Clinical trial NCT04134741: Assessment of Effectiveness of Neuromuscular Training in Treatment of Lumbar Spine in Football Players
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury Leg
Back Pain
Sport Injury
Training Group, Sensitivity
Prevention
Keywords: prevention
back pain
soccer
football
female
sport injury
kinetic control
Lead sponsor: John Paul II University in Biała Podlaska
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 18
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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:

1. Will the application of the KC training reduce the risk and frequency of spine and knee injuries in females football players?
2. Will the KC training lead to reduction of the intensity of lumbar spine and knee pain?
3. 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?
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Visual analogue scale of pain (VAS)
timeFrame: Visual analogue scale of pain (VAS) was carried out at the beginning of each season and after 6 months
measure: Modified Laitinen's pain questionnaire
timeFrame: Modified Laitinen's pain questionnaire was carried out at the beginning of each season and after 6 months
measure: Stratford's back pain functional scale (BPFS)
timeFrame: Stratford's back pain functional scale (BPFS) was carried out at the beginning of each season and after 6 months
Secondary outcomes:
measure: Single leg small knee bend test
timeFrame: Single leg small knee bend test was carried out at the beginning of each season and after 6 months
measure: Tests on the GAMMA dynamometric platform
timeFrame: Tests on the GAMMA dynamometric platform were carried out at the beginning of each season and after 6 months
measure: Measurement of muscle force torque on a UPR-02A chair
timeFrame: Measurement of muscle force torque on a UPR-02A chair were carried out at the beginning of each season and after 6 months
Other outcomes:
Locations:
city: Biała Podlaska
country: Poland
facility: Pope John Paul II State School Of Higher Education in Biała Podlaska
Study officials:
affiliation: John Paul II University in Biała Podlaska
name: Kamil Zaworski, PhD
role: STUDY_DIRECTOR
affiliation: John Paul II University in Biała Podlaska
name: Anna Kręgiel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: John Paul II University in Biała Podlaska
name: Krystyna Gawlik, PhD
role: STUDY_CHAIR
affiliation: John Paul II University in Biała Podlaska
name: Joanna Baj-Korpak, PhD
role: PRINCIPAL_INVESTIGATOR
References: