Toludesvenlafaxine for non-specific low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates toludesvenlafaxine as an active comparator for adults with chronic non-specific low back pain. Participants are adults 18 to 75 with moderate to severe pain lasting at least 3 months and no identifiable spinal pathology. The trial focuses on pain reduction as the primary outcome, using standard pain scales, under controlled conditions to compare toludesvenlafaxine with a reference treatment. Exclusion criteria include depression, prior antidepressant use, opioid use, and other conditions that could confound results. The lead sponsor is Beijing Tiantan Hospital, with recruitment centered in Beijing, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fang Luo
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fang Luo
• Email: 13611326978@163.com
• Phone: +8659976661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.