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

Total Knee Replacement Clinical Trial

Official title:

Influence of Manual Lymph Drainage During Hospitalization on Swelling, Function and Pain in Patients After Total Knee Replacement - Randomized Control Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01657149
• Other study ID #: 0081-12-RMC
• Status: Terminated
• Phase: N/A
• First received: July 15, 2012
• Last updated: April 5, 2016
• Start date: December 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Procedure:
• Lymphatic massage and individual physiotherapy
lymphatic massage and individual physiotherapy
• individual physiotherapy only
individual physiotherapy only

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Campus Golda	Petah Tiqva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circumferential measurement of limb volume		The circumferential measurements will be assesed pre operative and post operative on daily basis for 5 days post op	No
Secondary	Visual Analogue Scale (VAS) Inclinometer		VAS & INCLINOMETER will be assessed on a daily basis for 5 days post op	No
Secondary	Daily functional capacity Assessment		Daily functional capacity Assessment after 6 days post op. All Outcomes will be reassessed after 6 weeks post op	No