Venlafaxine for Non-specific Low Back Pain

NCT07737158 | Not Yet Recruiting DMC

• 1 other identifier: KY2026-110-02-02
• Study Type: interventional
• Target: 228
• 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 Venlafaxine 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; Pain Management

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: Control Group

Venlafaxine group

EXPERIMENTAL

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.

Drug: Venlafaxine group

Interventions

Control Group DRUG

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

Control Group

Venlafaxine group DRUG

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.

Venlafaxine 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)

Beijing Tiantan Hospital

Beijing, China, 100050, China

Location

Related Publications (7)

• Konno S, Oda N, Ochiai T, Alev L. Randomized, Double-blind, Placebo-controlled Phase III Trial of Duloxetine Monotherapy in Japanese Patients With Chronic Low Back Pain. Spine (Phila Pa 1976). 2016 Nov 15;41(22):1709-1717. doi: 10.1097/BRS.0000000000001707.

  PMID: 27831985 RESULT

• Skljarevski V, Ossanna M, Liu-Seifert H, Zhang Q, Chappell A, Iyengar S, Detke M, Backonja M. A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain. Eur J Neurol. 2009 Sep;16(9):1041-8. doi: 10.1111/j.1468-1331.2009.02648.x. Epub 2009 May 12.

  PMID: 19469829 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

• 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

• 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

• 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

• 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

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

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 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)