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

Not Applicable

Completed

• Conditions: Myofacial Pain Syndromes
• Interventions: Drug: Botulinum Toxin A Injection; Drug: Prilocaine HCl % 2 injectable solution

• Registration Number: NCT06899438
• Lead Sponsor: Bursa City Hospital

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.

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 Timeline

• Study Start: 2009-08-26
• Primary Completion: 2010-01-26
• Study Completion: 2010-01-26
• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Thirty eight patients (27 female, 11 male) admitted to the PM&R (physical medicine and rehabilitation) department with at least one TP identified at neck, upper back and lower back muscles were included to the study.

Exclusion Criterias:

Recent any injection to TP within the last 2 months, Diagnosed with fibromyalgia syndrome, Having respiratory or cardiovascular diseases, Allergies, Having psychiatric disorders, History of shoulder or cervical intervention within the last year, Cervical myelopathy, radiculopathy, Failure of cooperation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin injection group (BIG)	Botulinum Toxin A Injection	-
Prilocaine injection group (PIG)	Prilocaine HCl % 2 injectable solution	-

Primary Outcome Measures

Name	Time	Method
Visual analog scale, 4-point verbal rating scale, Pressure pain threshold	Pre-treatment, 2nd and 6th week scores were recorded.	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.