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.: PACTR202003721200086 Date of Approval: 26/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between two low doses of Amitriptyline in the management of chronic neck pain. A Randomized double-blind comparative study.
Official scientific title Comparison between two low doses of Amitriptyline in the management of chronic neck pain. A Randomized double-blind comparative study.
Brief summary describing the background and objectives of the trial Although idiopathic chronic neck pain (CNP) is a common and disabling condition, its management is not always optimal. CNP affects 10–20% of the general population and is more common in women and people under psychosocial stress with peak prevalence between the ages of 55 and 64 years.1,2 CNP has a high socio-economic impact with subsequent substantial disability and decreased quality of life.3,4 Almost three-quarters of subjects with CNP have no history of trauma. Factors incriminated in the transition from acute to chronic neck pain can be biomechanical, psychological and cognitive.2, 5, 6Although amitriptyline has a wide range of side effects at high doses, these are substantially lessened at lower doses and tend to gradually taper over time, while the analgesic effect remains long-lasting.15,16 Therefore, this drug has been commonly used empirically for the management of CNP, without clinical trials testing its efficacy and safety in the literature.14 one clinical trial reported that low dosage (5 mg) of amitriptyline was effective in the management of idiopathic CNP with few side effects.3 In this context, we will conduct a prospective, randomized double-blind comparative study to test the effectiveness and tolerance of two low doses (5 mg and 10 mg) of amitriptyline in patients with idiopathic CNP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Tryptizol two low doses
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2019
Actual trial start date 08/05/2019
Anticipated date of last follow up 20/12/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 137
Recruitment status Closed to recruitment,follow-up continuing
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 5 mg of amitriptyline. 5 mg oral dose of amitriptyline at bedtime. once 4 months. 5 mg oral dose of amitriptyline at bedtime for the treatment of chronic neck pain. 40 Active-Treatment of Control Group
Experimental Group 10 mg Amitriptyline dose 10 mg oral bedtime amitriptyline dose 4 months 10 mg oral bedtime amitriptyline dose for 4 months for treatment of chronic neck pain. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Presence of CNP for more than 15 days/month during at least three consecutive months. 2. Patients without previous trauma. 3. Patients free from other neurologic disorders except for chronic tension headaches. 4. Age from18 to 75 years. 5. Normal neurologic examination (performed by a neurologist) except for pericranial tenderness. 6. No imaging abnormalities except for a loss of cervical lordosis. 1. The presence of neurologic disorder revealed an abnormal clinical examination. 2. Abnormal imaging or history of cervical disc disease. 3. Migraine headache. 4. History of trauma. 5. Major depressive disorder. 6. Analgesic abuse. 7. History of intolerance to tricyclic or tetracyclic antidepressants. 8. Current psychiatric disorder. 9. Glaucoma, cardiac rhythm abnormalities, severe constipation. 10. Patients on medications for CNP other than NSAID or paracetamol taken during the last month. 11. Pregnancy in women and prostatic symptoms in men. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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 11/04/2019 Fayoum University Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Fayoum University District Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neck Pain Disability Index. NPDI 0 and after 4 months of treatment
Secondary Outcome Neck pain intensity 0 and 4 months after treatment
Secondary Outcome Athens Insomnia Scale 0 and 4 months after treatment.
Secondary Outcome Anxiety and depressive symptoms will be evaluated with Hospital Anxiety and Depression Scale (HADS), 0 and 4 months of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University Hospitals Pain Outpatient clinic Fayoum University District Fayoum 63514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University Hospitals Fayoum University District Fayoum 63514 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Joseph Makram Botros 105 Toman Bai street Cairo 11321 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Botros dr_jo27@yahoo.com 00127598825 105 Toman Bai Zeitoun
City Postal code Country Position/Affiliation
Cairo 11321 Egypt Associate Professsor of Anesthesiology of Fayoum University
Role Name Email Phone Street address
Public Enquiries Atef Khaleel. mygodprotection@yahoo.com 00842114059 Fayoum University District
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Lecturer of Anesthesiology Fayoum University
Role Name Email Phone Street address
Scientific Enquiries Joseph Makram Botros dr_jo27@yahoo.com 001227598825 105 Toman Bai street , Zeitoun, Cairo
City Postal code Country Position/Affiliation
Cairo 11321 Egypt Associate Professor of Anesthesiology Fayoum University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication 1-Researchers who provide a methodologically sound proposal. 2- all data analysis except personal data.To achieve aims in the approved proposal. For individual participant meta-analysis. By what mechanism will date be made available. Data are available indefinitely at 3- Proposal should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (Link to be included)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not yet designed. But will be available after the publication. 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