Low Back PainNCT04778215
Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts
A study testing A progressive specific lumbar stabilization program in people with Low Back Pain, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 10 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- A progressive specific lumbar stabilization program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- female TeamGym teams, aged 10-16 years, in the Stockholm area
- competing at national or international level
Who cannot join
- male TeamGym gymnasts
- female TeamGym teams on a regional competitive level
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center
Stockholm, 171 76 Stockholm
About this study
Official title: Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts - a Cluster Randomized Controlled Intervention Study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- A progressive specific lumbar stabilization program
- Keywords
- stabilization training, abdominal hollowing, gymnastics
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A progressive specific lumbar stabilization programOther
Also called Draw-in-action, abdominal hollowing, core
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | progressive, 8 week lumbar stabilizing program Receives: Other: A progressive specific lumbar stabilization program |
| Control group | No intervention | Continue as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 18 months
Secondary outcomes (2)
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
Measured: 18 months
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marita Löfgren Harringe, Karolinska Institutet
- Investigators
- Marita L Harringe, PhD,RPT, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778215
- Sponsor's protocol ID
- KI2009/1414-31/3
- Other IDs
- Dnr 4646/2011-631
- Status last verified
- Feb 2021
- First submitted
- 18 Aug 2011
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts - a Cluster Randomized Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT04778215
- Acronym / sponsor ID
- KI2009/1414-31/3
- Conditions
- Low Back Pain
- Keywords
- stabilization training, abdominal hollowing, gymnastics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: A progressive specific lumbar stabilization programprogressive, 8 week lumbar stabilizing program |
| Control group | No intervention | –Continue as usual |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- female TeamGym teams, aged 10-16 years, in the Stockholm area
- competing at national or international level
Key exclusion criteria (2 listed)
- male TeamGym gymnasts
- female TeamGym teams on a regional competitive level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A progressive specific lumbar stabilization programAlso: Draw-in-action, abdominal hollowing, coreThe 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. | Other | Intervention group |
Primary outcome
Weekly prevalence of LBP from baseline to end of the intervention program
Time frame: 3 months
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
Time frame: 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
Prevalence of LBP at 3-, 6- and 12 months follow up
Time frame: 18 months
Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group
2 secondary outcomes
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
Time frame: 18 months
Prevention of LBP evaluated after intervention and at 3-, 6- and 12 months
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marita L Harringe, PhD,RPT study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A progressive specific lumbar stabilization program in people with Low Back Pain, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly prevalence of LBP from baseline to end of the intervention program (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.