Trial Outcomes & Findings for Exercise for Low Back Pain in Children (NCT NCT00786864)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

3 months post-intervention

Results posted on

2008-11-06

Participant Flow

Recruited January 2007 from 2 Government primary schools in the Ekurhuleni West and Johannesburg East Districts of Gauteng

Only children who met the inclusion criteria for the study were included

Participant milestones

Participant milestones
Measure	Exercise Intervention Group Experimental Group	Control Group Control group - no intervention
Overall Study STARTED	39	33
Overall Study COMPLETED	38	32
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Exercise Intervention Group Experimental Group	Control Group Control group - no intervention
Overall Study Lost to Follow-up	0	1
Overall Study Sustained serious back injury	1	0

Baseline Characteristics

Exercise for Low Back Pain in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Intervention Group n=39 Participants Experimental Group	Control Group n=33 Participants Control group - no intervention	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	39 Participants n=5 Participants	33 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	12.21 years STANDARD_DEVIATION 0.66 • n=5 Participants	12.39 years STANDARD_DEVIATION 0.70 • n=7 Participants	12.29 years STANDARD_DEVIATION 0.68 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	15 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment South Africa	39 participants n=5 Participants	33 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post-intervention

Population: Intention to treat analysis

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.

Outcome measures

Outcome measures
Measure	Exercise Intervention Group n=38 Participants Experimental Group	Control Group n=32 Participants Control group - no intervention
Low Back Pain Prevalence	16 participants	26 participants

PRIMARY outcome

Timeframe: 3 months post-intervention

Population: Intention to treat analysis

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.

Outcome measures

Outcome measures
Measure	Exercise Intervention Group n=38 Participants Experimental Group	Control Group n=32 Participants Control group - no intervention
Low Back Pain Intensity	1.76 units on a scale Standard Deviation 2.59	3.73 units on a scale Standard Deviation 3.06

SECONDARY outcome

Timeframe: 3 months post-intervention

Population: Intention to treat analysis

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.

Outcome measures

Outcome measures
Measure	Exercise Intervention Group n=38 Participants Experimental Group	Control Group n=32 Participants Control group - no intervention
Neural Mobility	64.41 degrees Standard Deviation 17.10	44.44 degrees Standard Deviation 16.55

SECONDARY outcome

Timeframe: 3 months post-intervention

Population: Intention to treat analysis

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).

Outcome measures

Outcome measures
Measure	Exercise Intervention Group n=38 Participants Experimental Group	Control Group n=32 Participants Control group - no intervention
Hamstring Flexibility	54.00 degrees Standard Deviation 11.87	45.76 degrees Standard Deviation 9.59

Adverse Events

Exercise Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gina L Fanucchi

University of the Witwatersrand

Phone: +27 11 616 4400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place