A Phase 2/3 interventional study of Platelet-Rich Plasma intramuscular injections and Placebo Comparator: 0,9% NaCl intramuscular injections in PRP, Temporomandibular Disorder and Myalgia, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to participants aged 23 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Medical University of Silesia · Phase 2/3, Interventional, and Treatment
The Platelet-Rich Plasma intramuscular injections into the masseter and temporalis muscle were performed to reduce painful temporomandibular disorder symptoms,such as myalgia, myofascial pain and myofascial pain with referrals. Patients(n=120) were randomly divided into two groups: experimental(n=60) and control group(n=60). In controls injections with 0,9% NaCl were performed. Pain intensity was measured with NPRS (numeriic pain rating scale, 0= no pain, 11= the worst pain that one can imagine) before(0 day), during(10 day) and after(20 day) the therapy with PRP injections.
Patients(n=120) attending The Department of Temporomandibular Disorders and Orthodontics at the Silesian Medical University Poland, Zabrze were enrolled to the study and randomly divided into one of two groups: experimental and control group. Platelet-Rich Plasma(PRP) was prepared for each patient and an intramuscular injections of 0,5 ml PRP into 6 points at each side were performed in experimental group. A follow-up appointment was made after 10 and 20 days and in each visit an injection of PRP or 0,9% NaCl was performed. Pain intensity was measured in NPRS(numeric pain rating scale) and collected data data were analyzed.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's enrollment of 58 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Medical University of Silesia is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
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Intramuscular injection of Platelet-Rich Plasma into the masseter and temporalis muscle
Biological: Platelet-Rich Plasma intramuscular injections
Intramuscular injection of 0,9% NaCl into the masseter and temporalis muscle
Biological: Placebo Comparator: 0,9% NaCl intramuscular injections
A platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed.
Also known as: PRP intramuscular injections
A 0,9% NaCl intramuscular injections into the trigger points of painful muscles were performed.
Also known as: Saline intramuscular injections
Pain intensity reduction in VAS scale,(VAS scale 0-10 points)
Decrease in pain intensity in masseter and temporalis muscles.
Time frame: 14 days
Plan to share: No
Ran from Dec 2017 to primary completion in Dec 2018, 12 months.
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Temporomandibular Joint Disorders →
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