- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04778215
Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts
Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts - a Cluster Randomized Controlled Intervention Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Stockholm, Sverige, 171 76 Stockholm
- Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Intervention group
progressive, 8 week lumbar stabilizing 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.
Andra namn:
|
Inget ingripande: Control group
Continue as usual
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Weekly prevalence of LBP from baseline to end of the intervention program
Tidsram: 3 months
|
Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group
|
3 months
|
Weekly prevalence of SLBP (Substantial LBP) from baseline to end of the intervention program
Tidsram: 3 months
|
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
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3 months
|
Prevalence of LBP at 3-, 6- and 12 months follow up
Tidsram: 18 months
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Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group
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18 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
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
Tidsram: 18 months
|
Subgroup analysis including gymnasts with SLBP at the start of the study; comparing intervention and control group
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18 months
|
Prevention of LBP evaluated after intervention and at 3-, 6- and 12 months
Tidsram: 18 months
|
Subgroup analysis including gymnasts with no previous LBP at the start of the study; comparing intervention and control group
|
18 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Marita L Harringe, PhD,RPT, Karolinska Institutet
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KI2009/1414-31/3
- Dnr 4646/2011-631 (Annan identifierare: PUL, Karolinska Institutet, Sweden)
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