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Efficacy of Patellar Taping and Electromyographic Biofeedback Training at Various Knee Angles on Quadriceps Strength and Functional Performance in Patellofemoral Pain Syndrome

Primary Purpose

Patellofemoral Disorder, Anterior Knee Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Electromyographic-biofeedback guided (EMG-BF) isometric quadriceps strengthening with patellar taping five days a week for six weeks.
Sponsored by
Majmaah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Disorder focused on measuring Pain; Strength; Function; PFPS; Athletes; SLTHT

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Knee pain during activities such as descending and ascending stairs, squatting, and running,
  • Positive J sign (lateral tilt of patella),
  • Sign of patellar malalignment on the radiograph

Exclusion Criteria:

  • Fracture around the knee,
  • Patella dislocation,
  • Knee deformity (e.g., genu varum),
  • Knee flexion contracture,
  • Ligaments/meniscal injuries, and
  • Osteoarthritis of the knee.

Sites / Locations

  • Physiotherapy & Rehabilitation center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Control group

Arm Description

Experimental: Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training along with patellar taping

No Intervention: Control: Participants in this group will receive Sham EMG-BF guided strength training without patellar taping

Outcomes

Primary Outcome Measures

Mean changes in pain intensity
The 10-cm visual analogue scale (VAS) will be used for the assessment of pain intensity. Each participant will be instructed to report their current intensity of pain on a 10-cm scale between two anchors 0 (indicates no pain) and 10 (indicates maximum pain).
Mean changes in knee function
Knee function will be assessed using the validated Anterior Knee Pain scale. It comprised of 13 questions designed to evaluate difficulties related to PFPS such as presence of a limp, walking ability, need for support, squatting, stair climbing, jumping, running, pain, abnormal painful kneecap movement, prolonged sitting with knees flexed, atrophy of the thigh, swelling, and flexion deficiency. Total scores range between 0 and 100. A higher score suggests lower symptoms and better functional capacity.
Mean changes in quadriceps muscle strength
Maximum voluntary isometric strength of quadriceps femoris muscle will be measured using an isokinetic dynamometer. Participants will be made in a sitting position and secured using the stabilization straps with the knee joint in 30,60,90 degrees of flexion, as this position has resulted in the most significant torque output. They will be verbally encouraged to carry out three maximal voluntary isometric contractions of quadriceps with 5-sec rest. The best of the three maximum peak torque will be used for the analysis.
Mean changes in balance performance
The SLTH test measured the distance participants travelled from the starting point to where the back of their heel touched the ground. They conducted three trials with a 3-minute rest period in between. The maximum distance covered score of the three, i.e., the best, was used as the baseline score.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2021
Last Updated
September 23, 2021
Sponsor
Majmaah University
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1. Study Identification

