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NCT Number: NCT07709416

Toludesvenlafaxine for 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.

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Key information

Conditions

Non-specific Low Back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Comparator #1

Drug

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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."

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Incidence of Adverse Events

    Time frame: From randomization to 6 months after randomization

    Adverse events will be recorded throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

+8659976661

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Efficacy and Safety of Toludesvenlafaxine in the Treatment of Non-specific Low Back Pain

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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