Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Elbow Injury |
Procedure: Continuous Passive Motion Procedure: Physical Therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study |
- Recurrence of elbow contracture [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- Subsequent injury or disease of the affected elbow [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Continuous Passive Motion
Subjects randomized to CPM therapy.
|
Procedure: Continuous Passive Motion
Continuous passive motion.
|
|
Active Comparator: Physical Therapy
Subjects randomized to physical therapy.
|
Procedure: Physical Therapy
Physical therapy.
|
Detailed Description:
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. In our hands 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 will be organized according to whether they need open or arthroscopic contracture release, then randomly assigned to one of two postoperative treatment groups: Experimental - CPM and Control - Physical Therapy. The subjects of this study will be followed for 12 months postoperatively. Throughout this 12 month period the impact/effectiveness of CPM versus 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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included, each patient must meet ALL of the following:
- Lack of elbow flexion and/or extension, with or without pain.
- The contracture must have been present for at least six months and failed to respond to non-surgical treatment.
- Surgery to be performed will be an open or arthroscopic capsulectomy or osteocapsular arthroplasty with removal of heterotopic ossification as necessary (participants will be stratified according to open or arthroscopic surgery).
Exclusion Criteria:
- Contraindication to use of CPM or regional brachial plexus block, such as bleeding diathesis, use of anticoagulants or severe restriction in shoulder range of movement.
- Preoperative neuropathy or neuritis, except for isolated intermittent ulnar neuritis.
- Neuromuscular disorder, including spasticity that might limit ability to completely participate in rehabilitation.
- Psychiatric disorder, including spasticity that might limit ability to cooperate with rehabilitation.
- Progressive inflammatory disease such as rheumatoid arthritis.
Contacts and Locations| Contact: Tyson L. Scrabeck | 507-538-1016 | scrabeck.tyson@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic in Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Shawn O Driscoll, MD, PhD | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Shawn W. O'Driscoll, PI, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01420887 History of Changes |
| Other Study ID Numbers: | 11-000601 |
| Study First Received: | July 13, 2011 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
CPM elbow joint surgery continuous passive motion Recovery after surgery to restore elbow motion |
ClinicalTrials.gov processed this record on May 22, 2013