Neuromuscular Training Compared to Progressive Resistance Training for Patients With Anterior Knee Pain

Sponsor

University of Thessaly (Other)

Overall Status

Recruiting

CT.gov ID

NCT06110455

Collaborator

(none)

Enrollment

Location

Arms

15.4

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of this randomized control trial is to investigate patients' with anterior knee pain if a neuromuscular training program (NMT) has better results in pain and functionality, than an ordinary progressive resistance training program (PRT). Pain will be measured via a visual analog scale for pain (VAS) and functionality via questionnaires such as Kujala and the Greek version of the Modified Baecke Questionnaire (mBQ) and functional tests such as the Anterior Lunge test, Step up/down, squat, balance and reach test. The secondary aims are to investigate the:

Hip and knee muscles strength, which will be measured with the Kinvent K-Push dynamometer. Strength will be measured before and after the rehabilitation programs (at baseline and after 8 weeks of intervention).
Balance, will also be measured to see the effects of the NMT program.
Kinesiophobia, which will be measured with the Tampa Scale
Dynamic Knee Valgus, via the Single Leg Landing and Single Leg Squat tests

Condition or Disease	Intervention/Treatment	Phase
Anterior Knee Pain Syndrome	Other: Neuromuscular Training exercises Other: Hip and Knee Muscular Strength exercises	N/A

Detailed Description

Participants will be randomized into two groups: PRT or NMT. All sessions will be conducted in group sessions, with one physical therapist/researcher supervising the exercises. Patients will be taught on how to correctly do the exercises beforehand from trained physical therapists. Outcomes will be measured in person at baseline and after 8 weeks of treatment, the exercises will be supervised remotely. The duration of the intervention program will be 8 weeks, with 3 sessions per week with at least one day resting in between, totaling 24 training sessions.

The NMT intervention sessions consist of a 5 minute submaximal warm-up, followed by 25 minutes of NMT with exercises focused on functional and core stability, strength, agility, proprioception, balance, landing, plyometrics and coordination. The training sessions will consist of 5 different exercises. Each of them will be performed for 2 sets, and depending on the exercise either for 8 to 10 reps or for 30 seconds. In between the sets and the exercises there will be a 30 sec rest period. The exercises will be focused on the lower limb which has anterior knee pain and on the core. Four levels of difficulty will be given for each exercise to allow progression. Progression will be individualized for each patient. Every 2 weeks, there will be a progression that will be achieved by changing the exercise gradually, making it harder, or/and changing the support surface.

The PRT intervention will also consist of a 5 minute submaximal warm-up, followed by 25 minutes of the PRT exercises, targeting the hip and knee muscles. The program will consist of 5 different exercises, which each of them will focus on a different muscle group (hip abductors, knee extensors and knee flexors). Each exercise will be performed in sets of 3 of 10 repetitions and there will be a 30 sec rest period between sets and exercises.

Progression will be done by increasing the resistance and by increasing the range of motion. The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete 3 sets of 8-12 repetitions for a given exercise and a Borg Rating of Perceived Exertion (RPE) of 6-10. The progression will be done safely, based on VAS, patients tolerance and movement quality.

Adherence to the program for both groups will be assessed by the total number of training sessions performed in 8 weeks (total=24 training sessions).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effects of Neuromuscular Training Compared to Progressive Resistance Training on Patients With Anterior Knee Pain. A Randomized Controlled Trial

Actual Study Start Date :

Feb 2, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

May 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neuromuscular Exercise Training (NMT) The 8-week exercise intervention program consists of group sessions of Neuromuscular training supervised by a physical therapist 3 times per week. Patients will be taught and familiarized with the proper way to do the exercises on a separate day prior to the start of their actual rehabilitation program. Each session consists of a 5 minute submaximal warm-up followed by 25 minutes of NMT. Every 2 weeks, there will be a progression that will be achieved by increasing the difficulty level of each exercise. We will take under consideration the individuality each patient has on how much progression is needed every two weeks and it will be done by maintaining a proper quality of performance, minimal exertion and control of the movement. Participants will be given special equipment including sliders and elastic tubing	Other: Neuromuscular Training exercises The 8 week exercise intervention consists of 25 minute group sessions of Neuromuscular training supervised by a physical therapist.
Experimental: Progressive Resistance Training (PRT) The 8-week exercise intervention program consists of group sessions of progressive resistance training supervised by a physical therapist 3 times per week. Patients will be taught and familiarized with the proper way to do the exercises on a separate day prior to the start of their actual rehabilitation program. Each session consists of a 5 minute submaximal warm-up followed by 25 minutes of PRT, targeting hip and knee muscles, such as hip abductors, knee flexors and extensors. The exercise intensity will be monitored by the physical therapist, as determined by the patients' ability to complete 3 sets of 8-12 repetitions for a given exercise and a Borg Rating of Perceived Exertion (RPE) of 6-8. Every 2 weeks, progression will be achieved by changing the resistance based on VAS and RPE, with an elastic tubing	Other: Hip and Knee Muscular Strength exercises The 8 week exercise intervention consists of 25 minute group sessions of progressive resistance training, supervised by a physical therapist.

