Venlafaxine for Non-specific Low Back Pain

Официальное название

Efficacy and Safety of Venlafaxine in the Treatment of Non-specific Low Back Pain

Обзор

Chronic non-specific low back pain is the leading cause of productivity loss and disability worldwide, constituting a major public health challenge. This study aims to systematically evaluate and compare the role of the antidepressant drug Venlafaxine in chronic non-specific low back pain, which is of critical importance for optimising clinical practice and developing precise, individualised treatment regimens.

Вмешательства

• Препарат Control Group
  Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
• Препарат Venlafaxine group
  Venlafaxine is administered orally at a starting dose of 75 mg once daily. In patients with insufficient pain response who can tolerate the adverse effects, the dose may be carefully titrated up to 225 mg once daily. The maintenance period is 3 months.

Первичные конечные точки

• Change From Baseline in Average Low Back Pain Intensity at Month 3 [Срок оценки: 3 months after randomization]

Вторичные конечные точки (9)

• Change From Baseline in Average Low Back Pain Intensity [Срок оценки: Baseline, 1 month, and 6 months after randomization]
• Change From Baseline in Functional Disability Assessed by the Roland-Morris Disability Questionnaire [Срок оценки: Baseline, 1 month, 3 months, and 6 months after randomization]
• Global Perceived Recovery [Срок оценки: 1 month, 3 months, and 6 months after randomization]
• Change From Baseline in Health-related Quality of Life Assessed by EQ-5D-5L [Срок оценки: Baseline, 1 month, 3 months, and 6 months after randomization]
• Change From Baseline in Sleep Quality Assessed by the Insomnia Severity Index [Срок оценки: Baseline, 1 month, 3 months, and 6 months after randomization]
• Change From Baseline in Back Pain Beliefs Assessed by the Back Beliefs Questionnaire [Срок оценки: Baseline, 1 month, 3 months, and 6 months after randomization]
• Change From Baseline in Neuropathic Pain Features Assessed by the painDETECT Questionnaire [Срок оценки: Baseline, 1 month, 3 months, and 6 months after randomization]
• Use of Nonsteroidal Anti-inflammatory Drugs [Срок оценки: Baseline, 1 month, 3 months, and 6 months after randomization]
• Incidence of Adverse Events [Срок оценки: From randomization to 6 months after randomization]

Критерии участия

Критерии включения

• Adults aged 18 to 75 years.
• Diagnosis of chronic nonspecific low back pain, defined as pain located below the costal margin and above the inferior gluteal folds, lasting for more than 3 months, without a specific pathological cause.
• Moderate to severe pain, defined as a Numerical Rating Scale score of 3 or higher.
• Able to understand the study procedures and sign written informed consent.

Критерии исключения

• Low back pain caused by a known specific pathological condition, including but not limited to fracture, malignancy, infection, inflammatory disease, or other identifiable structural or systemic causes.
• Major comorbidities that may interfere with study outcomes or represent contraindications to the study medication.
• Current or previous diagnosis of depression, regardless of whether treatment was received.
• Current or previous use of antidepressant medication.
• Current use of opioid analgesics.
• Pregnancy, breastfeeding, or planned pregnancy during the study period.
• Known allergy, hypersensitivity, or contraindication to toludesvenlafaxine.
• History of psychosis or other major psychiatric disorders.
• Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Публикации

• Konno S, Oda N, Ochiai T, Alev L. Randomized, Double-blind, Placebo-controlled Phase III Trial of Duloxetine Monotherapy in Japanese Patients With Chronic Low Back Pain. Spine (Phila Pa 1976). 2016 Nov 15;41(22):1709-1717. doi: 10.1097/BRS.0000000000001707. PMID 27831985
• Skljarevski V, Ossanna M, Liu-Seifert H, Zhang Q, Chappell A, Iyengar S, Detke M, Backonja M. A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain. Eur J Neurol. 2009 Sep;16(9):1041-8. doi: 10.1111/j.1468-1331.2009.02648.x. Epub 2009 May 12. PMID 19469829
• GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9. PMID 33069326
• Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-23 PMID 28192789
• Leao Nunes Filho MJ, Barreto ESR, Antunes Junior CR, Alencar VB, Falcao Lins-Kusterer LE, Azi LMTA, Kraychete DC. Efficacy of antidepressants in the treatment of chronic nonspecific low back pain: a systematic review and meta-analysis. Pain Manag. 2024;14(8):437-451. doi: 10.1080/17581869.2024.2408215. Epub 2024 Oct 8. PMID 39377458
• Skljarevski V, Zhang S, Desaiah D, Alaka KJ, Palacios S, Miazgowski T, Patrick K. Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. J Pain. 2010 Dec;11(12):1282-90. doi: 10.1016/j.jpain.2010.03.002. Epub 2010 May 15. PMID 20472510
• Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578-85. doi: 10.1097/BRS.0b013e3181d3cef6. PMID 20461028

Идентификаторы

NCT: NCT07737158 · KY2026-110-02-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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