Toludesvenlafaxine for Non-specific Low Back Pain

NCT07709416 | Recruiting DMC

• 1 other identifier: KY2026-110-02-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-specific Low Back Pain

Keywords

Toludesvenlafaxine; Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change From Baseline in Average Low Back Pain Intensity

  Baseline, 1 month, and 6 months after randomization

• Change From Baseline in Functional Disability Assessed by the Roland-Morris Disability Questionnaire

  Baseline, 1 month, 3 months, and 6 months after randomization

• Global Perceived Recovery

  1 month, 3 months, and 6 months after randomization

• Change From Baseline in Health-related Quality of Life Assessed by EQ-5D-5L

  Baseline, 1 month, 3 months, and 6 months after randomization

• Change From Baseline in Sleep Quality Assessed by the Insomnia Severity Index

  Baseline, 1 month, 3 months, and 6 months after randomization

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Drug: Active Comparator #1

Toludesvenlafaxine Group

EXPERIMENTAL

Participants in the toludesvenlafaxine group will receive oral toludesvenlafaxine in addition to background care.

Drug: Toludesvenlafaxine

Interventions

Active Comparator #1 DRUG

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

Control Group

Toludesvenlafaxine DRUG

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.

Toludesvenlafaxine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Fang Luo

Beijing, 100050, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 20461028 RESULT

• 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.

  PMID: 20472510 RESULT

• 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.

  PMID: 39377458 RESULT

• 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.

  PMID: 28192789 RESULT

• 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.

  PMID: 33069326 RESULT

Central Study Contacts

Fang Luo

CONTACT

+8659976661; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)