Jaw muscle pain relief following local injection with Botox. A randomized double-blind controlled multicenter pilot study

Masseter myofascial pain relief following an intra-muscular injection with botulinum toxin type A. A randomized double-blind controlled multicenter pilot study. - BTX1 - myalgia pain

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004704-35-SE

Enrollment

Registered

2020-02-12

Start date

2020-05-18

Completion date

Unknown

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myalgia of jaw muscle

Interventions

Trade Name: Botox 100 Allergan-units Pharmaceutical Form: Powder for solution for injection Pharmaceutical form of the placebo: Solvent for parenteral use Route of administration of the placebo: Intra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • age > 18 years • > 3-month complaints of jaw/face pain • the diagnose myalgia according to DC/TMD • understands Swedish verbally and in writing • in writing give his/her consent to participate 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 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: polyarthritis/connective tissue disease • fibromyalgia or other generalized pain • neurological disorders • whiplash associated disorders • ongoing virus or bacterial infection • ongoing dental treatment • botulinum toxin injection in the jaw or face past six months • complex psychiatric/psychological profile, institutional residence • employee at the trial clinic, internal resident • hypersensitivity to botulinum toxin, human albumin • serious health conditions according to the examiner's assessment • in the presence of infection at the proposed injection site(s) • pregnancy or lactating • fertile women not on contraception

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The primary efficacy measure will be the change from baseline in frequency in pain days.;Main Objective: To evaluate the reduction of days with pain two months after one session of Botox/placebo injection of the masseter and temporalis muscle in subjects with jaw muscle myalgia pain.;Secondary Objective: To perform exploratory analysis on a series of variables to identify those which could be sensitive to use in a later adequately dimensioned randomized controlled trial.;Timepoint(s) of evaluation of this end point: 2 months after intervention	—

Measure

Time frame

Primary end point(s): The primary efficacy measure will be the change from baseline in frequency in pain days.;Main Objective: To evaluate the reduction of days with pain two months after one session of Botox/placebo injection of the masseter and temporalis muscle in subjects with jaw muscle myalgia pain.;Secondary Objective: To perform exploratory analysis on a series of variables to identify those which could be sensitive to use in a later adequately dimensioned randomized controlled trial.;Timepoint(s) of evaluation of this end point: 2 months after intervention

—

Secondary

Measure	Time frame
Secondary end point(s): Exploratory analyses;Timepoint(s) of evaluation of this end point: 2 months after intervention	—

Countries

Sweden

Contacts

Public ContactUniversitetssjukhuset Örebro

Region Örebro

goran.isacsson@regionorebrolan.se+46767766 506

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026