The Effects of the Electro, Heat and Cold -Therapy During Physiotherapy Treatment in Osteoarthritis(OA) of KNEE
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Knee Pain Osteoarthritis |
Device: Elf care Other: control group |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | The Effects of the Electro, Heat and Cold -Therapy During Physiotherapy Treatment in OA of KNEE - Prospective Randomize Trial |
- The effects of the electro, heat and cold -therapy during physiotherapy treatment [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | May 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Elf_care
The trial group will receive with Elf_Care unit (Hot-Cold & Electrotherapy) during physiotherapy treatment ( 28 minutes twice a week)
|
Device: Elf care
elfcare device
|
|
Active Comparator: control group
The control group will receive before physiotherapy COLD HOT or Electrotherapy treatment depends on the patient and physiotherapy prefer.
|
Other: control group
regular 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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT01112319 History of Changes |
| Other Study ID Numbers: | 041-2010 |
| Study First Received: | April 26, 2010 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United States: Food and Drug Administration Israel: The Israel National Institute for Health Policy Research and Health Services Research Israel: Clalit Health Services |
Keywords provided by Meir Medical Center:
|
COLD HOT or Electrotherapy treatment |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013