EUCTR2021-002784-21-SE
Active, Not Recruiting
Phase 1
Botulinum toxin type A as treatment for chronic myogenous orofacial pain - a radomized controlled, double-blind clinical trial
ConditionsChronic myalgia (>6months) in the facial region.Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsBOTOX Allergan
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic myalgia (>6months) in the facial region.
- Sponsor
- Västra Götalandsregionen
- Enrollment
- 72
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, Not Recruiting
Phase 1
Botulinum toxin-A as a treatment for chronic muscle-related pain in adults with spastic cerebral palsy: a randomized controlled trial.Spastic cerebral palsyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2015-000095-10-SEKarolinska Institutet48
Active, Not Recruiting
Phase 1
Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer SurgeryPost Thoracotomy Pain Syndrome (PTPS)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]EUCTR2020-003300-14-DKDepartment of Cardiothoracic Surgery, Aalborg Universityhospital30
Recruiting
Phase 4
Efficacy of botulinum toxin A for the management of melasma: A split-face, randomized control studyClinical diagnosis of melasma with symmetrical involvement of both malar areasMelasmaTCTR20240721002Division of Dermatology, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand30
Not Yet Recruiting
N/A
The combination treatment of Botulinum toxin and ablative fractional CO2 lasering to prevent scar formation after thyroidectomy and removal of neck massKCT0006396The Catholic University of Korea, St. Vincent's Hospital75
Completed
N/A
se of Botulinum Toxin for Treatment of Idiopathic Rhinitisidiopathic rhinitisC08.460.799RBR-4jbw4sFaculdade de Medicina da Universidade de São Paulo