Musculoskeletal Diseases
Conditions
Interventions
Placebo
Sponsors
El Ayachi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male and female participants aged 20-80 years with chronic lumbar radicular pain whatever the etiology, defined as pain lumbosacral radicular radiating into the leg below the knee, which had been present for greater than 3 months, with VAS pain= 6/10, and which was not improved by NSAIDs, analgesics and physical treatment.
Exclusion criteria
Exclusion criteria: (1) a specific spinal pathological entity such as infection, inflammatory or tumor pathology, or fractures, (2) spinal surgery within the last 4 weeks, (3) a coexisting major disease for which clomipramine may be inappropriate: glaucoma, urinary problems, recent myocardial infarction, convulsions, (4) any current use of other antidepressants, (5) current use of recommended full and regular doses of another analgesic, (6) allergy or contraindication for experimental drugs, (7) pregnancy, planning or trying to become pregnant or breastfeeding. All participants will benefit from an initial cardiac evaluation. We will also exclude all subjects with a major cardiovascular risk factor or cardiac pathology with risk of decompensation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain intensity using a Visual Analog Scale (VAS) of 10 mm, scale where patients will be asked to estimate their current pain, with 0 indicating no pain and 10 indicating the worst pain imaginable | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) changes in neuropathic pain symptoms, measured with the DN4 : douleur neuropathic questionnaire, scores ranging from 0 to 10, greater scores sign more neuropathic pain symptoms are present, Cutoff =4 [15]. 2) lumbar radicular discomfort measured using a Visual Analog Scale (VAS) of 10 mm. 3) pain-free perimeter of walking, where participants were asked to estimate how long can they walk without pain, calculated by minutes. 4) Disability by using the Roland Morris Disability Questionnaire (RMDQ) [16], a 24-item instrument designed to assess self-rated low back disability, (0 indicates no functional impairment; 24 indicates maximum functional impairment). 5) severity of mood symptoms by using the Hospital Anxiety and Depression scale (HAD), an instrument for detecting anxiety and depressive disorders, it comprises 14 items rated from 0 to 3 : Seven questions relate to anxiety and seven others to the depressive dimension, thus allowing two scores to be obtained (scores ranging from 0 to 21 of each score), with higher scores (=11) indicating certain sympomatology, 8 to 10 : doubtful symptomatology, =7 : absence of symptomatology [17]. 6) spinal mobility was assessed using Schober’s index (cm) and Finger to Floor Distance (FFD) (cm). | — |
Countries
Morocco
Contacts
Public ContactRedouane Abouqal
Laboratory of Biostatistics Clinical Research and Epidemiology Rabat
Outcome results
None listed