Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202001764151121 Date of Approval: 14/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Clomipramine for chronic lumbar radicular pain: A Randomized Clinical Trial
Official scientific title Efficacy of Clomipramine for chronic lumbar radicular pain: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Lumbar radicular pain is the most common chronic neuropathic pain syndrome. Antidepressants are highly recommended for neuropathic pain, but there is no evidence for their efficacy. The aim of this double-blind, randomised, placebo-controlled trial is to determine whether Clomipramine (an antidepressant) is more effective than placebo in reducing pain in individuals with chronic lumbar radicular pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 27/05/2019
Actual trial start date 27/05/2019
Anticipated date of last follow up 06/11/2019
Actual Last follow-up date 06/11/2019
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants) 62
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo 500 ml of physiological serum a day 10 days Eligible patients will be randomized in order to receive Clomipramine by slow intravenous infusion for 10 days in a hospital setting with progressively increasing doses, 25 mg on the first day, 50 mg on the second day and 75 mg on the third day, until the tenth day, or placebo (500 ml of physiological serum a day). For both groups, paracetamol is added intravenously at a dose of 3g per day for ten days, Parecoxib injection for 3 days and ten sessions of lumbar spine rehabilitation including analgesic massage, muscle strengthening and joint maintenance. At the exit, clomipramine will be relayed with 25 mg per day orally until the 90th day, and paracetamol will be authorized in both groups, in case of severe pain. A gradual increase in doses was chosen to avoid the adverse effects of CMP such as somnolence, orthostatic hypoyesis, vertigo and epiagralgia, which are generally well tolerated. 31 Placebo
Experimental Group Clomipramine Clomipramine by slow intravenous infusion for 10 days in a hospital setting with progressively increasing doses, 25 mg on the first day, 50 mg on the second day and 75 mg on the third day, until the tenth day. At the exit, clomipramine will be relayed with 25 mg per day orally until the 90th day. 90 days Eligible patients will be randomized in order to receive Clomipramine by slow intravenous infusion for 10 days in a hospital setting with progressively increasing doses, 25 mg on the first day, 50 mg on the second day and 75 mg on the third day, until the tenth day, or placebo (500 ml of physiological serum a day). For both groups, paracetamol is added intravenously at a dose of 3g per day for ten days, Parecoxib injection for 3 days and ten sessions of lumbar spine rehabilitation including analgesic massage, muscle strengthening and joint maintenance. At the exit, clomipramine will be relayed with 25 mg per day orally until the 90th day, and paracetamol will be authorized in both groups, in case of severe pain. A gradual increase in doses was chosen to avoid the adverse effects of CMP such as somnolence, orthostatic hypoyesis, vertigo and epiagralgia, which are generally well tolerated. 31
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. (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 Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/05/2019 ethics committee for biomedical research of the University Mohammed V Souissi Rabat
Ethics Committee Address
Street address City Postal code Country
Impasse souissi, rabat Rabat 10100 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 measured at baseline, 5th day, 10th day and 90th day.
Secondary Outcome 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). assessed on days 0, 5, 10 and 90.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Ayachi Hospital street Sidi Bouhaja sale 11150 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
El Ayachi Hospital street sidi Bouhaja sale 11150 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor El Ayachi Hospital street sidi bouhaja sale 11150 Morocco Hospital
COLLABORATORS
Name Street address City Postal code Country
El Ayachi Hospital Street Sidi Bouhaja sale 11150 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator saloua afilal salouaafilal@gmail.com +212670667249 street sidi bouhaja
City Postal code Country Position/Affiliation
sale 11150 Morocco Rheumatology B Department El Ayachi Hospital
Role Name Email Phone Street address
Scientific Enquiries fadoua allali fadouaallali@yahoo.fr +212661181824 street sidi bouhaja
City Postal code Country Position/Affiliation
sale 11150 Morocco Rheumatology B Department El Ayachi Hospital.
Role Name Email Phone Street address
Public Enquiries Redouane Abouqal Redouane.abouqal@yahoo.fr +212613734606 Faculty of Medicine and Pharmacy, impasse souissi, Rabat, Morocco
City Postal code Country Position/Affiliation
Rabat Morocco Laboratory of Biostatistics Clinical Research and Epidemiology Rabat
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Clinical data Outcome data Informed Consent Form,Study Protocol 2 months access controlled data analysis permitted: clinical data and outcome data process for requesting data: by request by e-mail who will decide: El ayachi Hospital, Allali Fadoua reviewing requests: academics
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information