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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin injection group (BIG) | Experimental |
| |
| Prilocaine injection group (PIG) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin A Injection | Drug |
| ||
| Prilocaine HCl % 2 injectable solution |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Baki Özdemir, MD | LHU Ankara Hospital Department of Rheumatology | Principal Investigator |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
The data that support the findings of this study are available from Military Medical Academy of Turkish Army but restrictions apply to the availability of these data (All patients are retired or active soldiers and their spouses) and so are not publicly available. However, under appropriate circumstances findings are available from the author upon reasonable request. If it is requested, data will be available for reviewers from Dr Taner Dandinoglu, E-mail: dandinoglu@gmail.com.
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| ID | Term |
|---|---|
| D005156 | Facial Neuralgia |
| ID | Term |
|---|---|
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Drug |
|
| D009422 |
| Nervous System Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |