Topical Nitrates for Myofascial Trigger Points

NCT ID: NCT01675700

Last Updated: 2012-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

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.

Detailed Description

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Conditions

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Myofascial Trigger Points

Keywords

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Myofascial pain Trigger point Nitroglycerin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Myofascial trigger point

Patients diagnosed with myofascial trigger points who will receive a nitroglycerin patch over the trigger point.

Group Type EXPERIMENTAL

Nitroglycerin patch

Intervention Type DRUG

Nitroglycerin 0.1 mg/hr patch

Interventions

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Nitroglycerin patch

Nitroglycerin 0.1 mg/hr patch

Intervention Type DRUG

Other Intervention Names

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Nitro-Dur 0.1

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GF Strong Rehabilitation Centre

OTHER

Sponsor Role lead

Responsible Party

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Anibal Bohorquez

Medical Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hubert A Anton, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Other Identifiers

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122975

Identifier Type: -

Identifier Source: org_study_id