Total Knee ArthroplastyNCT04795011
Outcomes for Manual Lymphatic Drainage
A study testing exercise and manual lymphatic drainage and exercise in people with Total Knee Arthroplasty, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
In this context, the purpose of our study is to investigate the effect of MLD(manual lymphatic drainage) technique applied in addition to the standard postoperative rehabilitation protocol on pain, kinesophobia and quality of life in early periods in patients undergoing primary TKA(total knee arthroplasty) surgery. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- exercise and manual lymphatic drainage and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2021to 22 Apr 2021
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 40-85
- were diagnosed with stage IV gonarthrosis
- planned primary total knee arthroplasty (TKA)
- were evaluated before the operation
- whose informed consents
Who cannot join
- Patients with postoperative pulmonary thromboembolism or treatment-related complications in the past,
- patients with osteoarthritis secondary bone or joint infections,
- patients with morbid obesity,
- patients with presence of hematological disease and malignancy,
- major cardiac pathology,
- venous insufficiency,
- patients taking high-dose anticoagulants
- patients with communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Manual Lymph Drainage to Standard Postoperative Rehabilitation Protocol in Primary Total Knee Arthroplasty Patients Improves Postoperative Kinesiophobia, Pain and Quality of Life: Preliminary Clinical Results
In this context, the purpose of our study is to investigate the effect of MLD(manual lymphatic drainage) technique applied in addition to the standard postoperative rehabilitation protocol on pain, kinesophobia and quality of life in early periods in patients undergoing primary TKA(total knee arthroplasty) surgery. Our hypothesis is that the addition of the MLD technique to the standard postoperative rehabilitation protocol will improve the early clinical outcomes of patients undergoing primary TKA. In the future perspective, we anticipate that the data obtained as a result of our study will make a significant contribution to the relevant literature on the early and mid-term ameliorative effects of MLD on postoperative pain, kinesiophobia and quality of life, which will be possibly applied in addition to standard postoperative rehabilitation protocols in patients undergoing primary TKA.
- Conditions
- Total Knee Arthroplasty
- Being tested
- exercise and manual lymphatic drainage, exercise
- Keywords
- Total Knee Arthroplasty, Manual Lymph Drainage, Kinesiophobia, Pain, Quality of Life
- Medical subject headings
- Kinesiophobia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and manual lymphatic drainageOther
MLD will be launched with simple neck application. Hemodynamics of blood and lower extremity motoring will be increased by combining active bilateral shoulder-twisting with breathing after effleurage. Cervical lymph nodes will be stimulated. Back-up treatment will be applied for the abdominal area. Suction power in the ductus thoracicus will be increased with breathing exercises. Ventral drainage will be applied to the lower extremity in accordance with the surgery of the patient.
exerciseOther
range of motion and walking exercise
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Standard rehabilitation protocol will be administered to the control group. In the standard rehabilitation protocol for the first three days after surgery, 3 sets of exercises will be applied as 10 repetitions. The treatment will be initiated for the patients with tolerable coughing and deep breathing exercises. Active dorsi-plantar flexion of the ankle, isometric contraction for the quadriceps, hamstrings and gluteus maximus, for the knee in the supine position on the bed; active heel shift exercises, straight leg raising and standing knee and hip flexion, active hamstring curling, and self-hamstring stretching will be performed. After the exercise, the morning treatment protocol will be completed with a walker at a tolerable distance. The patient will be given assignment in the form of walking and repetition of morning exercises at a tolerable level at least twice during the day. Receives: Other: exercise |
| manual lymphatic drainage group | Experimental | manual lymphatic drainage (MLD) will be applied to the second group (MLD group) in addition to the standard rehabilitation protocol Receives: Other: exercise and manual lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Kinesiophobia Scale
The scale consists of 17 statements. Each statement contains the answers to strongly disagree, disagree, agree, strongly agree. While scoring according to the 4-point Likert scoring system, items 4, 8, 12, and 16 are subjected to reverse scoring. Scoring ranges from 17-68. As the score increases, the painful patient is considered to have an increase in kinesiophobia
Measured: 10 minute
Visual Analog Scale (VAS)
It will be explained to the patients that "0" means "no pain" and "10" means "unbearable pain" on a 10 cm horizontal line. The patients will be asked to mark the pain of activity on the line with the help of a pencil. The values will be calculated with the help of a ruler in centimeters.
