Botox for Non-surgical Lateral Release in Patellofemoral Pain - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Botox for Non-surgical Lateral Release in Patellofemoral Pain

Resource links provided by NLM:

MedlinePlus related topics: Botox Exercise and Physical Fitness

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Visual Analog Scale Pain Ratings (VAS) [ Time Frame: 4, 6, 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Lower Extremity Functional Scale [ Time Frame: 4, 6, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximal Knee Extensor Force During Concentric and Isometric Contractions [ Time Frame: 4, 6, 12 weeks ] [ Designated as safety issue: No ]
Knee Extensor Fatigue [ Time Frame: 4, 6, 12 weeks ] [ Designated as safety issue: No ]
Muscle Activation During Maximal Contractions and Fatigue Contractions [ Time Frame: 4, 6, 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Singer BJ, Silbert PL, Dunne JW, Song S, Singer KP. An open label pilot investigation of the efficacy of Botulinum toxin type A [Dysport] injection in the rehabilitation of chronic anterior knee pain. Disabil Rehabil. 2006 Jun 15;28(11):707-13.

Crossley K, Bennell K, Green S, McConnell J. A systematic review of physical interventions for patellofemoral pain syndrome. Clin J Sport Med. 2001 Apr;11(2):103-10. Review.

Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004 May;85(5):815-22.

Responsible Party:	Sheryl Finucane, Assistant Professor, Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00496964 History of Changes
Other Study ID Numbers:	PT_PMR_3700
Study First Received:	July 5, 2007
Results First Received:	March 14, 2011
Last Updated:	April 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

Botulinum toxin type A
Patellofemoral pain syndrome
Knee Injuries
Exercise Therapy

Additional relevant MeSH terms:

Somatoform Disorders
Patellofemoral Pain Syndrome
Mental Disorders
Joint Diseases
Musculoskeletal Diseases
Botulinum Toxins, Type A
Botulinum Toxins

Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013