Viewing Study NCT04778215



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Last Modification Date: 2024-10-26 @ 1:58 PM
Study NCT ID: NCT04778215
Status: COMPLETED
Last Update Posted: 2021-03-03
First Post: 2011-08-18

Brief Title: Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts
Sponsor: Karolinska Institutet
Organization: Karolinska Institutet

Study Overview

Official Title: Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts - a Cluster Randomized Controlled Intervention Study
Status: COMPLETED
Status Verified Date: 2021-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
Dnr 46462011-631 OTHER PUL Karolinska Institutet Sweden None