- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07576101
Low Blood Flow Restriction Training on Low Back Pain (the)
Effect of Low Blood Flow Restriction Training on Nonspecific Low Back Pain Patients
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: KINZA ANWAR, MS-OMPT
- Número de telefone: +92-3239735427
- E-mail: kinza.anwar@riphah.edu.pk
Locais de estudo
-
-
-
Islamabad, Paquistão, 46000
- Recrutamento
- National Institute Of Rehabilitation Medicine G-8/2, Islamabad
-
Contato:
- KINZA ANWAR, MS-OMPT
- Número de telefone: +92-3239735427
- E-mail: kinza.anwar@riphah.edu.pk
-
Contato:
- MUZAMMEL FATIMA, MS-OMPT*
-
Subinvestigador:
- MUZAMMEL FATIMA, MS-OMPT*
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: PT Convencional
Fisioterapia Convencional
|
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
|
|
Outro: Low blood flow restriction training
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Manual Muscle Testing (MMT)
Prazo: : 4 weeks
|
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.
|
: 4 weeks
|
|
Numeric Pain Rating Scale (NPRS)
Prazo: 4 weeks
|
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.
|
4 weeks
|
|
Oswestry Disability Index (ODI)
Prazo: 4 weeks
|
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
|
4 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: KINZA ANWAR, MS-OMPT, Riphah International University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Muzammel Fatima
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Dor lombar
-
Cancer Institute and Hospital, Chinese Academy...RecrutamentoHER2-Low Low irressectável/metastático câncer de mama complicado com crise visceralChina
-
National Taiwan University HospitalBuddhist Tzu Chi General Hospital; Taipei Medical University Hospital; E-DA Hospital e outros colaboradoresDesconhecidoColonoscopia | Limpeza do cólon | Dieta Low-ResideTaiwan
-
Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)ConcluídoEficácia e Tolerância do B-Back® na Síndrome de BurnoutFrança
-
Shanghai Henlius BiotechRecrutamentoHER2-Low Hormon Receptor positivo Câncer de mamaChina
-
Aminex Therapeutics, Inc.RecrutamentoMelanoma (câncer de pele) | HER2-Low Hormon Receptor positivo Câncer de mamaEstados Unidos
-
Yeon Hee ParkHelsinn Healthcare SAInscrevendo-se por convitePacientes com câncer de mama avançado positivo para HER2 tratado com T-DXD | Pacientes com câncer de mama Avançado com HER2-Low tratado com T-DXDCoréia do Sul
-
National Cancer Institute (NCI)RecrutamentoCâncer de Mama Anatômico Estágio III AJCC v8 | Câncer de Mama Anatômico Estágio IV AJCC v8 | Neoplasia sólida maligna irressecável | Neoplasia Sólida Maligna Metastática | Carcinoma de Mama Invasivo | Carcinoma de mama irressecável | Carcinoma de Mama Triplo Negativo Metastático | Carcinoma de Mama... e outras condiçõesEstados Unidos
-
BicycleTx LimitedAtivo, não recrutandoNeoplasias da Mama | Neoplasias da Mama Triplo Negativas | Tumor Sólido Avançado | Neoplasia ovariana | Neoplasia da Bexiga Urinária | Neoplasias positivas para receptor hormonal e negativas para HER2 | Receptor hormonal positivo, neoplasias HER2-low | Neoplasias pulmonares de células não pequenasFrança, Estados Unidos, Espanha, Reino Unido, Itália, Canadá
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione IRCCS... e outros colaboradoresRecrutamentoCâncer de mama | Neoplasias da Mama | Doenças da mama | Neoplasia de Mama | Tumores de mama | Carcinoma de mama | Neoplasias da Mama, Masculino | Câncer de Mama Estágio IV | Neoplasia Maligna da Mama Receptor Hormonal Positivo | Câncer de Mama RH positivo | Carcinoma de Mama Receptor Hormonal Positivo | Câncer... e outras condiçõesItália
Ensaios clínicos em Low Blood Flow Restriction Training
-
Virginia Commonwealth UniversityConcluídoFibrose císticaEstados Unidos