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Low Doses Amitriptyline & Chronic Neck Pain

This study has been completed.
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: June 9, 2014
Last verified: June 2014
  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:


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


Enrollment: 220
Study Start Date: March 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Lebanon
Hotel Dieu de france Hospital
Beirut, Lebanon, 16 6830
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: June 9, 2014
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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Amitriptyline
Amitriptyline, perphenazine drug combination
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014