NCT04134741

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

September 1, 2019

Enrollment Period

5 months

First QC Date

September 25, 2019

Last Update Submit

October 18, 2019

Conditions

Keywords

preventionback painsoccerfootballfemalesport injurykinetic control

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

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.

Other: Kinetic Control

Traditional Training Group

NO INTERVENTION

Players 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.

Also known as: Neuromuscular training
Kinetic Control Group

Eligibility Criteria

Age19 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Leg InjuriesBack PainHypersensitivity

Condition Hierarchy (Ancestors)

Wounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsImmune System Diseases

Study Officials

  • Kamil Zaworski, PhD

    John Paul II University in Biała Podlaska

    STUDY DIRECTOR
  • Anna Kręgiel, PhD

    John Paul II University in Biała Podlaska

    PRINCIPAL INVESTIGATOR
  • Krystyna Gawlik, PhD

    John Paul II University in Biała Podlaska

    STUDY CHAIR
  • Joanna Baj-Korpak, PhD

    John Paul II University in Biała Podlaska

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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

Locations