Patients With Osteoarthritis Undergoing CAS-TKANCT04136431
Effects of Programmed Cryotherapy and Continuous Passive Motion After Computer-Assisted Total Knee Arthroplasty
A study testing Programed cryotherapy and continuous passive motion and Unrogramed cryotherapy and continuous passive motion in people with Patients With Osteoarthritis Undergoing CAS-TKA, run by Chang Gung Memorial Hospital.
Trial summary
The hypothesis of this study was the patients, who received programed cryotherapy and CPM, had experienced less postoperative pain, joint swelling, and increased ROM following CAS-TKA. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Patients With Osteoarthritis Undergoing CAS-TKA
- What is being tested?
- Programed cryotherapy and continuous passive motion and Unrogramed cryotherapy and continuous passive motion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 Mar 2012to 5 Mar 2013
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary and unilateral computer-assisted total knee arthroplasty
Who cannot join
- (1) patients who underwent bilateral TKAs, unicompartmental TKA or revision TKA
- (2) patients who had to remove previous implants or history of high-tibial or distal femoral corrective osteotomy
- (3) patients who were unable to response to the questionnaires.
About this study
Official title: The Effects of Programmed Cryotherapy and Continuous Passive Motion in Patients After Computer-Assisted Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
The hypothesis of this study was the patients, who received programed cryotherapy and CPM, had experienced less postoperative pain, joint swelling, and increased ROM following CAS-TKA.
Read the detailed description
The International Association for the Study of Pain (IASP) has proposed the definition of pain as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Therefore, adequate pain management and control of localized swelling and stiffness after TKA has become a priority because it is essential for improving patient satisfaction, prevention of complications, and enhancing quality of life by faster recovery. Systemic and local analgesics are the most common strategies for postoperative pain management in TKR. However, patients might experience nausea, vomiting, constipation, or respiratory failure due to opioid-related side effects, subsequently refusing to mobilize and delaying the rehabilitation program).
In addition to pain control, cryotherapy and continuous passive motion (CPM) are commonly used for TKA patients as non-pharmacological methods to reduce the postoperative pain and swelling and to increase the amount of knee flexion. The application of cryotherapy after TKA has been described extensively in the literature and is part of standard care globally. However, its benefits and value remain controversial due to the disparity in practice, such as differences in clinical protocols and the type of cryotherapy application. Continuous passive motion is a motorized device, which passively moves the knee joint within a certain range of motion (ROM) to decrease analgesics requirements, reduce the incidence of deep vein thrombosis, and increase ROM. But the effects of CPM remain contentious in the literature. Although controversial, cryotherapy and CPM have been used extensively as part of the standard postoperative management protocol for TKA patients without knowing its cost-effectiveness. However, the value of combined therapy of cryotherapy and CPM remains uncertainty and unclear following CAS-TKA.
The hypothesis of this study was the patients, who received programed cryotherapy and CPM, had experienced less postoperative pain, joint swelling, and increased ROM following CAS-TKA.
- Being tested
- Programed cryotherapy and continuous passive motion, Unrogramed cryotherapy and continuous passive motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programed cryotherapy and continuous passive motionOther
The intervention group started to use a CPM machine and applied programed cryotherapy intermittently within one hour while returning to the ward on the day of surgery.
Unrogramed cryotherapy and continuous passive motionOther
A CPM machine and cryotherapy were not applied on the day of surgery while returning to the ward
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Programed cryotherapy and continuous passive motion |
| Control group | Placebo comparator | Not described Receives: Other: Unrogramed cryotherapy and continuous passive motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
Pain score. The scale is 0-10 where 0 is no pain and 10 is the worst pain
Measured: Postoperative day 1
Numeric Rating Scale (NRS)
Pain score. The scale is 0-10 where 0 is no pain and 10 is the worst pain
Measured: Postoperative day 4
Secondary outcomes (6)
The short-form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ include 11 words of sensory subscale 4 words of affective subscale. These words are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Measured: Postoperative day 1
The short-form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ include 11 words of sensory subscale 4 words of affective subscale. These words are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe.
Measured: Postoperative day 4
Thigh and calf circumference
The measurement of the thigh circumference was performed 15 cm proximal to the superior pole of the patella with a measurement tape, meanwhile 15 cm distal to the inferior pole of the patella for the calf circumference.
Measured: Postoperative day 1
Thigh and calf circumference
The measurement of the thigh circumference was performed 15 cm proximal to the superior pole of the patella with a measurement tape, meanwhile 15 cm distal to the inferior pole of the patella for the calf circumference.
Measured: Postoperative day 4
Range of motion of knee joints
A universal goniometer was used to measure extension and flexion arcs of the knee joints.
Measured: Postoperative day 1
Range of motion of knee joints
A universal goniometer was used to measure extension and flexion arcs of the knee joints.
