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NCT Number: NCT04136431

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

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Programed cryotherapy and continuous passive motion

Other

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

Other

A CPM machine and cryotherapy were not applied on the day of surgery while returning to the ward

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. The short-form McGill Pain Questionnaire (SF-MPQ)

    Time frame: Postoperative day 1

    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.

  2. The short-form McGill Pain Questionnaire (SF-MPQ)

    Time frame: Postoperative day 4

    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.

  3. Thigh and calf circumference

    Time frame: Postoperative day 1

    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.

  4. Thigh and calf circumference

    Time frame: Postoperative day 4

    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.

  5. Range of motion of knee joints

    Time frame: Postoperative day 1

    A universal goniometer was used to measure extension and flexion arcs of the knee joints.

  6. Range of motion of knee joints

    Time frame: Postoperative day 4

    A universal goniometer was used to measure extension and flexion arcs of the knee joints.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 23, 2019
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.