An interventional study of Functional Massage According to Olaf Evjenth and Passive Manual Knee Mobilization in Recovery After Total Knee Arthroplasty, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Not applicable, Interventional, and Treatment
This study compares two physiotherapy treatments to help adults recover movement after total knee replacement: functional massage and passive knee mobilization. The main question is whether functional massage helps patients bend their knee further by the time they leave the acute hospital ward.
Forty adults undergoing replacement of one knee or both knees during the same operation will be randomly assigned to one of two groups. One group will receive functional massage according to Olaf Evjenth, and the other will receive passive manual knee mobilization. Both groups will also receive the same standard rehabilitation and pain management.
The assigned treatment will be provided once daily, starting on the first day after surgery and continuing until hospital discharge. Each treatment will last 10 minutes per operated knee.
A clinician who does not know which treatment the patient received will assess knee movement. The study will also evaluate pain, functional mobility, patient-reported outcomes, and length of hospital stay.
This is a single-center, randomized, parallel-group superiority trial comparing two manual physiotherapy approaches during the acute phase after total knee arthroplasty.
An independent researcher will generate the random allocation sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes, opened after eligibility has been confirmed and written informed consent obtained.
The primary analysis will follow the intention-to-treat principle. Passive knee flexion at discharge will be compared between groups using analysis of covariance, with baseline knee flexion as a covariate. For participants undergoing simultaneous bilateral total knee arthroplasty, one knee will be randomly selected for the primary analysis. A sensitivity analysis using mixed-effects models will account for paired knee measurements. Exploratory analyses will compare treatment effects in participants undergoing unilateral and simultaneous bilateral surgery.
Discharge timing depends on the availability of a bed in an inpatient rehabilitation facility rather than on predefined functional recovery thresholds.
Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 95 studies on the registry; 18 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive functional massage according to Olaf Evjenth once daily from postoperative day 1 until hospital discharge, together with standardized pain management, assisted walking, and strengthening exercises.
Other: Functional Massage According to Olaf Evjenth
Participants receive passive manual knee mobilization once daily from postoperative day 1 until hospital discharge, together with standardized pain management, assisted walking, and strengthening exercises.
Other: Passive Manual Knee Mobilization
Functional massage of the anterior thigh with passive or active-assisted knee flexion, performed with the patient seated. Treatment lasts 10 minutes per operated knee, once daily, from postoperative day 1 until hospital discharge.
Passive manual knee flexion and extension in the sagittal plane, performed with the patient supine. Treatment lasts 10 minutes per operated knee, once daily, from postoperative day 1 until hospital discharge.
Knee Flexion
Passive knee flexion is measured in degrees using a standard goniometer, with the assessor moving the knee. Measurements are collected daily from postoperative day 1 until hospital discharge
Time frame: Daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Pain Intensity
Pain intensity is assessed using a Visual Analogue Scale and recorded on a 0-10 scale, with higher scores indicating greater pain. Measurements are collected at baseline and daily after each rehabilitation session from postoperative day 1 until hospital discharge, including the discharge day. Each daily measurement is recorded separately.
Time frame: At baseline and daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Timed Up and Go Test
Time in seconds required to stand up, walk 3 meters, turn, walk back, and sit down. The test is performed daily after the rehabilitation session from postoperative day 1 until hospital discharge, including the discharge day. Shorter times indicate better functional mobility. Each daily measurement is recorded separately.
Time frame: Daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Length of Hospital Stay
Number of days from admission to the acute hospital ward until discharge
Time frame: At discharge from the acute hospital ward, typically 5-7 days after surgery.
Oxford Knee Score on Postoperative Day 1
The Oxford Knee Score is a 12-item questionnaire assessing knee pain and difficulties with everyday activities over the previous four weeks. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating less pain and better function.
Time frame: Postoperative day 1.
Oxford Knee Score at Hospital Discharge
The Oxford Knee Score is a 12-item questionnaire assessing knee pain and difficulties with everyday activities over the previous four weeks. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating less pain and better function.
Time frame: At discharge from the acute hospital ward, typically 5-7 days after surgery.
Oxford Knee Score at 1 Month
The Oxford Knee Score is a 12-item questionnaire assessing knee pain and difficulties with everyday activities over the previous four weeks. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating less pain and better function. The questionnaire is administered by telephone interview.
Time frame: 1 month after surgery
Oxford Knee Score at 3 Months
The Oxford Knee Score is a 12-item questionnaire assessing knee pain and difficulties with everyday activities over the previous four weeks. Each item is scored from 0 to 4. The total score ranges from 0 to 48, with higher scores indicating less pain and better function. The questionnaire is administered by telephone interview.
Time frame: 3 months after surgery
EQ-5D-5L Utility Index at day 1
The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses are converted into a health utility index using a country-specific value set. Higher index values indicate better health-related quality of life
Time frame: Postoperative day 1.
EQ-5D-5L Utility Index at discharge
The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses are converted into a health utility index using a country-specific value set. Higher index values indicate better health-related quality of life.
Time frame: At discharge from the acute hospital ward, typically 5-7 days after surgery.
EQ-5D-5L Utility Index at 1 Month
The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses are converted into a health utility index using a country-specific value set. Higher index values indicate better health-related quality of life. The questionnaire is administered by telephone
Time frame: 1 month after surgery
EQ-5D-5L Utility Index at 3 Months
The EQ-5D-5L assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses are converted into a health utility index using a country-specific value set. Higher index values indicate better health-related quality of life. The questionnaire is administered by telephone
Time frame: 3 months after surgery
EQ VAS on Postoperative Day 1
Participants rate their overall health today on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). Higher scores indicate better self-rated health.
Time frame: On postoperative day 1.
EQ VAS at Hospital Discharge
Participants rate their overall health today on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). Higher scores indicate better self-rated health.
Time frame: At hospital discharge, typically 5-7 days after surgery.
EQ VAS at 1 Month
Participants rate their overall health today on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). Higher scores indicate better self-rated health.The assessment is administered by telephone
Time frame: At 1 month after surgery.
EQ VAS at 3 Months
Participants rate their overall health today on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine). Higher scores indicate better self-rated health. The assessment is administered by telephone
Time frame: At 3 months after surgery.
Walking Distance During Assisted Ambulation
Distance walked during assisted ambulation, measured in meters and recorded daily after the rehabilitation session.
Time frame: Daily from postoperative day 1 until hospital discharge, typically 5-7 days after surgery.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2028, 18 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Universitaria Integrata Verona