Measured: Postoperative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start7 Mar 2012
- Primary completion5 Mar 2013
- Study completion5 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Osteoarthritis Undergoing CAS-TKAStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136431
- Sponsor's protocol ID
- 201102015B0
- Status last verified
- Feb 2012
- First submitted
- 20 Oct 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen MC, Lin CC, Ko JY, Kuo FC. The effects of immediate programmed cryotherapy and continuous passive motion in patients after computer-assisted total knee arthroplasty: a prospective, randomized controlled trial. J Orthop Surg Res. 2020 Sep 3;15(1):379. doi: 10.1186/s13018-020-01924-y.
PubMed 32883309
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Programmed Cryotherapy and Continuous Passive Motion in Patients After Computer-Assisted Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04136431
- Acronym / sponsor ID
- 201102015B0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 7 Mar 2012 (actual)
- Primary completion
- 5 Mar 2013 (actual)
- Study completion
- 5 Mar 2013 (actual)
- First posted
- 23 Oct 2019 (actual)
- 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.
The hypothesis of this study was the patients, who received programed cryotherapy and CPM, had experienced less postoperative pain, joint swelling, and increased ROM following CAS-TKA.
Detailed description
The International Association for the Study of Pain (IASP) has proposed the definition of pain as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Therefore, adequate pain management and control of localized swelling and stiffness after TKA has become a priority because it is essential for improving patient satisfaction, prevention of complications, and enhancing quality of life by faster recovery. Systemic and local analgesics are the most common strategies for postoperative pain management in TKR. However, patients might experience nausea, vomiting, constipation, or respiratory failure due to opioid-related side effects, subsequently refusing to mobilize and delaying the rehabilitation program).
In addition to pain control, cryotherapy and continuous passive motion (CPM) are commonly used for TKA patients as non-pharmacological methods to reduce the postoperative pain and swelling and to increase the amount of knee flexion. The application of cryotherapy after TKA has been described extensively in the literature and is part of standard care globally. However, its benefits and value remain controversial due to the disparity in practice, such as differences in clinical protocols and the type of cryotherapy application. Continuous passive motion is a motorized device, which passively moves the knee joint within a certain range of motion (ROM) to decrease analgesics requirements, reduce the incidence of deep vein thrombosis, and increase ROM. But the effects of CPM remain contentious in the literature. Although controversial, cryotherapy and CPM have been used extensively as part of the standard postoperative management protocol for TKA patients without knowing its cost-effectiveness. However, the value of combined therapy of cryotherapy and CPM remains uncertainty and unclear following CAS-TKA.
The hypothesis of this study was the patients, who received programed cryotherapy and CPM, had experienced less postoperative pain, joint swelling, and increased ROM following CAS-TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Programed cryotherapy and continuous passive motion |
| Control group | Placebo comparator | Other: Unrogramed cryotherapy and continuous passive motion |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary and unilateral computer-assisted total knee arthroplasty
Key exclusion criteria (3 listed)
- (1) patients who underwent bilateral TKAs, unicompartmental TKA or revision TKA
- (2) patients who had to remove previous implants or history of high-tibial or distal femoral corrective osteotomy
- (3) patients who were unable to response to the questionnaires.
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 |
|---|---|---|
| Programed cryotherapy and continuous passive motionThe intervention group started to use a CPM machine and applied programed cryotherapy intermittently within one hour while returning to the ward on the day of surgery. | Other | Intervention group |
| Unrogramed cryotherapy and continuous passive motionA CPM machine and cryotherapy were not applied on the day of surgery while returning to the ward | Other | Control group |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: Postoperative day 1
Pain score. The scale is 0-10 where 0 is no pain and 10 is the worst pain
Numeric Rating Scale (NRS)
Time frame: Postoperative day 4
Pain score. The scale is 0-10 where 0 is no pain and 10 is the worst pain
6 secondary outcomes
The short-form McGill Pain Questionnaire (SF-MPQ)
Time frame: Postoperative day 1
The short-form McGill Pain Questionnaire (SF-MPQ)
Time frame: Postoperative day 4
Thigh and calf circumference
Time frame: Postoperative day 1
Thigh and calf circumference
Time frame: Postoperative day 4
Range of motion of knee joints
Time frame: Postoperative day 1
Range of motion of knee joints
Time frame: Postoperative day 4
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 23 Oct 2019.
- Derived from this study: PubMed 32883309Chen MC, Lin CC, Ko JY, Kuo FC. The effects of immediate programmed cryotherapy and continuous passive motion in patients after computer-assisted total knee arthroplasty: a prospective, randomized controlled trial. J Orthop Surg Res. 2020 Sep 3;15(1):379. doi: 10.1186/s13018-020-01924-y.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Programed cryotherapy and continuous passive motion and Unrogramed cryotherapy and continuous passive motion in people with Patients With Osteoarthritis Undergoing CAS-TKA, run by Chang Gung Memorial Hospital.
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 1 inclusion and 3 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Numeric Rating Scale (NRS) (time frame: Postoperative day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04136431, which also lists 1 linked publication.
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 23 Oct 2019.