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

Osteoarthritis Clinical Trial

Official title:

The Effects of the Electro, Heat and Cold -Therapy During Physiotherapy Treatment in OA of KNEE - Prospective Randomize Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01112319
• Other study ID #: 041-2010
• Status: Withdrawn
• Phase: Phase 1
• First received: April 26, 2010
• Last updated: September 6, 2012
• Start date: March 2010
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: The Israel National Institute for Health Policy Research and Health Services ResearchIsrael: Clalit Health Services
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Knee Pain
• Osteoarthritis

Intervention

Device:
• Elf care
elfcare device

Other:
• control group
regular physiotherapy treatment

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of the electro, heat and cold -therapy during physiotherapy treatment		one year	Yes

External Links

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