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Low Doses Amitriptyline & Chronic Neck Pain

This study is currently recruiting participants.
Verified March 2012 by St Joseph University, Beirut, Lebanon
Sponsor:
Information provided by (Responsible Party):
Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier:
NCT01561209
First received: March 14, 2012
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Neck Pain
 Drug: Amitryptiline
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St Joseph University, Beirut, Lebanon:

Primary Outcome Measures:
  • Visual analog scale (VAS) [ Time Frame: 2 months after treatment ] [ Designated as safety issue: No ]
    Pain assessment on VAS


Secondary Outcome Measures:
  • Bergen insomnia score [ Time Frame: 0, 1, 2, 3 months ] [ Designated as safety issue: No ]
    it assesses the sleep quality of the patient

  • Neck pain disability score [ Time Frame: 0, 2, 3 months ] [ Designated as safety issue: No ]
    NECK PAIN DISABILITY INDEX QUESTIONNAIRE

  • Neck pain diary [ Time Frame: 0, 2, 3 months ] [ Designated as safety issue: No ]
    daily pain intensity according to VAS

  • side effects [ Time Frame: Up to 12 weeks after treatment ] [ Designated as safety issue: Yes ]
    reporting the side effects by the patient

  • Visual analog scale (VAS) [ Time Frame: 1 and 3 months after treatment ] [ Designated as safety issue: No ]
    Pain assessment on VAS


Estimated Enrollment: 224
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 1, 2 and 3 months and outcome measures are assessed.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561209

Contacts
Contact: Joseph Maarrawi, MD, PhD 01615300 ext 9512 joseph.maarrawi@usj.edu.lb

Locations
Lebanon
Hotel Dieu de france Hospital Recruiting
Beirut, Lebanon, 16 6830
Contact: Joseph Maarrawi, MD, PhD     01615300 ext 9512     joseph.maarrawi@usj.edu.lb    
Sponsors and Collaborators
St Joseph University, Beirut, Lebanon
Investigators
Principal Investigator: Joseph Maarrawi, MD, PhD St Joseph University, Beirut, Lebanon
  More Information

No publications provided

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
Study First Received: March 14, 2012
Last Updated: March 21, 2012
Health Authority: Lebanon: Ministry of Public Health

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

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

ClinicalTrials.gov processed this record on October 17, 2012