Chronic Low Back Pain (CLBP)
Conditions
Keywords
Focal Extracorporeal Shock Wave Therapy, Low Back Pain, Dosing Regimens, Physical Medicine and Rehabilitation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFocal Extracorporeal Shock Wave Therapy (F-ESWT)
Non-invasive shock wave therapy applied to specific painful lumbar points using the BTL-6000 FSWT focused shockwave device. The equipment delivers focused acoustic energy to modulate localized pain and stimulate tissue response, according to the designated dosing regimens established in the study protocol.
Sponsors
Armando Tonatiuh Avila Garcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned to one of two parallel groups (Group A or Group B) in a 1:1 allocation ratio. Group A will receive focal extracorporeal shock wave therapy (F-ESWT) using the first specific dosing regimen, while Group B will receive F-ESWT using the second dosing regimen. Both groups will follow identical assessment schedules at baseline and during post-intervention follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS) | Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment | Pain intensity will be evaluated using a 100-mm Visual Analog Scale (VAS), where 0 mm represents "no pain" and 100 mm represents "the worst possible pain". Higher scores indicate greater pain severity. The outcome is measured as the change in millimeter scores from baseline to each subsequent post-treatment follow-up assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Lumbar Functional Disability Using the Oswestry Disability Index (ODI) | Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment | Functional disability associated with mechanical low back pain will be measured using the Oswestry Disability Index (ODI). The questionnaire consists of 10 items assessing limitations in daily activities. Total scores range from 0% (no disability) to 100% (maximum disability). Higher percentages reflect greater functional impairment. |
| Incidence of Treatment-Related Adverse Events | From the first treatment session up to 12 months post-treatment | Safety and tolerability will be evaluated by monitoring and recording the frequency, severity, and type of any localized adverse events associated with focal extracorporeal shock wave therapy (F-ESWT), such as transient erythema, mild bruising, or temporary pain increase. |
Countries
Mexico
Contacts
CONTACTArmando Tonatiuh Ávila García, MD
CONTACTAna Lilia Villagrana, MD
PRINCIPAL_INVESTIGATORTonatiuh Avila Ávila García, MD
Hospital Civil de Guadalajara
Outcome results
None listed