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Completed

NCT Number: NCT06899438

Does Botulinum Toxin Type-A Injection an Effective Way of Relieving Pain in Myofascial Pain Syndrome Patients 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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin A Injection

Drug

Prilocaine HCl % 2 injectable solution

Drug

Primary outcomes

  1. Visual analog scale, 4-point verbal rating scale, Pressure pain threshold

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 28, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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