An interventional study of Control Group and Venlafaxine group in Non-specific Low Back Pain and Pain Management, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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.
1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's planned enrollment of 228 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.
Browse Agnosia studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
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Exclusion Criteria:
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain
Drug: Control Group
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
Participants in the control group will receive routine clinical care for chronic nonspecific low back pain.
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.
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.
Time frame: 3 months after randomization
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.
Time frame: 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.
Time frame: 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."
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
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 month, 3 months, and 6 months after randomization
Incidence of Adverse Events
Adverse events will be recorded throughout the study
Time frame: From randomization to 6 months after randomization
Plan to share: Yes
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital