Myofascial Trigger PointsNCT01675700
Topical Nitrates for Myofascial Trigger Points
A study testing Nitroglycerin patch in people with Myofascial Trigger Points, run by GF Strong Rehabilitation Centre.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Myofascial Trigger Points
- What is being tested?
- Nitroglycerin patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Myofascial Trigger Points
- Being tested
- Nitroglycerin patch
- Keywords
- Myofascial pain, Trigger point, Nitroglycerin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin patchDrug
Also called Nitro-Dur 0.1
Nitroglycerin 0.1 mg/hr patch
| Study group | Role | What they receive |
|---|---|---|
| Myofascial trigger point | Experimental | Patients diagnosed with myofascial trigger points who will receive a nitroglycerin patch over the trigger point. Receives: Drug: Nitroglycerin patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger PointsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GF Strong Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anibal Bohorquez, GF Strong Rehabilitation Centre
- Investigators
- Hubert A Anton, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675700
- Sponsor's protocol ID
- 122975
- Status last verified
- Aug 2012
- First submitted
- 28 Aug 2012
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Nitrates for Myofascial Trigger Points
- ClinicalTrials.gov ID
- NCT01675700
- Acronym / sponsor ID
- 122975
- Conditions
- Myofascial Trigger Points
- Keywords
- Myofascial pain, Trigger point, Nitroglycerin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GF Strong Rehabilitation CentreUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myofascial trigger point | Experimental | Drug: Nitroglycerin patchPatients diagnosed with myofascial trigger points who will receive a nitroglycerin patch over the trigger point. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerin patchAlso: Nitro-Dur 0.1Nitroglycerin 0.1 mg/hr patch | Drug | Myofascial trigger point |
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.
Time frame: 1 month
1 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.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert A Anton, MD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Nitroglycerin patch in people with Myofascial Trigger Points, run by GF Strong Rehabilitation Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2012.