NCT01675700

Brief Summary

The purpose of this study is to determine whether a topical nitroglycerine patch applied daily over a trapezius trigger point can improve patients' symptoms. If there is improvement, this open label study will help determine the degree of improvement and contribute to the design of a larger double blind placebo controlled trial. We would consider moving forward to a large randomized trial if:

  • The intervention is acceptable to patients (\>= 70%) and
  • Compliance is satisfactory (\>=80%) and
  • We find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the VAS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

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

January 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

August 28, 2012

Last Update Submit

August 28, 2012

Conditions

Myofascial Trigger Points

Keywords

Myofascial painTrigger pointNitroglycerin

Outcome Measures

Primary Outcomes (1)

  • Pain at the time of clinic visit and over the previous week as measured by a Visual Analog Scale, VAS, for pain and a pressure algometer measurement to obtain pressure pain thresholds over the patients trigger point.

    1 month

Secondary Outcomes (1)

  • As another secondary outcome we will ask the participants whether the benefits of the treatment are good enough that they would continue using the nitroglycerin patch. This will be a yes or no response.

    1 month

Study Arms (1)

Myofascial trigger point

EXPERIMENTAL

Patients diagnosed with myofascial trigger points who will receive a nitroglycerin patch over the trigger point.

Drug: Nitroglycerin patch

Interventions

Nitroglycerin patchDRUG

Nitroglycerin 0.1 mg/hr patch

Also known as: Nitro-Dur 0.1
Myofascial trigger point

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Nitroglycerin

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Study Officials

  • Hubert A Anton, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Resident

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

August 30, 2012

Record last verified: 2012-08