Arm

Intervention/Treatment

Experimental: Neuromuscular Exercise Training (NMT)

The 8-week exercise intervention program consists of group sessions of Neuromuscular training supervised by a physical therapist 3 times per week. Patients will be taught and familiarized with the proper way to do the exercises on a separate day prior to the start of their actual rehabilitation program. Each session consists of a 5 minute submaximal warm-up followed by 25 minutes of NMT. Every 2 weeks, there will be a progression that will be achieved by increasing the difficulty level of each exercise. We will take under consideration the individuality each patient has on how much progression is needed every two weeks and it will be done by maintaining a proper quality of performance, minimal exertion and control of the movement. Participants will be given special equipment including sliders and elastic tubing

Other: Neuromuscular Training exercises

The 8 week exercise intervention consists of 25 minute group sessions of Neuromuscular training supervised by a physical therapist.

Experimental: Progressive Resistance Training (PRT)

The 8-week exercise intervention program consists of group sessions of progressive resistance training supervised by a physical therapist 3 times per week. Patients will be taught and familiarized with the proper way to do the exercises on a separate day prior to the start of their actual rehabilitation program. Each session consists of a 5 minute submaximal warm-up followed by 25 minutes of PRT, targeting hip and knee muscles, such as hip abductors, knee flexors and extensors. The exercise intensity will be monitored by the physical therapist, as determined by the patients' ability to complete 3 sets of 8-12 repetitions for a given exercise and a Borg Rating of Perceived Exertion (RPE) of 6-8. Every 2 weeks, progression will be achieved by changing the resistance based on VAS and RPE, with an elastic tubing

Other: Hip and Knee Muscular Strength exercises

The 8 week exercise intervention consists of 25 minute group sessions of progressive resistance training, supervised by a physical therapist.

Outcome Measures

Primary Outcome Measures

Pain Intensity [Measured at baseline and at the end of the program (week 8)]
Pain will be assessed by a numeric Visual Analogue Scale (VAS), where patients will be asked how much their pain level is. Maximum Score Will be a 10, which is the worst pain they ever felt and minimum score will be 0, which is no pain. Higher scores indicate more pain.
Functionality [Measured at baseline and at the end of the program (week 8)]
Functionality will be assessed by the greek translated version of the Kujala Questionnaire, which is dedicated to assess the functionality of patients with Anterior Knee Pain. The questionnaire is consisted of 13 questions, the maximum score is 100 and minimum score is 0. The lower the score, the less functional the person is.

Secondary Outcome Measures

Stability/Balance [Measured at baseline and at the end of the program (week 8)]
Stability and balance will be assessed via the Y-balance test as well
Strength [Measured at baseline and at the end of the program (week 8)]
Muscle strength of hip and knee muscles will be assessed with the Hogan hand-held dynamometer
Kinesiophobia [Measured at baseline and at the end of the program (week 8)]
Kinesiophobia will be assessed with The Tampa Scale of Kinesiophobia (TSK). It is consisted of 17 items and minimum score is 17 and maximum score is 68. Higher scores indicate an increased level of Kinesiophobia.
Dynamic Knee Valgus [Measured at baseline and at the end of the program (week 8)]
It will be assessed via the Single Leg Landing and Single Leg Squat tests and we will calculate the angle using the Kinovea application

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pain ≥ 3 months
Pain VAS now ≥ 3
18-40 y/o
No pain relief medicine 2 weeks prior to the program
Kujala 50-80
Pain during squat, knee bending, palpation, isometric contraction on 60°, long sitting, jumping, step up/down, running.
Theatre sign
Positive functional tests: grind test, 45 sec anterior knee provocation, McConnel

Exclusion Criteria:

Patellar dislocation
Lower extremity surgery
Ligament instability
Rheumatoid Arthritis
Osteoarthritis
Tendinopathy
Meniscus tear
Ligamentous knee injury or laxity
Bursitis
Sinding Larsen Johansson Syndrome
Previous pathology
Low back surgery
Metabolic diseases
NSAIDs for extended period of time
Cardiorespiratory diseases
Sacroiliac joint pain
Pregnancy
Physical therapy 2 months ago

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Thessaly	Lamia	Central Greece	Greece	GR-35132

Sponsors and Collaborators

University of Thessaly

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Savvas Spanos, Official Title: Head of Human Performance and Rehabilitation Laboratory of the Physiotherapy Department, University of Thessaly

ClinicalTrials.gov Identifier:

NCT06110455

Other Study ID Numbers:

NMT PRT Thess

First Posted:

Oct 31, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Patellofemoral Pain Syndrome

Study Results

No Results Posted as of Oct 31, 2023