- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03300375
Exercise Intervention for Unilateral Amputees With Low Back Pain
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Amputation to the lower extremity is a life-changing event. Approximately 2 million Americans live with limb loss, with ~45% of losses occurring from traumatic mechanisms. After the injury has healed and a prosthetic limb is fitted, the long-term care for amputees typically focuses on maintenance of the prosthesis fit and optimizing physical function. Even with high-quality prostheses, amputation permanently impacts biomechanical symmetry of gait. After unilateral transtibial or transfemoral amputation, skeletal muscle atrophy occurs in the lower extremity and back. Asymmetric gait causes mechanical stresses at lumbar spine, and loss of muscle mass and strength, all of which exaggerate gait aberrations. As a result, chronic low back pain (LBP) can develop. LBP is a common, but often unaddressed, secondary complication in over half of the unilateral amputee population.
Lower extremity amputees face numerous physical and emotional challenges after their injuries. Performing ambulatory activities are more physically demanding with an amputation than without. The psychological stress levels are often high after an amputation, contributing to activity avoidance and limiting participation in load-bearing activities. LBP independently contributes to costly health burdens such as addiction to pain medicine, depression and lifestyle diseases and LBP erodes physical and mental quality of life (QOL). Pain is also related to skeletal muscle atrophy in the low back. The combination of an amputation injury and LBP may amplify ambulation-related limitations and further deteriorate QOL. Unilateral lower extremity amputees who suffer from chronic LBP therefore may therefore experience greater walking limitations, physical activity avoidance and physiological changes to skeletal muscle, strength and perceived QOL than people with back pain or amputation alone.
Long-term care for amputees requires a team of physicians, prostheticians, therapists and other specialists. Patients often travel long distances to receive their care. Patients with limited resources may not be able to maintain a long-term relationship with therapists due to cost restrictions. Home-based interventions that target LBP could substantially impact the secondary disease burden and help restore QOL in the amputee population. In the general population, evidence indicates that consistently-performed muscle strengthening activity is associated with significantly lower odds of developing back pain in men and women. Resistance exercise is effective for lumbar muscle strength gains, functional gains in ambulation and movement and for improving both physical and mental aspects of QOL. Resistance training benefits in strength, motor skills, and many aspects of quality of life (both functional and psychosocial) are seen throughout several different demographics; from young adults to the elderly.
Current clinical paradigms to treat general LBP include referral to physical therapy for strengthening exercise programs. For amputees, challenges to receiving therapeutic care include travel distance, and financial limitations for exercise facility memberships or therapy copayments. Patients may not be able to sustain and therapy gains over the long-term when therapy benefits run out. Thus, exercise to treat LBP in amputees must be accessible, low or no cost and sustainable. A significant deficit in the clinical literature is that the study team does not know the effectiveness of home-based resistance training on different chronic musculoskeletal pains in amputees. Moreover, the mechanisms that may contribute to effectiveness of strength training on pain relief in amputees are not clear. The problem is therefore multifaceted: 1) amputees experience permanent anatomic changes that impact load-bearing activity, back pain and QOL; 2) chronic LBP treatment is not often a focus for the long-term management of the unilateral lower extremity amputee; 3) chronic LBP can develop in amputees as a consequence of asymmetric movement patterns, lumbar muscle atrophy and low muscle strength, but the relative contribution of each to pain severity is not known. These evidence gaps are significant barriers to the optimization of care for this special population by clinical teams who care for these individuals, and for determination of pain responders with strengthening exercise.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Florida
-
Gainesville, Florida, Estados Unidos, 32611
- University of Florida
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Between 18-60 years of age
- English speaking
- Suffering from chronic LBP (>3 months with ≥3 pain episodes per week)
- Baseline pain of ≥3 points out of 10 on the NRSPain scale
- Amputation ≥1 year prior and their current prosthesis must have been worn for at least 6 months (prosthesis K-Level of K2 or greater, indicating the subject is able to ambulate and traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces).
- Must have regular access to a computer for skype, or a mobile phone or iPAD to perform facetime
Exclusion Criteria:
- Acute back injury
- Any other chronic back pathology (i.e. herniated disc, ankylosing spondylosis, other related neurologic disease)
- Pain symptoms or functional limitations (including those that may require assistive devices) that preclude participation in resistance exercise or physical activity
- Back surgery within the past two years that restrict daily physical activities
- Currently enrolled in any other resistance or strengthening exercise interventions
- Pregnant
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 |
|---|---|
|
Comparador Ativo: Home-Based Resistance Exercise Intervention Group
Participants in the HBRX group will be coached through six phases of the intervention with two weeks per phase.
Exercise will use body weight and resistance exercise bands.
A set of commercial elastic resistive bands and a stability pad (TheraBand, Inc.) will be provided to each participant to keep for personal use after their participation in the study.
The use of elastic bands for resistance training can induce similar results in neuromuscular adaptations as well as strength to those achieved by weight machines and free-weights.
|
Home-based, progressive exercise program using resistance bands
|
|
Experimental: Wait-List Control Condition Group
Participants who are assigned to the CON group will wait to participate in the resistance training after a three month wait period.
Participants will follow all instructions provided to them by their physician and care team, but will be asked to refrain from starting any new strengthening exercise protocols or begin any new physical therapies during this time.
The participants will be contacted by phone on a monthly basis during the study period to determine if any changes in LBP symptoms have occurred.
At month three, these participants will also receive the elastic resistive bands and a stability pad.
|
Home-based, progressive exercise program using resistance bands
Participants will follow all instructions provided to them by their physician and care team, but will be asked to refrain from starting any new strengthening exercise protocols or begin any new physical therapies during this time.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain assessment
Prazo: Up to 6 months
|
Pain and Catastrophizing Scale (PCS) is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time).
The PCS is broken into three subscales being magnification, rumination, and helplessness.
The scale was developed as a self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations.
|
Up to 6 months
|
|
Functional impairment due to back pain
Prazo: Up to 6 months
|
Roland Disability Questionnaire consist of 24 items (see below).
Those 24 questions are related specifically to physical functions that were likely to be affected by low back pain.
Greater levels of disability are reflected by higher numbers.
Scores under 4 and over 20 may not show significant change over time in patients with scores of less than 4 and deterioration in patients who have scores greater than 20.
|
Up to 6 months
|
|
Quality of Life Assessment
Prazo: Up to 6 months
|
Medical Outcomes Short-Form 36 (SF-36) This instrument has 36 items and yields eight domain scores and two component scores (Mental, Physical).
The eight domains are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and emotional well-being.
The SF-36 has shown good internal consistency (Cronbach's range of 0.95-0.93).
This instrument has been used to track QOL after traumatic injury, such as amputation.50
|
Up to 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional disability in patients with low back pain
Prazo: up to 6 months
|
Oswestry Disability Questionnaire: 0-20% Minimal disability; 20-40% Moderate disability; 40-60% Severe disability; 60-80% Crippled; 80-100% bed-bound.
|
up to 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Heather Vincent, MD, University of Florida
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB201701256
- OCR18330 (Outro identificador: University of Florida)
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 Home exercise program
-
Cefaly TechnologyConcluído
-
Universiti Sains MalaysiaConcluídoPlaca dentária | Comportamento | Saúde Bucal | Atitude | ConhecimentoMalásia
-
NYU Langone HealthNational Institute on Aging (NIA)Concluído
-
National Taiwan University HospitalNational Science and Technology Council, TaiwanAinda não está recrutandoDoença Renal Crônica | Diabetes (DM) | Obesidade e Sobrepeso | Osteoartrite do joelhoTaiwan
-
Palo Alto Veterans Institute for ResearchStanford University; Meru Health, Inc.ConcluídoDepressão | Sintomas DepressivosEstados Unidos
-
USDA Grand Forks Human Nutrition Research CenterCalifornia Polytechnic State University-San Luis ObispoConcluídoConsumo de frutas e vegetais | Nutrição infantil | Escolha de comida saudável | Preparação de Alimentos SaudáveisEstados Unidos
-
The University of Hong KongInscrevendo-se por convite
-
Axem Neurotechnology Inc.Massachusetts General HospitalRecrutamento
-
Weill Medical College of Cornell UniversityNational Institute on Aging (NIA); Visiting Nurse Service of New YorkConcluído