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

NCT04426123 | Unknown Phase 2 DMC

• 1 other identifier: 273697
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain days

  The change in frequency (number) of pain days

  2 months

Secondary Outcomes (6)

• Pain intensity

  2 months

• Pain intensity on maximal opening of the jaw

  2 months

• JFLS-20

  2 months

• PHQ-9

  2 months

• PGIC

  2 months

Study Arms (2)

Botulinum toxin

ACTIVE COMPARATOR

Botulinum toxin type A

Drug: Botulinum toxin type A

Saline solution

PLACEBO COMPARATOR

NaCl

Other: saline solution

Interventions

Botulinum toxin type A DRUG

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

Also known as: Botox

Botulinum toxin

saline solution OTHER

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

Also known as: Physiologic NaCl

Saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead
• Region Västmanland: collaborator
• Landstinget i Värmland: collaborator

MeSH Terms

Conditions

Myalgia

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Göran Isacsson, Assoc. Prof.

  Region Stockholm

  STUDY DIRECTOR

• Mohamad Schumann, DDS

  Västerås

  STUDY DIRECTOR

• Daniel Ovesson, DDS

  Karlstad

  STUDY DIRECTOR

Central Study Contacts

Ava Minston, DDS

CONTACT

+46196024070; ava.minston@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share