The effect of ultrasound guided intramuscular injection of botulinum toxin (type A) in the distal of the vastus lateralis muscle on pain relief and performance improvement in patients with patellofemoral pain syndrome: A randomized clinical trial
Determining the effect of intramuscular botulinum toxin A injection under ultrasound in the distal vestus lateralis muscle on reducing pain and improving performance in patients with patellofemoral pain syndrome.
Design
Two arm double blinded parallel group randomised trial, phase III trial, with a minimum of 52 patients
Settings and conduct
The participants are divided into two groups. During the treatment period and one week before the start of the physiotherapy program, patients will not be allowed to use non-steroidal anti-inflammatory drugs and pain relievers. After the screening, the included patients will be subjected to initial evaluations. In all patients, AP, lateral and axial view radiography of the knee will be done to check the grade of arthritis and joint space.
All measurements will be done before starting the treatment and 2 months later.
Participants/Inclusion and exclusion criteria
Aged 18 to 45 years old; clinical diagnosis of PFP syndrome for more than 3 months; pain rating (out of 10) 4 or more; failure to respond to treatment despite receiving at least 8 weeks of non-invasive treatment including exercise therapy, exercise therapy and physical therapy.
Intervention groups
Patients of the intervention group will be treated with an ultrasound guided intramuscular injection of botulinum neurotoxin type A to induce temporary weakening of the distal vestus lateralis muscle in addition to the standard physiotherapy exercise program to strengthen and improve hip and knee joint muscle control for 8 weeks.
The patients of the control group will undergo a placebo injection (normal saline) in the same place as the patients of the intervention group, as well as a standard exercise program.
Main outcome variables
Knee pain level; Knee function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221202056684N1
Registration date:2023-01-17, 1401/10/27
Registration timing:retrospective
Last update:2023-01-17, 1401/10/27
Update count:0
Registration date
2023-01-17, 1401/10/27
Registrant information
Name
Mohammadreza mashhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 0182
Email address
ahmad_khalili@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-05, 1401/10/15
Expected recruitment end date
2023-01-12, 1401/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ultrasound guided intramuscular injection of botulinum toxin (type A) in the distal of the vastus lateralis muscle on pain relief and performance improvement in patients with patellofemoral pain syndrome: A randomized clinical trial
Public title
Effect botulinum toxin (type A) in patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 45 years
Clinical diagnosis of PFP syndrome for more than 3 months
Pain rating (out of 10) 4 or more
Failure to respond to treatment despite receiving at least 8 weeks of non-invasive treatment including exercise therapy, exercise therapy and physical therapy
Exclusion criteria:
Presence of knee joint effusion
Presence of any evidence in favor of other tibiofemoral pathologies (patellar tendinopathy, presence of evidence of tibiofemoral osteoarthritis or patellofemoral joint space narrowing or arthrosis on radiographs (Kellgren-Lawrence grade II or higher), meniscal tear, knee instability)
Evidence in favor of spinal canal stenosis, lumbar radiculopathy, neuropathy and lower limb neuronal damage
Any intra-articular injection of the knee in the last 6 months (including hyaluronic acid, ozone or steroids)
Body mass index > 35
Previous knee surgery
Evidence of injury or inflammatory arthritis of the hip joint
Allergy to BoNT-A
Pregnancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
After signing the consent form to participate in this research, patients will be divided into two groups: A: BoNT-A injection and exercise therapy, and B: Placebo (normal saline) injection and exercise therapy.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study will be double-blind, so that the patient and the person who compares and records the results of the two groups will be unaware of the type of intervention. To keep them blind, the patients are placed in a lying position and their knees are protected with a cloth, and they will not actually see the injection.
Placebo
Used
Assignment
Parallel
Other design features
In addition to the original interventionو all of the included patients in both groups will be subjected to exercise therapy in the form of stretching of the gastrosoleus muscles, hamstrings, strengthening of the quadriceps muscles and hip adductor muscles for 8 weeks.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the Faculty of Medicine, Shahid Beheshti University of Medical Sciences
The amount of pain assessed by Visual Analogue Scale score
Timepoint
The beginning of the study and 2 months after the injection
Method of measurement
Visual Analogue Scale
2
Description
Examination of knee function using the Anterior Knee Pain Scale
Timepoint
The beginning of the study and 2 months after the injection
Method of measurement
Anterior Knee Pain Scale
3
Description
Examination of knee function using the Knee injury and Osteoarthritis Outcome Score-Patellofemoral subscale
Timepoint
The beginning of the study and 2 months after the injection
Method of measurement
Knee injury and Osteoarthritis Outcome Score-Patellofemoral subscale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: each knee will be receiving a total of one vial of 100 units of Botox Allergan (100U/vial) diluted to 10U in 0.1 ml (10 ml in total) in 5 divided doses by injection with ultrasound guidance, in the distal third of the VL muscle. The injections will start from a distance of 3 cm from the upper side of the patella bone and will be injected along a line towards the proximal side of the muscle. The distance between each injection and the next injection will be 2 cm. All injection cases will be given at a fixed time and for all participants in the same period of time, with full compliance with sterile conditions. In addition, each patient in both groups is subjected to exercise therapy in the form of stretching gastrosoleus muscles, hamstrings, strengthening the quadriceps muscles and hip adductor muscles for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: each of the knees will receive a total of 10 ml of normal saline in 5 divided doses by injection with ultrasound guidance, in the distal third of the VL muscle, starting at a distance of 3 cm from the upper side of the patella and along a line will be injected into the proximal side of the muscle. The distance between each injection and the next injection will be 2 cm. All injection cases will be done in a fixed time and for all participants in the same period of time, with full observance of sterile conditions. In addition, each patient in both groups is subjected to exercise therapy in the form of stretching gastrosoleus muscles, hamstrings, strengthening the quadriceps muscles and hip adductor muscles for 8 weeks.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The collected data, including the background data, and the results investigated in this current study will be published in the form of an Excel file along with the publication of the results and the study protocol in a reputable research journal.
When the data will become available and for how long
The data of the study will be accessible from the time of publication of the study by sending an email to the corresponding author of the study
To whom data/document is available
The data of the study will be accessible for the use of researchers by sending an email to the corresponding author of the study
Under which criteria data/document could be used
The use of non-identifiable data of individuals is acceptable for cinducting systematic review and meta-analysis studies
From where data/document is obtainable
In order to receive the data of this study, by sending an email to the corresponding author of this study, if the conditions required to access the information are met, the data will be provided to the requester.
What processes are involved for a request to access data/document
The application should contain information about the applicant, his/her affiliation, phone number, e-mail and the reason for his/her request. If these items are presented and the information related to the applicant's plan is registered and confirmed in the PROSPERO system, the information will be provided to the applicant.