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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Injection of either twin block or trigger point injection.
Sponsored by
Rutgers University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain - Dysfunction Syndrome of TMJ

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Twin Block Group

    Trigger Point Injection Group

    Arm Description

    This group will receive twin block injections.

    This group will receive trigger point injections.

    Outcomes

    Primary Outcome Measures

    Pain relief: numerical pain scale
    The pain relief received from each injection will be measured using the numerical pain scale. This scale is between 0-10 with 0 meaning no pain and 10 is the most pain.Higher values represent worse pain.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 8, 2019
    Last Updated
    June 17, 2020
    Sponsor
    Rutgers University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03870191
    Brief Title
    Comparison of Therapeutic Effects of Trigger Point Injection and Twin Nerve Block in Chronic Myofascial Pain Patients
    Official Title
    Comparison of Therapeutic Effects of Trigger Point Injection and Twin Nerve Block in Chronic Myofascial Pain Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 21, 2016 (Actual)
    Primary Completion Date
    June 5, 2018 (Actual)
    Study Completion Date
    May 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rutgers University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myofascial Pain - Dysfunction Syndrome of TMJ, Trigger Point Pain, Myofascial, Nerve Block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Twin Block Group
    Arm Type
    Active Comparator
    Arm Description
    This group will receive twin block injections.
    Arm Title
    Trigger Point Injection Group
    Arm Type
    Active Comparator
    Arm Description
    This group will receive trigger point injections.
    Intervention Type
    Other
    Intervention Name(s)
    Injection of either twin block or trigger point injection.
    Intervention Description
    Study participants will be randomized into either group and will receive the intervention.
    Primary Outcome Measure Information:
    Title
    Pain relief: numerical pain scale
    Description
    The pain relief received from each injection will be measured using the numerical pain scale. This scale is between 0-10 with 0 meaning no pain and 10 is the most pain.Higher values represent worse pain.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rafeal Benoliel, BDS
    Organizational Affiliation
    Rutgers School of Dental Medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32009005
    Citation
    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.
    Results Reference
    derived

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

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