Knee Pain SwellingNCT04580069
Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis.
A study testing Lymphatic drainage in people with Knee Pain Swelling, run by Presidio Ospedaliero di Asiago at 2 sites in Italy.
Trial summary
The investigators studied the influence of two aproved rehabilitative treatments, connective tissue techniques and lymphatic drainage, on acute inflammation markers. Furthermore, the role of mediterranean diet on the same values was investigated in the first postoperative period Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Pain Swelling
- What is being tested?
- Lymphatic drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesItaly
- Study dates
- 30 Sep 2019to 30 Sep 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50<age<80 years
- Bicompartmental knee arthroplasty
- Weight bearing 7 days after surgery
- Transfusions according to hospital protocol
- Alteration of the indices at T0
- Standard analgesic therapy
Who cannot join
- Joint replacements from other Units
- Inflammatory arthropathies
- Autoimmune / rheumatic diseases
- Obesity
- Diabetes mellitus
- Infections
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
presidio ospedaliero di Asiago
Asiago, Vicenza, 36012
ULSS 7 Pedemontana
Asiago, Vicenza, 36012
About this study
Official title: Effectiveness of Two Rehabilitative Treatments in the Modulation of Inflammation During the Acute Phase in Patients With Knee Prosthesis and Assessment of the Role of the Diet in Determining Post-surgical Inflammation.
The investigators studied the influence of two aproved rehabilitative treatments, connective tissue techniques and lymphatic drainage, on acute inflammation markers. Furthermore, the role of mediterranean diet on the same values was investigated in the first postoperative period
Read the detailed description
The main objective of this study is to demonstrate the effectiveness of lymphatic drainage and connective tissue techniques in modulating systemic inflammation. Another objective is to evaluate the existence, at baseline, of a correlation between the inflammation indices and the level of adherence to the Mediterranean diet.
Methods. 34 patients were recruited, and divided into three groups. The control group followed the normal rehabilitation protocol. The other two groups were subjected, in addition to the standard treatment, to manual lymphatic drainage treatment or connective tissue techniques. The outcomes (PCR, ESR, Oedema) were recorded in three stages: upon entering the hospital, 1 week after entry and at follow-up 21 days after surgery.
- Conditions
- Knee Pain Swelling
- Being tested
- Lymphatic drainage
- Keywords
- total Knee Arthroplasty (TKA), C-reactive protein (CRP), erythrosedimentation rate (ESR), Over Knee Oedema (EDO), Under Knee Oedema (EDU), MEDIET Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic drainageProcedure or surgery
Also called Connective tissue massage
The interventions follow the validated techniques normally used in international rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Lymphatic drainage | Experimental | Patients subjected to manual lymphatic drainage Receives: Procedure: Lymphatic drainage |
| Connective tissue | Experimental | Patients subjected to connective tissue massage Receives: Procedure: Lymphatic drainage |
| control group | Active comparator | Subjects hat followed standard rehabilitative treatment Receives: Procedure: Lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP variation
blood test
Measured: 21 days
ESR variation
blood test
Measured: 21 days
lower limb oedema
leg circumference
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start30 Sep 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
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 Pain SwellingStudies 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
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Presidio Ospedaliero di Asiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Rigoni, Presidio Ospedaliero di Asiago
- Investigators
- Sergio Rigoni, Study director, Presidio Ospedaliero di Asiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580069
- Sponsor's protocol ID
- POAsiago
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rigoni S, Tagliaro L, Bau D, Scapin M. Effectiveness of two rehabilitation treatments in the modulation of inflammation during the acute phase in patients with knee prostheses and assessment of the role of the diet in determining post-surgical inflammation. J Orthop. 2021 May 15;25:237-243. doi: 10.1016/j.jor.2021.05.016. eCollection 2021 May-Jun.
PubMed 34099953
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Rehabilitative Treatments in the Modulation of Inflammation During the Acute Phase in Patients With Knee Prosthesis and Assessment of the Role of the Diet in Determining Post-surgical Inflammation.
- ClinicalTrials.gov ID
- NCT04580069
- Acronym / sponsor ID
- POAsiago
- Conditions
- Knee Pain Swelling
- Keywords
- total Knee Arthroplasty (TKA), C-reactive protein (CRP), erythrosedimentation rate (ESR), Over Knee Oedema (EDO), Under Knee Oedema (EDU), MEDIET Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Presidio Ospedaliero di AsiagoUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 8 Oct 2020 (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.
The investigators studied the influence of two aproved rehabilitative treatments, connective tissue techniques and lymphatic drainage, on acute inflammation markers. Furthermore, the role of mediterranean diet on the same values was investigated in the first postoperative period
Detailed description
The main objective of this study is to demonstrate the effectiveness of lymphatic drainage and connective tissue techniques in modulating systemic inflammation. Another objective is to evaluate the existence, at baseline, of a correlation between the inflammation indices and the level of adherence to the Mediterranean diet.
Methods. 34 patients were recruited, and divided into three groups. The control group followed the normal rehabilitation protocol. The other two groups were subjected, in addition to the standard treatment, to manual lymphatic drainage treatment or connective tissue techniques. The outcomes (PCR, ESR, Oedema) were recorded in three stages: upon entering the hospital, 1 week after entry and at follow-up 21 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Lymphatic drainage | Experimental | Procedure: Lymphatic drainagePatients subjected to manual lymphatic drainage |
| Connective tissue | Experimental | Procedure: Lymphatic drainagePatients subjected to connective tissue massage |
| control group | Active comparator | Procedure: Lymphatic drainageSubjects hat followed standard rehabilitative treatment |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50<age<80 years
- Bicompartmental knee arthroplasty
- Weight bearing 7 days after surgery
- Transfusions according to hospital protocol
- Alteration of the indices at T0
Key exclusion criteria (6 listed)
- Joint replacements from other Units
- Inflammatory arthropathies
- Autoimmune / rheumatic diseases
- Obesity
- Diabetes mellitus
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 |
|---|---|---|
| Lymphatic drainageAlso: Connective tissue massageThe interventions follow the validated techniques normally used in international rehabilitation | Procedure or surgery | Connective tissue, Lymphatic drainage, control group |
Primary outcome
CRP variation
Time frame: 21 days
blood test
ESR variation
Time frame: 21 days
blood test
lower limb oedema
Time frame: 21 days
leg circumference
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 8 Oct 2020.
- Derived from this study: PubMed 34099953Rigoni S, Tagliaro L, Bau D, Scapin M. Effectiveness of two rehabilitation treatments in the modulation of inflammation during the acute phase in patients with knee prostheses and assessment of the role of the diet in determining post-surgical inflammation. J Orthop. 2021 May 15;25:237-243. doi: 10.1016/j.jor.2021.05.016. eCollection 2021 May-Jun.
- Individual participant dataSharing planned: No
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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.
Sergio Rigoni study director
Presidio Ospedaliero di Asiago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphatic drainage in people with Knee Pain Swelling, run by Presidio Ospedaliero di Asiago at 2 sites in Italy.
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 6 inclusion and 6 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
CRP variation (time frame: 21 days). The study lists 3 primary outcomes in all. 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 NCT04580069, 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 8 Oct 2020.