Chronic Low Back Pain (CLBP)ESWT-LBPNCT07646132
Focal Extracorporeal Shock Wave Therapy With Two Different Dosing Regimens for Chronic Low Back Pain
A study testing Focal Extracorporeal Shock Wave Therapy (F-ESWT) in people with Chronic Low Back Pain (CLBP), run by Armando Tonatiuh Avila Garcia at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Focal Extracorporeal Shock Wave Therapy (F-ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jun 2026to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Medicina Física y Rehabilitación
Guadalajara, Jalisco, 44280
Armando Tonatiuh Ávila García, MD, 523339424400 ext. 71234, atavila@hcg.gob.mx
Ana Lilia Villagrana, MD, 523339424400 ext. 71234, alvillagrana@hcg.gob.mx
About this study
Official title: Effects of Two Dosing Regimens of Focal Extracorporeal Shock Wave Therapy in Patients With Chronic Low Back Pain: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Focal Extracorporeal Shock Wave Therapy (F-ESWT)
- Keywords
- Focal Extracorporeal Shock Wave Therapy, Low Back Pain, Dosing Regimens, Physical Medicine and Rehabilitation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Focal Extracorporeal Shock Wave Therapy (F-ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
Incidence of Treatment-Related Adverse Events
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.
Measured: From the first treatment session up to 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armando Tonatiuh Avila Garcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armando Tonatiuh Avila Garcia, Hospital Civil de Guadalajara
- Investigators
- Tonatiuh Avila Ávila García, MD, Principal investigator, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646132
- Sponsor's protocol ID
- CEI 121/26
- Acronym
- ESWT-LBP
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in future publications (including text, tables, and figures) will be made available to researchers for secondary academic and clinical analyses.
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.
PubMed 24667365Back 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.
PubMed 40276911Tsai 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.
PubMed 41195354Jenks 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.
PubMed 35584027Taheri 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.
PubMed 34336620De 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.
PubMed 37957975Taheri 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.
PubMed 33453192Sun 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.
PubMed 36375191Nedelka 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.
PubMed 40391994Rompe 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.
PubMed 9619954Liu 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.
PubMed 37355623Wu 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.
PubMed 38206739Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.
PubMed 12846521Farley 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.
PubMed 39063567Deyo 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.
PubMed 17077742
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Dosing Regimens of Focal Extracorporeal Shock Wave Therapy in Patients With Chronic Low Back Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07646132
- Acronym / sponsor ID
- ESWT-LBP / CEI 121/26
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- Focal Extracorporeal Shock Wave Therapy, Low Back Pain, Dosing Regimens, Physical Medicine and Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Armando Tonatiuh Avila GarciaUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A: Regimen 1 | Experimental | Device: Focal Extracorporeal Shock Wave Therapy (F-ESWT)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. |
| Group B: Regimen 2 | Experimental | Device: Focal Extracorporeal Shock Wave Therapy (F-ESWT)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group A: Regimen 1, Group B: Regimen 2 |
Primary outcome
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
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 24667365Ioppolo 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.
- Background: PubMed 40276911Back 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.
- Background: PubMed 41195354Tsai 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.
- Background: PubMed 35584027Jenks 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.
- Background: PubMed 34336620Taheri 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.
- Background: PubMed 37957975De 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.
- Background: PubMed 33453192Taheri 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.
- Background: PubMed 36375191Sun 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.
- Background: PubMed 40391994Nedelka 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.
- Background: PubMed 9619954Rompe 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.
- Background: PubMed 37355623Liu 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.
- Background: PubMed 38206739Wu 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in future publications (including text, tables, and figures) will be made available to researchers for secondary academic and clinical analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tonatiuh Avila Ávila García, MD principal investigator
Hospital Civil de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal Extracorporeal Shock Wave Therapy (F-ESWT) in people with Chronic Low Back Pain (CLBP), run by Armando Tonatiuh Avila Garcia at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armando Tonatiuh Ávila García, MD (523339424400 ext. 43021, atavila@hcg.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07646132, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.