Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01112319
Other study ID # 041-2010
Secondary ID
Status Withdrawn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Status Withdrawn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


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
See also
  Status Clinical Trial Phase
Completed NCT04657926 - A Trial of APPA in the Treatment of Knee Osteoarthritis Phase 2
Completed NCT02536833 - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects Phase 2
Completed NCT03014037 - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration N/A
Recruiting NCT05937542 - A Qualitative Investigation of CLEAT Participants
Completed NCT03644615 - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT03850665 - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach N/A
Completed NCT02826902 - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial N/A
Completed NCT04402502 - Dynamic 4DCT to Examine Wrist Carpal Mechanics N/A
Completed NCT02923700 - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial Phase 4
Completed NCT04564053 - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants Phase 1
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT05036174 - Diphenhydramine Ointment for Knee Osteoarthritis N/A
Recruiting NCT02666443 - Low Dose Dexamethasone in Supraclavicular Blocks N/A
Recruiting NCT02912429 - Onlay vs. Inlay Patellofemoral Arthroplasty N/A
Active, not recruiting NCT02723929 - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Terminated NCT02820766 - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting N/A
Withdrawn NCT02921594 - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties N/A

External Links