Comparative Effectiveness of Injectable platelet-rich Plasma, Photo biomodulation Therapy, and Sequential Application of Platelet-Rich Plasma Followed by Photo biomodulation in management of myofascial trigger points in masseter muscle – A randomized clinical trial

Rationale  A myofascial trigger point is a hyperirritable spot within a palpable taut band of muscle  Platelet rich plasma PRP therapy and Photo biomodulation PBM have both been used as a successful treatment modality for treating trigger points PBM has been found to have an additive effect to PRP by increased ATP production  reduction of oxidative stress and increased production of collagen in an in vitro study Hence the present study intends to compare  the effectiveness of  injectable PRP  photo biomodulation therapy and sequential application of platelet rich plasma followed by photo biomodulation in management of trigger point in masseter muscle

Research Question Is the sequential application of platelet rich plasma followed by photo biomodulation more effective compared to either PRP or PBM alone in the treatment of trigger points in masseter

P Population Patients with active myofascial trigger points in the masseter muscle

I InterventionInjectable PRP followed by PBM

C Comparator 1 Injectable platelet plasma followed by Photo biomodulation administrated on                                                   trigger point

Comparator 2 photobiomodulation administrated on trigger point

O Outcome pain intensity functional jaw movements

T Time Frame 1year 6 months

S Study Design randomized comparative trial

Setting in Haryana India

AIM AND OBJECTIVES

AIM Toevaluate the effectiveness of platelet rich plasma followed by photo biomodulation for treatment of trigger points in masseter muscle

OBJECTIVES

Primary objective

1 To evaluate and compare the change in intensity of pain in all the study groups

2 To evaluate and compare the improvement in functional limitation of jaw in the three groups

 Secondary objective

1 To assess patient satisfaction

2 To evaluate the need for alternative treatment modalities

3 To evaluate the side effects of PRP injection and PBM therapy

Materials and Methodology

Setting Department of Oral Medicine and Radiology  PGIDS  Rohtak Haryana

Study Design Randomized comparative trial

Study Duration  This study will be completed in 1 5 years

Population Patients suffering from myalgia with active trigger points in masseter muscle will be recruited in study from regular OPD of the Department of Oral Medicine and Radiology

Sample size  A total of 69 patients with 23 patients in each group

Methods In group 1Injectable PRP will be prepared and administrated in the trigger points in masseter muscle followed by the application of laser photo biomodulation of the trigger points  In group 2  Injectable PRP will be prepared and administrated in the trigger points in masseter muscle  In group 3 a Diode laser of 980nm will be applied to the trigger points in masseter muscle  twice weekly for 4 weeks

Outcome measures  Primary outcome measures will be

NRS assessment of pain intensity.

Mean mouth opening MO in millimeters

Range of right and left lateral excursive movements RTLEM and LTLEM respectively in  millimeters

Range of protrusive movement PM in  millimeters

Secondary outcome measures will be

Need for additional pain medicine number of tablets consumed per week

Likert scale 1 5  assessment of patient satisfaction LPS

Statistical analysis  Data will be tabulated in Microsoft Excel sheet  All analysis will be performed by SPSS software Descriptive and inferential statistics will be used  Baseline assessment of all subjects will be done  All results shall be calculated at 5 percentage  significance level I e less than  0 05  Normality of dependent variable will be assessed by using Shapiro Wilk test Independent T test shall be used to compare pain between the two groups if data is normal else Mann Whitney U will be used