Comparison of Therapeutic Effects of Trigger Point Injection and Twin Nerve Block in Chronic Myofascial Pain Patients
1 other identifier
interventional
48
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2018
CompletedFirst Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedJune 19, 2020
June 1, 2020
2 years
March 8, 2019
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 COMPARATORThis group will receive twin block injections.
Trigger Point Injection Group
ACTIVE COMPARATORThis group will receive trigger point injections.
Interventions
Study participants will be randomized into either group and will receive the intervention.
Eligibility Criteria
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.
PMID: 32009005DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rafeal Benoliel, BDS
Rutgers School of Dental Medicine
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