Back to results

Latent Myofascial Trigger Points in the Craniocervical Region

Primary Purpose

Myofascial Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Neural mobilization

Soft tissue techniques and Stretching

Control group

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Trigger points, Trigegeminal nerve, Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Neck pain

Exclusion Criteria:

myelopathy
fracture
infection
dystonia
tumor
inflammatory disease
fibromyalgia
or osteoporosis

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group 1

Experimental Group 2

Control group

Arm Description

Neural mobilization for a total of 12 minutes

Soft tissue techniques and Stretching right side of the craniocervical for a total of 12 minutes

Control group

Outcomes

Primary Outcome Measures

Change from Pain intensity at 24 hours

Pressure Pain Thresholds (PPT) will be assessed bilaterally over the masseter, temporalis, trapezius and suboccipital muscles by an assessor blinded to the subjects condition.

Maximum mouth opening without pain at 24 hours

Is the ability to open the mouth so widely as you could without pain.

Secondary Outcome Measures

Pain Catastrophizing Scale (PCS) at 24 hours

Will be used to measure PCS

Full Information

NCT ID

NCT03327545

First Posted

October 23, 2017

Last Updated

October 26, 2017

Sponsor

Fondazione Don Carlo Gnocchi Onlus

1. Study Identification

Unique Protocol Identification Number

NCT03327545

Brief Title

Latent Myofascial Trigger Points in the Craniocervical Region

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

January 2017 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myofascial Pain Syndrome

Keywords

Trigger points, Trigegeminal nerve, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group 1

Arm Type

Experimental

Arm Description

Neural mobilization for a total of 12 minutes

Arm Title

Experimental Group 2

Arm Type

Experimental

Arm Description

Soft tissue techniques and Stretching right side of the craniocervical for a total of 12 minutes

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Control group

Intervention Type

Device

Intervention Name(s)

Neural mobilization

Intervention Description

Neural mobilization on the right side of the craniocervical region for a total of 12 minutes.

Intervention Type

Device

Intervention Name(s)

Soft tissue techniques and Stretching

Intervention Description

Soft tissue techniques and Stretching on the right side of the craniocervical region for a total of 12 minutes

Intervention Type

Device

Intervention Name(s)

Control group

Intervention Description

Did not receive any treatment.

Primary Outcome Measure Information:

Title

Change from Pain intensity at 24 hours

Description

Pressure Pain Thresholds (PPT) will be assessed bilaterally over the masseter, temporalis, trapezius and suboccipital muscles by an assessor blinded to the subjects condition.

Time Frame

24 hours, 5 minutes after the treatment

Title

Maximum mouth opening without pain at 24 hours

Description

Is the ability to open the mouth so widely as you could without pain.

Time Frame

24 hours, 5 minutes after the treatment

Secondary Outcome Measure Information:

Title

Pain Catastrophizing Scale (PCS) at 24 hours

Description

Will be used to measure PCS

Time Frame

24 hours, 5 minutes after the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Neck pain Exclusion Criteria: myelopathy fracture infection dystonia tumor inflammatory disease fibromyalgia or osteoporosis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JORGE H VILLAFAÑE

Organizational Affiliation

IRCCS Don Gnocchi Foundation

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Latent Myofascial Trigger Points in the Craniocervical Region

We'll reach out to this number within 24 hrs