Evaluation of efficacy of kinesiotape as first line therapy in myofascial masticatory pain.

RATIONALE OF THE PRESENT STUDY

TITLE:

Evaluation of efficacy of kinesiotape as first line therapy in myofascial masticatory pain.

RATIONALE

Tenderness in massestor muscle is most common region of pain in orofacial region in myofascial masticatory pain. Pharmacotherapy has been the initial line of drug for Myofascial masticatory pain. Kinesiotaping though has been widely used in musculoskeleton region in physiotherapy and sports medicine its use in maxillofacial region especially masticatory myofascial pain has been limited but promising. Moreover, there is a gap in literature regarding its use as primary treatment modality in myofascial muscle pain.

 Thus, the present study is designed to evaluate the efficacy of kinesiotape as first line therapy in myofascial masticatory pain..

 P: Population (Patients with tenderness in masticatory muscles)

I:  Intervention (kinesiotape application)

C: Control (Nsaids+ Muscle relaxant)

O: Outcome (Improvement in symptom of pain)

T: Time Frame (12 months)

S: Study Design (Randomised clinical trial)

Setting in Haryana, India.

 AIM AND OBJECTIVES:

AIM

To study the efficacy of Kinesiotape as first line therapy in myofascial masticatory pain.

OBJECTIVE

Primary objective-

1.     To evaluate change in pain intensity in both groups.

Secondary Objective-

1. To evaluate the change in masticatory efficiency in both groups.

2 .To evaluate the treatment satisfaction in both groups.

3 .Adverse side effects associated with treatment in both groups.

4.To evaluate changes in pain related disability and functional limitation.

MATERIALS AND METHODOLOGY:

Study Setting: Department of Oral Medicine and Radiology, PGIDS, Rohtak

Study Design: Randomised clinical trial

Study Duration:  This study will be completed in 12 months.

Study Subjects:

Patients diagnosed with Myofascial masticatory pain ,based on RDC TMD criteria (IDC- 9729.1; ICD- 10M79.1) clinically will be recruited in the study from regular OPD of the Department of Oral Medicine and Radiology, PGIDS, Rohtak, Haryana. A total of 70 patients would compromise; Test group (n=35) and Control group (n=35)

Inclusion Criteria:

The following patients will be included in the study:

1.  Patients diagnosed with Myofascial masticatory pain to recent RDC Criteria.

2.  Patients consent for participation in this study.

 Exclusion Criteria:

1. Patients with history of trauma in temporomandibular joint.
2. Patient having any developmental anomaly related to TMJ.
3. Patients having history of TMJ arthralgia.
4. Patients having pregnancy, asthma or any psychiatric disorder ,rheumatoid arthritis ,gastric or duodenal ulcer etc.
5. Known tolerance/allergy to  study drug..
6. