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
Device: Control group
Did not receive any treatment.
Experimental: Experimental Group 1
Neural mobilization for a total of 12 minutes
Device: Neural mobilization
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
Device: Soft tissue techniques and Stretching
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.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

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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