- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07710404
Effectiveness of Joint Distraction Versus Passive End Range Overpressure in Osteoarthritis:
Comparative Effectiveness of Joint Distraction Versus Passive End Range Overpressure in Managing Knee Osteoarthritis: A Randomized Clinical Trial
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Punjab Province
-
Faisalābad, Punjab Province, 파키스탄, 3800
- The University of Faisalabad
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria
- Patients diagnosed with Grade 2 or Grade 3 Knee Osteoarthritis.
- A Kellgren-Lawrence Grade (KLG) of at least 2.
- Age between 40-60 years.
- Knee pain for at least 6 months.
- A minimum pain score of 3 on the Visual Analogue Scale (VAS).
Exclusion Criteria
- Acute inflammation.
- Total Knee Replacement (TKR) surgery.
- Any lumbar spine disease (disc herniation or lumbar stenosis).
- Intra-articular injection.
- Recent tibia or femur fracture.
- Any systemic inflammatory arthritic condition or neurological condition (e.g., rheumatoid arthritis or stroke).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: GROUP A
The joint distraction is the manual approach in knee osteoarthritis.
This is very efficient in managing pain, to increase range of motion and reduce stiffness of joint due to osteoarthritis.
|
The joint distraction is the manual approach in knee osteoarthritis. This is very efficient in managing pain, to increase range of motion and reduce stiffness of joint due to osteoarthritis. A specialized greave would be created to distract the knee joint. Using a platform beneath the lower leg to create counterpressure, the knee would be put in flexion while sustained traction will be performed for 20 minutes while the patient would be in a supine posture. In each session, the traction would be adjusted to the patients' perceived threshold. The least amount of work that caused patients to get distracted would be employed as a diversion |
|
실험적: GROUP B
The passive joint end-range overpressure is the technique of Maitland grade IV which is performed passively.
End-range Individual Maitland mobilizations were carried out at the tibiofemoral joint.
|
The passive joint end-range overpressure is the technique of Maitland grade IV which is performed passively.
End-range Individual Maitland mobilizations were carried out at the tibiofemoral joint.
Depending on the patient's level of pain and tolerance, an oscillatory accessory approach using Grade III or IV was carried out.
Patients positioned their knees in their true end range while lying supine on the plinth.
The most limited or reproducible knee pain was caused by the accessory approach that was employed.
By moving the therapist's body without making any additional movements, the physical contact accurately replicated the hand position of the mobilization.
For three minutes, Maitland mobilization was carried out twice at a rate of one oscillation every one or two seconds, with a 30-second break in between
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
pain intensity
기간: 4 months
|
Primary Outcome Measure Pain Tool Used: Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) was used to assess the patient's pain level. Participants were asked to rate their pain on a scale from 0 to 10. 0 = No pain 1-3 = Mild pain 4-6 = Moderate pain 7-10 = Severe pain This scale was used to categorize the intensity of pain experienced by patients with knee osteoarthritis. |
4 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of Life / Broader Function
기간: 4 months
|
Quality of Life / Broader Function Tool Used: KOOS Questionnaire (Knee Injury and Osteoarthritis Outcome Scale. The KOOS questionnaire was used to assess: Pain Symptoms Activities of Daily Living (ADLs) Sport and Recreation Function Knee-related Quality of Life It contains 42 items divided into five sections: Pain = 9 items Symptoms = 7 items Activities of Daily Living = 17 items Sport and Recreation Function = 5 items Quality of Life = 4 items Each item is scored from 0 to 4. Maximum score: 42 items × 4 = 168 Interpretation (Percentage Based): < 40% = Extreme disability 40-59% = Severe problems 60-79% = Moderate problems 80-99% = Mild disability This questionnaire evaluates the overall impact of knee osteoarthritis on function and quality of life.4 months |
4 months
|
|
Disability
기간: 4 months
|
Secondary Outcome Measures 1) Osteoarthritis Symptoms and Functions Tool Used: WOMAC Questionnaire (Western Ontario McMaster Universities Osteoarthritis Index) The WOMAC questionnaire was used to assess: Pain Stiffness Physical function It contains 24 items divided into three sections: Pain = 5 items Stiffness = 2 items Physical Function = 17 items Each question has 5 response options ranging from None to Extreme. Scoring: Each item = 0-4 points Pain section total = 20 Stiffness section total = 8 Physical function section total = 68 Total WOMAC score = 96 Interpretation: 0-30 = Mild 31-60 = Moderate 61-96 = Severe The higher the score, the greater the symptoms and functional limitations. |
4 months
|
|
Passive Range of Motion
기간: 4 months
|
Passive Range of Motion Tool Used: Goniometer A goniometer was used to assess joint range of motion. The instrument consists of three parts: Moving Arm - aligned with the body segment that moves. Stationary Arm - aligned with the body segment that remains stationary. Fulcrum - positioned over the joint being assessed. The goniometer was used to measure the knee joint's range of motion before and after treatment. |
4 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
Joint distraction GROUP A에 대한 임상 시험
-
Institute of Health and ResilienceAegean College, Athens, Greece; Coventry University, United Kingdom완전한
-
Maharishi Markendeswar University (Deemed to be...완전한
-
Figen Akay아직 모집하지 않음
-
Middle East University모집하지 않고 적극적으로
-
Lahore University of Biological and Applied Sciences모병