Topical Nitrates for Myofascial Trigger Points

Not Applicable

Completed

• Conditions: Myofascial Trigger Points
• Interventions: Drug: Nitroglycerin patch

• Registration Number: NCT01675700
• Lead Sponsor: GF Strong Rehabilitation Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-07
• Study Completion: 2009-12
• Status Verified: 2012-08
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Last Update Submitted: 2012-08-28
• Study First Posted: 2012-08-30
• Last Update Posted: 2012-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myofascial trigger point	Nitroglycerin patch	Patients diagnosed with myofascial trigger points who will receive a nitroglycerin patch over the trigger point.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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