Chronic myalgia (>6months) in the facial region.
Conditions
Interventions
Trade Name: BOTOX Allergan
Product Name: Botox
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo:
Sponsors
Västra Götalandsregionen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1 months, 3 months, 4 months, 6 months and 9 months for all patients. ;Main Objective: Evaluate whether botulinum toxin A provides a significantly better pain-relieving effect for patients with orofacial myalgia compared to saline up to 6 months via evaluation of subjective perception of pain reduction and number of millimeters of pain free mouth opening. ;Secondary Objective: The secondary objectives are to 1) evaluate if pain reduction is correlated to psychosocial factors 2) evalute the time aspect of any possible pain reduction in patients that have received Botox 6 months after final injection.;Primary end point(s): 30% subjective pain reduction on a VAS scale and at least 40millimeter pain free mouth opening. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate if pain reduction is correlated to psychosocial factors at baseline. ;Timepoint(s) of evaluation of this end point: 9 months | — |
Countries
Sweden
Contacts
Public ContactInstitute of odontology
Sahlgrenska Academy at the University of Gotheburg
Outcome results
None listed