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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04778215
Other study ID # KI2009/1414-31/3
Secondary ID Dnr 4646/2011-63
Status Completed
Phase N/A
First received
Last updated
Start date March 2009
Est. completion date June 2010

Study information

Verified date February 2021
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date June 2010
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 10 Years to 16 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
A progressive specific lumbar stabilization program
The aim of these programs is to optimize the stabilization and control of segmental motion of the lumbar spine. It is based on the draw-in action, hereafter called the abdominal hollowing, presented by Richardson and Jull (1995). The training program consists of three levels. Level 1 introduces the abdominal hollowing exercise in the prone and four-point kneeling position. Level 2 is a progression of these exercises and the gymnasts are also instructed to perform the abdominal hollowing standing on a balance board with slightly flexed knees while slowly moving the arms. Level 3 takes the training into sports specificity and the abdominal hollowing are to be held during three different basic trampette jumps with emphasis on good trunk and body control during jumping and landing.

Locations

Country Name City State
Sweden Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weekly prevalence of LBP from baseline to end of the intervention program Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group 3 months
Primary Weekly prevalence of SLBP (Substantial LBP) from baseline to end of the intervention program Number of gymnasts reporting LBP 3 days or more or modification of participation (SLBP)/ Total number of gymnasts' reports; comparing the intervention and control group 3 months
Primary Prevalence of LBP at 3-, 6- and 12 months follow up Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group 18 months
Secondary 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 Subgroup analysis including gymnasts with SLBP at the start of the study; comparing intervention and control group 18 months
Secondary Prevention of LBP evaluated after intervention and at 3-, 6- and 12 months Subgroup analysis including gymnasts with no previous LBP at the start of the study; comparing intervention and control group 18 months
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