Unique Protocol Identification Number
NCT05055284
Brief Title
Efficacy of Patellar Taping and Electromyographic Biofeedback Training at Various Knee Angles on Quadriceps Strength and Functional Performance in Patellofemoral Pain Syndrome
Official Title
Efficacy of Patellar Taping and Electromyographic Biofeedback Training at Various Knee Angles on Quadriceps Strength and Functional Performance in Young Adult Male Athletes With Patellofemoral Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Majmaah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study compared the effects of patellar taping and electromyographic-biofeedback (EMG-BF) guided isometric quadriceps strengthening at different knee angles in patello-femoral pain syndrome (PFPS).
Detailed Description
A total of 60 adult male athletes aged 18 to 45 years were recruited. Subjects will be included with the history of knee pain during activities such as descending and ascending stairs, squatting, and running, had positive J sign (lateral tilt of patella), and a sign of patellar malalignment on the radiograph. Individuals with a history of fracture around the knee, patella dislocation, knee deformity (e.g., genu varum), flexion contracture, ligaments/meniscal injuries, and osteoarthritis of the knee will be excluded from the study. The protocol was submitted to and approved by the ethical sub-committee of the College of applied medical science, Majmaah, Saudi Arabia (Ethics number: MUREC-Nov./COM-2O20/11-2). Participants were requested to sign a written informed consent form approved by the institution ethics committee. Participants were randomly assigned to Group A (experimental group): electromyography biofeedback (EMG-BF) guided maximum voluntary isometric contraction exercise with patellar taping; Group B (control group): sham EMG-BF guided maximum voluntary isometric contraction without patellar taping. The outcome measure for this study will be the mean changes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle at different angles, pain intensity, single-leg triple hop test (SLTH), and functional status up to 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Disorder, Anterior Knee Pain Syndrome
Keywords
Pain; Strength; Function; PFPS; Athletes; SLTHT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental: Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training along with patellar taping at 30, 60, and 90-degree angles. No Intervention: Control: Participants in this group will receive Sham EMG-BF guided strength training without patellar taping at 30, 60, and 90-degree angles.
Masking
ParticipantOutcomes Assessor
Masking Description
Double
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental: Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training along with patellar taping
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
No Intervention: Control: Participants in this group will receive Sham EMG-BF guided strength training without patellar taping
Intervention Type
Other
Intervention Name(s)
Electromyographic-biofeedback guided (EMG-BF) isometric quadriceps strengthening with patellar taping five days a week for six weeks.
Other Intervention Name(s)
Control group will receive Sham EMG-BF guided isometric quadriceps strengthening without patellar taping five days a week for six weeks.
Intervention Description
Patellar Taping, electromyography biofeedback (EMG-BF), Strength Training
Primary Outcome Measure Information:
Title
Mean changes in pain intensity
Description
The 10-cm visual analogue scale (VAS) will be used for the assessment of pain intensity. Each participant will be instructed to report their current intensity of pain on a 10-cm scale between two anchors 0 (indicates no pain) and 10 (indicates maximum pain).
Time Frame
6 weeks
Title
Mean changes in knee function
Description
Knee function will be assessed using the validated Anterior Knee Pain scale. It comprised of 13 questions designed to evaluate difficulties related to PFPS such as presence of a limp, walking ability, need for support, squatting, stair climbing, jumping, running, pain, abnormal painful kneecap movement, prolonged sitting with knees flexed, atrophy of the thigh, swelling, and flexion deficiency. Total scores range between 0 and 100. A higher score suggests lower symptoms and better functional capacity.
Time Frame
6 weeks
Title
Mean changes in quadriceps muscle strength
Description
Maximum voluntary isometric strength of quadriceps femoris muscle will be measured using an isokinetic dynamometer. Participants will be made in a sitting position and secured using the stabilization straps with the knee joint in 30,60,90 degrees of flexion, as this position has resulted in the most significant torque output. They will be verbally encouraged to carry out three maximal voluntary isometric contractions of quadriceps with 5-sec rest. The best of the three maximum peak torque will be used for the analysis.
Time Frame
6 weeks
Title
Mean changes in balance performance
Description
The SLTH test measured the distance participants travelled from the starting point to where the back of their heel touched the ground. They conducted three trials with a 3-minute rest period in between. The maximum distance covered score of the three, i.e., the best, was used as the baseline score.
Time Frame
6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Knee pain during activities such as descending and ascending stairs, squatting, and running, Positive J sign (lateral tilt of patella), Sign of patellar malalignment on the radiograph Exclusion Criteria: Fracture around the knee, Patella dislocation, Knee deformity (e.g., genu varum), Knee flexion contracture, Ligaments/meniscal injuries, and Osteoarthritis of the knee.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahnaz Hasan, PhD
Organizational Affiliation
Majmaah University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy & Rehabilitation center
City
Al Majma'ah,
State/Province
Riyadh
ZIP/Postal Code
11952
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35958675
Citation
Hasan S, Alonazi A, Anwer S, Jamal A, Parvez S, Alfaiz FAS, Li H. Efficacy of Patellar Taping and Electromyographic Biofeedback Training at Various Knee Angles on Quadriceps Strength and Functional Performance in Young Adult Male Athletes with Patellofemoral Pain Syndrome: A Randomized Controlled Trial. Pain Res Manag. 2022 Aug 1;2022:8717932. doi: 10.1155/2022/8717932. eCollection 2022.
Results Reference
derived

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Efficacy of Patellar Taping and Electromyographic Biofeedback Training at Various Knee Angles on Quadriceps Strength and Functional Performance in Patellofemoral Pain Syndrome

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