Patellofemoral DisorderPFPSNCT04753333
Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes
A study testing Electromyography biofeedback (EMG-BF) in people with Patellofemoral Disorder and Anterior Knee Pain, run by Majmaah University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patellofemoral Disorder, Anterior Knee Pain
- What is being tested?
- Electromyography biofeedback (EMG-BF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Nov 2020to 28 Feb 2021
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Fracture around knee,
- Patella dislocation,
- Knee deformity (e.g., genu varum),
- Knee flexion contracture,
- Ligaments/meniscal injuries, and
- Osteoarthritis of knee.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Physiotherapy & Rehabilitation center
Al Majma'ah, Riyadh Region, 11952
About this study
Official title: Efficacy of Electromyographic-biofeedback Supplementation Training on Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes
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).
Read the detailed description
A total of 60 adult male athletes aged 18 to 45 years will be recruited from two cities (Majmaah and Riyadh) of Saudi Arabia. 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 the history of fracture around knee, patella dislocation, knee deformity (e.g., genu varum), flexion contracture, ligaments/meniscal injuries, and osteoarthritis of knee will be excluded from the study. The protocol was submitted to and approved by the ethical sub-committee of College of applied medical science, Majmaah, Saudi Arabia (Ethics number: MUREC-Nov./COM-2O20/11-2). Participants will be requested to sign a written informed consent form approved by the institution ethics committee.
Participants will be 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, pain intensity, and functional status up to 6 weeks.
- Conditions
- Patellofemoral Disorder, Anterior Knee Pain
- Being tested
- Electromyography biofeedback (EMG-BF), Sham electromyography biofeedback (EMG-BF)
- Keywords
- Pain; Strength; Function; PFPS; Athletes; Young adults
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyography biofeedback (EMG-BF)Behavioural
Also called Patellar Taping
Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training with patellar taping
Sham electromyography biofeedback (EMG-BF)Behavioural
Participants in this group will receive Sham electromyography biofeedback (EMG-BF) guided strength training without patellar taping
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sham electromyography biofeedback (EMG-BF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start30 Nov 2020
- Primary completion15 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral DisorderStudies of the same condition, open and under way.
- 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
- Model 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Hasan, PhD, Majmaah University
- Investigators
- Shahnaz Hasan, PhD, Principal investigator, Majmaah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753333
- Sponsor's protocol ID
- DSRMajmaahU
- Other IDs
- 2020-26
- Acronym
- PFPS
- Status last verified
- Sep 2021
- First submitted
- 22 Jan 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be kept secure with the principal investigator (Dr. Asma Alonazi) and sub-investigator (Dr. Shahnaz Hasan) due to confidentiality issues
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electromyographic-biofeedback Supplementation Training on Quadriceps Strengthening With Patellar Taping in Patellofemoral Pain Syndrome Among Young Adult Male Athletes
- ClinicalTrials.gov ID
- NCT04753333
- Acronym / sponsor ID
- PFPS / DSRMajmaahU
- Conditions
- Patellofemoral Disorder, Anterior Knee Pain
- Keywords
- Pain; Strength; Function; PFPS; Athletes; Young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 15 Feb 2021 (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.
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).
Detailed description
A total of 60 adult male athletes aged 18 to 45 years will be recruited from two cities (Majmaah and Riyadh) of Saudi Arabia. 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 the history of fracture around knee, patella dislocation, knee deformity (e.g., genu varum), flexion contracture, ligaments/meniscal injuries, and osteoarthritis of knee will be excluded from the study. The protocol was submitted to and approved by the ethical sub-committee of College of applied medical science, Majmaah, Saudi Arabia (Ethics number: MUREC-Nov./COM-2O20/11-2). Participants will be requested to sign a written informed consent form approved by the institution ethics committee.
Participants will be 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, pain intensity, and functional status up to 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model 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
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Electromyography biofeedback (EMG-BF)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. |
| Control | Placebo comparator | Behavioral: Sham electromyography biofeedback (EMG-BF)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Fracture around knee,
- Patella dislocation,
- Knee deformity (e.g., genu varum),
- Knee flexion contracture,
- Ligaments/meniscal injuries, and
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 |
|---|---|---|
| Electromyography biofeedback (EMG-BF)Also: Patellar TapingParticipants in this group will receive electromyography biofeedback (EMG-BF) guided strength training with patellar taping | Behavioural | Experimental |
| Sham electromyography biofeedback (EMG-BF)Participants in this group will receive Sham electromyography biofeedback (EMG-BF) guided strength training without patellar taping | Behavioural | Control |
Primary outcome
Mean changes in pain intensity
Time frame: up to 6 weeks
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
Time frame: up to 6 weeks
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
Time frame: up to 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No. Data will be kept secure with the principal investigator (Dr. Asma Alonazi) and sub-investigator (Dr. Shahnaz Hasan) due to confidentiality issues
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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.
Shahnaz Hasan, PhD principal investigator
Majmaah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyography biofeedback (EMG-BF) in people with Patellofemoral Disorder and Anterior Knee Pain, run by Majmaah University at 1 site in Saudi Arabia.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Sep 2021. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean changes in pain intensity (time frame: up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2021.