Focal Extracorporeal Shock Wave Therapy With Two Different Dosing Regimens for Chronic Low Back Pain

Official title

Effects of Two Dosing Regimens of Focal Extracorporeal Shock Wave Therapy in Patients With Chronic Low Back Pain: A Randomized Clinical Trial

Overview

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

• Device Focal 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.

Primary outcome measures

• Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS) [Time frame: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment]

Secondary outcome measures (2)

• Change from Baseline in Lumbar Functional Disability Using the Oswestry Disability Index (ODI) [Time frame: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment]
• Incidence of Treatment-Related Adverse Events [Time frame: From the first treatment session up to 12 months post-treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Mexico · 1 center

• Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Medicina Física — Guadalajara

Publications

• Ioppolo F, Rompe JD, Furia JP, Cacchio A. Clinical application of shock wave therapy (SWT) in musculoskeletal disorders. Eur J Phys Rehabil Med. 2014 Apr;50(2):217-30. Epub 2014 Mar 26. PMID 24667365
• Back CGN, Peron R, Lopes CVR, de Souza JVE, Liebano RE. Immediate effect of extracorporeal shockwave therapy in patients with chronic nonspecific low back pain: A randomized placebo-controlled triple-blind trial. Clin Rehabil. 2025 May;39(5):701-702. doi: 10.1177/02692155251333532. Epub 2025 Apr 25. No abstract available. PMID 40276911
• Tsai AWW, Fin M, Liu IAW, Fontana R, Melo Junior SM, Forni JEN. [Update on Non-surgical Treatments for Lumbar Pain]. Rev Bras Ortop (Sao Paulo). 2025 Nov 4;60(5):s00451810405. doi: 10.1055/s-0045-1810405. eCollection 2025 Oct. Portuguese. PMID 41195354
• Jenks A, Hoekstra T, van Tulder M, Ostelo RW, Rubinstein SM, Chiarotto A. Roland-Morris Disability Questionnaire, Oswestry Disability Index, and Quebec Back Pain Disability Scale: Which Has Superior Measurement Properties in Older Adults With Low Back Pain? J Orthop Sports Phys Ther. 2022 Jul;52(7):457-469. doi: 10.2519/jospt.2022.10802. Epub 2022 May 18. PMID 35584027
• Taheri P, Naderi M, Khosravi S. Extracorporeal Shock Wave Therapy Versus Phonophoresis Therapy for Neck Myofascial Pain Syndrome: A Randomized Clinical Trial. Anesth Pain Med. 2021 May 1;11(2):e112592. doi: 10.5812/aapm.112592. eCollection 2021 Apr. PMID 34336620
• De la Corte-Rodriguez H, Roman-Belmonte JM, Rodriguez-Damiani BA, Vazquez-Sasot A, Rodriguez-Merchan EC. Extracorporeal Shock Wave Therapy for the Treatment of Musculoskeletal Pain: A Narrative Review. Healthcare (Basel). 2023 Oct 26;11(21):2830. doi: 10.3390/healthcare11212830. PMID 37957975
• Taheri P, Khosrawi S, Ramezani M. Extracorporeal Shock Wave Therapy Combined With Oral Medication and Exercise for Chronic Low Back Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Jul;102(7):1294-1299. doi: 10.1016/j.apmr.2020.12.008. Epub 2021 Jan 14. PMID 33453192
• Sun H, Chen H, Mu G, Fu H, Yue L. Comparison of Different Treatment Regimens of Extracorporeal Shockwave Therapy in Chronic Low-back Pain: A Randomized Controlled Trial. Pain Physician. 2022 Nov;25(8):E1211-E1218. PMID 36375191

Identifiers

NCT: NCT07646132 · CEI 121/26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