- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07917611
Effect of Retro Walking in Patients With Sacroiliac Joint Dysfunction
Effect of Retro Walking on Isokinetic Peak Torque of Lower Limb Muscles in Patients With Sacroiliac Joint Dysfunction
The goal of this clinical trial is to investigate the effect of adding retro-walking (RW) to core stabilization exercises (CSE) on isokinetic peak torque of lower limb muscles, pain severity, and disability level in patients with sacroiliac joint dysfunction(SIJD).The main questions it aims to answer are:
Will there be any effect for the combined application of RW training and CSE on isokinetic peak torques of, hip extensors and abductors, knee extensors, and ankle planter-flexors, pain severity, and disability level in patients with SIJD? Will there be any difference between the combined application of RW training and CSE and the solo application of CSE on isokinetic peak torques hip extensors and abductors, knee extensors, and ankle planter-flexors, pain severity, and disability level in patients with SIJD?
연구 개요
상태
정황
상세 설명
One of the most overlooked sources of low back pain (LBP) is the sacroiliac joint dysfunction (SIJD). The reported prevalence of chronic mechanical LBP originating from the sacroiliac joint (SIJ) ranges from 15% to 30% with females being affected more than males. SIJ is the largest axial joint in the body that connects the spine to the pelvis and thus transfers load from the lumbar spine to lower extremities and vice versa. During weight bearing activities, the ankle, knee and hip act as a linked system minimizing the transmission of force to the pelvis and spine.
Some studies investigated electromyographic activity of gluteus maximus, gluteus medius and other lumbo-pelvic muscles in patients with SIJD. They found reduced activity of these muscles and delayed onset of activation in SIJD compared with the controls. Also, recent studies found there was a relation between pelvic, and lower limb injuries and SIJD.
Treatment of SIJ pain is variable, and there are no guidelines or an appropriate management plan for this dysfunction. Core Stabilization Exercises (CSE) are a common form of exercise therapy used to treat LBP and SIJD. Backward walking (BW) or retro-walking (RW) is a recently emerging exercise that helps enhance the balance, muscle strength of the lower limbs and hamstring flexibility. Reviewing the literature revealed that there was no study investigated the effect of BW training on lower limb muscles' strength, pain, and disability in patients with SIJD. Yet, there is a gap in literature regarding the effect of RW training on hip, knee, and ankle muscles' strength in such patients. Furthermore, the effect of adding RW training to CSE on such variables wasn't previously investigated. So, the current study will be conducted to fill this gap, by investigating the effect of adding RW to CSE on isokinetic peak torques of hip extensors and abductors, knee extensors, ankle planter-flexors, pain severity, and disability level in patients with SIJD. Additionally, this study aims to compare the changes in the selected parameters after applying RW in addition to CSE versus applying CSE only in patients with SIJD.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age ranging from 20-40 years.
- pain lasting for more than 3 months
- ≥ 4 in diagnostic scoring system (Kurosawa et al., 2017).
- 3 or more positive provocative test of SIJ tests (distraction test, compression test, sacral trust, thigh trust test, gaenslen test).
- Pain in or around the sacroiliac region with or without leg pain.
Exclusion Criteria:
- Midline or symmetrical pain above the level of L5 or radicular pain with neurological deficits (sensory or motor deficit).
- A history of spinal surgery, infection, tumors fracture of the spine, pelvis or lower extremities.
- Hospitalization for severe trauma or car accident.
- Pregnancy or lactation.
- Any systemic disease such as arthritis, tuberculosis.
- Leg length discrepancy and scoliosis.
- Injection of corticosteroids or anesthetics in the SIJ during the previous month.
- Participating in physical therapy for 3 months prior the study.
- Taking non-steroidal anti-inflammatory drugs during the therapy.
- Participating in any regular exercise.
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: Experimental group
Patients will perform core stabilization exercises combined with backward walking training. The intervention will be administered for 3 times per week for 6 weeks. Each session lasts for approximately 40-50 minutes. |
core stabilization exercises will be performed followed by backward walking three times per week for six weeks. core stabilization exercises will be performed three times per week for six weeks. Each exercise will be repeated 15 times, with a brief rest interval of 3s between repetitions and 1-min between exercises. |
|
활성 비교기: Control group
Patients will perform core stabilization exercises only. The intervention will be administered for 3 times per week for 6 weeks. Each session lasts for approximately 20-30 minutes. |
core stabilization exercises will be performed followed by backward walking three times per week for six weeks. core stabilization exercises will be performed three times per week for six weeks. Each exercise will be repeated 15 times, with a brief rest interval of 3s between repetitions and 1-min between exercises. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Isokinetic peak torque of lower limb muscles
기간: The isokinetic peak torques of the four tested muscles will be measured at the beginning and after six weeks for the two tested groups
|
Biodex System 3 Multi-Joint system testing and rehabilitation (Biodex Medical system, Shirley, NY, USA) will be used to measure peak torques of hip extensors and abductors, in addition to knee extensors and ankle planter flexors at an angular velocity of 60°/sec. |
The isokinetic peak torques of the four tested muscles will be measured at the beginning and after six weeks for the two tested groups
|
|
Pain intensity
기간: VAS pain score will be measured at the beginning and after six weeks for the two tested groups
|
Visual analog scale (VAS) will be used for measuring the pain intensity. |
VAS pain score will be measured at the beginning and after six weeks for the two tested groups
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Functional disability
기간: ODI score will be measured at the beginning and after six weeks for the two tested groups
|
Oswestry disability index (ODI) will be used for assessing pain related disability and quality of life |
ODI score will be measured at the beginning and after six weeks for the two tested groups
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- P.T.REC/012/005650
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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