Topical Nitrates for Myofascial Trigger Points
Information source: GF Strong Rehabilitation Centre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myofascial Trigger Points
Intervention: Nitroglycerin patch (Drug)
Phase: N/A
Status: Completed
Sponsored by: GF Strong Rehabilitation Centre Official(s) and/or principal investigator(s): Hubert A Anton, MD, Principal Investigator, Affiliation: University of British Columbia
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.
Clinical Details
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: January 2009
Last updated: August 28, 2012
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