Focal Extracorporeal Shock Wave Therapy With Two Different Dosing Regimens for Chronic Low Back Pain (ESWT-LBP)
2026年6月9日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Armando Tonatiuh Ávila García, MD
- 電話番号：43021 523339424400
- メール：atavila@hcg.gob.mx
研究連絡先のバックアップ
- 名前：Ana Lilia Villagrana, MD
- 電話番号：43021 523339424400
- メール：alvillagrana@hcg.gob.mx
研究場所
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Jalisco
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Guadalajara、Jalisco、メキシコ、44280
- Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde", Servicio de Medicina Física y Rehabilitación
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コンタクト：
- Armando Tonatiuh Ávila García, MD
- 電話番号：71234 523339424400
- メール：atavila@hcg.gob.mx
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コンタクト：
- Ana Lilia Villagrana, MD
- 電話番号：71234 523339424400
- メール：alvillagrana@hcg.gob.mx
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主任研究者：
- Armando Tonatiuh Ávila García, MD
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副調査官：
- Ana Lilia Villagrana Rodríguez, MD
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副調査官：
- Carlos Fernando Godínez González, MD
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副調査官：
- Ismael Caballero Quirarte, MD
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副調査官：
- Daniel Miller Serrano, MD
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副調査官：
- Aram Jesús Gómez Nájera, MD
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副調査官：
- José de Jesús Sandoval Zuno, MD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Lumbar Functional Disability Using the Oswestry Disability Index (ODI)
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Tonatiuh Avila Ávila García, MD、Hospital Civil de Guadalajara
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月15日
一次修了 (推定)
2027年12月30日
研究の完了 (推定)
2028年1月30日
試験登録日
最初に提出
2026年6月9日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12日
QC基準を満たした最後の更新が送信されました
2026年6月9日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CEI 121/26
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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IPD 共有時間枠
Data will become available beginning 6 months after main publication and will remain accessible for up to 3 years.
IPD 共有アクセス基準
Data will be shared with qualified researchers who provide a methodologically sound proposal.
Requests should be directed to the corresponding investigator.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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いいえ
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いいえ
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