A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin on the Relief of Jaw Muscles Myofascial Pain

Cairo University (CU)

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Patients with Jaw Muscles Myofascial Pain

Treatments: Drug: Platelet rich plasma; Drug: Botulinum Toxin A / Botulinum Toxin A; Drug: Saline -- placebo comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT06814535

CEBD_CU_9122023

Details and patient eligibility

About

This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain .

The 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles.

The 2nd group will receive ,5 ml of PRP per trigger point in masseter and/or temporalis muscles.

The 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles.

The 1st follow up session will be after 1 week then 1 month then 3 months . The patients are advised to limit excessive Mouth opening, yawning or singing. And when pain episode , theta re advised to take only paracetamol as analgesic drug .

At the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , VAS to measure the intensity of pain , Likert scale , current pain intensity, worst pain intensity and the need to take analgesics in Numbers.

Then comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it .

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patient with myofascial trigger points in masseter or temporalis previously ----*identified by manual palpation.

  • 18 years or More "Willingness to follow instructions.

Exclusion criteria

• therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint.

  • Clinical conditions as pregnancy
  • Medical problems that will interfere with the procedure as bleeding disorders.
  • Cognitive impairment or present inadequate cooperation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

Botulinum toxin A

Active Comparator group

Description:

20 Patients with Myofascial pain will be injected by 5 units botulinum toxin A per trigger point in masseter and/or temporalis

Treatment:

Drug: Botulinum Toxin A / Botulinum Toxin A

Platelet rich plasma

Active Comparator group

Description:

20 patients with Myofascial pain will be injected by .5 ml PRP solution per trigger point in masseter and/or temporalis

Physiologic saline

Placebo Comparator group

Description:

20 patients with Myofascial pain will be injected by.5 ml physiologic saline per each trigger point