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

Primary Purpose

Knee Pain, Osteoarthritis

Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Elf care
control group
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Pain focused on measuring COLD HOT or Electrotherapy treatment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elf_care

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The effects of the electro, heat and cold -therapy during physiotherapy treatment

Secondary Outcome Measures

Full Information

First Posted
April 26, 2010
Last Updated
September 6, 2012
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01112319
Brief Title
The Effects of the Electro, Heat and Cold -Therapy During Physiotherapy Treatment in Osteoarthritis(OA) of KNEE
Official Title
The Effects of the Electro, Heat and Cold -Therapy During Physiotherapy Treatment in OA of KNEE - Prospective Randomize Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Why Stopped
not patient recruitment
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain, Osteoarthritis
Keywords
COLD HOT or Electrotherapy treatment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elf_care
Arm Type
Experimental
Arm Description
The trial group will receive with Elf_Care unit (Hot-Cold & Electrotherapy) during physiotherapy treatment ( 28 minutes twice a week)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The control group will receive before physiotherapy COLD HOT or Electrotherapy treatment depends on the patient and physiotherapy prefer.
Intervention Type
Device
Intervention Name(s)
Elf care
Intervention Description
elfcare device
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
regular physiotherapy treatment
Primary Outcome Measure Information:
Title
The effects of the electro, heat and cold -therapy during physiotherapy treatment
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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