Neck Pain Clinical Trial
Official title:
Prospective Randomized & Controlled Study of the Role of Low Doses Amitriptyline in the Management of Chronic Neck Pain
Verified date | August 2017 |
Source | St Joseph University, Beirut, Lebanon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 212 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Lebanon | Hotel Dieu de france Hospital | Beirut |
Lead Sponsor | Collaborator |
---|---|
St Joseph University, Beirut, Lebanon |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Visual analog scale (VAS) | Pain assessment on VAS at 2 months compared to baseline | 0 and 2 months after treatment | |
Secondary | Change in Bergen insomnia score | it assesses the sleep quality of the patient at 2 months compared to baseline | 0, 2 months | |
Secondary | Change in Neck pain disability score | NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline | 0, 2 months | |
Secondary | side effects | reporting the side effects by the patient | Up to 12 weeks after treatment | |
Secondary | Percentage of satisfaction | Pain subjective percentage of improvement | 2 months after treatment | |
Secondary | 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 |
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