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CompletedNCT03327545Updated Oct 31, 2017

Latent Myofascial Trigger Points in the Craniocervical Region

An interventional study of Neural mobilization and Soft tissue techniques and Stretching in Myofascial Pain Syndrome, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2017, registered Oct 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Myofascial Pain Syndrome

Keywords

  • Trigger points
  • Trigegeminal nerve
  • Pain
03

In context

Myofascial Pain Syndromes

339 studies on the registry are indexed under Myofascial Pain Syndromes; 66 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 307 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Neck pain

Exclusion criteria

Exclusion Criteria:

  • myelopathy
  • fracture
  • infection
  • dystonia
  • tumor
  • inflammatory disease
  • fibromyalgia
  • or osteoporosis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Experimental Group 1

    Neural mobilization for a total of 12 minutes

    Device: Neural mobilization

  • 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

  • Placebo comparator
    Control group

    Control group

    Device: Control group

Interventions

  • DeviceNeural mobilization

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

  • DeviceSoft tissue techniques and Stretching

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

  • DeviceControl group

    Did not receive any treatment.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours, 5 minutes after the treatment

  2. Maximum mouth opening without pain at 24 hours

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

    Time frame: 24 hours, 5 minutes after the treatment

Secondary outcomes

  1. Pain Catastrophizing Scale (PCS) at 24 hours

    Will be used to measure PCS

    Time frame: 24 hours, 5 minutes after the treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Feb 2017, 1 month.

Of 202 non-industry interventional studies with no phase under Myofascial Pain Syndromes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's 1 month is below that.

Counting every sponsor, half of 204 studies reached it within 5 months; a quarter within 2 and three quarters within 13.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2017
First posted
Oct 31, 2017
StartActual
Jan 2017
Primary completionActual
Feb 2017
CompletionActual
Jul 2017
Last update
Oct 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03327545
Responsible party
Jorge Hugo Villafañe, PhD (Researcher, Fondazione Don Carlo Gnocchi Onlus) — Principal investigator
First posted
Oct 31, 2017
Start date
Jan 2017
Primary completion
Feb 2017
Completion
Jul 2017
Last update
Oct 31, 2017

Study contacts

JORGE H VILLAFAÑE
principal investigator · IRCCS Don Gnocchi Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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