Topical Nitrates for Myofascial Trigger Points

Study Overview
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Brief Summary
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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.

Conditions
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Myofascial Trigger Points

Intervention / Treatment
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* Drug: Nitroglycerin patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myofascial trigger point<br>Patients diagnosed with myofascial trigger points who will receive a nitroglycerin patch over the trigger point. | Drug: Nitroglycerin patch<br>* Nitroglycerin 0.1 mg/hr patch<br>* Other names: Nitro-Dur 0.1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial pain, Trigger point, Nitroglycerin