Comparison Between Botox and Magnesium Sulfate Effect in Treatment of Myofascial Pain Trigger Points Within the Masseter Muscle (MPS MTrPs BTA)

November 4, 2024 updated by: Mayada tarek, Misr University for Science and Technology

Comparison of the Effectiveness of Botulinum Toxin and Magnesium Sulfate Injections in the Treatment of Myofascial Trigger Points in the Masseter Muscle Randomized Controlled Clinical Trial

The goal of this randomized clinical trial is to compare the effectiveness of Botulinum toxin type A, magnesium sulfate and saline injections in treatment of the masseter muscle trigger points, in patients between 16 - 50 years old with myofascial pain with masseter muscle trigger points. The main questions it aims to answer are:

  • which treatment has longer effect of pain release with the least possible side effects and recurrence rate?
  • Which treatment has greater impact on improving patient's quality of life? Researchers will compare Botulinum toxin type A, magnesium sulfate to a placebo saline injections in treatment of the masseter muscle trigger points Participants will attend to the clinic 4 times
  • 1st visit will include taking preoperative records and treatment injection
  • 2nd visit will be follow up and taking records after 1 month
  • 3rd visit will be follow up and taking records after 3 months
  • 4th visit will be follow up and taking records after 6 months

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Myofascial pain syndrome (MPS) is common syndrome in patients with musculoskeletal pain problems. It's a pain condition originating from muscle and surrounding fascia. Patient usually complains from localized pain in a certain area or referred pain of various patterns. On physical examinations, trigger points (TrPs) may reveal on the involved muscles. (Tantanatip, Chang,2018). TrPs are usually palpable and hyperirritable nodule found within a taut band of muscle. By Stimulating these points, two characteristic phenomena are produced: sudden contractions of the taut band and referred pain, which is known as the local twitch response (LTR). Active MTrPs usually produce pain spontaneously, and sometimes referred pain, while Latent MTrPs produce referred pain in response to the applied pressure, but not spontaneously (Simons, D.G, 2004).

Multiple factors can contribute to MPS. The risk factors are; Traumatic events, ergonomic factors (e.g., overuse activities, abnormal posture, Structural factors (e.g., spondylosis, scoliosis, osteoarthritis), systemic factors (e.g., hypothyroidism, vitamin D deficiency, iron deficiency). (Saxena,et al,2015), however Intramuscular injections are considered the first-line treatment for myofascial TrPs(Yilmaz, et al 2021). Injections could be wet as local anesthetic agents, steroid, platelet rich plasma, saline or botulinum toxin, or it could be dry by dry needling without solutions MPS is a result of inappropriate activity of acetylcholine (ACh) at the neuromuscular junction, producing a sustained contraction of the sarcomere. The ACh-related effects are relevant to the taut band development, which leads to increasing the local energy demand or energy crisis (Simons, D.G, 2004). The pain in the local muscle occurs secondary to the substances released from the damaged muscle, and from the extracellular fluid around the TrP, such as protons (H+) on acid-sensing ion channels which occurs in ischemia and in exercise. In these metabolic conditions, sensitizing amines may be released stimulating the nociceptors and giving rise to pain. Therefore, MTrPs are better defined by two phenomena: altered ACh activity and nociceptive stimulation (Sluka, Kalra, Moore,2001). The fact of myofascial muscles are a part of the stomatognathic system, any imbalance in this system could have a disturbing impact on its function such as mastication, posture and non-physiological occlusion, affecting the patient's quality of life (Fiorillo, 2020).

