Myofacial Pain SyndromesNCT06899438
Does Botulinum Toxin Type-A Injection an Effective Way of Relieving Pain in Myofascial Pain Syndrome Patients or Not
A study testing Botulinum Toxin A Injection and Prilocaine HCl % 2 injectable solution in people with Myofacial Pain Syndromes, run by Bursa City Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Myofacial Pain Syndromes
- What is being tested?
- Botulinum Toxin A Injection and Prilocaine HCl % 2 injectable solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2009to 26 Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 20 years
- Presence of myofascial pain syndrome (MPS) symptoms for more than 3 months
- Ability and willingness to provide written informed consent
Who cannot join
- 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
About this study
Official title: Does Botulinum Toxin Type-A an Effective Way of Relieving Pain in Myofascial Pain Syndrome 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.
Read the 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.
- Conditions
- Myofacial Pain Syndromes
- Being tested
- Botulinum Toxin A Injection, Prilocaine HCl % 2 injectable solution
- Keywords
- Myofascial pain, Botulinum toxin, Prilocaine, İnjection
- Medical subject headings
- Facial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin A InjectionDrug
Prilocaine HCl % 2 injectable solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin injection group (BIG) | Experimental | Not described Receives: Drug: Botulinum Toxin A Injection |
| Prilocaine injection group (PIG) | Active comparator | Not described Receives: Drug: Prilocaine HCl % 2 injectable solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment, 2nd and 6th week scores were recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start26 Aug 2009
- Primary completion26 Jan 2010
- Study completion26 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofacial Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Taner Dandinoğlu, Bursa City Hospital
- Investigators
- Baki Özdemir, MD, Principal investigator, LHU Ankara Hospital Department of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899438
- Sponsor's protocol ID
- 2009-PMR-1
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Botulinum Toxin Type-A an Effective Way of Relieving Pain in Myofascial Pain Syndrome or Not
- ClinicalTrials.gov ID
- NCT06899438
- Acronym / sponsor ID
- 2009-PMR-1
- Conditions
- Myofacial Pain Syndromes
- Keywords
- Myofascial pain, Botulinum toxin, Prilocaine, İnjection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 26 Aug 2009 (actual)
- Primary completion
- 26 Jan 2010 (actual)
- Study completion
- 26 Jan 2010 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin injection group (BIG) | Experimental | Drug: Botulinum Toxin A Injection |
| Prilocaine injection group (PIG) | Active comparator | Drug: Prilocaine HCl % 2 injectable solution |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥ 20 years
- Presence of myofascial pain syndrome (MPS) symptoms for more than 3 months
- Ability and willingness to provide written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin A Injection | Drug | Botulinum toxin injection group (BIG) |
| Prilocaine HCl % 2 injectable solution | Drug | Prilocaine injection group (PIG) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Myofacial Pain Syndromes
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Myofacial Pain, Myofacial Pain Syndrome
Not yet recruiting
Focused Versus Multi-Target Trigger Point Injection for Chronic Myofascial Neck Pain
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Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome
Myofacial Pain Syndrome
Recruiting
Massage Gun vs Deep Friction Massage for Upper Trapezius Trigger Points
Myofacial Trigger Points of Upper Trapezius
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Effect of Occlusal Splint on Head and Neck Muscles in Patients With Bruxism and Myofascial Pain
Myofacial Pain Syndrome, Local Myalgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baki Özdemir, MD principal investigator
LHU Ankara Hospital Department of Rheumatology
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin A Injection and Prilocaine HCl % 2 injectable solution in people with Myofacial Pain Syndromes, run by Bursa City Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale, 4-point verbal rating scale, Pressure pain threshold (time frame: Pre-treatment, 2nd and 6th week scores were recorded.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.