Effects of Programmed Cryotherapy and Continuous Passive Motion After Computer-Assisted Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Patients With Osteoarthritis Undergoing CAS-TKA
• Intervention / Treatment: Other: Programed cryotherapy and continuous passive motion; Other: Unrogramed cryotherapy and continuous passive motion

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• primary and unilateral computer-assisted total knee arthroplasty

Exclusion Criteria:

• (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Other: Programed cryotherapy and continuous passive motion; 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.
Placebo Comparator: Control group	Other: Unrogramed cryotherapy and continuous passive motion; A CPM machine and cryotherapy were not applied on the day of surgery while returning to the ward

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS)	Pain score. The scale is 0-10 where 0 is no pain and 10 is the worst pain	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	Postoperative day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Postoperative day 4
Range of motion of knee joints	A universal goniometer was used to measure extension and flexion arcs of the knee joints.	Postoperative day 1
Range of motion of knee joints	A universal goniometer was used to measure extension and flexion arcs of the knee joints.	Postoperative day 4

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2012
• Primary Completion (Actual): March 5, 2013
• Study Completion (Actual): March 5, 2013

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 201102015B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No