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Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty

Influence of Compressive Cryotherapy Compared to Conventional Cryotherapy on Articular, Trophic and Functional Recovery After Total Knee Arthroplasty: a Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06037824
Enrollment
40
Registered
2023-09-14
Start date
2019-01-01
Completion date
2023-06-30
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryotherapy Effect, Knee Arthropathy

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.

Interventions

OTHERcryotherapy

cryotherapy was added to rehabilitation\*. One group received compressive cryotherapy and the other conventional cold pack cryotherapy. \* rehabilitation includes (=classic rehabilitation) 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.

Sponsors

Institut de Formation en Masso-Kinésithérapie Saint Michel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
knee range of motionDay 1-Day 8-Day 15-Day 21Measurement of passive flexion and active extension with a goniometer

Secondary

MeasureTime frameDescription
Knee perimetryDay 1-Day 8-Day 15-Day 21A perimetry measurement with a tape measure was carried out
SwellingDay 1-Day 8-Day 15-Day 21Swelling 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 exertionDay 1-Day 8-Day 15-Day 21Pain 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 testDay 1-Day 8-Day 15-Day 21The 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 21Only the 17 items of the questionnaire dealing with quality of life were considered in this study. Subjects had to complete the questions

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026