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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01657149
First received: July 15, 2012
Last updated: August 6, 2012
Last verified: January 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analogue Scale (VAS) Inclinometer [ Time Frame: VAS & INCLINOMETER will be assessed on a daily basis for 5 days post op ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657149

Locations
Israel
Rabin Medical Center, Campus Golda Not yet recruiting
Petah Tiqva, Israel
Principal Investigator: Nimrod Nachmias, M.D         
Sponsors and Collaborators
Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01657149     History of Changes
Other Study ID Numbers: 0081-12-RMC
Study First Received: July 15, 2012
Last Updated: August 6, 2012
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

ClinicalTrials.gov processed this record on April 14, 2014