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

June 17, 2020 updated by: Sowmya Ananthan, Rutgers University
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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Twin Block Group
This group will receive twin block injections.
Other: Injection of either twin block or trigger point injection.
Study participants will be randomized into either group and will receive the intervention.
Active Comparator: Trigger Point Injection Group
This group will receive trigger point injections.
Other: Injection of either twin block or trigger point injection.
Study participants will be randomized into either group and will receive the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief: numerical pain scale
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers University

Investigators

  • Study Director: Rafeal Benoliel, BDS, Rutgers School of Dental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2016

Primary Completion (Actual)

June 5, 2018

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro20160000530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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