Effect botulinum toxin (type A) in patellofemoral pain syndrome

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20221202056684N1

Enrollment

Registered

2023-01-17

Start date

2023-01-05

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellofemoral pain syndrome. Patellofemoral disorders, unspecified knee

Interventions

Intervention 1: 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

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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.;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.;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.	—

Measure

Time frame

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.;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.;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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Mashhadi

Shahid Beheshti University of Medical Sciences

ahmad_khalili@sbmu.ac.ir+98 21 2228 0182

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026