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Myofascial Pain - Dysfunction Syndrome of TMJNCT04339673

Is Masseteric Nerve Block Effective in Myofascial Pain

A study testing masseteric nerve block, trigger point injection and dry needling in people with Myofascial Pain - Dysfunction Syndrome of TMJ and Myofascial Trigger Point Pain, run by Erzincan University at 1 site in Turkey (Türkiye).

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

The aim of the present study was to compare the efficacy of three different treatment methods in the management of myofascial pain: masseteric nerve block (MN), trigger point injection(TrP) with local anesthetic (LA) and dry needling (DN).Study Design: 45 subjects aged 18-54 years were randomly assigned to the MN… Read more about this study

Who is it for?
Ages 18 to 54 yearsHealthy volunteers can take part
What is being tested?
masseteric nerve block, trigger point injection and dry needling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2019to 30 Nov 2019
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 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Clinical diagnosis of myofascial pain.
  • Presence of at least one trigger point in masseter muscle.

Who cannot join

  • Generalized muscle disorders.
  • Hypersensitivity to local anesthetics.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Erzincan Ağiz Ve Diş Sağlığı Egt Araş Hastanesi

    Erzincan

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Efficacy of Different Treatment Modalities in Masseteric Myofascial Pain: Masseteric Nerve Block, Local Anesthetic Injection and Dry-needling

The aim of the present study was to compare the efficacy of three different treatment methods in the management of myofascial pain: masseteric nerve block (MN), trigger point injection(TrP) with local anesthetic (LA) and dry needling (DN).Study Design: 45 subjects aged 18-54 years were randomly assigned to the MN group (n= 15), LA group (n=15) and DN group (n=15).

Read the detailed description

The study sample consisted 45 patients with masseter muscle originated myofascial pain, were selected in accordance with the following criteria:

Patients were grouped according to the treatment they received: dry-needling (DN), TrP injections with local anesthetic (LA) and masseteric nerve block (MNB). Localization of the masseteric trigger points (MTPs) was based on clinician's sense and patients' expressions of pain. Local twitch response was not observable in all case. This procedure was completed by using digital palpation (1.5 Kg), and the clinical examiner's palpation was calibrated using a pressure algometer.

Being tested
masseteric nerve block, trigger point injection, dry needling
Keywords
pain, injections, anesthetics
Medical subject headings
Temporomandibular Joint Disorders, Myofascial Pain Syndromes, Pain

What participants receive

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

  • masseteric nerve blockProcedure or surgery

    regional bloc of masseter

  • trigger point injectionProcedure or surgery

    trigger point injection with local anesthetic

  • dry needlingProcedure or surgery

    needling with acupuncture needles of trigger points in masseter

Study groups in NCT04339673
Study groupRoleWhat they receive
MNB- masseteric nerve blockActive comparatormasseteric nerve block with local anesthesia lidocaine single app.
Receives: Procedure: masseteric nerve block
LA -trigger point injection with local anestheticActive comparatorlocal anesthetic injections on trigger points in masseter
Receives: Procedure: trigger point injection
DN-dry needlingPlacebo comparatordren needling to masseter
Receives: Procedure: dry needling

What is being measured

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

  1. The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)

    Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)

    Measured: before the injections (T0, Baseline)

  2. The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)

    Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)

    Measured: At 1st week (t1)

  3. The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)

    Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)

    Measured: At 4th week (t2)

  4. The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS)

    Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)

    Measured: At 12th week (t3)

Secondary outcomes (8)

  1. The Rate of Pain Intensity on Palpation (PoP)

    Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle.

    Measured: before the injections (T0, Baseline)

  2. The Rate of Pain Intensity on Palpation (PoP)

    Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle.

    Measured: At 1st week (t1)

  3. The Rate of Pain Intensity on Palpation (PoP)

    Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle.

    Measured: At 4th week (t2)

  4. The Rate of Pain Intensity on Palpation (PoP)

    Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle.

    Measured: At 12th week (t3)

  5. The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded.

    Measured: before the injections (T0, Baseline)

  6. The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded.

    Measured: At 1st week (t1)

  7. The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded.

    Measured: At 4th week (t2)

  8. The measurement of pain-free maximum mouth opening (MMO) in millimeters

    Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded.

    Measured: At 12th week (t3)

Timeline

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

  1. First posted9 Apr 2020
  2. Study start1 Jul 2019
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2019

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
Model description
randomized parallel controlled
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04339673
Sponsor's protocol ID
135162
Status last verified
Apr 2020
First submitted
2 Apr 2020
Last updated
9 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Venancio Rde A, Alencar FG Jr, Zamperini C. Botulinum toxin, lidocaine, and dry-needling injections in patients with myofascial pain and headaches. Cranio. 2009 Jan;27(1):46-53. doi: 10.1179/crn.2009.008.

    PubMed 19241799

  • Quek SY, Subramanian G, Patel J, Ananthan S, Zagury JG, Khan J. Efficacy of regional nerve block in management of myofascial pain of masseteric origin. Cranio. 2015 Oct;33(4):285-90. doi: 10.1080/08869634.2015.1097300. Epub 2015 Dec 29.

    PubMed 26715419

Questions about this trial

What is this clinical trial studying?

A study testing masseteric nerve block, trigger point injection and dry needling in people with Myofascial Pain - Dysfunction Syndrome of TMJ and Myofascial Trigger Point Pain, run by Erzincan University at 1 site in Turkey (Türkiye).

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 2 inclusion and 2 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 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS) (time frame: before the injections (T0, Baseline)). The study lists 4 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 NCT04339673, which also lists 2 linked publications.

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 9 Apr 2020.

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