale

Measure	Exercise Intervention Group n = 38	Control Group n = 32
Value	1.76 (2.59)	3.73 (3.06)

Exercise Intervention Group vs Control Group: p = p<0.001, ANCOVA

Population analysed: Intention to treat analysis

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exercise Intervention Group	0 of ?	0 of ?	Not reported
Control Group	0 of ?	0 of ?	Not reported

Limitations and caveats (from the sponsor): Only 2 schools, in a similar geographic and socioeconomic area were included, and therefore the results may not necessarily be generalized to a larger population

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2008.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19463080Fanucchi 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.

Related trials for Low Back Pain

Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Hybrid mHealth for Low Back Pain
Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gina L Fanucchi, MSc (Physio) principal investigator

University of Witwatersrand, South Africa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing exercise programme in people with Low Back Pain, run by University of Witwatersrand, South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Low Back Pain Prevalence (time frame: 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00786864, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2008.