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comparison of the effect of botulinium toxin A injection with placebo in reducing the pain of patients with myofacial pain

Evaluation of the effect of botulinum toxin type A injection for reducing the pain in patients with myofascial pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016051527894N2
Enrollment
34
Registered
2017-04-26
Start date
2016-03-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

temporomandibular disorder. Temporomandibular joint disorders

Interventions

Intervention 1: Intervention: Patients in intervention group will receive 150 units of botulinium toxin A (diluted in 1 cc normal saline) which will be injected in several points on masseter and temp
Treatment - Drugs
Intervention: Patients in intervention group will receive 150 units of botulinium toxin A (diluted in 1 cc normal saline) which will be injected in several points on masseter and temporalis muscles a
Control: The patients in placebo group firstly will receive 1 cc of normal saline which will be injected in several points on masseter and temporalis muscles, then they are followed up at the first an

Sponsors

Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria are: minimum patient's age of 18 years; the disease being diagnosed as myofascial type of temporomandibular disorder; the pain score equal or more than 30 based on visual analogue scale. Exclusion criteria: presence of connective tissue inflammatory diseases such as rheumatoid arthritis; temporomandibular disorder other than myofascial type; neuropathic pain or neurologic disorders; history of allergic reaction to botulinium toxin A; pregnancy;

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Patient's pain. Timepoint: before intervention, one month after intervention, 4 months after intervention. Method of measurement: Measurement based on visual analogue scale.

Secondary

MeasureTime frame
Patient's Psychosocial status. Timepoint: Before intervention, 1 month after, 4 months after. Method of measurement: MCGill and SCL-90R questionnaires.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdis Masoudrad

Ahvaz Jundishapur University of Medical Sciences

mahdis.mr@gmail.com+98 61 3221 6504

Outcome results

None listed

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