Clinical trial NCT04778215: Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts
Official title: Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts - a Cluster Randomized Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: stabilization training
abdominal hollowing
gymnastics
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 258
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Specific stabilization training targeting the deep trunk muscles has shown good effect in the rehabilitation of Low Back Pain (LBP) in young female TeamGym (TG) gymnasts. However, if this training can prevent LBP in this young population remains to be investigated. The aim of the present study was to investigate if a specific lumbar stabilization program can reduce and prevent LBP in young female TG gymnasts.

Detailed description: Objectives: To study if a progressive specific lumbar stabilization program can reduce and prevent low back pain (LBP) in young female TeamGym (TG) gymnasts aged 10-16 years.

Design A cluster randomized controlled intervention study

Participants: All available competitive youth female TG teams including gymnasts aged 10-16 years, in the area of Stockholm, were invited to participate in the present study. A team consists of approximately 16 gymnasts. Fourteen out of 17 teams and a total of 258 gymnasts accepted to participate. Gymnasts and parents were informed about the study and written consent was collected. A cluster randomization process was undertaken as follows: the gymnasts in each team answered questions at inclusion and the teams were matched with respect to age, level of competition, amount of training sessions per week and reports of LBP. LBP in this study was defined as; "pain between the 12th rib and the gluteal fold". Thereafter a cluster randomization took place. This means that all gymnasts in one team were either in the control or in the intervention group. There were no differences with respect to demographic and training data and reports of LBP between the two groups at randomization. Ninety gymnasts did not report LBP at inclusion or during baseline and were included in a subgroup analysis on the preventive effect of the exercise program.

Methods Every week the gymnasts were visited by a registered physical therapist (RPT). The RPT answered questions from the gymnasts concerning injuries and collected a weekly-based questionnaire. The gymnasts in the intervention group were instructed to perform an eight-week progressive specific lumbar stabilization program, implemented in the warm-up at every training session. The gymnasts answered a weekly based questionnaire regarding training and LBP during the intervention period, and thereafter a questionnaire at 3-, 6- and 12 months follow-up. The gymnasts and the coaches were also instructed to continue with the lumbar stabilization program after the intervention period.

Eligibility criteria: Inclusion Criteria:

* female TeamGym teams, aged 10-16 years, in the Stockholm area
* competing at national or international level

Exclusion Criteria:

* male TeamGym gymnasts
* female TeamGym teams on a regional competitive level

Primary outcomes:
measure: Weekly prevalence of LBP from baseline to end of the intervention program
timeFrame: 3 months
measure: Weekly prevalence of SLBP (Substantial LBP) from baseline to end of the intervention program
timeFrame: 3 months
measure: Prevalence of LBP at 3-, 6- and 12 months follow up
timeFrame: 18 months
Secondary outcomes:
measure: Change of Intensity and prevalence of LBP in gymnasts that report SLBP at the start of the study - from baseline to end of intervention, and at 3-, 6- and 12 months follow-up
timeFrame: 18 months
measure: Prevention of LBP evaluated after intervention and at 3-, 6- and 12 months
timeFrame: 18 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center
Study officials:
affiliation: Karolinska Institutet
name: Marita L Harringe, PhD,RPT
role: STUDY_DIRECTOR
References: