Focal Extracorporeal Shock Wave Therapy With Two Different Dosing Regimens for Chronic Low Back Pain (ESWT-LBP)
2026년 6월 9일 업데이트: Armando Tonatiuh Avila Garcia
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Armando Tonatiuh Ávila García, MD
- 전화번호: 43021 523339424400
- 이메일: atavila@hcg.gob.mx
연구 연락처 백업
- 이름: Ana Lilia Villagrana, MD
- 전화번호: 43021 523339424400
- 이메일: alvillagrana@hcg.gob.mx
연구 장소
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Jalisco
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Guadalajara, Jalisco, 멕시코, 44280
- Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Medicina Física y Rehabilitación
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연락하다:
- Armando Tonatiuh Ávila García, MD
- 전화번호: 71234 523339424400
- 이메일: atavila@hcg.gob.mx
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연락하다:
- Ana Lilia Villagrana, MD
- 전화번호: 71234 523339424400
- 이메일: alvillagrana@hcg.gob.mx
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수석 연구원:
- Armando Tonatiuh Ávila García, MD
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부수사관:
- Ana Lilia Villagrana Rodríguez, MD
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부수사관:
- Carlos Fernando Godínez González, MD
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부수사관:
- Ismael Caballero Quirarte, MD
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부수사관:
- Daniel Miller Serrano, MD
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부수사관:
- Aram Jesús Gómez Nájera, MD
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부수사관:
- José de Jesús Sandoval Zuno, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group A: Regimen 1
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.
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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.
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실험적: Group B: Regimen 2
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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)
기간: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
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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.
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Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in Lumbar Functional Disability Using the Oswestry Disability Index (ODI)
기간: Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
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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.
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Baseline, 2 months, 4 months, 6 months, and 12 months post-treatment
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Incidence of Treatment-Related Adverse Events
기간: From the first treatment session up to 12 months post-treatment
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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.
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From the first treatment session up to 12 months post-treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Tonatiuh Avila Ávila García, MD, Hospital Civil de Guadalajara
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 15일
기본 완료 (추정된)
2027년 12월 30일
연구 완료 (추정된)
2028년 1월 30일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CEI 121/26
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예
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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.
IPD 공유 기간
Data will become available beginning 6 months after main publication and will remain accessible for up to 3 years.
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Data will be shared with qualified researchers who provide a methodologically sound proposal.
Requests should be directed to the corresponding investigator.
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