Knee ArthropathyNCT06037824
Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty
A study testing cryotherapy in people with Knee Arthropathy and Cryotherapy Effect, run by Institut de Formation en Masso-Kinésithérapie Saint Michel at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Knee Arthropathy, Cryotherapy Effect
- What is being tested?
- cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Compressive Cryotherapy Compared to Conventional Cryotherapy on Articular, Trophic and Functional Recovery After Total Knee Arthroplasty: a Randomized Controlled Study
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.
- Conditions
- Knee Arthropathy, Cryotherapy Effect
- Being tested
- cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Other: cryotherapy |
| Control Group | Active comparator | 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. Receives: Other: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee range of motion
Measurement of passive flexion and active extension with a goniometer
Measured: Day 1-Day 8-Day 15-Day 21
Secondary outcomes (5)
Knee perimetry
A perimetry measurement with a tape measure was carried out
Measured: Day 1-Day 8-Day 15-Day 21
Swelling
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.
Measured: Day 1-Day 8-Day 15-Day 21
Pain at rest and on exertion
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.
Measured: Day 1-Day 8-Day 15-Day 21
6min walking test
The instructions were to cover the greatest distance possible for 6 minutes
Measured: Day 1-Day 8-Day 15-Day 21
KOOS score (Knee injury and Osteoarthritis Outcome Score)
Only the 17 items of the questionnaire dealing with "quality of life" were considered in this study. Subjects had to complete the questions
Measured: Day 1-Day 8-Day 15-Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Jan 2019
- Primary completion22 Mar 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Formation en Masso-Kinésithérapie Saint Michel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037824
- Sponsor's protocol ID
- IFMK01
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Quesnot A, Mouchel S, Salah SB, Baranes I, Martinez L, Billuart F. Randomized controlled trial of compressive cryotherapy versus standard cryotherapy after total knee arthroplasty: pain, swelling, range of motion and functional recovery. BMC Musculoskelet Disord. 2024 Feb 28;25(1):182. doi: 10.1186/s12891-024-07310-7.
PubMed 38419032
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Compressive Cryotherapy Compared to Conventional Cryotherapy on Articular, Trophic and Functional Recovery After Total Knee Arthroplasty: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06037824
- Acronym / sponsor ID
- IFMK01
- Conditions
- Knee Arthropathy, Cryotherapy Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut de Formation en Masso-Kinésithérapie Saint MichelUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: cryotherapyThis 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. |
| Control Group | Active comparator | Other: cryotherapyThis 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapycryotherapy 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. | Other | Control Group, Experimental Group |
Primary outcome
knee range of motion
Time frame: Day 1-Day 8-Day 15-Day 21
Measurement of passive flexion and active extension with a goniometer
5 secondary outcomes
Knee perimetry
Time frame: Day 1-Day 8-Day 15-Day 21
Swelling
Time frame: Day 1-Day 8-Day 15-Day 21
Pain at rest and on exertion
Time frame: Day 1-Day 8-Day 15-Day 21
6min walking test
Time frame: Day 1-Day 8-Day 15-Day 21
KOOS score (Knee injury and Osteoarthritis Outcome Score)
Time frame: Day 1-Day 8-Day 15-Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Derived from this study: PubMed 38419032Quesnot A, Mouchel S, Salah SB, Baranes I, Martinez L, Billuart F. Randomized controlled trial of compressive cryotherapy versus standard cryotherapy after total knee arthroplasty: pain, swelling, range of motion and functional recovery. BMC Musculoskelet Disord. 2024 Feb 28;25(1):182. doi: 10.1186/s12891-024-07310-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy in people with Knee Arthropathy and Cryotherapy Effect, run by Institut de Formation en Masso-Kinésithérapie Saint Michel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee range of motion (time frame: Day 1-Day 8-Day 15-Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06037824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.