NCT03327545

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

October 23, 2017

Last Update Submit

October 26, 2017

Conditions

Keywords

Trigger pointsTrigegeminal nervePain

Outcome Measures

Primary Outcomes (2)

  • 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.

    24 hours, 5 minutes after the treatment

  • Maximum mouth opening without pain at 24 hours

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

    24 hours, 5 minutes after the treatment

Secondary Outcomes (1)

  • Pain Catastrophizing Scale (PCS) at 24 hours

    24 hours, 5 minutes after the treatment

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

Neural mobilization for a total of 12 minutes

Device: Neural mobilization

Experimental Group 2

EXPERIMENTAL

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

Device: Soft tissue techniques and Stretching

Control group

PLACEBO COMPARATOR

Control group

Device: Control group

Interventions

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

Experimental Group 1

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

Experimental Group 2

Did not receive any treatment.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neck pain

You may not qualify if:

  • myelopathy
  • fracture
  • infection
  • dystonia
  • tumor
  • inflammatory disease
  • fibromyalgia
  • or osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myofascial Pain SyndromesPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • JORGE H VILLAFAÑE

    IRCCS Don Gnocchi Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 31, 2017

Study Start

January 1, 2017

Primary Completion

February 1, 2017

Study Completion

July 1, 2017

Last Updated

October 31, 2017

Record last verified: 2017-10