- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07576101
Low Blood Flow Restriction Training on Low Back Pain (the)
Effect of Low Blood Flow Restriction Training on Nonspecific Low Back Pain Patients
연구 개요
상세 설명
Low back pain (LBP)-related disability and the related socioeconomic burden remain high despite the many treatment options and health care resources available for LBP. LBP can be caused by a specific pathology or trauma; however, in >90% of cases, an underlying disease is absent. The clinical course of this called as nonspecific LBP which is the most common type of low back pain and, some patients recover within weeks, and others experience persistent disabling symptoms leading to chronic LBP. Chronic low back pain (CLBP, pain lasting more than 12 weeks duration) is one of the most common chronic musculoskeletal disorders with high prevalence rates worldwide. Patients with CLBP have varying degrees of pain in the lumbar region of the spine, generally located between the lower ribs and the gluteal region.
Approximately 85% of patients have chronic non-specific low back pain (CNLBP) who do not have a specific patho-anatomical cause attributable to their pain in clinical examination. More than 50% of people in the United States are affected by CLBP. 90% adults will experience LBP in their lifetime, and the recurrence of LBP following chronic episode ranges from 24 to 87 %. The prevalence of LBP in children and adolescents has reaching around 39% of LBP lifetime prevalence in adults at 18 years of age. The prevalence of low back pain was 55.51% in Lahore, Pakistan.
Common nonspecific LBP symptoms include paravertebral muscle spasms, tight hamstrings, trigger points in the muscles, limited spinal range of motion, discomfort and pain. CNLBP is the most common musculoskeletal condition impacting performance leads to functional disability. Various factors associated with CLBP, including smoking, excessive BMI, poor muscle endurance, occupational ergonomic factors, poor posture, altered muscle firing rates, muscular imbalance, psychological factors as depression, inflexibility of the lower extremities, and leg length discrepancies.
Muscle tightness linked to postural disturbances and reduced extensibility resulting from increased hamstring stiffness could be a possible contributing factor to low back pain. Tight hamstring draws the pelvic into posterior rotation with greater flattening of lumbar lordosis which increase mechanical stress on the spinal soft tissues and altered hip biomechanics and lumbopelvic rhythm. If hamstrings are tight, then blood supply will be squeezed out of them leads to decreased muscle capacity, deconditioning and reduced strength which may cause abnormal changes in the bodily posture lead to lumbar hypo-lordosis causing LBP.
Chronic low back pain involves complex interaction of neuromuscular, inflammatory and neurophysiological processes that leads to constant pain. Long-term alterations in movement patterns due to muscular tightness result in structural changes within muscle fibers. The mechanism involved behind is arthrogenous muscle inhibition that inhibits alpha-motor neurons leading to decreased activation of stabilizing muscles. At molecular level, Peripheral and central sensitization contribute to LBP by releasing inflammatory mediators (substance P, bradykinin, cytokines and histamine) and by enhancing the excitability of spinal neurons respectively. Impaired neural drives alter proprioceptive feedback signals linked with increased adipose infiltration, reduced muscle quality, and diminished muscle efficiency.
In 1966, Yoshiaki Sato began developing the Kaatsu training method that has led to the current BFR training techniques that partially restrict arterial inflow. The physiologic effects of BFR at cellular level leads to activation of fast twitch muscle fibers increase in glycogen stores and protein synthesis that stimulates hypertrophy. On the molecular level, a state of localized metabolic stress due to hypoxic environment, causes an increase in growth hormone, stress-related upregulation of signaling factors and Insulin growth factor (IGF)-1 levels that improves vascular functions at low load training.
Conventional Physical Therapy leads to restoration or augmentation of the ability of neuromuscular system which is the most effective rehabilitation strategies for chronic LBP tackle the maladaptive changes in hamstring muscle morphology and function, and ranked third for improving LBP. It plays a major role in stabilizing the pelvis during trunk rotation, or when the center of gravity is grossly shifted as in CLBP. The main focus is on retraining the function of back and hip muscles by integration of exercise resulting in the fine-tuning of intersegmental motion of the spine.
