Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial Summary

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).


Description:

The study sample consisted 45 patients with masseter muscle originated myofascial pain, were selected in accordance with the following criteria:

Patients were grouped according to the treatment they received: dry-needling (DN), TrP injections with local anesthetic (LA) and masseteric nerve block (MNB). Localization of the masseteric trigger points (MTPs) was based on clinician's sense and patients' expressions of pain. Local twitch response was not observable in all case. This procedure was completed by using digital palpation (1.5 Kg), and the clinical examiner's palpation was calibrated using a pressure algometer.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
masseteric nerve block
regional bloc of masseter
trigger point injection
trigger point injection with local anesthetic
dry needling
needling with acupuncture needles of trigger points in masseter

Locations

Country Name City State
Turkey Erzincan Agiz Ve Dis Sagligi Egt Aras Hastanesi Erzincan

Sponsors (1)

Lead Sponsor Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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

Outcome

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)
See also
  Status Clinical Trial Phase
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Completed NCT03262857 - Effect of Lidocaine With Magnesium Sulfate on the Success of the Inferior Alveolar Nerve Block Phase 2
Withdrawn NCT03502135 - Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment Phase 4
Not yet recruiting NCT02535273 - The Effect of Dexmedetomidine Analgesia and Sedation in Minimally Invasive Spine Surgery Under Local Anesthesia Phase 4
Not yet recruiting NCT05902780 - Can Caudal Dexmedetomidine Provide Effective Analgesia? N/A
Completed NCT04885777 - Topical Lidocaine Anesthesia for Nasopharyngeal Sampling N/A
Recruiting NCT04086394 - PECS Block in Partial Mastectomy for Postoperative Pain Control N/A
Recruiting NCT06129162 - Pain Perception Comparison of Computerized vs Conventional Injection Methods N/A
Completed NCT02922504 - Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia N/A
Completed NCT00539084 - A Study to Assess the Safety and Efficacy of a Microneedle Device for Local Anesthesia N/A
Completed NCT03176446 - Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment N/A
Completed NCT04947267 - To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor Phase 2
Completed NCT02825225 - A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes N/A
Completed NCT01360749 - Efficacy and Safety of Lambdalina (Lidocaine Cream) Versus Placebo as an Anesthetic for Laser Hair Removal Phase 2
Completed NCT00889642 - Safety and Efficacy Study of an Iontophoretic Patch Containing Lidocaine and Epinephrine for Venipuncture in Healthy Adult Volunteers Phase 2
Not yet recruiting NCT06395987 - Result Of Use Of Wide Awake Local Anaesthesia In Fixation Of Ankle Fractures
Active, not recruiting NCT05473819 - Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Injection N/A
Completed NCT04653974 - Pain Perception of Needle-free System N/A
Completed NCT02884596 - Success of Inferior Alveolar Nerve Block in Women Taking Selective Serotonin Reuptake Inhibitors
Completed NCT02440347 - Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block Phase 4