Assessment of Effectiveness of Neuromuscular Training in Treatment of Lumbar Spine in Football Players
1 other identifier
interventional
18
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2019
CompletedFirst Submitted
Initial submission to the registry
September 25, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedOctober 22, 2019
September 1, 2019
5 months
September 25, 2019
October 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
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
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
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
Measurement of muscle force torque on a UPR-02A chair were carried out at the beginning of each season and after 6 months
Study Arms (2)
Kinetic Control Group
EXPERIMENTALThe 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 INTERVENTIONPlayers participated in the classic training.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pope John Paul II State School Of Higher Education in Biała Podlaska
Biała Podlaska, 21-500, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kamil Zaworski, PhD
John Paul II University in Biała Podlaska
- PRINCIPAL INVESTIGATOR
Anna Kręgiel, PhD
John Paul II University in Biała Podlaska
- STUDY CHAIR
Krystyna Gawlik, PhD
John Paul II University in Biała Podlaska
- PRINCIPAL INVESTIGATOR
Joanna Baj-Korpak, PhD
John Paul II University in Biała Podlaska
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2019
First Posted
October 22, 2019
Study Start
January 3, 2019
Primary Completion
June 16, 2019
Study Completion
June 16, 2019
Last Updated
October 22, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share