Injury LegNCT04134741
Assessment of Effectiveness of Neuromuscular Training in Treatment of Lumbar Spine in Football Players
A study of Injury Leg and Back Pain, run by John Paul II University in Biała Podlaska at 1 site in Poland.
Trial summary
The project aims to assess the effectiveness of neuromuscular training according to the concept of Kinetic Control (KC) in prevention and treatment of lumbar spine and knee pain and in reduction of risk of injury in female football players. Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Injury Leg, Back Pain, Sport Injury
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jan 2019to 16 Jun 2019
- 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 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female players not taking nonsteroidal anti-inflammatory drugs (NSAIDs) for at least a week before the start of the study,
- written consent for the participation in the study.
Who cannot join
- female players with acute inflammation (neuralgia) and massive intervertebral disk herniation requiring a surgery,
- female players who suffered from a lumbar spine and/or knee injury up to 6 months before the start of the study,
- female players with acute knee inflammation and after knee surgeries.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Pope John Paul II State School Of Higher Education in Biała Podlaska
Biała Podlaska, 21-500
About this study
Official title: Assessment of Effectiveness of Neuromuscular Training According to the Concept of Kinetic Control in Treatment of Lumbar Spine and Knee Pain and in Reduction of Risk of Injury in Female Football Players
The project aims to assess the effectiveness of neuromuscular training according to the concept of Kinetic Control (KC) in prevention and treatment of lumbar spine and knee pain and in reduction of risk of injury in female football players.
The study was designed as single-blind Randomized Controlled Trial (RCT) and conducted on a group of 18 female football players from University Club of the Academic Sports Association of Pope John Paul II State School of Higher Education in Biała Podlaska. Participants were randomly divided into two 9-person groups: A - used standard training and neuromuscular training (Kinetic Control) and B - used only standard training.
Read more
Main hypothesis:
The application of neuromuscular therapy (KC) reduces the risk of injuries and pain of the lumbar spine and the knee and improves the static and dynamic balance.
Research questions:
- Will the application of the KC training reduce the risk and frequency of spine and knee injuries in females football players?
- Will the KC training lead to reduction of the intensity of lumbar spine and knee pain?
- Will the application of the KC training lead to increase in the torque strength of knee flexors and extensors and improved stability of the knee?
- Will the application of the neuromuscular training (KC) lead to reduction of the disability level and improved functional level?
Read the detailed description
The research was conducted upon acquiring an approval of the Bioethical Commission of Pope John Paul II State School of Higher Education in Biała Podlaska, no. 3/2018.
The study was designed as single-blind Randomized Controlled Trial (RCT) and conducted on a group of 18 female football players from University Club of the Academic Sports Association of Pope John Paul II State School of Higher Education in Biała Podlaska. Participants were randomly divided into two 9-person groups: A - used standard training and neuromuscular training (Kinetic Control) and B - used only standard training.
None of the physiotherapists were personally involved in the preparation and the manner of performing the test. Before commencing the tests, each participant was familiarised with their course, expressed their informed written consent for the participation and random assignment to the specified tested group.
The random placement was performed with the use of computer software.
The players participate in two training cycles over a year: from July to December and from January to June. Therefore, the above mentioned training regime will be performed twice.
A medical interview takes place before the training cycle. Physical examination, back pain functional scale (BPFS) and tests on the dynamographic platform will be performed two times - before and after each season.
- Conditions
- Injury Leg, Back Pain, Sport Injury, Training Group, Sensitivity, Prevention
- Being tested
- Kinetic Control
- Keywords
- prevention, back pain, soccer, football, female, sport injury, kinetic control
- Medical subject headings
- Leg Injuries, Back Pain, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinetic ControlOther
Also called Neuromuscular training
The Kinetic Control training included a functional examination of motor disorders and individual training. The KC training included active exercises, active exercises with torso muscle resistance and exercises involving lower limbs.
The duration of one training was 20-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Kinetic Control Group | Experimental | The players participated in the classic training and for 4 weeks (3 times a week) underwent the Kinetic Control neuromuscular training with assistance of a physical therapist.
The duration of one training was 20-30 minutes. Receives: Other: Kinetic Control |
| Traditional Training Group | No intervention | Players participated in the classic training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale of pain (VAS)
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Measured: Visual analogue scale of pain (VAS) was carried out at the beginning of each season and after 6 months
Modified Laitinen's pain questionnaire
Laitinen's pain questionnaire took into account four indicators evaluated in the scale from 0 to 4: the intensity of pain, the frequency of its occurrence, the use of analgesic medications and limitation of the participant's motor activity. A research participant could have been granted from 0 to 16 points, the maximum score means the highest level of pain.
Measured: Modified Laitinen's pain questionnaire was carried out at the beginning of each season and after 6 months
Stratford's back pain functional scale (BPFS)
In Stratford's scale (BFPS), the research participants assessed twelve actions related to everyday life activity in the scale from 0 to 5. The result fell within a range from 0 to 60 points, where the higher final result, the lower level of pain.
Measured: Stratford's back pain functional scale (BPFS) was carried out at the beginning of each season and after 6 months
Secondary outcomes (3)
Single leg small knee bend test
The test is performed in the standing position with feet a hip distance apart and parallel inner sides. The participant is then asked to transfer their body weight on one leg and raise the other leg over the ground. The body weight should be placed over the metatarsus. The participant is then asked to slightly bend the knee whilst keeping the heel on the ground. A photo is taken with a camera. Subsequently, computer software is used to determine the axis of the bent limb. The participant undergoes the test twice. If the test is not performed properly the first time, the participant is instructed how to perform the movement and the test is repeated.
Proper test performance for the first time scores 2 points. Proper test performance after the guidance of the physical therapist scores 1 point and improper test performance twice scores 0 points.
Measured: Single leg small knee bend test was carried out at the beginning of each season and after 6 months
Tests on the GAMMA dynamometric platform
- Assessment of the load of lower limbs in the standing position for 30 seconds with eyes open. 1-1.15 was assumed as the proper load distribution ratio.
- Assessment of the load of lower limbs in the standing position for 30 seconds with eyes closed. 1-1.15 was assumed as the proper load distribution ratio.
- Assessment of the load of lower limbs in the squat test. The platform marks the load of lower limbs in three phases - standing up, stabilisation and squatting. 1-1.15 was assumed as the proper load distribution ratio in each phase.
- Assessment of the load of lower limbs in the jumping test. The platform marks the load of lower limbs in three phases - jumping up, landing and stabilisation. 1-1.15 was assumed as the proper load distribution ratio in each phase.
Measured: Tests on the GAMMA dynamometric platform were carried out at the beginning of each season and after 6 months
Measurement of muscle force torque on a UPR-02A chair
The test was performed under isometric conditions and included two measurements of each muscle group, for both the left and the right lower limb. The tested limb was stabilised at the 30-degree bend at the knee in order to measure the flexors and at the 60-degree bend in order to measure the extensors, assuming the 0 degree angle as full extension at the knee. In addition, the torso and distal thighs were stabilised with a belt. During the test, upper limbs were crossed on the chest. The axis of the torque measuring device was placed at the level of the knee joint gap (joint rotation axis). The measurements were taken in the following sequence: extension of the right limb, flexion of the right limb, extension of the left limb and flexion of the left limb.
Measured: Measurement of muscle force torque on a UPR-02A chair were carried out at the beginning of each season and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start3 Jan 2019
- Primary completion16 Jun 2019
- Study completion16 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury LegStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The players were placed at random in the studied groups, 9 participants in each group: A - group with additional Kinetic Control neuromuscular training; and B - group with standard training.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Paul II University in Biała Podlaska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamil Zaworski, PhD, Study director, John Paul II University in Biała PodlaskaAnna Kręgiel, PhD, Principal investigator, John Paul II University in Biała PodlaskaKrystyna Gawlik, PhD, Study chair, John Paul II University in Biała PodlaskaJoanna Baj-Korpak, PhD, Principal investigator, John Paul II University in Biała Podlaska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134741
- Sponsor's protocol ID
- PopeJohnPaulIIStateSchHigherEd
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Effectiveness of Neuromuscular Training According to the Concept of Kinetic Control in Treatment of Lumbar Spine and Knee Pain and in Reduction of Risk of Injury in Female Football Players
- ClinicalTrials.gov ID
- NCT04134741
- Acronym / sponsor ID
- PopeJohnPaulIIStateSchHigherEd
- Conditions
- Injury Leg, Back Pain, Sport Injury, Training Group, Sensitivity, Prevention
- Keywords
- prevention, back pain, soccer, football, female, sport injury, kinetic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- John Paul II University in Biała PodlaskaUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 16 Jun 2019 (actual)
- First posted
- 22 Oct 2019 (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.
The project aims to assess the effectiveness of neuromuscular training according to the concept of Kinetic Control (KC) in prevention and treatment of lumbar spine and knee pain and in reduction of risk of injury in female football players.
The study was designed as single-blind Randomized Controlled Trial (RCT) and conducted on a group of 18 female football players from University Club of the Academic Sports Association of Pope John Paul II State School of Higher Education in Biała Podlaska. Participants were randomly divided into two 9-person groups: A - used standard training and neuromuscular training (Kinetic Control) and B - used only standard training.
Main hypothesis:
The application of neuromuscular therapy (KC) reduces the risk of injuries and pain of the lumbar spine and the knee and improves the static and dynamic balance.
Research questions:
- Will the application of the KC training reduce the risk and frequency of spine and knee injuries in females football players?
- Will the KC training lead to reduction of the intensity of lumbar spine and knee pain?
- Will the application of the KC training lead to increase in the torque strength of knee flexors and extensors and improved stability of the knee?
- Will the application of the neuromuscular training (KC) lead to reduction of the disability level and improved functional level?
Detailed description
The research was conducted upon acquiring an approval of the Bioethical Commission of Pope John Paul II State School of Higher Education in Biała Podlaska, no. 3/2018.
The study was designed as single-blind Randomized Controlled Trial (RCT) and conducted on a group of 18 female football players from University Club of the Academic Sports Association of Pope John Paul II State School of Higher Education in Biała Podlaska. Participants were randomly divided into two 9-person groups: A - used standard training and neuromuscular training (Kinetic Control) and B - used only standard training.
None of the physiotherapists were personally involved in the preparation and the manner of performing the test. Before commencing the tests, each participant was familiarised with their course, expressed their informed written consent for the participation and random assignment to the specified tested group.
The random placement was performed with the use of computer software.
The players participate in two training cycles over a year: from July to December and from January to June. Therefore, the above mentioned training regime will be performed twice.
A medical interview takes place before the training cycle. Physical examination, back pain functional scale (BPFS) and tests on the dynamographic platform will be performed two times - before and after each season.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The players were placed at random in the studied groups, 9 participants in each group: A - group with additional Kinetic Control neuromuscular training; and B - group with standard training.
| Arm | Type | Receives |
|---|---|---|
| Kinetic Control Group | Experimental | Other: Kinetic ControlThe players participated in the classic training and for 4 weeks (3 times a week) underwent the Kinetic Control neuromuscular training with assistance of a physical therapist. The duration of one training was 20-30 minutes. |
| Traditional Training Group | No intervention | –Players participated in the classic training. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female players not taking nonsteroidal anti-inflammatory drugs (NSAIDs) for at least a week before the start of the study,
- written consent for the participation in the study.
Key exclusion criteria (3 listed)
- female players with acute inflammation (neuralgia) and massive intervertebral disk herniation requiring a surgery,
- female players who suffered from a lumbar spine and/or knee injury up to 6 months before the start of the study,
- female players with acute knee inflammation and after knee surgeries.
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 |
|---|---|---|
| Kinetic ControlAlso: Neuromuscular trainingThe Kinetic Control training included a functional examination of motor disorders and individual training. The KC training included active exercises, active exercises with torso muscle resistance and exercises involving lower limbs. The duration of one training was 20-30 minutes. | Other | Kinetic Control Group |
Primary outcome
Visual analogue scale of pain (VAS)
Time frame: Visual analogue scale of pain (VAS) was carried out at the beginning of each season and after 6 months
Visual analogue scale of pain (VAS) evaluates intensity of pain in the scale from 0 to 10. Maximum score means the highest level of pain.
Modified Laitinen's pain questionnaire
Time frame: Modified Laitinen's pain questionnaire was carried out at the beginning of each season and after 6 months
Laitinen's pain questionnaire took into account four indicators evaluated in the scale from 0 to 4: the intensity of pain, the frequency of its occurrence, the use of analgesic medications and limitation of the participant's motor activity. A research participant could have been granted from 0 to 16 points, the maximum score means the highest level of pain.
Stratford's back pain functional scale (BPFS)
Time frame: Stratford's back pain functional scale (BPFS) was carried out at the beginning of each season and after 6 months
In Stratford's scale (BFPS), the research participants assessed twelve actions related to everyday life activity in the scale from 0 to 5. The result fell within a range from 0 to 60 points, where the higher final result, the lower level of pain.
3 secondary outcomes
Single leg small knee bend test
Time frame: Single leg small knee bend test was carried out at the beginning of each season and after 6 months
Tests on the GAMMA dynamometric platform
Time frame: Tests on the GAMMA dynamometric platform were carried out at the beginning of each season and after 6 months
Measurement of muscle force torque on a UPR-02A chair
Time frame: Measurement of muscle force torque on a UPR-02A chair were carried out at the beginning of each season and after 6 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 22 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Kamil Zaworski, PhD study director
John Paul II University in Biała Podlaska
Anna Kręgiel, PhD principal investigator
John Paul II University in Biała Podlaska
Krystyna Gawlik, PhD study chair
John Paul II University in Biała Podlaska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Injury Leg and Back Pain, run by John Paul II University in Biała Podlaska at 1 site in Poland.
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 3 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 22 Oct 2019. 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 Poland. 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?
Visual analogue scale of pain (VAS) (time frame: Visual analogue scale of pain (VAS) was carried out at the beginning of each season and after 6 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 22 Oct 2019.