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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03870191
Other study ID # Pro20160000530
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 21, 2016
Est. completion date May 31, 2020

Study information

Verified date June 2020
Source Rutgers University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date May 31, 2020
Est. primary completion date June 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Injection of either twin block or trigger point injection.
Study participants will be randomized into either group and will receive the intervention.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rutgers University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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