NCT06110455

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:

  1. 1.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).
  2. 2.Balance, will also be measured to see the effects of the NMT program.
  3. 3.Kinesiophobia, which will be measured with the Tampa Scale
  4. 4.Dynamic Knee Valgus, via the Single Leg Landing and Single Leg Squat tests

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 18, 2023

Last Update Submit

October 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 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 at baseline and at the end of the program (week 8)

Secondary Outcomes (4)

  • Stability/Balance

    Measured at baseline and at the end of the program (week 8)

  • Strength

    Measured at baseline and at the end of the program (week 8)

  • Kinesiophobia

    Measured at baseline and at the end of the program (week 8)

  • Dynamic Knee Valgus

    Measured at baseline and at the end of the program (week 8)

Study Arms (2)

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

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

Other: Hip and Knee Muscular Strength exercises

Interventions

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

Neuromuscular Exercise Training (NMT)

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

Progressive Resistance Training (PRT)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain ≥ 3 months
  • Pain VAS now ≥ 3
  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Lamia, Central Greece, GR-35132, Greece

RECRUITING

Related Publications (3)

  • 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.

    PMID: 30958707BACKGROUND
  • Willy 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.

    PMID: 31475628BACKGROUND
  • Bennell 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.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Papaverine

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

BenzylisoquinolinesAlkaloidsHeterocyclic CompoundsOpiate AlkaloidsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Official Title: Head of Human Performance and Rehabilitation Laboratory of the Physiotherapy Department

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 31, 2023

Study Start

February 2, 2023

Primary Completion

December 15, 2023

Study Completion

May 15, 2024

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations