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

Phase 1

Withdrawn

• Conditions: Knee Pain; Osteoarthritis
• Interventions: Device: Elf care; Other: control group

• Registration Number: NCT01112319
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Primary Completion: 2011-03
• Study Completion: 2012-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elf_care	Elf care	The trial group will receive with Elf_Care unit (Hot-Cold \& Electrotherapy) during physiotherapy treatment ( 28 minutes twice a week)
control group	control group	The control group will receive before physiotherapy COLD HOT or Electrotherapy treatment depends on the patient and physiotherapy prefer.

Primary Outcome Measures

Name	Time	Method
The effects of the electro, heat and cold -therapy during physiotherapy treatment	one year

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel