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Non-specific Low Back PainNCT07709416

Toludesvenlafaxine for Non-specific Low Back Pain

A study testing Active Comparator #1 and Toludesvenlafaxine in people with Non-specific Low Back Pain, run by Beijing Tiantan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-specific Low Back Pain
What is being tested?
Active Comparator #1 and Toludesvenlafaxine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteChina
Study dates
15 Jul 2026to 1 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fang Luo contact

+8659976661

13611326978@163.com

China1 site, 1 recruiting

  • Fang Luo

    Beijing, 100050

    Fang Luo, 59976661, 13611326978@163.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Active Comparator #1, Toludesvenlafaxine
Keywords
Toludesvenlafaxine, Non-specific Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Comparator #1Drug

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

  • ToludesvenlafaxineDrug

    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.

Study groups in NCT07709416
Study groupRoleWhat they receive
Control GroupActive comparatorParticipants in the control group will receive routine clinical care for chronic nonspecific low back pain.
Receives: Drug: Active Comparator #1
Toludesvenlafaxine GroupExperimentalParticipants in the toludesvenlafaxine group will receive oral toludesvenlafaxine in addition to background care.
Receives: Drug: Toludesvenlafaxine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months after randomization

Secondary outcomes (9)

  1. 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.

    Measured: Baseline, 1 month, and 6 months after randomization

  2. 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.

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

  3. Global Perceived Recovery

    Overall improvement will be assessed using a 6-point Likert scale ranging from "much worse" to "completely recovered."

    Measured: 1 month, 3 months, and 6 months after randomization

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. Use of Nonsteroidal Anti-inflammatory Drugs

    The amount and frequency of nonsteroidal anti-inflammatory drug use during the study period will be recorded.

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

  9. Incidence of Adverse Events

    Adverse events will be recorded throughout the study.

    Measured: From randomization to 6 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start15 Jul 2026
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709416
Sponsor's protocol ID
KY2026-110-02-01
Status last verified
Jul 2026
First submitted
12 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 20461028

  • 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.

    PubMed 20472510

  • 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.

    PubMed 39377458

  • 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.

    PubMed 28192789

  • 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.

    PubMed 33069326

Questions about this trial

What is this clinical trial studying?

A study testing Active Comparator #1 and Toludesvenlafaxine in people with Non-specific Low Back Pain, run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fang Luo (+8659976661, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Average Low Back Pain Intensity at Month 3 (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07709416, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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