Venlafaxine for Non-specific Low Back Pain

NCT07737158 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tiantan Hospital

Phase

Not applicable

Started

2026-09-01

Last updated

2026-07-30

Condition(s) studied

Non-specific Low Back PainPain Management

Investigational drug(s) / intervention(s)

Control GroupVenlafaxine group

Control Group: Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.

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.

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 Venlafaxine 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

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)

Facility	City	Region	Status
Beijing Tiantan Hospital	Beijing	China

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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 NCT07737158 on ClinicalTrials.gov ↗ ← All trials in China