Low Back PainNCT04549883
Low Back Motor Control in Rhythmic Gymnasts During Hip Extension
A study testing Theoretical practical educational session in people with Low Back Pain, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
CONTEXT: Low back pain (LBP) is a common complaint in gymnasts. A deficit in the control of lumbopelvic movement has been related to low back pain. OBJECTIVE: This study aims to examine the effectiveness of an education session about low back motor control during hip extension in the lumbopelvic sagittal movement… Read more about this study
- Who is it for?
- Ages 10 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Theoretical practical educational session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 10 Nov 2020to 30 Dec 2020
- 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 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- pre-established level of practice: minimum 13 hours
- taking part in the Italian federal championship
- sign an informed consent form
Who cannot join
- not fulfill Inclusion Criteria
- had surgery in the low back pain or the hip joint
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
Zaragoza, 50009
María Fortún Agud, PhD, 0041763755327, fortunmaria@gmail.com
María Fortún Agud, PhD
About this study
CONTEXT: Low back pain (LBP) is a common complaint in gymnasts. A deficit in the control of lumbopelvic movement has been related to low back pain. OBJECTIVE: This study aims to examine the effectiveness of an education session about low back motor control during hip extension in the lumbopelvic sagittal movement control of elite gymnasts.
DESIGN: single-group, pretest-posttest clinical trial. PARTICIPANTS: 70 Elite Rhythmic Gymnasts INTERVENTION: One standardized theoretical practical session of 15 Min that includes anatomical issues and one practical exercise in quadruped position for controlling the movement of lumbar spine during hip extension and flexion.
- Conditions
- Low Back Pain
- Being tested
- Theoretical practical educational session
- Keywords
- gymnastics, low back pain, Physical Therapy Specialty
- 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.
Theoretical practical educational sessionOther
1 Theoretical practical educational session of 15 Min about the importance of low back control during hip extension. Includes anatomical issues and one practical exercise in quadruped position
| Study group | Role | What they receive |
|---|---|---|
| Performing after session | Experimental | LB control during hip extension after intervention Receives: Other: Theoretical practical educational session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- spinal movement control in 10º of hip extension
Preintervention movement control of the spine in 10º of hip extension
Measured: Min 0 - Min 15
Post- spinal movement control in 10º of hip extension
Postintervention movement control of the spine in 10º of hip extension
Measured: Min 30 - Min 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start10 Nov 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-group, pretest-posttest clinical trial
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Fortun Agud, Universidad de Zaragoza
- Investigators
- Maria Fortun Agud, PhD, Principal investigator, Unidad de Investigación en Fisioterapia Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549883
- Sponsor's protocol ID
- LBcontrolGymnasts
- Status last verified
- Nov 2020
- First submitted
- 9 Sep 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share per email to specialized manual physical therapists
Publications
Sweeney EA, Daoud AK, Potter MN, Ritchie L, Howell DR. Association Between Flexibility and Low Back Pain in Female Adolescent Gymnasts. Clin J Sport Med. 2019 Sep;29(5):379-383. doi: 10.1097/JSM.0000000000000660.
PubMed 31460951Crasto CFB, Montes AM, Carvalho P, Carral JMC. Pressure biofeedback unit to assess and train lumbopelvic stability in supine individuals with chronic low back pain. J Phys Ther Sci. 2019 Oct;31(10):755-759. doi: 10.1589/jpts.31.755. Epub 2019 Oct 19.
PubMed 31645801Ramos LAV, Callegari B, Franca FJR, Magalhaes MO, Burke TN, Carvalho E Silva APMC, Almeida GPL, Comachio J, Marques AP. Comparison Between Transcutaneous Electrical Nerve Stimulation and Stabilization Exercises in Fatigue and Transversus Abdominis Activation in Patients With Lumbar Disk Herniation: A Randomized Study. J Manipulative Physiol Ther. 2018 May;41(4):323-331. doi: 10.1016/j.jmpt.2017.10.010.
PubMed 29751850Azevedo DC, Lauria AC, Pereira AR, Andrade GT, Ferreira ML, Ferreira PH, Van Dillen L. Intraexaminer and interexaminer reliability of pressure biofeedback unit for assessing lumbopelvic stability during 6 lower limb movement tests. J Manipulative Physiol Ther. 2013 Jan;36(1):33-43. doi: 10.1016/j.jmpt.2012.12.008.
PubMed 23380212Fawcett L, Heneghan NR, James S, Rushton A. Perceptions of low back pain in elite gymnastics: A multi-disciplinary qualitative focus group study. Phys Ther Sport. 2020 Jul;44:33-40. doi: 10.1016/j.ptsp.2020.04.003. Epub 2020 Apr 18.
