- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
단계
- 1단계
연락처 및 위치
연구 장소
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Kfar Saba, 이스라엘, 44281
- Meir Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Elf_care
The trial group will receive with Elf_Care unit (Hot-Cold & Electrotherapy) during physiotherapy treatment ( 28 minutes twice a week)
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elfcare device
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활성 비교기: control group
The control group will receive before physiotherapy COLD HOT or Electrotherapy treatment depends on the patient and physiotherapy prefer.
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regular physiotherapy treatment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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The effects of the electro, heat and cold -therapy during physiotherapy treatment
기간: one year
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one year
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .