Elbow InjuryCPMNCT01420887
Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study
A study testing Continuous Passive Motion and Physical Therapy in people with Elbow Injury, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Elbow Injury
- What is being tested?
- Continuous Passive Motion and Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2016to 19 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 arthroscopic capsulectomy or osteocapsular arthroplasty with removal of heterotopic ossification as necessary
Who cannot join
- 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.
- Progressive or recalcitrant neuropathy or neuritis, except for isolated intermittent ulnar neuritis.
- Pre-existing factors that might limit ability to completely participate in rehabilitations such as neuromuscular or psychosocial condition.
- Progressive or recurrent contracture due to inflammatory disease such as rheumatoid arthritis, juvenile idiopathic arthritis or chondrolysis.
- Altered anatomy that might limit elbow motion, independent of the condition being treated, such as dysplasia, malunion, osteonecrosis, and congenital deformity.
- A reasonable restoration of motion and function cannot be expected.
Show all 13Show fewer
- Inadequate postoperative regional anesthesia
- Intra-operative or postoperative complication that could affect outcome
- Injury or disease in the postoperative period that could affect elbow function
- Not possible to have postoperative physical therapy appointment
- Significant portion of the procedure performed in an open manner
- Women that know they are pregnant or breastfeeding
- Current or prior septic arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the 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. 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.
- Conditions
- Elbow Injury
- Being tested
- Continuous Passive Motion, Physical Therapy
- Keywords
- CPM, elbow joint surgery, continuous passive motion, Recovery after surgery to restore elbow motion
- Medical subject headings
- Elbow Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Passive MotionProcedure or surgery
Continuous passive motion.
Physical TherapyProcedure or surgery
Physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Passive Motion | Experimental | Subjects randomized to CPM therapy. Receives: Procedure: Continuous Passive Motion |
| Physical Therapy | Active comparator | Subjects randomized to physical therapy. Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study start18 Dec 2016
- Primary completion19 May 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow InjuryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn W. O'Driscoll, Mayo Clinic
- Investigators
- Shawn O Driscoll, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420887
- Sponsor's protocol ID
- 11-000601
- Acronym
- CPM
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2011
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study
- ClinicalTrials.gov ID
- NCT01420887
- Acronym / sponsor ID
- CPM / 11-000601
- Conditions
- Elbow Injury
- Keywords
- CPM, elbow joint surgery, continuous passive motion, Recovery after surgery to restore elbow motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Dec 2016 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Passive Motion | Experimental | Procedure: Continuous Passive MotionSubjects randomized to CPM therapy. |
| Physical Therapy | Active comparator | Procedure: Physical TherapySubjects randomized to physical therapy. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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 arthroscopic capsulectomy or osteocapsular arthroplasty with removal of heterotopic ossification as necessary
Key exclusion criteria (13 listed)
- 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.
- Progressive or recalcitrant neuropathy or neuritis, except for isolated intermittent ulnar neuritis.
- Pre-existing factors that might limit ability to completely participate in rehabilitations such as neuromuscular or psychosocial condition.
- Progressive or recurrent contracture due to inflammatory disease such as rheumatoid arthritis, juvenile idiopathic arthritis or chondrolysis.
- Altered anatomy that might limit elbow motion, independent of the condition being treated, such as dysplasia, malunion, osteonecrosis, and congenital deformity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Passive MotionContinuous passive motion. | Procedure or surgery | Continuous Passive Motion |
| Physical TherapyPhysical therapy. | Procedure or surgery | Physical Therapy |
Primary outcome
Recurrence of elbow contracture
Time frame: 1 year
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.
1 secondary outcome
Subsequent injury or disease of the affected elbow
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn O Driscoll, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Passive Motion and Physical Therapy in people with Elbow Injury, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of elbow contracture (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.