CLINICAL TRIAL

Botulinum toxin type A for Myofascial Pain Syndromes

Recruiting · 18+ · All Sexes · Chicago, IL

Botulinum Toxin Versus Placebo Injections to Temporalis and Masseter Muscles

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About the trial for Myofascial Pain Syndromes

Eligible Conditions
Syndrome · Syndrome Pain · Temporomandibular Joint Dysfunction Syndrome · Temporomandibular Joint Disorders · Fibromyalgia · Pain Syndrome Myofascial · Somatoform Disorders · Pain, Head · Myofascial Pain Syndromes · Headache · Temporomandibular Disorders

Treatment Groups

This trial involves 2 different treatments. Botulinum Toxin Type A is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Botulinum toxin type A
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
0.9% Sodium Chloride Injection
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diphenhydramine
FDA approved

Side Effect Profile for Dysport ® 500 U

Dysport ® 500 U
Show all side effects
7%
Head injury
7%
Insomnia
4%
Fall
4%
Pneumonia
4%
Vomiting
4%
Hypokalaemia
4%
Pain
4%
Urinary tract infection
4%
Asthma
4%
Tachycardia
4%
Constipation
4%
Pyrexia
4%
Hypertensive crisis
4%
Cough
0%
Epistaxis
0%
Dizziness
0%
Neuralgia
Head injury
7%
Insomnia
7%
Fall
4%
Pneumonia
4%
Vomiting
4%
Hypokalaemia
4%
Pain
4%
Urinary tract infection
4%
Asthma
4%
Tachycardia
4%
Constipation
4%
Pyrexia
4%
Hypertensive crisis
4%
Cough
4%
Epistaxis
0%
Dizziness
0%
Neuralgia
0%
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT02321436) in the Dysport ® 500 U ARM group. Side effects include: Head injury with 7%, Insomnia with 7%, Fall with 4%, Pneumonia with 4%, Vomiting with 4%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
18-65 years of age
Ability to give informed consent
Myofascial pain of masticatory muscles as defined according to the RDC/TMD criteria
Baseline pain measured by the subject ≥3.5/10 on visual analog scale
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-intervention
Screening: ~3 weeks
Treatment: Varies
Reporting: Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-intervention
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-intervention.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Botulinum toxin type A will improve 1 primary outcome and 3 secondary outcomes in patients with Myofascial Pain Syndromes. Measurement will happen over the course of Pre-intervention, Change at 1 month post-intervention, Change at 2 months post-intervention, Change at 3 months post-intervention.

Change in objectively assessed quality of life as measured by Short Form 36
PRE-INTERVENTION, CHANGE AT 1 MONTH POST-INTERVENTION, CHANGE AT 2 MONTHS POST-INTERVENTION, CHANGE AT 3 MONTHS POST-INTERVENTION
Short Form 36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are utilized for routine monitoring and assessment of care outcomes in adult patients. A high score of 100 on this survey indicates the patient is self-reporting a high quality-of-life, a low score of 0 indicates a low quality-of-life.
PRE-INTERVENTION, CHANGE AT 1 MONTH POST-INTERVENTION, CHANGE AT 2 MONTHS POST-INTERVENTION, CHANGE AT 3 MONTHS POST-INTERVENTION
Change in Jaw Function as measured by Maximum interincisal opening
PRE-INTERVENTION, CHANGE AT 1 MONTH POST-INTERVENTION, CHANGE AT 2 MONTHS POST-INTERVENTION, CHANGE AT 3 MONTHS POST-INTERVENTION
Mouth opening measurements in mm both when patient is in pain and not in pain. This measurement is taken from the maxillary central incisor to mandibular central incisor.
PRE-INTERVENTION, CHANGE AT 1 MONTH POST-INTERVENTION, CHANGE AT 2 MONTHS POST-INTERVENTION, CHANGE AT 3 MONTHS POST-INTERVENTION
Change in Jaw Function as measured by Jaw Function Limitation Scale
PRE-INTERVENTION, CHANGE AT 1 MONTH POST-INTERVENTION, CHANGE AT 2 MONTHS POST-INTERVENTION, CHANGE AT 3 MONTHS POST-INTERVENTION
A series of yes or no questions to determine what activities a patient's jaw problem prevents or limits them from doing. A high score of 7 indicates severe jaw limitation, a low score of 0 indicates no jaw limitation.
PRE-INTERVENTION, CHANGE AT 1 MONTH POST-INTERVENTION, CHANGE AT 2 MONTHS POST-INTERVENTION, CHANGE AT 3 MONTHS POST-INTERVENTION
Comparison in Jaw Pain as reported by patient on Visual Analog Scale
PRE-INTERVENTION, CHANGE AT 1 MONTH POST-INTERVENTION, CHANGE AT 2 MONTHS POST-INTERVENTION, CHANGE AT 3 MONTHS POST-INTERVENTION
Visual Analog Scale ranging from "no pain" to "pain as bad as it could possibly be"
PRE-INTERVENTION, CHANGE AT 1 MONTH POST-INTERVENTION, CHANGE AT 2 MONTHS POST-INTERVENTION, CHANGE AT 3 MONTHS POST-INTERVENTION

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is myofascial pain syndromes?

