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

NCT06899438 | Completed

• 1 other identifier: 2009-PMR-1
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myofacial Pain Syndromes

Keywords

Myofascial pain; Botulinum toxin; Prilocaine; İnjection

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Botulinum toxin injection group (BIG)

EXPERIMENTAL

Drug: Botulinum Toxin A Injection

Prilocaine injection group (PIG)

ACTIVE COMPARATOR

Drug: Prilocaine HCl % 2 injectable solution

Interventions

Botulinum Toxin A Injection DRUG

Botulinum toxin injection group (BIG)

Prilocaine HCl % 2 injectable solution DRUG

Prilocaine injection group (PIG)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 20 years
• Presence of myofascial pain syndrome (MPS) symptoms for more than 3 months
• Ability and willingness to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa City Hospital: lead

MeSH Terms

Conditions

Facial Neuralgia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Baki Özdemir, MD

  LHU Ankara Hospital Department of Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: August 26, 2009
• Primary Completion: January 26, 2010
• Study Completion: January 26, 2010
• Last Updated: January 9, 2026

Record last verified: 2026-01