Low Back Pain
Conditions
Keywords
Randomised controlled trial, low back pain, exercise, children, school-based, prevalence, intensity
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.
Interventions
OTHERexercise programme
Specific low back pain exercise programme for children
Sponsors
University of Witwatersrand, South Africa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Back Pain Prevalence | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neural Mobility | 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. |
| Hamstring Flexibility | 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). |
Countries
South Africa
Participant flow
Recruitment details
Recruited January 2007 from 2 Government primary schools in the Ekurhuleni West and Johannesburg East Districts of Gauteng
Pre-assignment details
Only children who met the inclusion criteria for the study were included
Participants by arm
| Arm | Count |
|---|---|
| Exercise Intervention Group Experimental Group | 39 |
| Control Group Control group - no intervention | 33 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Sustained serious back injury | 1 | 0 |
Baseline characteristics
| Characteristic | Control Group | Exercise Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 39 Participants | 72 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 12.39 years STANDARD_DEVIATION 0.7 | 12.21 years STANDARD_DEVIATION 0.66 | 12.29 years STANDARD_DEVIATION 0.68 |
| Region of Enrollment South Africa | 33 participants | 39 participants | 72 participants |
| Sex: Female, Male Female | 15 Participants | 24 Participants | 39 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / — | 0 / — |
| serious Total, serious adverse events | 0 / — | 0 / — |
Outcome results
Primary
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.
Time frame: 3 months post-intervention
Population: Intention to treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Intervention Group | Low Back Pain Intensity | 1.76 units on a scale | Standard Deviation 2.59 |
| Control Group | Low Back Pain Intensity | 3.73 units on a scale | Standard Deviation 3.06 |
p-value: p<0ANCOVA
Primary
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.
Time frame: 3 months post-intervention
Population: Intention to treat analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exercise Intervention Group | Low Back Pain Prevalence | 16 participants |
| Control Group | Low Back Pain Prevalence | 26 participants |
p-value: p=0ANCOVA
Secondary
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).
Time frame: 3 months post-intervention
Population: Intention to treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Intervention Group | Hamstring Flexibility | 54.00 degrees | Standard Deviation 11.87 |
| Control Group | Hamstring Flexibility | 45.76 degrees | Standard Deviation 9.59 |
p-value: p<0ANCOVA
Secondary
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.
Time frame: 3 months post-intervention
Population: Intention to treat analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Intervention Group | Neural Mobility | 64.41 degrees | Standard Deviation 17.1 |
| Control Group | Neural Mobility | 44.44 degrees | Standard Deviation 16.55 |
p-value: p<0ANCOVA