Topical Nitrates for Myofascial Trigger Points

Myofascial Trigger Points Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675700
• Other study ID #: 122975
• Status: Completed
• Phase: N/A
• First received: August 28, 2012
• Last updated: August 28, 2012
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2012
• Source: GF Strong Rehabilitation Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myofascial Trigger Points

Intervention

Drug:
• Nitroglycerin patch
Nitroglycerin 0.1 mg/hr patch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GF Strong Rehabilitation Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No