Measured: 3 minute
Nottingham Health Profile (NHP)
The questionnaire consists of 38 questions consisting of 6 main topics, namely, energy level, pain, physical mobility, sleep, social isolation, and emotional reactions. The total score for each subtitle is 100, and the total score is obtained by adding the scores obtained from these subtitles. A low score indicates a high quality of life
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start9 Mar 2021
- Primary completion9 Mar 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795011
- Sponsor's protocol ID
- SelcukUEC1
- Status last verified
- May 2021
- First submitted
- 9 Mar 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Manual Lymph Drainage to Standard Postoperative Rehabilitation Protocol in Primary Total Knee Arthroplasty Patients Improves Postoperative Kinesiophobia, Pain and Quality of Life: Preliminary Clinical Results
- ClinicalTrials.gov ID
- NCT04795011
- Acronym / sponsor ID
- SelcukUEC1
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Manual Lymph Drainage, Kinesiophobia, Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 12 Mar 2021 (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 this context, the purpose of our study is to investigate the effect of MLD(manual lymphatic drainage) technique applied in addition to the standard postoperative rehabilitation protocol on pain, kinesophobia and quality of life in early periods in patients undergoing primary TKA(total knee arthroplasty) surgery. Our hypothesis is that the addition of the MLD technique to the standard postoperative rehabilitation protocol will improve the early clinical outcomes of patients undergoing primary TKA. In the future perspective, we anticipate that the data obtained as a result of our study will make a significant contribution to the relevant literature on the early and mid-term ameliorative effects of MLD on postoperative pain, kinesiophobia and quality of life, which will be possibly applied in addition to standard postoperative rehabilitation protocols in patients undergoing primary TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: exerciseStandard rehabilitation protocol will be administered to the control group. In the standard rehabilitation protocol for the first three days after surgery, 3 sets of exercises will be applied as 10 repetitions. The treatment will be initiated for the patients with tolerable coughing and deep breathing exercises. Active dorsi-plantar flexion of the ankle, isometric contraction for the quadriceps, hamstrings and gluteus maximus, for the knee in the supine position on the bed; active heel shift exercises, straight leg raising and standing knee and hip flexion, active hamstring curling, and self-hamstring stretching will be performed. After the exercise, the morning treatment protocol will be completed with a walker at a tolerable distance. The patient will be given assignment in the form of walking and repetition of morning exercises at a tolerable level at least twice during the day. |
| manual lymphatic drainage group | Experimental | Other: exercise and manual lymphatic drainagemanual lymphatic drainage (MLD) will be applied to the second group (MLD group) in addition to the standard rehabilitation protocol |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between the ages of 40-85
- were diagnosed with stage IV gonarthrosis
- planned primary total knee arthroplasty (TKA)
- were evaluated before the operation
- whose informed consents
Key exclusion criteria (8 listed)
- Patients with postoperative pulmonary thromboembolism or treatment-related complications in the past,
- patients with osteoarthritis secondary bone or joint infections,
- patients with morbid obesity,
- patients with presence of hematological disease and malignancy,
- major cardiac pathology,
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 |
|---|---|---|
| exercise and manual lymphatic drainageMLD will be launched with simple neck application. Hemodynamics of blood and lower extremity motoring will be increased by combining active bilateral shoulder-twisting with breathing after effleurage. Cervical lymph nodes will be stimulated. Back-up treatment will be applied for the abdominal area. Suction power in the ductus thoracicus will be increased with breathing exercises. Ventral drainage will be applied to the lower extremity in accordance with the surgery of the patient. | Other | manual lymphatic drainage group |
| exerciserange of motion and walking exercise | Other | control group |
Primary outcome
Tampa Kinesiophobia Scale
Time frame: 10 minute
The scale consists of 17 statements. Each statement contains the answers to strongly disagree, disagree, agree, strongly agree. While scoring according to the 4-point Likert scoring system, items 4, 8, 12, and 16 are subjected to reverse scoring. Scoring ranges from 17-68. As the score increases, the painful patient is considered to have an increase in kinesiophobia
Visual Analog Scale (VAS)
Time frame: 3 minute
It will be explained to the patients that "0" means "no pain" and "10" means "unbearable pain" on a 10 cm horizontal line. The patients will be asked to mark the pain of activity on the line with the help of a pencil. The values will be calculated with the help of a ruler in centimeters.
Nottingham Health Profile (NHP)
Time frame: 10 minute
The questionnaire consists of 38 questions consisting of 6 main topics, namely, energy level, pain, physical mobility, sleep, social isolation, and emotional reactions. The total score for each subtitle is 100, and the total score is obtained by adding the scores obtained from these subtitles. A low score indicates a high quality of life
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 17 May 2021.
- 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.
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 exercise and manual lymphatic drainage and exercise in people with Total Knee Arthroplasty, run by Selcuk University at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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 17 May 2021. 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 Turkey (Türkiye). 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?
Tampa Kinesiophobia Scale (time frame: 10 minute). 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?
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 17 May 2021.