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

Not Applicable

Completed

• Conditions: Nerve Block; Trigger Point Pain, Myofascial; Myofascial Pain - Dysfunction Syndrome of TMJ
• Interventions: Other: Injection of either twin block or trigger point injection.

• Registration Number: NCT03870191
• Lead Sponsor: Rutgers University

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.

Study Timeline

• Study Start: 2016-06-21
• Primary Completion: 2018-06-05
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-12
• Study Completion: 2020-05-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twin Block Group	Injection of either twin block or trigger point injection.	This group will receive twin block injections.
Trigger Point Injection Group	Injection of either twin block or trigger point injection.	This group will receive trigger point injections.

Primary Outcome Measures

Name	Time	Method
Pain relief: numerical pain scale	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.