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

NCT07646132 | Not Yet Recruiting

• 1 other identifier: CEI 121/26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

Focal Extracorporeal Shock Wave Therapy; Low Back Pain; Dosing Regimens; Physical Medicine and Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)

  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.

  Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment

Secondary Outcomes (2)

• 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

• Incidence of Treatment-Related Adverse Events

  From the first treatment session up to 12 months post-treatment

Study Arms (2)

Group A: Regimen 1

EXPERIMENTAL

Participants in this group will receive focal extracorporeal shock wave therapy (F-ESWT) administered to the lumbar region using the first specific dosing scheme, characterized by designated energy flux density and session frequency parameters as outlined in the protocol.

Device: Focal Extracorporeal Shock Wave Therapy (F-ESWT)

Group B: Regimen 2

EXPERIMENTAL

Participants in this group will receive focal extracorporeal shock wave therapy (F-ESWT) administered to the lumbar region using the second specific dosing scheme, characterized by alternative energy flux density and session frequency parameters as outlined in the protocol.

Device: Focal Extracorporeal Shock Wave Therapy (F-ESWT)

Interventions

Focal Extracorporeal Shock Wave Therapy (F-ESWT) DEVICE

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.

Group A: Regimen 1; Group B: Regimen 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Armando Tonatiuh Avila Garcia: lead

Study Sites (1)

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Medicina Física y Rehabilitación

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Nedelka T, Katolicky J, Nedelka J, Hobrough P, Knobloch K. Efficacy of high-energy, focused ESWT in treatment of lumbar facet joint pain: a randomized sham-controlled trial. Int J Surg. 2025 Jul 1;111(7):4177-4186. doi: 10.1097/JS9.0000000000002538. Epub 2025 May 20.

  PMID: 40391994 BACKGROUND

• Rompe JD, Kirkpatrick CJ, Kullmer K, Schwitalle M, Krischek O. Dose-related effects of shock waves on rabbit tendo Achillis. A sonographic and histological study. J Bone Joint Surg Br. 1998 May;80(3):546-52. doi: 10.1302/0301-620x.80b3.8434.

  PMID: 9619954 BACKGROUND

• Liu K, Zhang Q, Chen L, Zhang H, Xu X, Yuan Z, Dong J. Efficacy and safety of extracorporeal shockwave therapy in chronic low back pain: a systematic review and meta-analysis of 632 patients. J Orthop Surg Res. 2023 Jun 24;18(1):455. doi: 10.1186/s13018-023-03943-x.

  PMID: 37355623 BACKGROUND

• Wu Z, Zhou T, Ai S. Extracorporeal shock wave therapy for low back pain: A systematic review and meta-analysis. Medicine (Baltimore). 2023 Dec 29;102(52):e36596. doi: 10.1097/MD.0000000000036596.

  PMID: 38206739 BACKGROUND

• Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.

  PMID: 12846521 BACKGROUND

• Farley T, Stokke J, Goyal K, DeMicco R. Chronic Low Back Pain: History, Symptoms, Pain Mechanisms, and Treatment. Life (Basel). 2024 Jun 27;14(7):812. doi: 10.3390/life14070812.

  PMID: 39063567 BACKGROUND

• Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2724-7. doi: 10.1097/01.brs.0000244618.06877.cd.

  PMID: 17077742 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tonatiuh Avila Ávila García, MD

  Hospital Civil de Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armando Tonatiuh Ávila García, MD

CONTACT

523339424400; atavila@hcg.gob.mx

Ana Lilia Villagrana, MD

CONTACT

523339424400; alvillagrana@hcg.gob.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of the Department of Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available beginning 6 months after main publication and will remain accessible for up to 3 years.
• Access Criteria: Data will be shared with qualified researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding investigator.

Locations

ME (1)