PubMed 32375075
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Back Motor Control in Rhythmic Gymnasts During Hip Extension
- ClinicalTrials.gov ID
- NCT04549883
- Acronym / sponsor ID
- LBcontrolGymnasts
- Conditions
- Low Back Pain
- Keywords
- gymnastics, low back pain, Physical Therapy Specialty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 10 Nov 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 16 Sep 2020 (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.
CONTEXT: Low back pain (LBP) is a common complaint in gymnasts. A deficit in the control of lumbopelvic movement has been related to low back pain. OBJECTIVE: This study aims to examine the effectiveness of an education session about low back motor control during hip extension in the lumbopelvic sagittal movement control of elite gymnasts.
DESIGN: single-group, pretest-posttest clinical trial. PARTICIPANTS: 70 Elite Rhythmic Gymnasts INTERVENTION: One standardized theoretical practical session of 15 Min that includes anatomical issues and one practical exercise in quadruped position for controlling the movement of lumbar spine during hip extension and flexion.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-group, pretest-posttest clinical trial
| Arm | Type | Receives |
|---|---|---|
| Performing after session | Experimental | Other: Theoretical practical educational sessionLB control during hip extension after intervention |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- pre-established level of practice: minimum 13 hours
- taking part in the Italian federal championship
- sign an informed consent form
Key exclusion criteria (2 listed)
- not fulfill Inclusion Criteria
- had surgery in the low back pain or the hip joint
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 |
|---|---|---|
| Theoretical practical educational session1 Theoretical practical educational session of 15 Min about the importance of low back control during hip extension. Includes anatomical issues and one practical exercise in quadruped position | Other | Performing after session |
Primary outcome
Pre- spinal movement control in 10º of hip extension
Time frame: Min 0 - Min 15
Preintervention movement control of the spine in 10º of hip extension
Post- spinal movement control in 10º of hip extension
Time frame: Min 30 - Min 45
Postintervention movement control of the spine in 10º of hip extension
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Results publication: PubMed 31460951Sweeney EA, Daoud AK, Potter MN, Ritchie L, Howell DR. Association Between Flexibility and Low Back Pain in Female Adolescent Gymnasts. Clin J Sport Med. 2019 Sep;29(5):379-383. doi: 10.1097/JSM.0000000000000660.
- Results publication: PubMed 31645801Crasto CFB, Montes AM, Carvalho P, Carral JMC. Pressure biofeedback unit to assess and train lumbopelvic stability in supine individuals with chronic low back pain. J Phys Ther Sci. 2019 Oct;31(10):755-759. doi: 10.1589/jpts.31.755. Epub 2019 Oct 19.
- Results publication: PubMed 29751850Ramos LAV, Callegari B, Franca FJR, Magalhaes MO, Burke TN, Carvalho E Silva APMC, Almeida GPL, Comachio J, Marques AP. Comparison Between Transcutaneous Electrical Nerve Stimulation and Stabilization Exercises in Fatigue and Transversus Abdominis Activation in Patients With Lumbar Disk Herniation: A Randomized Study. J Manipulative Physiol Ther. 2018 May;41(4):323-331. doi: 10.1016/j.jmpt.2017.10.010.
- Results publication: PubMed 23380212Azevedo DC, Lauria AC, Pereira AR, Andrade GT, Ferreira ML, Ferreira PH, Van Dillen L. Intraexaminer and interexaminer reliability of pressure biofeedback unit for assessing lumbopelvic stability during 6 lower limb movement tests. J Manipulative Physiol Ther. 2013 Jan;36(1):33-43. doi: 10.1016/j.jmpt.2012.12.008.
- Results publication: PubMed 32375075Fawcett L, Heneghan NR, James S, Rushton A. Perceptions of low back pain in elite gymnastics: A multi-disciplinary qualitative focus group study. Phys Ther Sport. 2020 Jul;44:33-40. doi: 10.1016/j.ptsp.2020.04.003. Epub 2020 Apr 18.
- Individual participant dataSharing planned: Yes. Share per email to specialized manual physical therapists
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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.
Maria Fortun Agud, PhD principal investigator
Unidad de Investigación en Fisioterapia Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theoretical practical educational session in people with Low Back Pain, run by Universidad de Zaragoza at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Nov 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Fortun Agud, PhD (+41763755327, fortunmaria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- spinal movement control in 10º of hip extension (time frame: Min 0 - Min 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04549883, which also lists 5 linked publications.
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 5 Nov 2020.