Anterior Knee Pain SyndromeNCT06110455
Neuromuscular Training Compared to Progressive Resistance Training for Patients With Anterior Knee Pain
A study testing Neuromuscular Training exercises and Hip and Knee Muscular Strength exercises in people with Anterior Knee Pain Syndrome, run by University of Thessaly at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Neuromuscular Training exercises and Hip and Knee Muscular Strength exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 2 Feb 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patellar dislocation
- Lower extremity surgery
- Ligament instability
- Rheumatoid Arthritis
- Osteoarthritis
- Tendinopathy
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
University of Thessaly
Lamia, Central Greece, GR-35132
About this study
Official title: Effects of Neuromuscular Training Compared to Progressive Resistance Training on Patients With Anterior Knee Pain. A Randomized Controlled Trial
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
Read the 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).
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Neuromuscular Training exercises, Hip and Knee Muscular Strength exercises
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Training exercisesOther
The 8 week exercise intervention consists of 25 minute group sessions of Neuromuscular training supervised by a physical therapist.
Hip and Knee Muscular Strength exercisesOther
The 8 week exercise intervention consists of 25 minute group sessions of progressive resistance training, supervised by a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Exercise Training (NMT) | Experimental | 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 Receives: Other: Neuromuscular Training exercises |
| Progressive Resistance Training (PRT) | Experimental | 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 Receives: Other: Hip and Knee Muscular Strength exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
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.
Measured: Measured at baseline and at the end of the program (week 8)
Functionality
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.
Measured: Measured at baseline and at the end of the program (week 8)
Secondary outcomes (4)
Stability/Balance
Stability and balance will be assessed via the Y-balance test as well
Measured: Measured at baseline and at the end of the program (week 8)
Strength
Muscle strength of hip and knee muscles will be assessed with the Hogan hand-held dynamometer
Measured: Measured at baseline and at the end of the program (week 8)
Kinesiophobia
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.
Measured: Measured at baseline and at the end of the program (week 8)
Dynamic Knee Valgus
It will be assessed via the Single Leg Landing and Single Leg Squat tests and we will calculate the angle using the Kinovea application
Measured: Measured at baseline and at the end of the program (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start2 Feb 2023
- Primary completion15 Dec 2023 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savvas Spanos, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110455
- Sponsor's protocol ID
- NMT PRT Thess
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hott A, Brox JI, Pripp AH, Juel NG, Paulsen G, Liavaag S. Effectiveness of Isolated Hip Exercise, Knee Exercise, or Free Physical Activity for Patellofemoral Pain: A Randomized Controlled Trial. Am J Sports Med. 2019 May;47(6):1312-1322. doi: 10.1177/0363546519830644. Epub 2019 Apr 8.
PubMed 30958707Willy RW, Hoglund LT, Barton CJ, Bolgla LA, Scalzitti DA, Logerstedt DS, Lynch AD, Snyder-Mackler L, McDonough CM. Patellofemoral Pain. J Orthop Sports Phys Ther. 2019 Sep;49(9):CPG1-CPG95. doi: 10.2519/jospt.2019.0302.
PubMed 31475628Bennell KL, Egerton T, Wrigley TV, Hodges PW, Hunt M, Roos EM, Kyriakides M, Metcalf B, Forbes A, Ageberg E, Hinman RS. Comparison of neuromuscular and quadriceps strengthening exercise in the treatment of varus malaligned knees with medial knee osteoarthritis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2011 Dec 5;12:276. doi: 10.1186/1471-2474-12-276.
PubMed 22141334
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Training Compared to Progressive Resistance Training on Patients With Anterior Knee Pain. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06110455
- Acronym / sponsor ID
- NMT PRT Thess
- Conditions
- Anterior Knee Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Exercise Training (NMT) | Experimental | Other: Neuromuscular Training exercisesThe 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 |
| Progressive Resistance Training (PRT) | Experimental | Other: Hip and Knee Muscular Strength exercisesThe 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Pain ≥ 3 months
- Pain VAS now ≥ 3
- 18-40 y/o
- No pain relief medicine 2 weeks prior to the program
- Kujala 50-80
Key exclusion criteria (18 listed)
- Patellar dislocation
- Lower extremity surgery
- Ligament instability
- Rheumatoid Arthritis
- Osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Training exercisesThe 8 week exercise intervention consists of 25 minute group sessions of Neuromuscular training supervised by a physical therapist. | Other | Neuromuscular Exercise Training (NMT) |
| Hip and Knee Muscular Strength exercisesThe 8 week exercise intervention consists of 25 minute group sessions of progressive resistance training, supervised by a physical therapist. | Other | Progressive Resistance Training (PRT) |
Primary outcome
Pain Intensity
Time frame: 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
Time frame: 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.
4 secondary outcomes
Stability/Balance
Time frame: Measured at baseline and at the end of the program (week 8)
Strength
Time frame: Measured at baseline and at the end of the program (week 8)
Kinesiophobia
Time frame: Measured at baseline and at the end of the program (week 8)
Dynamic Knee Valgus
Time frame: Measured at baseline and at the end of the program (week 8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 30958707Hott A, Brox JI, Pripp AH, Juel NG, Paulsen G, Liavaag S. Effectiveness of Isolated Hip Exercise, Knee Exercise, or Free Physical Activity for Patellofemoral Pain: A Randomized Controlled Trial. Am J Sports Med. 2019 May;47(6):1312-1322. doi: 10.1177/0363546519830644. Epub 2019 Apr 8.
- Background: PubMed 31475628Willy RW, Hoglund LT, Barton CJ, Bolgla LA, Scalzitti DA, Logerstedt DS, Lynch AD, Snyder-Mackler L, McDonough CM. Patellofemoral Pain. J Orthop Sports Phys Ther. 2019 Sep;49(9):CPG1-CPG95. doi: 10.2519/jospt.2019.0302.
- Results publication: PubMed 22141334Bennell KL, Egerton T, Wrigley TV, Hodges PW, Hunt M, Roos EM, Kyriakides M, Metcalf B, Forbes A, Ageberg E, Hinman RS. Comparison of neuromuscular and quadriceps strengthening exercise in the treatment of varus malaligned knees with medial knee osteoarthritis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2011 Dec 5;12:276. doi: 10.1186/1471-2474-12-276.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Training exercises and Hip and Knee Muscular Strength exercises in people with Anterior Knee Pain Syndrome, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nick Chatziavraam (6974653813 ext. +30, nikoschatziavraam2392@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Measured at baseline and at the end of the program (week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110455, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023; AzTrials last refreshed its copy on 5 Nov 2026.