Myofascial Pain - Dysfunction Syndrome of TMJNCT03870191
Comparison of Therapeutic Effects of Trigger Point Injection and Twin Nerve Block in Chronic Myofascial Pain Patients
A study testing Injection of either twin block or trigger point injection. in people with Myofascial Pain - Dysfunction Syndrome of TMJ and Trigger Point Pain, Myofascial, run by Rutgers University.
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? Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Myofascial Pain - Dysfunction Syndrome of TMJ, Trigger Point Pain, Myofascial, Nerve Block
- What is being tested?
- Injection of either twin block or trigger point injection.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2016to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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?
Read the 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.
- Conditions
- Myofascial Pain - Dysfunction Syndrome of TMJ, Trigger Point Pain, Myofascial, Nerve Block
- Being tested
- Injection of either twin block or trigger point injection.
- Medical subject headings
- Temporomandibular Joint Disorders, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of either twin block or trigger point injection.Other
Study participants will be randomized into either group and will receive the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Twin Block Group | Active comparator | This group will receive twin block injections. Receives: Other: Injection of either twin block or trigger point injection. |
| Trigger Point Injection Group | Active comparator | This group will receive trigger point injections. Receives: Other: Injection of either twin block or trigger point injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start21 Jun 2016
- Primary completion5 Jun 2018
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain - Dysfunction Syndrome of TMJStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sowmya Ananthan, Rutgers University
- Investigators
- Rafeal Benoliel, BDS, Study director, Rutgers School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870191
- Sponsor's protocol ID
- Pro20160000530
- Status last verified
- Jun 2020
- First submitted
- 8 Mar 2019
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32009005
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Therapeutic Effects of Trigger Point Injection and Twin Nerve Block in Chronic Myofascial Pain Patients
- ClinicalTrials.gov ID
- NCT03870191
- Acronym / sponsor ID
- Pro20160000530
- Conditions
- Myofascial Pain - Dysfunction Syndrome of TMJ, Trigger Point Pain, Myofascial, Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twin Block Group | Active comparator | Other: Injection of either twin block or trigger point injection.This group will receive twin block injections. |
| Trigger Point Injection Group | Active comparator | Other: Injection of either twin block or trigger point injection.This group will receive trigger point injections. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of either twin block or trigger point injection.Study participants will be randomized into either group and will receive the intervention. | Other | Trigger Point Injection Group, Twin Block Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Derived from this study: PubMed 32009005Ananthan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafeal Benoliel, BDS study director
Rutgers School of Dental Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Injection of either twin block or trigger point injection. in people with Myofascial Pain - Dysfunction Syndrome of TMJ and Trigger Point Pain, Myofascial, run by Rutgers University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief: numerical pain scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03870191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.