Toludesvenlafaxine for Non-specific Low Back Pain

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: Not yet recruiting
• Conditions: Non-specific Low Back Pain
• Intervention / Treatment: Drug: Active Comparator #1; Drug: Toludesvenlafaxine

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Luo; Phone Number: +8659976661; Email: 13611326978@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average Low Back Pain Intensity at Month 3	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

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average Low Back Pain Intensity	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	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	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	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	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	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	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	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	Adverse events will be recorded throughout the study.	From randomization to 6 months after randomization

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Non-specific Low Back Pain; Toludesvenlafaxine
• Other Study ID 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