- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03327545
Latent Myofascial Trigger Points in the Craniocervical Region
October 26, 2017 updated by: Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi Onlus
Clinical Efficacy of Mobilization of the Nervous System Compared to Soft Tissue Techniques Intervention in Asymptomatic Subjects With Latent Myofascial Trigger Points in the Craniocervical Region: a Randomized Controlled Trial
Myofascial pain is a clinical problem that has generated interest, debate and confusion for decades.
According to studies anywhere between 33 and 97 % of patients with musculoskeletal pain visiting physicians and manual therapists are diagnosed with Myofascial Trigger Points (MTrPs).
MTrPs are localized, hyperirritable points that are associated with palpable nodules in taut bands (TB) of muscle fibres.
MTrPs can be classified into active and latent.
Latent MTrPs demonstrate the same clinical characteristics as active MTrPs but they do not provoke spontaneous pain.
The myofascial trigger points (MTrPs) are common in healthy subjects and in patients with musculoskeletal pain, and could produce sensitive disturbances and motor dysfunctions
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Neck pain
Exclusion Criteria:
- myelopathy
- fracture
- infection
- dystonia
- tumor
- inflammatory disease
- fibromyalgia
- or osteoporosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
|
Did not receive any treatment.
|
Experimental: Experimental Group 1
Neural mobilization for a total of 12 minutes
|
Neural mobilization on the right side of the craniocervical region for a total of 12 minutes.
|
Experimental: Experimental Group 2
Soft tissue techniques and Stretching right side of the craniocervical for a total of 12 minutes
|
Soft tissue techniques and Stretching on the right side of the craniocervical region for a total of 12 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Pain intensity at 24 hours
Time Frame: 24 hours, 5 minutes after the treatment
|
Pressure Pain Thresholds (PPT) will be assessed bilaterally over the masseter, temporalis, trapezius and suboccipital muscles by an assessor blinded to the subjects condition.
|
24 hours, 5 minutes after the treatment
|
Maximum mouth opening without pain at 24 hours
Time Frame: 24 hours, 5 minutes after the treatment
|
Is the ability to open the mouth so widely as you could without pain.
|
24 hours, 5 minutes after the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Catastrophizing Scale (PCS) at 24 hours
Time Frame: 24 hours, 5 minutes after the treatment
|
Will be used to measure PCS
|
24 hours, 5 minutes after the treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: JORGE H VILLAFAÑE, IRCCS Don Gnocchi Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
October 23, 2017
First Submitted That Met QC Criteria
October 26, 2017
First Posted (Actual)
October 31, 2017
Study Record Updates
Last Update Posted (Actual)
October 31, 2017
Last Update Submitted That Met QC Criteria
October 26, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMTrP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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