Toludesvenlafaxine for Non-specific Low Back Pain
24 de julio de 2026 actualizado por: Fang Luo, Beijing Tiantan Hospital
Efficacy and Safety of Toludesvenlafaxine in the Treatment of Non-specific Low Back Pain
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 toludesvenlafaxine in chronic non-specific low back pain, which is of critical importance for optimising clinical practice and developing precise, individualised treatment regimens.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
132
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Fang Luo
- Número de teléfono: +8659976661
- Correo electrónico: 13611326978@163.com
Ubicaciones de estudio
-
-
-
Beijing, Porcelana, 100050
- Reclutamiento
- Fang Luo
-
Contacto:
- Fang Luo
- Número de teléfono: 59976661
- Correo electrónico: 13611326978@163.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Control Group
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
|
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
|
|
Experimental: Toludesvenlafaxine Group
Participants in the toludesvenlafaxine group will receive oral toludesvenlafaxine in addition to background care.
|
Participants in the toludesvenlafaxine group will receive oral toludesvenlafaxine in addition to background care.
Toludesvenlafaxine will be administered at 80 mg once daily.
For participants with insufficient pain relief and acceptable tolerability, the dose may be cautiously increased to 160 mg once daily.
The maintenance treatment period will be 3 months.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Average Low Back Pain Intensity at Month 3
Periodo de tiempo: 3 months after randomization
|
Average low back pain intensity during the previous week will be assessed using an 11-point Numerical Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
3 months after randomization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Average Low Back Pain Intensity
Periodo de tiempo: Baseline, 1 month, and 6 months after randomization
|
Average low back pain intensity during the previous week will be assessed using an 11-point Numerical Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
Baseline, 1 month, and 6 months after randomization
|
|
Change From Baseline in Functional Disability Assessed by the Roland-Morris Disability Questionnaire
Periodo de tiempo: Baseline, 1 month, 3 months, and 6 months after randomization
|
Functional disability related to low back pain will be assessed using the Roland-Morris Disability Questionnaire.
Higher scores indicate greater functional disability.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Global Perceived Recovery
Periodo de tiempo: 1 month, 3 months, and 6 months after randomization
|
Overall improvement will be assessed using a 6-point Likert scale ranging from "much worse" to "completely recovered."
|
1 month, 3 months, and 6 months after randomization
|
|
Change From Baseline in Health-related Quality of Life Assessed by EQ-5D-5L
Periodo de tiempo: Baseline, 1 month, 3 months, and 6 months after randomization
|
Health-related quality of life will be assessed using the EQ-5D-5L.
The EQ-5D-5L includes five health dimensions, and each dimension has five severity levels.
Higher health utility scores indicate better health status.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Change From Baseline in Sleep Quality Assessed by the Insomnia Severity Index
Periodo de tiempo: Baseline, 1 month, 3 months, and 6 months after randomization
|
Sleep quality and insomnia symptoms will be assessed using the patient-reported version of the Insomnia Severity Index.
The scale contains 7 items evaluating sleep onset difficulty, sleep maintenance difficulty, early morning awakening, satisfaction with sleep, interference with daytime functioning, noticeability of sleep problems, and distress caused by sleep difficulties.
Each item is scored from 0 to 4, and the total score ranges from 0 to 28.
Scores are interpreted as follows: 0-7, no clinically significant insomnia; 8-14, subthreshold insomnia; 15-21, moderate insomnia; and 22-28, severe insomnia.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Change From Baseline in Back Pain Beliefs Assessed by the Back Beliefs Questionnaire
Periodo de tiempo: Baseline, 1 month, 3 months, and 6 months after randomization
|
Beliefs about back pain will be assessed using the Back Beliefs Questionnaire.
Scores range from 9 to 45, with lower scores indicating more pessimistic beliefs about the consequences of back pain.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Change From Baseline in Neuropathic Pain Features Assessed by the painDETECT Questionnaire
Periodo de tiempo: Baseline, 1 month, 3 months, and 6 months after randomization
|
Neuropathic pain features will be assessed using the painDETECT questionnaire.
A score of 19 or higher suggests the presence of a neuropathic pain component.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Use of Nonsteroidal Anti-inflammatory Drugs
Periodo de tiempo: Baseline, 1 month, 3 months, and 6 months after randomization
|
The amount and frequency of nonsteroidal anti-inflammatory drug use during the study period will be recorded.
|
Baseline, 1 month, 3 months, and 6 months after randomization
|
|
Incidence of Adverse Events
Periodo de tiempo: From randomization to 6 months after randomization
|
Adverse events will be recorded throughout the study.
|
From randomization to 6 months after randomization
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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/M16-2367. Epub 2017 Feb 14.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de julio de 2026
Finalización primaria (Estimado)
1 de septiembre de 2028
Finalización del estudio (Estimado)
1 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
12 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- KY2026-110-02-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available.
Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .