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Myofascial Pain SyndromeNCT03327545

Latent Myofascial Trigger Points in the Craniocervical Region

A study testing Neural mobilization and Soft tissue techniques and Stretching in people with Myofascial Pain Syndrome, run by Fondazione Don Carlo Gnocchi ETS.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Myofascial Pain Syndrome
What is being tested?
Neural mobilization and Soft tissue techniques and Stretching
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
No sites listed yet
Study dates
Jan 2017to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Neck pain

Who cannot join

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

About this study

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

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

Being tested
Neural mobilization, Soft tissue techniques and Stretching, Control group
Keywords
Trigger points, Trigegeminal nerve, Pain
Medical subject headings
Myofascial Pain Syndromes, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neural mobilizationDevice

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

  • Soft tissue techniques and StretchingDevice

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

  • Control groupDevice

    Did not receive any treatment.

Study groups in NCT03327545
Study groupRoleWhat they receive
Experimental Group 1ExperimentalNeural mobilization for a total of 12 minutes
Receives: Device: Neural mobilization
Experimental Group 2ExperimentalSoft tissue techniques and Stretching right side of the craniocervical for a total of 12 minutes
Receives: Device: Soft tissue techniques and Stretching
Control groupPlacebo comparatorControl group
Receives: Device: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 24 hours, 5 minutes after the treatment

Secondary outcomes (1)

  1. Pain Catastrophizing Scale (PCS) at 24 hours

    Will be used to measure PCS

    Measured: 24 hours, 5 minutes after the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2017
  2. Study startJan 2017
  3. Primary completionFeb 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03327545
Sponsor's protocol ID
LMTrP
Status last verified
Oct 2017
First submitted
23 Oct 2017
Last updated
31 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Neural mobilization and Soft tissue techniques and Stretching in people with Myofascial Pain Syndrome, run by Fondazione Don Carlo Gnocchi ETS.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Pain intensity at 24 hours (time frame: 24 hours, 5 minutes after the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03327545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.

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