Hamstring tightness leads to posterior rotation of pelvis that alters the lumbopelvic rhythm or flattening of lumbar curve subsequently increased stress on the spinal soft tissues and it may be the reason for dysfunctions that may cause CLBP. Recent literature focused on different manual and therapeutic modalities with their short-term effects on non-specific low back pain. BFR induces muscle hypertrophy and improves strength and endurance, moreover serve as a stimulus to promote protein synthesis leading to the muscle activation and integration of hamstring. BFR has been identified as an alternative when high-load resistance training is not allowed and has been extensively documented in quadriceps and upper limb muscles in literature, however its effect on hamstring remains scarcely investigated as evidence linking hamstring tightness to altered lumbopelvic mechanics and an increased risk of low back pain. This study aims to find the effect of low load blood flow restriction training on improving hamstring strength, alleviating pain and decreasing functional disability in nonspecific low back pain patients
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: KINZA ANWAR, MS-OMPT
- 전화번호: +92-3239735427
- 이메일: kinza.anwar@riphah.edu.pk
연구 장소
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Islamabad, 파키스탄, 46000
- 모병
- National Institute Of Rehabilitation Medicine G-8/2, Islamabad
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연락하다:
- KINZA ANWAR, MS-OMPT
- 전화번호: +92-3239735427
- 이메일: kinza.anwar@riphah.edu.pk
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연락하다:
- MUZAMMEL FATIMA, MS-OMPT*
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부수사관:
- MUZAMMEL FATIMA, MS-OMPT*
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Participants falling in this category would be recruited into the study.
- Both gender
- Age is between 18-45 years
- Individuals with pain localized posteriorly below the costal margin and above the inferior gluteal folds for more than 12 weeks
- A score greater than or equal to 4/10 on Numeric Pain Rating Scale (NPRS)
- Hamstring muscle strength graded between (3- to 4) on MMT
- Proximal thigh circumference between (27.0 cm to 56.0 cm), measured 10cm below the inguinal crease
- Eligible for BFR training as per the Blood Flow Restriction Blood Flow Training Questionnaire
Exclusion Criteria:
Participants falling in this category would be excluded from the study.
- Patients of spinal stenosis, disc herniation spondylolisthesis, spondylosis or osteoporosis will be excluded
- Participants had a history of hip or lower extremity pathology requiring medical or surgical intervention.
- History of venous thromboembolism (VTE), clotting or other hematologic disorder
- Peripheral arterial disease, hypertension (blood pressure >140/90 mm Hg), coronary artery disease
- Current Pregnancy
- Patients who had difficulties in exercise performance due to mental problems.
- Spinal cord infection like Cauda equina syndrome
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 |
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다른: 기존 물리치료
전통적 물리치료
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All interventional participants will attend 3 weekly 45-50 minutes sessions for a duration of four week.
Group B will receive electrical hot packs for 8-10 minutes followed by myofascial releases using a foam roller for 5-8 minutes primarily targeting the hamstring.
Total 4 sets of each exercise (Glute bridge exercises, lumbar extension exercise, straight leg raise from prone and table top exercises) with 20 repetitions will be performed.
Allow 30-60 sec rest interval
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다른: Low blood flow restriction training
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All interventional participants will attend 3 weekly 45-50 minutes sessions for a duration of four week.
Group A will receive electrical hot packs for 8-10 minutes followed by myofascial releases using a foam roller for 5-8 minutes primarily targeting the hamstring.
For low load BFR training therapist will place sphygmomanometer cuff 10cm below the inguinal crease on the upper 3rd of thigh.
The inflation pressure range will be individualized intended to produce complete arterial occlusion measured manually by palpating posterior tibial artery until the pulse will be felt no longer.
Deflate the pressure cuff up to 60-80% of the AOP to create partial arterial occlusion.
Total 4 sets of each exercise (Hamstring curls, Single leg hamstring curls on stability ball, standing hamstring curl, hamstring curl with sliders) with 30 repetitions in 1st set and then 15 repetitions in remaining 3 sets.
Allow 30-60 sec rest interval between sets
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Manual Muscle Testing (MMT)
기간: : 4 weeks
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MMT is the most commonly used method for documenting impairments in muscle strength.
The examiner in the application of force to the subject's resistance evaluates the muscles being studied as subjectively "weak" or "strong" on a 5-point scale.
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: 4 weeks
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Numeric Pain Rating Scale (NPRS)
기간: 4 weeks
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The NPRS is a segmented numeric version of the visual analog scale which is used to assess pain.
It scores ranges from 0-10, 0 means No pain and 10 means Severe pain.
Patient will be asked to verbally report the pain score.
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4 weeks
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Oswestry Disability Index (ODI)
기간: 4 weeks
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The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of pain-related disability in persons with low back pain (LBP).
The Oswestry Disability Index (ODI) addresses a broader concept of disability than that directly related to pain intensity
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4 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: KINZA ANWAR, MS-OMPT, Riphah International University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
- Muzammel Fatima
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
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. .
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