Myofascial pain syndromes (MPS) are a group of illnesses and diagnoses that involve tender, tight, and painful parts of the body. The cause is often a combination of a number of factors. The MPS has many types and each class of syndromes can have different treatments.\n

Anonymous Patient Answer

How many people get myofascial pain syndromes a year in the United States?

About 10 million people in the U.S. are diagnosed with myofascial pain or tension-type headaches every year, and there are over 25 million people who suffer with myofascial pain. The prevalence of myofascial pain in North American populations is high enough to suggest that a significant number of people in the U.S. may have myofascial pain.

Anonymous Patient Answer

What are common treatments for myofascial pain syndromes?

The common treatments used by MPS specialists include intra-articular injections with local anesthetics and corticosteroids; massage/myofascial trigger point therapy; chiropractic manipulation; acupuncture; and transcutaneous electrical nerve stimulation.\n

Anonymous Patient Answer

What are the signs of myofascial pain syndromes?

Myofascial pain syndromes can be painful and debilitating or painless and asymptomatic. In many cases, patients describe either a referral pattern or a pattern of referral and clinical response that are consistent with myofascial pain syndromes but are difficult to explain using the International Association for the Study of Pain's diagnostic criteria. Because patients describe this referral pattern, they can be treated in a standardized manner.

Anonymous Patient Answer

Can myofascial pain syndromes be cured?

Based on this limited evidence, most MPSs are noncurable and most can be managed to a minimum of clinical symptoms, even though all patients have a substantial pain burden. Further research and experience from other medical communities will be needed to determine if MPS symptoms are more or less self-limited than many chronic pain conditions and whether MPS pain responds to conservative and non-pharmacological techniques.

Anonymous Patient Answer

What causes myofascial pain syndromes?

Myofascial pain can occur due to a variety of causes, yet the most common is an overuse injury. Some of the secondary causes are non-injury, and are most common in younger persons. Most commonly, myofascial pain is due to weakness of the myofascial compartment because of a history of an overuse injury. However, a few secondary causes are as a result of injury. The most common form of an overuse injury is a frozen shoulder that develops because of weakness in the shoulder and forearm muscles. However, most patients are symptomatic before being diagnosed with frozen shoulder. Many physicians will not suspect overuse injury when a history of overuse injury is not present, and do not consider this option.

Anonymous Patient Answer

What are the latest developments in botulinum toxin type a for therapeutic use?

Current scientific findings highlight the effectiveness and safety of botulinum toxin type a (Botox®) as a first-line, most effective and most efficacious treatment for various pain syndromes, such as myofascial pain syndrome, neuromuscular disorders and migraines.

Anonymous Patient Answer

What does botulinum toxin type a usually treat?

The injection of BTXA into muscles can produce acute relief of a variety of muscle soreness syndromes, but the magnitude of effect is negligible. The use of BTXA is contraindicated in individuals with known myofascial pain syndrome. BTXA should be carefully considered for management of chronic myofascial pain syndrome.

Anonymous Patient Answer

What is the primary cause of myofascial pain syndromes?

A primary myofascial pain syndrome is caused by an overactive myofascial trigger point. Patients usually do not have a palpable trigger point; however, there may be an associated tension-type trigger point nearby. Secondary myofascial pain syndromes are more of a secondary problem of the muscles and tendons rather than the muscles themselves.

Anonymous Patient Answer

What is the average age someone gets myofascial pain syndromes?

There has been relatively little data collected regarding this subgroup of patients. Most studies have reported patients within the age of 25 to 50 years. While the reasons for this age range remain uncertain, it seems common that the pain is caused by a myofascial injury as opposed to an unrelated pathology. Further research is needed to gather more data.

Anonymous Patient Answer

What are the common side effects of botulinum toxin type a?

[Botulinum toxin type A injections into the face cause painful nodules to form at their delivery sites. These may last up to 4 months after the injection, and can be very painful. This is not necessarily a problem unless the patient believes it to be. For a quick fix, the drug usually works for a few days or weeks, and so they can then be used repeatedly to help with the effect. Occasionally, the nodules spontaneously disappear so they are only painful after injection. In most cases, this requires some treatment and often requires multiple treatments. If the nodules recur after a long time, this is usually when the patient is not taking the drug.

Anonymous Patient Answer

What is botulinum toxin type a?

• Biotoxin type A is a neurotoxin found in the bacteria Clostridium botulinum. • Botulinum toxin type A is one of the treatments for focal dystonias. • A case report shows that botulinum toxin type A, along with botulinum toxin type A and botulinum toxin type B, is an effective, long-term treatment for myofascial pain and myofascial trigger point syndrome.

Anonymous Patient Answer
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