0
Scientific Articles   |    
Botulinum Toxin Injection in the Treatment of Tennis ElbowA Double-Blind, Randomized, Controlled, Pilot Study
M.J. Hayton, FRCS(Tr and Orth)1; A.J.A. Santini, FRCS(Tr and Orth)2; P.J. Hughes, FRCS(Tr and Orth)3; S.P. Frostick, MA, FRCS, DM2; I.A. Trail, MD, FRCS1; J.K. Stanley, MCh(Orth), FRCS1
1 Wrightington Hospital, Hall Lane, Appley Bridge, Wigan WN6 9EP, United Kingdom. E-mail address for M.J. Hayton: mjhayton@aol.com
2 Royal Liverpool University Hospital, Prescot Street, Liverpool L7 8XP, United Kingdom
3 Royal Preston Hospital, Sharoe Green Lane, Preston PR2 9HT, United Kingdom
View Disclosures and Other Information
The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. One or more of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity (the botulinum toxin was supplied by Allergan). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.
Investigation performed at Wrightington Hospital, Wigan, and Royal Liverpool University Hospital, Liverpool, United Kingdom

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2005 Mar 01;87(3):503-507. doi: 10.2106/JBJS.D.01896
5 Recommendations (Recommend) | 3 Comments | Saved by 3 Users Save Case

Abstract

Background: A recent report has suggested that local injection of botulinum toxin type A is an effective method of treatment for chronic tennis elbow. The toxin is thought to provide temporary paralysis of the painful common extensor origin, thereby allowing a healing response to occur. To test this theory, we performed a double-blind, randomized, controlled, pilot trial comparing injections of botulinum toxin type A with those of a placebo (normal saline solution) in the treatment of chronic tennis elbow.

Methods: Forty patients with a history of chronic tennis elbow for which all conservative treatment measures, including steroid injection, had failed were randomized into two groups. Half the patients received 50 units of botulinum toxin type A, and the remainder received normal saline solution. The intramuscular injections were performed 5 cm distal to the maximum point of tenderness at the lateral epicondyle, in line with the middle of the wrist. The two solutions used for the injections were identical in appearance and temperature. The results of a quality-of-life assessment with the Short Form-12 (SF-12), the pain score on a visual analogue scale, and the grip strength measured with a validated Jamar dynamometer were recorded before and three months after the injection.

Results: Three months following the injections, there was no significant difference between the two groups with regard to grip strength, pain, or quality of life.

Conclusions: With the numbers studied, we failed to find a significant difference between the two groups; thus, we have no evidence of a benefit from botulinum toxin injection in the treatment of chronic tennis elbow.

Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article
    Sign In to Your Personal ProfileSign In To Access Full Content
    Not a Subscriber?
    Get online access for 30 days for $35
    New to JBJS?
    Sign up for a full subscription to both the print and online editions
    Register for a FREE limited account to get full access to all CME activities, to comment on public articles, or to sign up for alerts.
    Register for a FREE limited account to get full access to all CME activities
    Have a subscription to the print edition?
    Current subscribers to The Journal of Bone & Joint Surgery in either the print or quarterly DVD formats receive free online access to JBJS.org.
    Forgot your password?
    Enter your username and email address. We'll send you a reminder to the email address on record.

     
    Forgot your username or need assistance? Please contact customer service at subs@jbjs.org. If your access is provided
    by your institution, please contact you librarian or administrator for username and password information. Institutional
    administrators, to reset your institution's master username or password, please contact subs@jbjs.org

    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
    CME Activities Associated with This Article
    Submit a Comment
    Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
    Comments are moderated and will appear on the site at the discretion of JBJS editorial staff.

    * = Required Field
    (if multiple authors, separate names by comma)
    Example: John Doe





    M.J. Hayton, FRCS(Tr and Orth)
    Posted on May 23, 2005
    MJ Hayton and colleagues respond to Mr. Ampat
    Wrightington Hospital, Hall Lane, Appley Bridge, Wigan WN6 9EP, United Kingdom

    We thank Mr. Ampat for his comments on our paper and answer them as numbered in his letter.

    1. The patients were in a pilot study and recruited when presenting to clinic and randomised through block randomisation as discussed with a statistician prior to the trial as detailed in the paper.

