Neck Pain
Conditions
Keywords
amitryptiline, Chronic pain, Neck pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGAmitryptiline
Amitryptiline 5 mg before bedtime for 2 months
DRUGPlacebo
Placebo pill 1 before bedtime
Sponsors
St Joseph University, Beirut, Lebanon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic neck pain (since more than 3 months, and more than 15 days/month) * Normal neurologic exam * X-ray = normal or loss of lordosis
Exclusion criteria
* Neurologic signs or symptoms * Past history of neck surgery * MRI = abnormal findings except for loss of lordosis * Past cervical trauma * severe depression * drug abuse * pregnancy * Follow-up not possible * cardiac rhythms problems * Glaucoma * Urinary tract obstruction or prostatism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual analog scale (VAS) | 0 and 2 months after treatment | Pain assessment on VAS at 2 months compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bergen insomnia score | 0, 2 months | it assesses the sleep quality of the patient at 2 months compared to baseline |
| Change in Neck pain disability score | 0, 2 months | NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline |
| side effects | Up to 12 weeks after treatment | reporting the side effects by the patient |
| Percentage of satisfaction | 2 months after treatment | Pain subjective percentage of improvement |
| Change in Hospital Anxiety and Depression Scale (HADS) | 0 and 2 months after treatment | Assessment of anxiety and depressive symptoms at 2 months compared to baseline |
Countries
Lebanon
Outcome results
None listed