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OpenTrials
Completed

NCT Number: NCT01675700

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.

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Key information

Conditions

Myofascial Trigger Points

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitroglycerin patch

Drug

Nitroglycerin 0.1 mg/hr patch

Other names: Nitro-Dur 0.1

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.

    Time frame: 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.

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

GF Strong Rehabilitation Centre

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 30, 2012
Registry last updated
Aug 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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