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CompletedNCT04795011Updated May 17, 2021

Outcomes for Manual Lymphatic Drainage

An interventional study of exercise and manual lymphatic drainage and exercise in Total Knee Arthroplasty, sponsored by Selcuk University. Completed at 1 site in Turkey. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-05-17.

Sponsored by Selcuk University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
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Study 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. 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.

02

Conditions studied

  • Total Knee Arthroplasty

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Keywords

  • Total Knee Arthroplasty
  • Manual Lymph Drainage
  • Kinesiophobia
  • Pain
  • Quality of Life
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In context

Kinesiophobia

243 studies on the registry are indexed under Kinesiophobia; 89 are open to participants now.

This study's enrollment of 21 is below the median of 51 across 145 interventional studies indexed under Kinesiophobia.

Browse Kinesiophobia studies →

Lead sponsor

Selcuk University is the lead sponsor of 248 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    control group

    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.

    Other: exercise

  • Experimental
    manual lymphatic drainage group

    manual lymphatic drainage (MLD) will be applied to the second group (MLD group) in addition to the standard rehabilitation protocol

    Other: exercise and manual lymphatic drainage

Interventions

  • Otherexercise and manual lymphatic drainage

    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.

  • Otherexercise

    range of motion and walking exercise

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 minute

  2. 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.

    Time frame: 3 minute

  3. 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

    Time frame: 10 minute

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Study locations

1 site
  • Selcuk University
    Konya, Selcuklu 42130, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04795011
Lead sponsor
Selcuk University
Responsible party
Emine Cihan (PhD Student, Selcuk University) — Principal investigator
First posted
Mar 12, 2021
Start date
Mar 9, 2021
Primary completion
Mar 9, 2021
Completion
Apr 22, 2021
Last update
May 17, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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