Comparative Efficacy of PRP and Dry Needling in Management of Trigger Points in Masseter Muscle in MPS Patients

Phase 3

• Conditions: Myofascial Pain Syndrome
• Interventions: Procedure: PRP injection; Procedure: Dry needling

• Registration Number: NCT04286880
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Brief Summary

Title: Comparative Efficacy of Platelet Rich Plasma injection and Dry Needling in management of trigger points in masseter muscle in Myofascial Pain Syndrome patients.

Rationale: Pain and trismus caused by Myofascial pain syndrome in masticatory muscles are one of the prime concerns for the patients. In the recent times, Platelet Rich Plasma therapy has been studied extensively and has produced promising results. It is used to promote sarcomere repair by concentrating growth factors and decrease inflammation by inhibiting pro-inflammatory and apoptotic cells.

Thus, the present study is designed to evaluate the efficacy of Platelet Rich Plasma injection in trigger points in masseter muscle in myofascial pain syndrome patients.

Research Question P: Population (Patients with trigger points in masseter muscle) I: Intervention (PRP injection) C: Control (Dry needling) O: Outcome (Improvement in symptom of pain ) T: Time Frame (1 year) S: Study Design (Randomized clinical trial) Setting in Haryana , India Is Platelet Rich Plasma more effective as compared to dry needling alone in treatment of trigger points in masseter muscle in Myofascial Pain Syndrome patients ?

Detailed Description

Myofascial pain syndrome (MPS) is a commonly encountered condition frequently associated with the muscles of mastication. It is defined as a regional muscular pain condition characterized by myofascial trigger points found in one or more muscles and/ or connective tissues. A trigger point is an exquisitely tender spot in discrete taut band of hardened muscle that produce local and referred pain, among other symptoms. Associated symptoms may include muscle weakness, muscle spasm, stiffness, decreased range of motion and autonomic dysfunction. Trigger point can be active i.e. always tender or latent i.e. tender only when palpated.

Any kind of muscle overuse or direct trauma to the muscle can lead to the development of trigger points. Although muscle damage is not required for the development of trigger point, it may be caused by the disruption of the cell membrane, damage to the sarcoplasmic reticulum with a subsequent release of high amounts of calcium ions, and disruption of cytoskeletal proteins, such as desmin, titin and dystrophin. Muscle overuse leads to ATP depletion which causes oxidative stress resulting in local ischemia and lowered pH with subsequent accumulation of inflammatory mediators at these trigger points.

Various therapeutic modalities have been used to treat myofascial trigger points and myofascial pain syndrome including therapeutic ultrasound, muscle stretching, manipulation, acupuncture, occlusal appliances, botulinum injection, pharmacotherapy and dry needling. Platelet rich plasma (PRP) is a newer therapeutic modality for treatment of trigger points. PRP contains many growth factors important for muscle regeneration and myogenesis. The goal of PRP therapy is to concentrate the main growth factors from native blood and to reintroduce them in the injured tissue. Besides healing, it can also decrease pro-inflammatory and apoptotic cells, reducing inflammation. However, still there is paucity of literature and lack of RCT related to use of PRP in trigger points.

So, the present study has been designed to evaluate the efficacy of Platelet Rich Plasma injection in trigger points in masseter muscle in myofascial pain syndrome patients.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-18
• Study Start: 2020-02-24
• Study First Submitted QC: 2020-02-25
• Last Update Submitted: 2020-02-25
• Study First Posted: 2020-02-27
• Last Update Posted: 2020-02-27
• Primary Completion: 2021-01
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEST GROUP	PRP injection	Test group will be administered 0.5 ml of PRP solution per trigger point in masseter muscle.
CONTROL GROUP	Dry needling	In control group, dry needling will be performed.

Primary Outcome Measures

Name	Time	Method
Maximal Mouth Opening change from baseline to 3 months	3 months	measured by digital vernier callipers
assessment of pain improvement upto 3 months	3 months	using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain

Secondary Outcome Measures

Name	Time	Method
Range of Right and left Lateral excursion movements	3 months	measured in mm
assessment of Sleep pattern	3 months.	Visual Analog Scale score (0-10); higher score indicates sleep disturbance
Range of Protrusive movement	3 months	measured in mm
Need for pain medicine utilization	3 months	No. of tablets consumed per week
assessment of Patient satisfaction	3 months	by Likert scale

Trial Locations

Locations (1)

PGIDS; 🇮🇳 Rohtak, Haryana, India