Effectiveness of Botulinum toxin Type A injection (DysportÂ®) to restore quadriceps muscle balance and improve chronic knee pain

A double blind randomized controlled trial of the efficacy of Botulinum toxin Type A injection (DysportÂ®) to restore quadriceps muscle balance in patients with chronic patello-femoral pain syndrome

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000775617

Enrollment

Registered

2005-12-02

Start date

2005-07-31

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Abnormal tracking of the patella during knee joint movement, associated with imbalance of the pull of the inner quadriceps muscle (VM) and the outer quadriceps muscles (VL), has been proposed as a primary factor in anterior knee pain. Botulinum toxin (BTXA) can be used to reduce the relative overactivity in the VL muscle in addition to an exercise programme to strengthen the VM muscle in subjects with chronic anterior knee pain who had failed conservative management. We hypothesise that the combination of these therapies (BTXA and specific exercise for VM muscle control) has the potential to facilitate restoration of normal patello-femoral joint mechanics, particularly by restoring timing of onset of the VM muscle compared with VL, and consequently to reduce anterior knee pain and associated disability.

Interventions

1. Single occasion intramuscular injection of Botulinum toxin Type A injection (500U DysportÂ®) to distal third of vastus lateralis [VL] muscle. 2. Exercise programme for knee extensor muscles

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

15 Years to 55 Years

Healthy volunteers

Inclusion criteria

Anterior or retropatellar pain on at least two of the following: prolonged sitting, stairs, squat, running, kneeling and hopping/jumping unrelated to a recent traumatic incident no surgical intervention (arthroscopic investigation or menisectomy allowed).

Exclusion criteria

History of recurrent patella dislocation/subluxationClinical evidence of meniscal lesion, ligamentous instability, traction apophysitis around the patello-femoral complex, or patellar tendon pathology Radiographically determined osteoarthrotic changes of the PFJ Obesity BMI >30Previous BTXA injection within 3 months or any history of adverse reaction to BTXADisorders producing disturbed neuromuscular transmission (eg.myasthenia gravis)Concurrent use of aminoglycosides (potential for interaction with BTXA)History of infectious diseases or active rheumatoid arthritis.

Outcome results