Toludesvenlafaxine for Non-specific Low Back Pain

July 24, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
Drug: Active Comparator #1
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average Low Back Pain Intensity at Month 3
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average Low Back Pain Intensity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: From randomization to 6 months after randomization
Adverse events will be recorded throughout the study.
From randomization to 6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2026-110-02-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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