0
Scientific Articles   |    
A Prospective Randomized Controlled Trial of Dynamic Versus Static Progressive Elbow Splinting for Posttraumatic Elbow Stiffness
Anneluuk L.C. Lindenhovius, MD, PhD1; Job N. Doornberg, MD, PhD1; Kim M. Brouwer, MSc1; Jesse B. Jupiter, MD1; Chaitanya S. Mudgal, MD1; David Ring, MD, PhD1
1 Orthopaedic Hand and Upper Extremity Service, Department of Orthopaedic Surgery, Massachusetts General Hospital, Yawkey Center Suite 2100, 55 Fruit Street, Boston, MA 02114. E-mail address for D. Ring: dring@partners.org
View Disclosures and Other Information
  • Disclosure statement for author(s): PDF

Investigation performed at the Orthopaedic Hand and Upper Extremity Service, Department of Orthopaedic Surgery, Massachusetts General Hospital, Boston, Massachusetts



Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, one or more of the authors has had another relationship, or has engaged in another activity, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Apr 18;94(8):694-700. doi: 10.2106/JBJS.J.01761
5 Recommendations (Recommend) | 3 Comments | Saved by 3 Users Save Case

Abstract

Background: 

Both dynamic and static progressive (turnbuckle) splints are used to help stretch a contracted elbow capsule to regain motion after elbow trauma. There are advocates of each method, but no comparative data. This prospective randomized controlled trial tested the null hypothesis that there is no difference in improvement of motion and Disabilities of the Arm, Shoulder and Hand (DASH) scores between static progressive and dynamic splinting.

Methods: 

Sixty-six patients with posttraumatic elbow stiffness were enrolled in a prospective randomized trial: thirty-five in the static progressive and thirty-one in the dynamic cohort. Elbow function was measured at enrollment and at three, six, and twelve months later. Patients completed the DASH questionnaire at enrollment and at the six and twelve-month evaluation. Three patients asked to be switched to static progressive splinting. The analysis was done according to intention-to-treat principles and with use of mean imputation for missing data.

Results: 

There were no significant differences in flexion arc at any time point. Improvement in the arc of flexion (dynamic versus static) averaged 29° versus 28° at three months (p = 0.87), 40° versus 39° at six months (p = 0.72), and 47° versus 49° at twelve months after splinting was initiated (p = 0.71). The average DASH score (dynamic versus static) was 50 versus 45 points at enrollment (p = 0.52), 32 versus 25 points at six months (p < 0.05), and 28 versus 26 points at twelve months after enrollment (p = 0.61).

Conclusions: 

Posttraumatic elbow stiffness can improve with exercises and dynamic or static splinting over a period of six to twelve months, and patience is warranted. There were no significant differences in improvement in motion between static progressive and dynamic splinting protocols, and the choice of splinting method can be determined by the patients and their physicians.

Level of Evidence: 

Therapeutic Level I. See Instructions for 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





    David Ring, MD PhD
    Posted on February 23, 2013
    Response to Pivec and colleagues
    Chief of Hand Surgery, Massachusetts General Hospital

    You are quite keen on static progressive splints. May I ask if you have any relevant conflicts of interest? Regarding the science: This was a superiority trial powered for a relatively large difference because small differences are clinically irrelevant and because a splinting is not used commonly enough to perform a larger non-inferiority trial. We followed strict intention to treat principles, meaning that patients were analyzed according to the splint they were randomized to receive no matter which splint they actually used. This was also a pragmatic trial, meaning that we analyzed patients according to the prescription they received and made no attempt to account for whether they actually used the splint. Heterogeneity is accounted for by the randomization.

    Robert Pivec, MD, Anil Bhave, PT, Michael A. Mont, MD
    Posted on February 14, 2013
    Comment on Prospective Randomized Controlled Trial of Dynamic Versus Static Progressive Elbow Splinting for Posttraumatic Elbow Stiffness
    Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, Baltimore, Maryland, USA

    Lindenhovius and co-authors are to be commended for performing a prospective randomized trial concerning an important topic; which is the best method to non-operatively stretch a contracted elbow in an attempt to regain motion after elbow trauma? Nevertheless, we had several queries concerning their work.

    1) We have a slight reservation regarding the conclusion where the authors stated, “On the basis of the best available scientific evidence, patients who elect to use a splint as a tool to assist with elbow stretching can select either a dynamic or a static progressive splint.” The statistics do not warrant such a conclusion since a non-significant p-value in a superiority test does not necessarily prove there is no difference between the two groups (equivalence cannot be implied).[1] In order to demonstrate this, an equivalence or non-inferiority test is necessary. Thus the correct conclusion given the statistics that were utilized should have been “dynamic splinting did not result in a significantly greater range-of-motion improvement compared to static progressive stretch (or vice versa, depending on how the alternative hypothesis was formulated). Although this may sound like an arbitrarily technical point, because there are likely real differences in cost, patient compliance, and the amount of time patients must use each device (and hence cannot be doing other activities), this point becomes increasingly relevant to both surgeons and patients. For this reason an equivalence or non-inferiority test would be of great value.

    2) We noticed that three patients were asked to be switched to the static progressive splinting group. As the data was counted in the static stretch group, to me this would unfairly penalize that group and may have contributed to patient heterogeneity within the two treatment groups. Typically what occurs in this type of randomized study would be that these three patients would be considered treatment failures for the dynamic splinting group. They certainly could have received this treatment, but their data would not have been utilized for the final data analysis and statistical evaluation. At a minimum, this will have altered the results of the trial, since this group that crossed-over to the other treatment arm represents approximately 10% of the patients in the dynamic splinting group.

    3) It stands to reason that some patients might switch from the dynamic splinting to the static progressive group. This is likely because, if one looks in the “Methods,” the patients with the dynamic splinting were receiving their treatment between six to eight hours per day, whereas, the static progressive splinting group was patient-directed treatment for three thirty-minute sessions. Furthermore, patients in the static progressive splinting group may have also had a feeling of directing their own care and effectuating increases in range-of-motion.

    4) Assuming that any potential for heterogeneity in this study was minimized, it may make sense that a patient would prefer to use static progressive splinting because of the time efficiencies and active participation described. Certainly, some patients would prefer to passively improve their range-of-motion (no need to manually adjust the brace), but in our experience in treating patients with contractures of not only the elbow, but also the shoulder, wrist and knee, we have found that greater than 80 to 90% have preferred static progressive stretching. Because of this patient preference, we have seen better patient compliance and, therefore, overall superior results. However, in order to objectively answer this particular question, it would likely be appropriate to perform a one-tailed non-inferiority test, which may be an interesting avenue of future research.

    5) The authors did not mention a study by Ulrich et al.[2] which reported on the outcomes of 37 patients treated with a static progressive stretch orthosis for post-traumatic elbow stiffness. This study reported similar results as the authors’ mentioned in the “Results” and “Discussion;” the final flexion-extension arc was similar (106° compared to 103° in the present study). Although they had a smaller gain (26° versus 49°) this is likely because the patients studied by Ulrich et al. started from a higher baseline flexion-extension arc (80° versus 54°).

    6) In addition, when one uses dynamic splinting, it should be noted that patients need to apply two separate devices: one has to be applied to gain extension and the other one has to gain flexion. We think this can certainly be not only cumbersome to the patient, but confusing as well and may lead to poor patient compliance. It would also be interesting to examine the equipment costs between the two devices.

    In summary, we once again applaud the investigators for performing a well-controlled prospective randomized study, although we have some questions regarding their methodology as well as their overall conclusions concerning the best method of treating these difficult elbow contracture patients. We also feel that issues of compliance and cost are important to address, particularly in the current medical environment. This may be important when prescribing patients with dynamic splint since two different devices are necessary to treat flexion or extension deficits.

    REFERENCES
    [1] Lesaffre E. Use and misuse of the p-value. Bull NYU Hosp Jt Dis. 2008;66(2):146-9.
    [2] Ulrich SD, et al. Restoring range of motion via stress relaxation and static progressive stretch in posttraumatic elbow contractures. J Shoulder Elbow Surg. 2010 Mar;19(2):196-201.

    Related Content
    The Journal of Bone & Joint Surgery
    JBJS Case Connector
    Related Audio and Videos
    Clinical Trials
    Readers of This Also Read...
    JBJS Jobs
    12/31/2013
    SC - Department of Orthopaedic Surgery Medical Univerity of South Carlonina
    10/04/2013
    CA - Mercy Medical Group
    02/05/2014
    OR - The Center - Orthopedic and Neurosurgical Care and Research