Botulinum toxin type A is a neurotoxin used to reduce excessive muscle contraction. Its produced by gram-positive, anaerobic, spore-forming bacilli known as Clostridium botulinum which is widely distributed in aquatic and soil environments. (Tiwari,Nagalli 2024). Botulinum toxin inhibits neurotransmission at the neuromuscular junction. Several transport proteins participate in the process by which ACh is released; these proteins aggregate to form the SNARE complex (Soluble NSF (N-Ethylmaleimide-Sensitive Factor) Attachment Protein Receptor, responsible for fusion of the vesicles of ACh with the membrane and the subsequent release of the neurotransmitter. The heavy chain of the toxin has a high affinity for the membrane receptors and, once bound, BTA undergoes endocytosis. The light chain is released within the cell, where it acts as a zinc-dependent endoprotease. After cleavage of one of the proteins of the SNARE complex by BTA, the complex does not form and ACh is not released. (Aikawa,et al , 2006) Magnesium sulfate (MgSO4) is commonly used as analgesics for treatment of musculoskeletal problems, snice having muscle relaxant and vasodilator properties. (Ibrahim, Raoof, Mosaad,2021). These properties can likely be attributed to its ability to block presynaptic acetylcholine discharge from neuromuscular and sympathetic junctions (Dahle, et al ,1995). Therefore, MgSo4 injections are an effective treatment modality for myofascial TrPs of the masseter muscle. It helps in reducing the pain and improving the maximum mouth opening, in addition to the quality of patient's life. (Refahee, Mahrous, Shabaan,2022)

Intervention After the MTP is located and the overlying skin had been disinfected with alcohol, the taut muscle band is pinched between the thumb and index finger, and the needle is inserted 1-2 cm away from the targeted MTP at an angle of 30º to the skin. A negative aspiration should be performed to prevent any intravascular injections (Taşkesen, Cezairli, 2023). Group 1: 2ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt). Group 2: 2ml of BTX and Group 3: 2 ml of saline

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • GIza, Egypt
        • Misr University for Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

This study will include patients diagnosed with orofacial pain and trigger points in the masseter muscle unilaterally or bilaterally for at least period 6 months other criteria

  • (1) definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral (2) presence of one or more unilateral or bilateral trigger points in the masseter muscle; and (3) no history of any invasive procedures of the related masseter muscle (Taşkesen, Cezairli, 2023.)

Exclusion Criteria:

(1) any painful conditions (other than myofascial trigger points) affecting the orofacial region; (2) any systemic diseases that could affect masticatory function (e.g., rheumatoid arthritis and epilepsy); and (3) pregnancy and lactation. (Refahee, Mahrous, Shabaan,2022)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I: Patients will receive Magnesium Sulfate injection into trigger points
Drug: MgSO4
2ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt).
Active Comparator: Group II: Patients will receive Botulinum Toxin into trigger points
Drug: BOTOX-A
2ml of BTX
Placebo Comparator: Group III: Patients will receive Saline injection into trigger points
Drug: Saline (NaCl 0,9 %) (placebo)
2 ml of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating pain
Time Frame: preoperative - post operative - 1 , 3 ,6 months follow up
Pain will be recorded with a visual analog scale (VAS of 0-10, with zero being no pain and 10 the worst pain possible)
preoperative - post operative - 1 , 3 ,6 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain-free maximum mouth opening (MMO)
Time Frame: preoperative - post operative - 1 , 3 ,6 months follow up
Pain-free MMO will be measured as the distance between the incisal edges of the upper and lower incisors. Three measurements will be performed, and their average was recorded (Taşkesen, Cezairli, 2023).
preoperative - post operative - 1 , 3 ,6 months follow up
Muscle health and activity measured using electromyography
Time Frame: preoperative - post operative - 1 , 3 ,6 months follow up
Muscle health and activity measured using electromyography, EMG can provide valuable insights into altered muscle activity patterns and help in the diagnosis and management of MPDS through readings (Zieliński, et al, 2021).
preoperative - post operative - 1 , 3 ,6 months follow up
The quality of life will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14)
Time Frame: preoperative - post operative - 1 , 3 ,6 months follow up
The quality of life will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14) containing 14 questions divided into seven domains of oral health. The participant will be asked to score each question using a scale from 1 to 5 [never (score 0); hardly ever (score 1); occasionally (score 2); fairly often (score 3); and very often (score 4)], and the sum of all 14 items was calculated. The OHIP score could range from 0 to 56 units, with the former indicating no problems and higher scores representing greater impairment of quality of life (Slade and Spencer, 1994).
preoperative - post operative - 1 , 3 ,6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Misr University for Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200036178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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