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Low Doses Amitriptyline & Chronic Neck Pain

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ClinicalTrials.gov Identifier: NCT01561209
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : August 29, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Neck Pain Drug: Amitryptiline Drug: Placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized & Controlled Study of the Role of Low Doses Amitriptyline in the Management of Chronic Neck Pain
Study Start Date : March 2012
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Amitryptiline
Amitryptiline 5 mg before bedtime
Drug: Amitryptiline
Amitryptiline 5 mg before bedtime for 2 months
Other Names:
  • Tryptizol
  • Laroxyl
Placebo Comparator: Placebo
Placebo pill
Drug: Placebo

Placebo pill

1 before bedtime

Other Name: No brand name

Outcome Measures

Primary Outcome Measures :
  1. Change in Visual analog scale (VAS) [ Time Frame: 0 and 2 months after treatment ]
    Pain assessment on VAS at 2 months compared to baseline

Secondary Outcome Measures :
  1. Change in Bergen insomnia score [ Time Frame: 0, 2 months ]
    it assesses the sleep quality of the patient at 2 months compared to baseline

  2. Change in Neck pain disability score [ Time Frame: 0, 2 months ]
    NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline

  3. side effects [ Time Frame: Up to 12 weeks after treatment ]
    reporting the side effects by the patient

  4. Percentage of satisfaction [ Time Frame: 2 months after treatment ]
    Pain subjective percentage of improvement

  5. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 0 and 2 months after treatment ]
    Assessment of anxiety and depressive symptoms at 2 months compared to baseline

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561209

Hotel Dieu de france Hospital
Beirut, Lebanon, 16 6830
Sponsors and Collaborators
St Joseph University, Beirut, Lebanon
Principal Investigator: Joseph Maarrawi, MD, PhD St Joseph University, Beirut, Lebanon
More Information

Responsible Party: Dr Joseph Maarrawi, Assistant Professor : Researcher - Pain Specialist - Neurosurgeon, St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier: NCT01561209     History of Changes
Other Study ID Numbers: AMIT-CNP
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon:
Chronic pain
Neck pain

Additional relevant MeSH terms:
Neck Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants