Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Cryotherapy Effect; Knee Arthropathy
• Interventions: Other: cryotherapy

• Registration Number: NCT06037824
• Lead Sponsor: Institut de Formation en Masso-Kinésithérapie Saint Michel

Brief Summary

In the postoperative period of a total knee arthroplasty, subjects present limitations of articular amplitudes, swelling, pain and functional limitations. Functional rehabilitation is unanimously recommended, including the use of cryotherapy. However, there is no consensus regarding the methods of application of cryotherapy. Thus the objective of the study is to compare 2 cryotherapy techniques associated with a classic rehabilitation on the improvement of mobility, swelling, pain and functional parameters. The 2 cryotherapies were a compressive cryotherapy and a so-called classic cryotherapy by cold pack.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-03-22
• Study Completion: 2023-06-30
• Study First Submitted: 2023-08-31
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Volunteers
• First-line Total Knee Arthroplasty on an indication of knee osteoarthritis diagnosed by radio-clinical examination
• Between D3 and D10 postoperatively
• Age < 90 years.

Exclusion Criteria

• Intolerance to cryotherapy or compression,
• Occurrence of complications secondary to surgery,
• Withdrawal of consent,
• Non-compliance with the rehabilitation protocol (content and dosage of sessions).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	cryotherapy	This group received classic rehabilitation\* + classic cryotherapy \*classic rehabilitation include passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.
Experimental Group	cryotherapy	This group received classic rehabilitation\* + compressive cryotherapy \* classic rehabilitation include passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.

Primary Outcome Measures

Name	Time	Method
knee range of motion	Day 1-Day 8-Day 15-Day 21	Measurement of passive flexion and active extension with a goniometer

Secondary Outcome Measures

Name	Time	Method
Knee perimetry	Day 1-Day 8-Day 15-Day 21	A perimetry measurement with a tape measure was carried out
Swelling	Day 1-Day 8-Day 15-Day 21	Swelling has been measured with the "fluctuation test": the examiner placed his thumb and fingers on either side of the lower part of the patella, while with his other hand, he positioned himself at the level of the upper part of the sub quadriceps fornix. The fingers of the cranial hand exerted light pressure to mobilize the fluid from the quadriceps fornix. The test was positive if the fingers or thumb were pushed back by the effusion.
Pain at rest and on exertion	Day 1-Day 8-Day 15-Day 21	Pain assessment was based on the use of the Verbal Numerical Scale (NVS). The examiner asked the subject to quantify their pain on a scale ranging from 0 to 10 (0 corresponding to no pain and 10 to unbearable pain). Pain assessment was carried out at rest and during exercise during the rehabilitation sessions.
6min walking test	Day 1-Day 8-Day 15-Day 21	The instructions were to cover the greatest distance possible for 6 minutes
KOOS score (Knee injury and Osteoarthritis Outcome Score)	Day 1-Day 8-Day 15-Day 21	Only the 17 items of the questionnaire dealing with "quality of life" were considered in this study. Subjects had to complete the questions

Trial Locations

Locations (1)

Hôpital de la Porte Verte; 🇫🇷 Versailles, Yvelines, France