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

NCT ID: NCT06899438

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-26

Study Completion Date

2010-01-26

Brief Summary

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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

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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.

Conditions

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Myofacial Pain Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Botulinum toxin injection group (BIG)

Group Type EXPERIMENTAL

Botulinum Toxin A Injection

Intervention Type DRUG

Prilocaine injection group (PIG)

Group Type ACTIVE_COMPARATOR

Prilocaine HCl % 2 injectable solution

Intervention Type DRUG

Interventions

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Botulinum Toxin A Injection

Intervention Type DRUG

Prilocaine HCl % 2 injectable solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Taner Dandinoğlu

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baki Özdemir, MD

Role: PRINCIPAL_INVESTIGATOR

LHU Ankara Hospital Department of Rheumatology

Study Documents

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Document Type: Clinical Study Report

View Document

Other Identifiers

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2009-PMR-1

Identifier Type: -

Identifier Source: org_study_id

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