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Influence of Manual Lymph Drainage During Hospitalization on Swelling, Function and Pain in Patients After Total Knee Replacement

This study has been terminated.
(a cardinal member of The research team withdrawn from study, the study has beem terminated.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01657149
First Posted: August 6, 2012
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rabin Medical Center
  Purpose
To investigate the effects of lymphatic drainage massage performed immediately after total knee replacement in relation to reduction of limb circumference, pain reduction and functional improvement.

Condition Intervention
Total Knee Replacement Procedure: Lymphatic massage and individual physiotherapy Procedure: individual physiotherapy only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Manual Lymph Drainage During Hospitalization on Swelling, Function and Pain in Patients After Total Knee Replacement - Randomized Control Trial.

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Circumferential measurement of limb volume [ Time Frame: The circumferential measurements will be assesed pre operative and post operative on daily basis for 5 days post op ]

Secondary Outcome Measures:
  • Visual Analogue Scale (VAS) Inclinometer [ Time Frame: VAS & INCLINOMETER will be assessed on a daily basis for 5 days post op ]
  • Daily functional capacity Assessment [ Time Frame: Daily functional capacity Assessment after 6 days post op. All Outcomes will be reassessed after 6 weeks post op ]

Enrollment: 20
Study Start Date: December 2015
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Research Group
receive lymphatic massage and individual physiotherapy
Procedure: Lymphatic massage and individual physiotherapy
lymphatic massage and individual physiotherapy
Active Comparator: Control group
receive individual physiotherapy only
Procedure: individual physiotherapy only
individual physiotherapy only

Detailed Description:

In the past few decades there has been a rise in the number of knee replacements performed due to degenerative arthritis. In general over the years the number of operations has risen while the age of the patients has gone down. The aim of these operations is to improve quality of life, alleviate pain and improve function.

Post operative complications can delay recovery and rehabilitation, lengthen hospitalization duration and in extreme cases lead to failure of the operation. These complications include infection, deep vein thrombosis, swelling and edema, pain, impairment of range of motion, muscle weakness and functional disability.

Reduction of post operative edema may help to speed up recovery after total knee replacement.

Recently an effective treatment has been found for lymphatic edema that appears after oncological operations that include removal of lymph nodes or due to blood vessel disorders. This treatment is administered by a physiotherapist and includes lymphatic drainage massage, compression bandaging and exercises.

This trial will examine the effect of lymphatic massage treatment on orthopedic patients to ascertain if the use of this technique can shorten the duration and improve the quality of the post operative rehabilitation and prevent other post operative complications. At the present time not enough research has been done in this field and it is necessary to continue to investigate the efficiency of the lymphatic treatment in acute orthopedic patients.

Aims To investigate the effects of lymphatic drainage massage performed immediately after total knee replacement in relation to reduction of limb circumference, pain reduction and functional improvement.

Methods This blind randomized trial will take place in the Sharon hospital in Petach Tikvah with the cooperation of the orthopedic surgeons. The patients will be randomized into two groups- each containing 15 patients. The research group will receive lymphatic massage and individual physiotherapy while the control group will receive individual physiotherapy only.

Methods In order to assess the effects of the treatment the primary measurement will be circumferential measurement of limb volume. The secondary measurements will be pain assessment according to the VAS scale, a functional assessment according to BI"TI and range of motion measured with an inclinometer .

The measurements will be taken once prior to hospitalization. During hospitalization the measurements will be taken daily including the day of the release home and one last measurement will be taken 6 weeks after the operation. All measurements are valid and reliable.

The trial is scheduled to last 3-4 months

  Eligibility

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary total knee replacement
  • ages 50-85
  • preserved cognitive facilities and comprehension.

Exclusion Criteria:

  • Severe chronic heart failure.
  • previous episode of lymph edema.
  • surgical removal of lymph nodes in the lower limbs.
  • significant scarring of the lower limbs (larger than 10 cm).
  • Deterioration in a patient's medical condition or an infection of the lower limb during the trial period will also cause exclusion of that patient.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657149


Locations
Israel
Rabin Medical Center, Campus Golda
Petah Tiqva, Israel
Sponsors and Collaborators
Rabin Medical Center
  More Information

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01657149     History of Changes
Other Study ID Numbers: 0081-12-RMC
First Submitted: July 15, 2012
First Posted: August 6, 2012
Last Update Posted: April 6, 2016
Last Verified: August 2015