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Clinical Trials in China / NCT07709416
Recruiting Not applicable

Toludesvenlafaxine for Non-specific Low Back Pain

NCT07709416 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Not applicable
Started
2026-07-15
Last updated
2026-07-27

Condition(s) studied

Non-specific Low Back Pain

Investigational drug(s) / intervention(s)

Active Comparator #1Toludesvenlafaxine

Active Comparator #1: Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.

Toludesvenlafaxine: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change From Baseline in Average Low Back Pain Intensity at Month 3 — 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.

Trial sites (1)

FacilityCityRegionStatus
Fang Luo Beijing China Recruiting

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Other trials for the same condition

Venlafaxine for Non-specific Low Back Pain Starting soon
Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07709416 on ClinicalTrials.gov ↗ ← All trials in China