Low Doses Amitriptyline & Chronic Neck Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized & Controlled Study of the Role of Low Doses Amitriptyline in the Management of Chronic Neck Pain

Conditions
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Neck Pain

Intervention / Treatment
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* Drug: Amitryptiline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amitryptiline<br>Amitryptiline 5 mg before bedtime | Drug: Amitryptiline<br>* Amitryptiline 5 mg before bedtime for 2 months<br>* Other names: Laroxyl;|
| Placebo Comparator: Placebo<br>Placebo pill | Drug: Placebo<br>* Placebo pill 1 before bedtime<br>* Other names: No brand name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual analog scale (VAS) | Pain assessment on VAS at 2 months compared to baseline | 0 and 2 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bergen insomnia score | it assesses the sleep quality of the patient at 2 months compared to baseline | 0, 2 months | 
| Change in Neck pain disability score | NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline | 0, 2 months | 
| side effects | reporting the side effects by the patient | Up to 12 weeks after treatment | 
| Percentage of satisfaction | Pain subjective percentage of improvement | 2 months after treatment | 
| Change in Hospital Anxiety and Depression Scale (HADS) | Assessment of anxiety and depressive symptoms at 2 months compared to baseline | 0 and 2 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amitryptiline, Chronic pain, Neck pain