Venlafaxine for Non-specific Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Control Group
DrugParticipants in the control group will receive routine clinical care for chronic nonspecific low back pain.
Venlafaxine group
DrugVenlafaxine 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.
Treatment groups
228 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Venlafaxine groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
3 months after randomizationSecondary outcomes
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.
Time frame
Baseline, 1 month, and 6 months after randomization2
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 randomization3
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 randomization4
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 randomizationSponsors and contacts
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Source ClinicalTrials.gov
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