Effects of Two Dosing Regimens of Focal Extracorporeal Shock Wave Therapy in Patients With Chronic Low Back Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
The purpose of this clinical trial is to evaluate and compare the efficacy of two different dosing regimens of focal extracorporeal shock wave therapy (F-ESWT) in patients diagnosed with chronic mechanical low back pain. Participants will be randomly assigned to one of two experimental groups to receive different parameters of shock wave intervention. The main objective is to determine which dosing scheme provides a more significant reduction in pain intensity and a better recovery of lumbar function.
详细描述
Chronic mechanical low back pain is a common musculoskeletal condition that leads to functional disability and diminished quality of life. While focal extracorporeal shock wave therapy (F-ESWT) has emerged as a non-invasive treatment option to promote tissue regeneration and modulate inflammation, clinical protocols lack precise standardization regarding energy density and session distribution.
This randomized, double-blind clinical trial aims to analyze the clinical effects of two specific dosing regimens of F-ESWT. Eligible participants from the Physical Medicine and Rehabilitation Service will be randomly allocated to either Group A or Group B. Both groups will undergo targeted applications to the lumbar region using predefined therapeutic parameters detailed in the protocol.
Clinical evaluations will be performed at baseline and during post-treatment follow-up periods. Pain intensity, functional disability, and localized mobility will be measured using validated clinical tools to define which dosing scheme optimizes short-term and mid-term patient recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
A double-blind design will be implemented. Participants will not be informed of the specific dosing regimen parameters they are receiving during the applications. The outcomes assessor responsible for performing the baseline and post-treatment clinical evaluations will remain fully blinded to the group allocation of each participant throughout the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes.
- •Age between 18 and 65 years.
- •Clinical diagnosis of mechanical chronic low back pain (cLBP), defined as pain localized between the lower costal margin and the gluteal fold, with at least 12 weeks of evolution.
- •Lumbar pain intensity of at least 5/10 on the Numeric Pain Rating Scale (NPRS).
- •Predominantly mechanical pain, exacerbated by activities such as prolonged standing, trunk movements, extension, or lumbar rotation, and without clinical data of predominant radicular pain.
- •Plain radiograph of the lumbar spine available as part of the baseline evaluation.
- •Ability to attend all 4 treatment sessions and subsequent follow-up evaluations.
- •Signed informed consent form previously approved by the Institutional Review Board / Research Ethics Committee.
排除标准
- •Low back pain of probable non-mechanical origin or secondary to a specific cause that substantially modifies clinical management.
- •Clinical data of predominant lumbar radiculopathy, including pain radiating below the knee with a dermatomal distribution, focal motor deficit, objective sensory alterations, or compatible reflex changes.
- •Diagnosis or suspicion of cauda equina syndrome.
- •History of previous lumbar spine surgery.
- •Current vertebral fracture or recent history of lumbar fracture.
- •Spondylolisthesis grade II or higher.
- •Significant structural scoliosis or severe lumbar deformity that prevents treatment standardization.
- •Suspicion or evidence of a tumor, infection, spondylodiscitis, or axial inflammatory disease.
- •Severe clinically documented osteoporosis or history of vertebral fragility fracture.
- •Pregnancy or lactation.
- •Coagulation disorder, use of anticoagulants at therapeutic doses, or a hemorrhagic condition that increases procedure risk.
- •Previous epidural infiltration, facet block, radiofrequency, or other lumbar interventional procedure within a recent period defined by the protocol.
- •Current treatment with another physical rehabilitation modality or instrumental therapy directed at low back pain, if it cannot be suspended during the intervention period.
- •Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) that the patient cannot suspend according to the study indications.
- •Concomitant neurological, rheumatological, oncological, or musculoskeletal disease that significantly interferes with pain or disability evaluation.
- •Cognitive impairment, decompensated psychiatric disorder, or any condition that prevents understanding instructions, answering questionnaires, or completing follow-up.
研究者
Armando Tonatiuh Avila Garcia
Chief of the Department of Physical Medicine and Rehabilitation
Hospital Civil de Guadalajara