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

Patients With Osteoarthritis Undergoing CAS-TKA Clinical Trial

Official title:

The Effects of Programmed Cryotherapy and Continuous Passive Motion in Patients After Computer-Assisted Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04136431
• Other study ID #: 201102015B0
• Status: Completed
• Phase: N/A
• Start date: March 7, 2012
• Est. completion date: March 5, 2013

Study information

• Verified date: February 2012
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 5, 2013
• Est. primary completion date: March 5, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Patients With Osteoarthritis Undergoing CAS-TKA

Intervention

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.
• Unrogramed cryotherapy and continuous passive motion
A CPM machine and cryotherapy were not applied on the day of surgery while returning to the ward

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Range of motion of knee joints	A universal goniometer was used to measure extension and flexion arcs of the knee joints.	Postoperative day 1
Secondary	Range of motion of knee joints	A universal goniometer was used to measure extension and flexion arcs of the knee joints.	Postoperative day 4