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Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
A progressive specific lumbar stabilization program
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Back Pain focused on measuring stabilization training, abdominal hollowing, gymnastics

Eligibility Criteria

10 Years - 16 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

progressive, 8 week lumbar stabilizing program

Continue as usual

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
August 18, 2011
Last Updated
February 26, 2021
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04778215
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
stabilization training, abdominal hollowing, gymnastics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
progressive, 8 week lumbar stabilizing program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Continue as usual
Intervention Type
Other
Intervention Name(s)
A progressive specific lumbar stabilization program
Other Intervention Name(s)
Draw-in-action, abdominal hollowing, core
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weekly prevalence of LBP from baseline to end of the intervention program
Description
Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group
Time Frame
3 months
Title
Weekly prevalence of SLBP (Substantial LBP) from baseline to end of the intervention program
Description
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
Time Frame
3 months
Title
Prevalence of LBP at 3-, 6- and 12 months follow up
Description
Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group
Time Frame
18 months
Secondary Outcome Measure Information:
Title
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
Description
Subgroup analysis including gymnasts with SLBP at the start of the study; comparing intervention and control group
Time Frame
18 months
Title
Prevention of LBP evaluated after intervention and at 3-, 6- and 12 months
Description
Subgroup analysis including gymnasts with no previous LBP at the start of the study; comparing intervention and control group
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marita L Harringe, PhD,RPT
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center
City
Stockholm
ZIP/Postal Code
171 76 Stockholm
Country
Sweden

12. IPD Sharing Statement

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Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts

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