The Effects of the Electro, Heat and Cold -Therapy During Physiotherapy Treatment in Osteoarthritis(OA) of KNEE

NCT ID: NCT01112319

Last Updated: 2012-09-07

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-05-31

Brief Summary

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The objective of this clinical trial is to evaluate the pain relief and daily functioning improve, in patients suffering of Osteoarthritis of knee, with HOT/COLD/ Electro therapy during physiotherapy treatment

Detailed Description

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Prospective randomize trial. The patients with knee pain and osteoarthritis, that were referred to the physiotherapy treatment.

Each patient will be checked twice by the physiotherapy team, in the first and in the last physiotherapy treatment. Test muscle strength of QUADRICEPS, GLUTEOUS MEDIUS and HAMSTRING will be measured by Dynamometer (the dynamometer expressed in a quantitative way the muscle force) The population will randomized separated in trail and control group. The control group will receive before physiotherapy COLD HOT or Electrotherapy treatment depends on the patient and physiotherapy prefer.

The trial group will receive with Elf\_Care unit (Hot-Cold \& Electrotherapy) during physiotherapy treatment ( 28 minutes twice a week) The protocol treatment includes 28 minutes of cycling cold/hot/cold/hot treatment (2\*7 min cold: 10…15 degrees; 2\*7 min hot: 39..42 degrees,). During this 28 minutes the patient also receive tolerable intensity Premodulated Interferential current with sweep Beat frequency (3Hz…200Hz), Carrier frequency 5kHz ; Electrodes setup: Thermo Electrode and 2 Regular Electrodes After the treatment the control and trail group will evaluate with 0-10 visual analogue scale VAS, Oxford Knee Score and WOMAC The population will receive treatment twice a week for one month.

Conditions

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Knee Pain Osteoarthritis

Keywords

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COLD HOT or Electrotherapy treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Elf_care

The trial group will receive with Elf\_Care unit (Hot-Cold \& Electrotherapy) during physiotherapy treatment ( 28 minutes twice a week)

Group Type EXPERIMENTAL

Elf care

Intervention Type DEVICE

elfcare device

control group

The control group will receive before physiotherapy COLD HOT or Electrotherapy treatment depends on the patient and physiotherapy prefer.

Group Type ACTIVE_COMPARATOR

control group

Intervention Type OTHER

regular physiotherapy treatment

Interventions

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Elf care

elfcare device

Intervention Type DEVICE

control group

regular physiotherapy treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female patients more than 60 years old
* Patients suffering from knee pain due to osteoarthritic changes in radiographic plains.
* Patients in medical condition to receive physiotherapy treatment
* Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.

Exclusion Criteria

* Patients receiving other methods of treatment to this area,
* Patients with concomitant other injury of the knee.
* Dermatological affection with contraindication use of hot, cold and/or electrical stimulation
* Non cooperative patient with the basic rehab program.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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041-2010

Identifier Type: -

Identifier Source: org_study_id