NCT01657149

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
3.3 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

July 15, 2012

Last Update Submit

April 5, 2016

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

  • Circumferential measurement of limb volume

    The circumferential measurements will be assesed pre operative and post operative on daily basis for 5 days post op

Secondary Outcomes (2)

  • Visual Analogue Scale (VAS) Inclinometer

    VAS & INCLINOMETER will be assessed on a daily basis for 5 days post op

  • Daily functional capacity Assessment

    Daily functional capacity Assessment after 6 days post op. All Outcomes will be reassessed after 6 weeks post op

Study Arms (2)

Research Group

EXPERIMENTAL

receive lymphatic massage and individual physiotherapy

Procedure: Lymphatic massage and individual physiotherapy

Control group

ACTIVE COMPARATOR

receive individual physiotherapy only

Procedure: individual physiotherapy only

Interventions

Lymphatic massage and individual physiotherapyPROCEDURE

lymphatic massage and individual physiotherapy

Research Group
individual physiotherapy onlyPROCEDURE

individual physiotherapy only

Control group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Campus Golda

Petah Tikva, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2012

First Posted

August 6, 2012

Study Start

December 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 6, 2016

Record last verified: 2015-08

Locations

IL(1)