- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01112319
The Effects of the Electro, Heat and Cold -Therapy During Physiotherapy Treatment in Osteoarthritis(OA) of KNEE
The Effects of the Electro, Heat and Cold -Therapy During Physiotherapy Treatment in OA of KNEE - Prospective Randomize Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
-
Kfar Saba, Israel, 44281
- Meir Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Elf_care
The trial group will receive with Elf_Care unit (Hot-Cold & Electrotherapy) during physiotherapy treatment ( 28 minutes twice a week)
|
elfcare device
|
|
Aktiv komparator: control group
The control group will receive before physiotherapy COLD HOT or Electrotherapy treatment depends on the patient and physiotherapy prefer.
|
regular physiotherapy treatment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The effects of the electro, heat and cold -therapy during physiotherapy treatment
Tidsramme: one year
|
one year
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 041-2010 (Univeristy of Florida)
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