Botulinum toxin type A as treatment for chronic facial muscle pain.
- Conditions
- Chronic myalgia (>6months) in the facial region.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2021-002784-21-SE
- Lead Sponsor
- Västra Götalandsregionen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 72
Age at least 18years
Written consent
Adequate communicative skills in Swedish
Myalgia as defined by DC/TMD
Prior conservative treatment for at least 6months with a minimum of information on diagnosis and prognosis, patient councelling, instruction in resting the jaw, biofeedback training and jaw exercise
Subjective degree of pain = 40mm on a 100mm VAS scale
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Pain of dental origin
Athritis as defined by DC/TMD expanded taxonomy
Rheumatic disease diagnosed by physician (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis / Bechterew's disease, reactive arthritis, juvenile idiopathic arthritis)
Neuropathic pain, diagnosed by physician, of central / peripheral genesis or infectious / inflammatory genesis (eg stroke, multiple sclerosis, brain damage, traumatic or surgically triggered facial injury, tumor-induced nerve involvement, postherpetic neuralgia, trigeminal neuralgia, neuroborreliosis
Impaired neuromuscular transmission e.g. myasthenia gravis or Eaton Lambert's syndrome or peripheral motor neuropathic and neurological diseases (eg amyotrophic lateral sclerosis or motor neuropathy), diagnosed by physician
Hypersensitivety or allergy to any botulinum toxin product or to any of the components in the formulation
Pregnancy / breastfeeding or planned pregnancy. Women of childbearing potential must use highly effective contraceptives i.e oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception, oral, injectable or implantablie progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS) 2, bilateral tubal occlusion, vasectomised partner. CE- approved pregnancy tests are handed to the patient for monthly tests up to 6 months after the last injection (a total of 11 tests).
Infection at site of injection
Ongoing treatment with aminoglycosides, cholinesterase inhibitors or muscle relaxants
Prior or ongoing treatment with botulinum toxin A of any serotype
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method