Non-specific Low Back PainNCT07737158
Venlafaxine for Non-specific Low Back Pain
A study testing Venlafaxine group in people with Non-specific Low Back Pain and Pain Management, run by Beijing Tiantan Hospital at 1 site in China.
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 Venlafaxine 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, Pain Management
- What is being tested?
- Venlafaxine group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 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.
China1 site
Beijing Tiantan Hospital
Beijing, China, 100050
Fang Luo, 59976661, 13611326978@163.com
About this study
Official title: Efficacy and Safety of Venlafaxine 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 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
- Being tested
- Control Group, Venlafaxine group
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupDrug
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
Venlafaxine groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants in the control group will receive routine clinical care for chronic nonspecific low back pain Receives: 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. Receives: Drug: Venlafaxine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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.
- First posted30 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737158
- Sponsor's protocol ID
- KY2026-110-02-02
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27831985Skljarevski 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.
PubMed 19469829GBD 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 33069326Qaseem 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 28192789Leao 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 39377458Skljarevski 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 20472510Skljarevski 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Venlafaxine in the Treatment of Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07737158
- Acronym / sponsor ID
- KY2026-110-02-02
- Conditions
- Non-specific Low Back Pain, Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Control GroupParticipants in the control group will receive routine clinical care for chronic nonspecific low back pain |
| Venlafaxine group | Experimental | Drug: Venlafaxine groupVenlafaxine 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupParticipants in the control group will receive routine clinical care for chronic nonspecific low back pain. | Drug | Control Group |
| Venlafaxine groupVenlafaxine 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 |
Primary outcome
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.
9 secondary outcomes
Change From Baseline in Average Low Back Pain Intensity
Time frame: Baseline, 1 month, and 6 months after randomization
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
Global Perceived Recovery
Time frame: 1 month, 3 months, and 6 months after randomization
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
Change From Baseline in Sleep Quality Assessed by the Insomnia Severity Index
Time frame: Baseline, 1 month, 3 months, and 6 months after randomization
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
Change From Baseline in Neuropathic Pain Features Assessed by the painDETECT Questionnaire
Time frame: Baseline, 1 month, 3 months, and 6 months after randomization
Use of Nonsteroidal Anti-inflammatory Drugs
Time frame: Baseline, 1 month, 3 months, and 6 months after randomization
Incidence of Adverse Events
Time frame: From randomization to 6 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Results publication: PubMed 27831985Konno 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.
- Results publication: PubMed 19469829Skljarevski 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.
- Results publication: PubMed 33069326GBD 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.
- Results publication: PubMed 28192789Qaseem 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.
- Results publication: PubMed 39377458Leao 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.
- Results publication: PubMed 20472510Skljarevski 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.
- Results publication: PubMed 20461028Skljarevski 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venlafaxine group in people with Non-specific Low Back Pain and Pain Management, 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: opening soon, as of the sponsor's last update on 30 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 NCT07737158, which also lists 7 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 30 Jul 2026.