NCT01561209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

March 14, 2012

Last Update Submit

August 26, 2017

Conditions

Neck Pain

Keywords

amitryptilineChronic painNeck pain

Outcome Measures

Primary Outcomes (1)

  • Change in Visual analog scale (VAS)

    Pain assessment on VAS at 2 months compared to baseline

    0 and 2 months after treatment

Secondary Outcomes (5)

  • Change in Bergen insomnia score

    0, 2 months

  • Change in Neck pain disability score

    0, 2 months

  • side effects

    Up to 12 weeks after treatment

  • Percentage of satisfaction

    2 months after treatment

  • Change in Hospital Anxiety and Depression Scale (HADS)

    0 and 2 months after treatment

Study Arms (2)

Amitryptiline

ACTIVE COMPARATOR

Amitryptiline 5 mg before bedtime

Drug: Amitryptiline

Placebo

PLACEBO COMPARATOR

Placebo pill

Drug: Placebo

Interventions

AmitryptilineDRUG

Amitryptiline 5 mg before bedtime for 2 months

Also known as: Tryptizol, Laroxyl
Amitryptiline
PlaceboDRUG

Placebo pill 1 before bedtime

Also known as: No brand name
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic neck pain (since more than 3 months, and more than 15 days/month)
  • Normal neurologic exam
  • X-ray = normal or loss of lordosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu de france Hospital

Beirut, 16 6830, Lebanon

Location

MeSH Terms

Conditions

Neck PainChronic Pain

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Joseph Maarrawi, MD, PhD

    St Joseph University, Beirut, Lebanon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor : Researcher - Pain Specialist - Neurosurgeon

Study Record Dates

First Submitted

March 14, 2012

First Posted

March 22, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

LE(1)