Does Botulinum Toxin Type-A Injection an Effective Way of Relieving Pain in Myofascial Pain Syndrome Patients or Not

Does Botulinum Toxin Type-A an Effective Way of Relieving Pain in Myofascial Pain Syndrome or Not

In this research prilocaine and botulinum toxin (BoNT-A) interventions prospectively compared to find out the effect of BoNT-A injection on myofascial pain syndrome (MPS).

The main question it aims to answer is: Does Botulinum Toxin Type-A an Effective Way of Relieving Pain in Myofascial Pain Syndrome or not?

For this purpose thirty-eight patients randomly assigned into two study groups. While BoNT-A injection group (BIG group n=19) treated with 20 units of toxin to each trigger point (TP), remaining treated with 2 ml prilocaine (PIG group n=19) with same procedure.

Pre-treatment, 2nd and 6th weeks findings were clinically recorded.

Study Overview

• Status: Completed
• Conditions: Myofacial Pain Syndromes
• Intervention / Treatment: Drug: Botulinum Toxin A Injection; Drug: Prilocaine HCl % 2 injectable solution

Detailed Description

Visual Analog Scale (VAS), 4-Point Verbal Rating Scale (VRS), Pain Pressure Threshold (PPT), Short Form-36 (SF-36) and Beck Depression Inventory (BDI) tools were used to evaluate findings of the research.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age ≥ 20 years

Presence of myofascial pain syndrome (MPS) symptoms for more than 3 months

Ability and willingness to provide written informed consent

Exclusion Criteria:

Any injection to trigger points within the last 2 months

Diagnosis of fibromyalgia syndrome

Presence of significant respiratory or cardiovascular disease

Presence of psychiatric disorders that may interfere with study participation

History of shoulder or cervical spine intervention within the last year

Presence of cervical myelopathy or cervical radiculopathy

Inability to cooperate with study procedures or assessments

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum toxin injection group (BIG)	Drug: Botulinum Toxin A Injection
Active Comparator: Prilocaine injection group (PIG)	Drug: Prilocaine HCl % 2 injectable solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale, 4-point verbal rating scale, Pressure pain threshold	Visual analog scale (VAS) between 0 and 10 was used to measure subjective complaints of pain (0 painless-10 worst pain). 4-point verbal rating scale (VRS) was also used to evaluate the affected area covering the TP (3 Severe pain; strong verbal response, accompanied by grimacing of face, withdrawal of hand, 2 Modarate pain, complaint reported spontaneously or mostly response to asking, accompanied by behavioral changes like grimacing, 1 Mild pain, pain is expressed when questioning without behavioral responces and 0 None, no pain). An algometry device is used to evaluate "Pressure pain threshold" (PPT) and the sensitivity that the person felt is recorded in kg.	Pre-treatment, 2nd and 6th week scores were recorded.

Collaborators and Investigators

• Sponsor: Bursa City Hospital
• Investigators: Principal Investigator: Baki Özdemir, MD, LHU Ankara Hospital Department of Rheumatology

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2009
• Primary Completion (Actual): January 26, 2010
• Study Completion (Actual): January 26, 2010

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Myofascial pain; Prilocaine; Botulinum toxin; İnjection
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Facial Neuralgia; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A
• Other Study ID Numbers: 2009-PMR-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data that support the findings of this study are available from Military Medical Academy of Turkish Army but restrictions apply to the availability of these data (All patients are retired or active soldiers and their spouses) and so are not publicly available. However, under appropriate circumstances findings are available from the author upon reasonable request. If it is requested, data will be available for reviewers from Dr Taner Dandinoglu, E-mail: dandinoglu@gmail.com.

Study Data/Documents

1. Clinical Study Report

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