NCT04753333

Brief Summary

This study aims to investigate the effects of electromyography biofeedback (EMG-BF) guided isometric quadriceps strengthening with patellar taping and isometric exercise alone in young adult male athletes with patellofemoral pain syndrome (PFPS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

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

November 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

January 22, 2021

Last Update Submit

September 14, 2021

Conditions

Keywords

Pain; Strength; Function; PFPS; Athletes; Young adults

Outcome Measures

Primary Outcomes (3)

  • 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).

    up to 6 weeks

  • 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.

    up to 6 weeks

  • 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 60 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.

    up to 6 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

The participants in the experimental group will receive Electromyographic-biofeedback guided (EMG-BF) isometric quadriceps strengthening with patellar taping five days a week for four weeks.

Behavioral: Electromyography biofeedback (EMG-BF)

Control

PLACEBO COMPARATOR

The participants in the experimental group will receive Sham EMG-BF guided isometric quadriceps strengthening without patellar taping five days a week for four weeks.

Behavioral: Sham electromyography biofeedback (EMG-BF)

Interventions

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

Also known as: Patellar Taping
Experimental

Participants in this group will receive Sham electromyography biofeedback (EMG-BF) guided strength training without patellar taping

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 radiograph.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy & Rehabilitation center

Al Majma'ah, Riyadh Region, 11952, Saudi Arabia

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shahnaz Hasan, PhD

    Majmaah University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2021

First Posted

February 15, 2021

Study Start

November 30, 2020

Primary Completion

February 15, 2021

Study Completion

February 28, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Data will be kept secure with the principal investigator (Dr. Asma Alonazi) and sub-investigator (Dr. Shahnaz Hasan) due to confidentiality issues

Locations