Comparative evaluation of Efficacy of Combination therapy(Low level laser therapy and topical analgesic) with topical analgesic therapy alone in patients with Myofascial pain dysfunction syndrome-A randomized controlled trial

This study aims to compare the efficacy of Combination Therapy (Low Level Laser Therapy (LLLT) and Topical Analgesic) with Topical Analgesic Therapy alone in patients with Myofascial Pain Dysfunction Syndrome (MPDS).

Patients visiting OPD with chief complaint of pain in cheek, ear, lower jaw region/reduced

mouth opening between age groups 18-60 years of either gender will be selected .

Detailed case history of these patients will be recorded and based on clinical examination

patients diagnosed for MPDS based on LASKINS CRITERIA will be included in the study.

Laskin has proposed 4 cardinal signs and symptoms and two negative characteristics for MPDS.

A. Positive cardinal signs and symptoms-

1.Pain

2.Muscle tenderness

3.Clicking or popping in TMJ

4.Limitation of jaw movement with deviation or deflection

B. Negative Characteristics

1.An absence of clinical, radiographic or biochemical evidence of organic changes in  joint

2.Lack of tenderness in joint

A proforma assessment will be done for each selected patients with MPDS and all the details will be

recorded.

Detailed information of the study will be given to all the individuals .

Patients fulfilling the inclusion and exclusion criteria and ready to willingly participate in the study will

be enrolled for the study.

A written informed consent will be obtained.   After obtaining consent, patients will be assigned to groups.

The study will consist of 50 patients of either gender.

Study Group A-25 will receive LLLT with topical application of analgesic gel.

Control group B-25 will receive placebo laser session along with the topical application of analgesic gel.

A total duration of study is 7 weeks.

It consists of two phases-

1. Active (Treatment) Phase for 3 weeks

2.Passive (follow-up) Phase for next 4 weeks

In active treatment phase, individuals in STUDY GROUP A will receive a low level laser therapy using

INDILASE Duo Dual Wavelength Diode laser-with TMJ 20 mm attachment (810 nm in a non

contact mode, continuous wave 2.0-Watt power,600 Joule energy total,area-0.3 cm2 at light guide

tip end, Duration-5 minutes i.e. 300 seconds) twice a week for 3 weeks along with topical application

of analgesic gel(Diclofenac and Linseed oil) twice daily(which will be done by patient himself/herself) for 3

weeks duration.

And, individuals in STUDY GROUP B will receive placebo laser sessions(laser equipment on a standby

mode where there is no laser emission) twice a week for 3 weeks along with topical application of

analgesic gel twice daily for 3 weeks (which will be done by patient himself/herself).

An appropriate safety measures like wearing of safety goggles and recommended protocols will be

employed for both operator and patient.

After completion of treatment, patient will be re-called for follow-up visit once every week for next 4

weeks to check any recurrences.

This study will help to plan a proper treatment protocol for patients with myofascial pain dysfunction syndrome.