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

This study has been withdrawn prior to enrollment.
(not patient recruitment)
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01112319
First received: April 26, 2010
Last updated: September 6, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112319

Locations
Israel
Meir Medical Center
Kfar Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
  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 July 29, 2014