    2. The age and gender mix were similar in both groups.

    3. The VAS was scored out of 10, but the line was actually 15cm (but not marked as such). The figures presented were the actual lengths. The change in length and comparison between BoTox and placebo groups is the important factor.

    Yours faithfully.

    AJAS, MJH

    George Ampat, FRCS(Tr & Orth)
    Posted on April 22, 2005
    Is Botulinum Toxin effective for treating Tennis Elbow?
    Southport District General Hospital, Southport, PR8 6PN, UK

    To the Editor:

    I read with great interest the article entitled " Botulinum Toxin Injection in the Treatment of Tennis Elbow A Double-Blind, Randomized, Controlled, Pilot Study" (1). Tennis elbow is a self limiting condition that burns out in a year(2). Tennis elbow is, however, symptomatic during that year affecting function and ability to work. Measures to provide relief during the symptomatic period is required and we commend the authors for doing an excellent study to see the short term (3 month) benefit of Botulinum toxin vs placebo.

    Currently the terms epicondylitis and tendinitis are not used to describe tennis elbow which is now more commonly known as tendinosis(3). Since tennis elbow is not an inflammatory process, rest provided by botulinum toxin seems to be an excellent alternative(4,5).

    The current report however concludes “With the numbers studied, we failed to find a significant difference between the two groups; thus, we have no evidence of a benefit from botulinum toxin injection in the treatment of chronic tennis elbow”.

    This conclusion which contradicts earlier reports(4,5) led us to examine the patient groups, methodology and level of significance used in this current report. There are a number of issues that require clarification.

    (1) The current study has used 4 outcome measurements. The outcome measurements are:

    (a) Grip strength (Table I)

    (b) Pain on Visual Analogue Scale (Table II)

    (c) Physical function (Table III)

    (d) Mental (Table III)

    The PRE TREATMENT VALUES of both the Toxin and Placebo show that in 3 out of the 4 outcome measures tested the Toxin group is worse than the Placebo group and at least in the SF-12 Physical Function it reaches nearly clinical significance (p=0.06). p=0.06 is nearly as important as p=0.05(6). This makes one wonder whether the groups were really randomly selected and matched for comparison.

    (2) Could the authors please mention the gender and age distribution of each of the Toxin and placebo group and whether they were comparable?

    (3) The authors again describe in length the Visual Analogue Scale stating that it ranges from 0 to 10(7). If 10 is the maximum possible score on a Visual Analogue Scale how did the authors obtain Mean Post injection Pain Scores of 11.35 for the Toxin group and 12.46 cm for the Placebo group (Table II) ?

    References

    1. Hayton MJ, Santini AJA, Hughes PJ, Frostick SP, Trail IA and Stanley JK Botulinum Toxin Injection in the Treatment of Tennis Elbow A Double blind, Randomized, Controlled, Pilot Study (2005 87-A 3 Mar 503 – 507

    2. Smidt N, van der Windt DA, Assendelft WJ, Deville WL, Korthals-de Bos IB, Bouter LM. Corticosteroid injections, physiotherapy, or a wait-and -see policy for lateral epicondylitis: a randomised controlled trial. Lancet. 2002 Feb 23;359:657-62.

    3. Kraushaar BS, Nirschl RP. Tendinosis of the elbow (tennis elbow). Clinical features and findings of histological, immunohistochemical, and electron microscopy studies. J Bone Joint Surg Am. 1999;81:259-78.

    4. Keizer SB, Rutten HP, Pilot P, Morre HH, v Os JJ, Verburg AD. Botulinum toxin in-jection versus surgical treatment for tennis elbow: a randomized pilot study. Clin Orthop. 2002;401:125-31.

    5. Morre HH, Keizer SB, van Os JJ. Treatment of chronic tennis elbow with botulinum toxin. Lancet. 1997;349:1746.

    6. Rosnow RL Rosenthal R Statistical procedures and the justification of knowledge in psychological science. American Psychologist 44:1276-1284.

    7. Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976;2:

    Related Content
    The Journal of Bone & Joint Surgery
    JBJS Case Connector
    Topic Collections
    Related Audio and Videos
    PubMed Articles
    Clinical Trials
    Readers of This Also Read...
    JBJS Jobs
    04/02/2014
    Illinois - Hinsdale Orthopaedics
    02/05/2014
    Oregon - The Center - Orthopedic and Neurosurgical Care and Research