Assessment of Effectiveness of Neuromuscular Training in Treatment of Lumbar Spine in Football Players
Primary Purpose
Injury Leg, Back Pain, Sport Injury
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Kinetic Control
Sponsored by
About this trial
This is an interventional treatment trial for Injury Leg focused on measuring prevention, back pain, soccer, football, female, sport injury, kinetic control
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.
Sites / Locations
- Pope John Paul II State School Of Higher Education in Biała Podlaska
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Kinetic Control Group
Traditional Training Group
Arm Description
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.
Players participated in the classic training.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04134741
First Posted
September 25, 2019
Last Updated
October 18, 2019
Sponsor
John Paul II University of Applied Sciences in Biala Podlaska
1. Study Identification
Unique Protocol Identification Number
NCT04134741
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
June 16, 2019 (Actual)
Study Completion Date
June 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
John Paul II University of Applied Sciences in Biala Podlaska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury Leg, Back Pain, Sport Injury, Training Group, Sensitivity, Prevention
Keywords
prevention, back pain, soccer, football, female, sport injury, kinetic control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
None of the physiotherapists were personally involved in the preparation and the manner of performing the test.
The random placement was performed with the use of computer software.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kinetic Control Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Training Group
Arm Type
No Intervention
Arm Description
Players participated in the classic training.
Intervention Type
Other
Intervention Name(s)
Kinetic Control
Other Intervention Name(s)
Neuromuscular training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale of pain (VAS)
Description
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.
Time Frame
Visual analogue scale of pain (VAS) was carried out at the beginning of each season and after 6 months
Title
Modified Laitinen's pain questionnaire
Description
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.
Time Frame
Modified Laitinen's pain questionnaire was carried out at the beginning of each season and after 6 months
Title
Stratford's back pain functional scale (BPFS)
Description
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.
Time Frame
Stratford's back pain functional scale (BPFS) was carried out at the beginning of each season and after 6 months
Secondary Outcome Measure Information:
Title
Single leg small knee bend test
Description
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.
Time Frame
Single leg small knee bend test was carried out at the beginning of each season and after 6 months
Title
Tests on the GAMMA dynamometric platform
Description
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.
Time Frame
Tests on the GAMMA dynamometric platform were carried out at the beginning of each season and after 6 months
Title
Measurement of muscle force torque on a UPR-02A chair
Description
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.
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamil Zaworski, PhD
Organizational Affiliation
John Paul II University of Applied Sciences in Biala Podlaska
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anna Kręgiel, PhD
Organizational Affiliation
John Paul II University of Applied Sciences in Biala Podlaska
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Krystyna Gawlik, PhD
Organizational Affiliation
John Paul II University of Applied Sciences in Biala Podlaska
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Joanna Baj-Korpak, PhD
Organizational Affiliation
John Paul II University of Applied Sciences in Biala Podlaska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pope John Paul II State School Of Higher Education in Biała Podlaska
City
Biała Podlaska
ZIP/Postal Code
21-500
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of Effectiveness of Neuromuscular Training in Treatment of Lumbar Spine in Football Players
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