An interventional study of Continuous Passive Motion and Physical Therapy in Elbow Injury, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2020-07-02.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
This pilot study is designed to determine if the rehabilitative benefits of continuous passive motion (CPM) will help preserve/restore the joint function and significantly improve the rate of recovery of patients after the surgical release of elbow contractures better than standard physiotherapy and static splinting.
Elbow stiffness and reduced motion commonly occur after elbow injury or surgery. With traumatic injuries to the elbow, contractures are a common complication. Indeed, they are expected in most cases. For patients with these injuries who are otherwise healthy, active and require the restoration of full function in order to return to their previous level of activity/work, this reduced motion can be especially problematic and even debilitating. The investigators have found and published that most patients treated with postoperative Continuous Passive Motion following surgical repair of their stiffness have been able to recover all or nearly all of their prior elbow mobility and function. Though CPM has been in clinical use for decades, a prospective randomized clinical trial has never been published proving its effectiveness. The investigators believe and intend to show in this study that the rehabilitative benefits of continuous passive motion (CPM) will help preserve/restore the joint function and significantly improve the rate of recovery of patients after stiffness is surgically repaired. Specific Aim 1: To demonstrate that postoperative use of CPM enhances tissue healing and hastens recovery following surgical release of elbow contracture. Specific Aim 2: To demonstrate that postoperative use of CPM improves ultimate function following surgical release of elbow contracture. Specific Aim 3: To demonstrate that CPM is a cost-efficient treatment following surgical release of elbow contracture. Study Design: 50 patients who require arthroscopic contracture release, will be randomly assigned to one of two postoperative treatment groups: Experimental - CPM and Control - Physical Therapy. Participants of this study will be followed for 12 months postoperatively. Throughout this 12 month period the impact/effectiveness of CPM vs Physical Therapy will be evaluated by assessing functional status, pain, mobility, general health related quality of life, utility, and societal cost-effectiveness. In line with the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, this study will help anyone with elbow injuries that result in stiffness and loss of motion. Such a study has the advantage of being highly translational with the potential to have an immediate impact on patient treatment and care. The findings from this study will be able to help patients immediately and ensure that the principals of Evidence Based Medicine are applied to patients with these types of elbow injuries and that they receive the treatment they need for the best possible recovery based on hard evidence and scientific facts.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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To be included, each patient must meet ALL of the following:
Exclusion Criteria:
Subjects randomized to CPM therapy.
Procedure: Continuous Passive Motion
Subjects randomized to physical therapy.
Procedure: Physical Therapy
Continuous passive motion.
Physical therapy.
Recurrence of elbow contracture
There will be an 80% statistical power to detect a difference of 2 points in the pre-surgery to post-surgery change in VAS pain between subjects in the two study arms. Similarly, there will be an 80% power to detect a difference of 16 degrees in the pre-surgery to post-surgery change in total arc of motion between the two study groups. There will be 80% power to detect a difference of at least 9 points on the pre-surgery to post-surgery difference in the DASH score.
Time frame: 1 year
Subsequent injury or disease of the affected elbow
There will be an 80% statistical power to detect a difference of 2 points in the pre-surgery to post-surgery change in VAS pain between subjects in the two study arms. Similarly, there will be an 80% power to detect a difference of 16 degrees in the pre-surgery to post-surgery change in total arc of motion between the two study groups. There will be 80% power to detect a difference of at least 9 points on the pre-surgery to post-surgery difference in the DASH score.
Time frame: 1 year
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Elbow Injuries
Mayo Clinic