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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-03-31

Brief Summary

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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 .

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Detailed Description

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Conditions

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Patients with Jaw Muscles Myofascial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Botulinum toxin A

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

Group Type ACTIVE_COMPARATOR

Botulinum Toxin A / Botulinum Toxin A

Intervention Type DRUG

Botulinum toxin type A

Platelet rich plasma

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

Group Type ACTIVE_COMPARATOR

No interventions assigned to this group

Physiologic saline

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Botulinum Toxin A / Botulinum Toxin A

Botulinum toxin type A

Intervention Type DRUG

Platelet rich plasma

Plasma that contains concentrated platelets

Intervention Type DRUG

Saline -- placebo comparator

Physiological saline .9 %

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes