Outcomes for Manual Lymphatic Drainage

NCT04795011 | Completed

• 1 other identifier: SelcukUEC1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty; Manual Lymph Drainage; Kinesiophobia; Pain; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  10 minute

Study Arms (2)

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.

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

Other: exercise and manual lymphatic drainage

Interventions

exercise and manual lymphatic drainage OTHER

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.

manual lymphatic drainage group

exercise OTHER

range of motion and walking exercise

control group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia; Pain

Interventions

Exercise; Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: March 9, 2021
• Primary Completion: March 9, 2021
• Study Completion: April 22, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)