Local Anesthesia Clinical Trial
Official title:
Comparison of the Efficacy of Different Treatment Modalities in Masseteric Myofascial Pain: Masseteric Nerve Block, Local Anesthetic Injection and Dry-needling
NCT number | NCT04339673 |
Other study ID # | 135162 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | November 30, 2019 |
Verified date | April 2020 |
Source | Erzincan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the present study was to compare the efficacy of three different treatment methods in the management of myofascial pain: masseteric nerve block (MN), trigger point injection(TrP) with local anesthetic (LA) and dry needling (DN).Study Design: 45 subjects aged 18-54 years were randomly assigned to the MN group (n= 15), LA group (n=15) and DN group (n=15).
Status | Completed |
Enrollment | 45 |
Est. completion date | November 30, 2019 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 54 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of myofascial pain. - Presence of at least one trigger point in masseter muscle. Exclusion Criteria: - Generalized muscle disorders. - Hypersensitivity to local anesthetics. |
Country | Name | City | State |
---|---|---|---|
Turkey | Erzincan Agiz Ve Dis Sagligi Egt Aras Hastanesi | Erzincan |
Lead Sponsor | Collaborator |
---|---|
Erzincan University |
Turkey,
Quek SY, Subramanian G, Patel J, Ananthan S, Zagury JG, Khan J. Efficacy of regional nerve block in management of myofascial pain of masseteric origin. Cranio. 2015 Oct;33(4):285-90. doi: 10.1080/08869634.2015.1097300. Epub 2015 Dec 29. — View Citation
Venancio Rde A, Alencar FG Jr, Zamperini C. Botulinum toxin, lidocaine, and dry-needling injections in patients with myofascial pain and headaches. Cranio. 2009 Jan;27(1):46-53. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS) | Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable) | before the injections (T0, Baseline) | |
Primary | The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS) | Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable) | At 1st week (t1) | |
Primary | The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS) | Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable) | At 4th week (t2) | |
Primary | The Rate of Pain on Function (PoF) assessed by Numerical pain Scale (NRS) | Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable) | At 12th week (t3) | |
Secondary | The Rate of Pain Intensity on Palpation (PoP) | Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle. | before the injections (T0, Baseline) | |
Secondary | The Rate of Pain Intensity on Palpation (PoP) | Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle. | At 1st week (t1) | |
Secondary | The Rate of Pain Intensity on Palpation (PoP) | Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle. | At 4th week (t2) | |
Secondary | The Rate of Pain Intensity on Palpation (PoP) | Patients rated their pain intensity on masseter muscle by a 4-point Likert-type scale (0 = no pain, 3 = as worst pain imaginable) while a calibrated examiner palpating their masseter muscle. | At 12th week (t3) | |
Secondary | The measurement of pain-free maximum mouth opening (MMO) in millimeters | Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded. | before the injections (T0, Baseline) | |
Secondary | The measurement of pain-free maximum mouth opening (MMO) in millimeters | Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded. | At 1st week (t1) | |
Secondary | The measurement of pain-free maximum mouth opening (MMO) in millimeters | Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded. | At 4th week (t2) | |
Secondary | The measurement of pain-free maximum mouth opening (MMO) in millimeters | Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain in masseter muscle. Three measurements were performed, and their average is recorded. | At 12th week (t3) |
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