A Phase 4 interventional study of Amitryptiline and Placebo in Neck Pain, sponsored by St Joseph University, Beirut, Lebanon. Completed at 1 site in Lebanon. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by St Joseph University, Beirut, Lebanon · Phase 4, Interventional, and Treatment
The objective of this prospective randomized and controlled study is to evaluate the efficacy and safety of low dose of amitriptyline (5 mg) in the management of chronic neck pain.
Patients with chronic neck pain, lasting since at least 3 months, are recruited from our pain clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1-Amitriptyline 5 mg for 2 months 2- placebo for 2 months. Co-morbidities and other painful conditions are noted, and then clinical evaluation of the patient is performed; pain is assessed according to Visual Analog Scale, anxiety, depression, insomnia and disability are evaluated by adapted scores (Bergen insomnia scale, neck pain disability score, neck pain diary \& anxiety and depression score). Patients are followed at 2 months and outcome measures are assessed.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 212 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →St Joseph University, Beirut, Lebanon is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Amitryptiline 5 mg before bedtime
Drug: Amitryptiline
Placebo pill
Drug: Placebo
Amitryptiline 5 mg before bedtime for 2 months
Also known as: Tryptizol, Laroxyl
Placebo pill 1 before bedtime
Also known as: No brand name
Change in Visual analog scale (VAS)
Pain assessment on VAS at 2 months compared to baseline
Time frame: 0 and 2 months after treatment
Change in Bergen insomnia score
it assesses the sleep quality of the patient at 2 months compared to baseline
Time frame: 0, 2 months
Change in Neck pain disability score
NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline
Time frame: 0, 2 months
side effects
reporting the side effects by the patient
Time frame: Up to 12 weeks after treatment
Percentage of satisfaction
Pain subjective percentage of improvement
Time frame: 2 months after treatment
Change in Hospital Anxiety and Depression Scale (HADS)
Assessment of anxiety and depressive symptoms at 2 months compared to baseline
Time frame: 0 and 2 months after treatment
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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St Joseph University, Beirut, Lebanon