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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amitryptiline | Active Comparator | Amitryptiline 5 mg before bedtime |
|
| Placebo | Placebo Comparator | Placebo pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amitryptiline | Drug | Amitryptiline 5 mg before bedtime for 2 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Maarrawi, MD, PhD | St Joseph University, Beirut, Lebanon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu de france Hospital | Beirut | 16 6830 | Lebanon |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | Placebo pill 1 before bedtime |
|
|
| 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 |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |