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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Notify MeKey information
Conditions
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
Prilocaine HCl % 2 injectable solution
DrugPrimary outcomes
-
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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