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Botox for Non-surgical Lateral Release in Patellofemoral Pain

This study has been terminated.
(Insufficient recruitment in a reasonable time + expiration of study medication)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00496964
First Posted: July 6, 2007
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
The purpose of this study is to determine whether the use of botulinum toxin A injected into the lateral thigh muscle improves knee function and reduces knee pain secondary to patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises will be superior to specific exercises alone in improving knee function and reducing knee pain in individuals with patellofemoral syndrome.

Condition Intervention Phase
Patellofemoral Pain Syndrome Drug: Botulinum toxin A + exercise Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botox for Non-surgical Lateral Release in Patellofemoral Pain

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Visual Analog Scale Pain Ratings (VAS) [ Time Frame: 4, 6, 12 weeks ]
    Visual Analog Scale pain rating (VAS). 10 cm line with anchors at 0 (no pain) and 10 cm (worst imaginable pain). Scores are in cm (0 - 10) 0 no pain, higher values greater pain. Results given are for change at 12 weeks compared to baseline (week 12 score - baseline score)

  • Change in Anterior Knee Pain Scale. [ Time Frame: 4, 6, 12 weeks ]

    Anterior Knee Pain Scale: a 13-item questionnaire; a TOTAL score of 0 = severe disability; a score of 100 = no pain or disability. (items are scored 0-5 or 0-10).

    Change scores at 12 wks are reported. Inverted so positive values reflect improvement.

    Included items: difficulty with: weight bearing, walking, stairs, squat, run, jump, prolonged sitting; presence of limp, swelling, patellar subluxation, atrophy of thigh, reduced knee flexion. Reference: Kujala et al: Scoring of Patellofemoral Disorders. J Arthroscopic Rel Surg, 9(2)159-163, 1993


  • Functional Index Questionnaire [ Time Frame: 4, 6, 12 weeks ]
    The Functional Index Questionnaire (FIQ) is a self report functional rating scale. Individuals rate eight-activities. Each activity is rated from 0 - 2 with ) being unable to perform the activity and 2 being able to perform the activity without difficulty. The total score is summed for a final score of 0 - 16. 0 indicates that the individual is ubable to perform any of the tasks, 16 indicates that the subject is able to perform all tasks without difficulty. The eight items include: walking (1 block and 1 mile), climbing stairs (2 flights and 4 flights), squatting, kneeling, prolonged sitting, and running

  • Lower Extremity Functional Scale [ Time Frame: 4, 6, 12 weeks ]
    The lower extremity functional scale (LEFS) is a self report questionnaire. Subjects rate 19 items related to general activities that require the lower extremities on a scale of 0 - 4. 0 = extreme difficulty or unable to perform the activity, 4 = No difficulty performing the activity. The total of all rankings are summed and divided by the maximum score (76). The score is reported as a percentage. 100% = no difficulty in performing any of the tasks. 0% = extreme difficulty or unable to perform all of the tasks.


Secondary Outcome Measures:
  • Maximal Knee Extensor Force During Concentric and Isometric Contractions [ Time Frame: 4, 6, 12 weeks ]
  • Knee Extensor Fatigue [ Time Frame: 4, 6, 12 weeks ]
    This is not available due to data collection errors

  • Muscle Activation During Maximal Contractions and Fatigue Contractions [ Time Frame: 4, 6, 12 weeks ]
    muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees


Enrollment: 5
Study Start Date: May 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
Drug: Botulinum toxin A + exercise
Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain
Other Name: Botox
Placebo Comparator: 2
Placebo injection + exercise
Drug: Placebo
Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus lateralis of the study leg followed by 12 weeks of exercise for patellofemoral pain syndrome

Detailed Description:

Patellofemoral pain syndrome is a leading cause of knee pain in persons under 45 and is particularly common in women. The prevailing theory for the etiology of patellofemoral pain is an imbalance in force or timing of the pull of the knee extensor muscles on the patella resulting in improper tracking of the patella in the femoral grove. Specifically, the vastus medialis is thought to be ineffective in overcoming the lateral pull of the vastus lateralis. When exercises designed to focus on improving strength and timing of activation of the vastus medialis fail, surgical release of part of the attachment of the vastus lateralis to the patella is considered.

Botulinum toxin temporarily blocks acetylcholine release from motor neurons and is used clinically to produce muscle relaxation.

Subjects with patellofemoral syndrome will be recruited into the study. Half of the subjects will be given a placebo injection while the other half will be given an injection of Botox (Botulinum Toxin A, Allergen) into the vastus lateralis muscle. Group assignment will be randomized and a double blind protocol used. Prior to injection, the subject will record their level of knee pain, fill out several knee function questionnaires, and have the strength and endurance of their knee extensor muscles tested. All subjects will be given an exercise program designed to target strengthening of the medial thigh muscles as well as stretching of lateral structures.

At 4, 6 and 12 weeks knee pain and knee function will again be assessed.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • retropatellar knee pain
  • pain with two of: prolonged sitting, climbing stairs, squatting, running, kneeling, hopping, jumping
  • pain with patellar palpation
  • symptoms minimum 1 month
  • Visual Analog Scale for pain (VAS) usual pain 4 of 10 on VAS [0-10 scale, anchors 0 = no pain, 10 = worst pain imaginable]

Exclusion Criteria:

  • history knee surgery
  • history patellar dislocation
  • clinical evidence of meniscal lesion, ligamentous instability, traction apophysitis around the patellofemoral complex, patellar tendon pathology, chondral damage, osteoarthrosis, spinal referred pain
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496964


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Allergan
Investigators
Principal Investigator: Sheryl D Finucane, PhD, PT Department of Physical Therapy, Virginia Commonwealth University
  More Information

Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00496964     History of Changes
Other Study ID Numbers: PT_PMR_3700
First Submitted: July 5, 2007
First Posted: July 6, 2007
Results First Submitted: March 14, 2011
Results First Posted: May 18, 2011
Last Update Posted: October 23, 2017
Last Verified: September 2017

Keywords provided by Virginia Commonwealth University:
Botulinum toxin type A
Patellofemoral pain syndrome
Knee Injuries
Exercise Therapy

Additional relevant MeSH terms:
Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents