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

NCT ID: NCT01657149

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Research Group

receive lymphatic massage and individual physiotherapy

Group Type EXPERIMENTAL

Lymphatic massage and individual physiotherapy

Intervention Type PROCEDURE

lymphatic massage and individual physiotherapy

Control group

receive individual physiotherapy only

Group Type ACTIVE_COMPARATOR

individual physiotherapy only

Intervention Type PROCEDURE

individual physiotherapy only

Interventions

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Lymphatic massage and individual physiotherapy

lymphatic massage and individual physiotherapy

Intervention Type PROCEDURE

individual physiotherapy only

individual physiotherapy only

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rabin Medical Center, Campus Golda

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0081-12-RMC

Identifier Type: -

Identifier Source: org_study_id

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