NCT03870191

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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

March 8, 2019

Last Update Submit

June 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

Twin Block Group

ACTIVE COMPARATOR

This group will receive twin block injections.

Other: Injection of either twin block or trigger point injection.

Trigger Point Injection Group

ACTIVE COMPARATOR

This group will receive trigger point injections.

Other: Injection of either twin block or trigger point injection.

Interventions

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

Trigger Point Injection GroupTwin Block Group

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Temporomandibular Joint DisordersMyofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Rafeal Benoliel, BDS

    Rutgers School of Dental Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 12, 2019

Study Start

June 21, 2016

Primary Completion

June 5, 2018

Study Completion

May 31, 2020

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share