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Masseter Myofascial Pain Relief Following an Intra-muscular Injection With Botulinum Toxin Type A.

NCT04426123 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-06-11

No results posted yet for this study

Summary

Investigating the effect of a single intramuscular injection with botulinum toxin (BTX) compared to NaCl in patients with jaw muscle myalgia.

This investigation is designed as an double blind multicenter pilot study for hypothesis generation on 48 patients with chronic jaw muscle myalgia at four specialist dental clinics. The subjects visit the clinic on 3 predefined occasions, one telephone call and one scheduled evaluation by mail.

The objective is primarily to evaluate the change in number of days with pain at two months following one session of BTX injections of the masseter and temporalis muscles in subjects with jaw muscle myalgia pain.

The outcome of this study will serve as a basis for a later randomized controlled trial

Conditions

  • Myalgia
  • Myofascial Pain

Interventions

DRUG

Botulinum toxin type A

Intramuscular injection with Botulinum toxin type A in m.masseter and m.temporalis.

OTHER

saline solution

Intramuscular injection with NaCl in m.masseter and m.temporalis.

Sponsors & Collaborators

  • Region Västmanland

    collaborator OTHER

  • Landstinget i Värmland

    collaborator OTHER

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Göran Isacsson, Assoc. Prof. · Region Stockholm

  • Mohamad Schumann, DDS · Västerås

  • Daniel Ovesson, DDS · Karlstad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2020-12-31
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04426123 on ClinicalTrials.gov