Topical Nitrates for Myofascial Trigger Points

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Trigger Points
• Intervention / Treatment: Drug: Nitroglycerin patch

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria include age between 19 and 65 years old, myofascial pain lasting at least 6 months, and a myofascial trigger point point in the trapezius muscle.

Exclusion Criteria:

• Our exclusion criteria include symptomatic disc herniation, symptomatic cervical osteoarthritis, systemic infection, malignancy, collapsed vertebra, thoracic outlet syndrome, temporomandibular joint dysfunction, collagen-vascular disease, or brachial plexopathy. Patients with ongoing litigation regarding their symptoms are not eligible for this study. Also excluded are patients with underlying cardiac disease, hypotension, or medical conditions that may not allow them to tolerate the use of vasodilators, and those who use phosphodiesterase inhibitors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Myofascial trigger point; Patients diagnosed with myofascial trigger points who will receive a nitroglycerin patch over the trigger point.	Drug: Nitroglycerin patch; Nitroglycerin 0.1 mg/hr patch; Other Names: Nitro-Dur 0.1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GF Strong Rehabilitation Centre
• Investigators: Principal Investigator: Hubert A Anton, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (ESTIMATE): August 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2012
• Last Update Submitted That Met QC Criteria: August 28, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Myofascial pain; Trigger point; Nitroglycerin
• Additional Relevant MeSH Terms: Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 122975