Comparison of Therapeutic Effects of Trigger Point Injection and Twin Nerve Block in Chronic Myofascial Pain Patients

NCT ID: NCT03870191

Last Updated: 2020-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-21

Study Completion Date

2020-05-31

Brief Summary

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To see if there is there any difference in the treatment outcomes/results such as changes in pain intensity in patients with myofascial pain who have been treated with trigger point injections or twin block?

Detailed Description

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Most treatment approaches for chronic myofascial pain are not evidence-based. Studies are usually controversial. Most are short-term, non-randomized. An essential limitation has been the lack of standardization of diagnosis. Some studies do not differentiate between joint pain and muscle pain, which can significantly affect the outcome of the treatment provided.

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) was recently published and validated. Their protocol allows standardization of the assessment and diagnosis of patients with temporomandibular disorder, including myofascial pain.

To the investigator's knowledge, no previous prospective, randomized study has been conducted demonstrating the treatment outcomes of either trigger point injections or twin block in patients with chronic myofascial pain.

Conditions

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Myofascial Pain - Dysfunction Syndrome of TMJ Trigger Point Pain, Myofascial Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Twin Block Group

This group will receive twin block injections.

Group Type ACTIVE_COMPARATOR

Injection of either twin block or trigger point injection.

Intervention Type OTHER

Study participants will be randomized into either group and will receive the intervention.

Trigger Point Injection Group

This group will receive trigger point injections.

Group Type ACTIVE_COMPARATOR

Injection of either twin block or trigger point injection.

Intervention Type OTHER

Study participants will be randomized into either group and will receive the intervention.

Interventions

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Injection of either twin block or trigger point injection.

Study participants will be randomized into either group and will receive the intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with Myofascial pain with referral based on the DC/TMD criteria
* Pain on the masseter and or temporalis muscles
* Pain present for at least 3 months

Exclusion Criteria

* Generalized muscle disorder such as fibromyalgia
* Subjects on chronic pain medication
* Subjects who are known to have hypersensitivity to the local anesthetics.
* Pregnant women. A pregnancy test will not be given before subject enrollment. Women of childbearing ages will be asked verbally if they are pregnant. If they are unsure, then they will be excluded from the study.
* Subjects with cognitive problems e.g. Alzheimer's disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers University

OTHER

Sponsor Role lead

Responsible Party

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Sowmya Ananthan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafeal Benoliel, BDS

Role: STUDY_DIRECTOR

Rutgers School of Dental Medicine

References

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Ananthan S, Kanti V, Zagury JG, Quek SYP, Benoliel R. The effect of the twin block compared with trigger point injections in patients with masticatory myofascial pain: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Mar;129(3):222-228. doi: 10.1016/j.oooo.2019.09.014. Epub 2019 Oct 13.

Reference Type DERIVED
PMID: 32009005 (View on PubMed)

Other Identifiers

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Pro20160000530

Identifier Type: -

Identifier Source: org_study_id

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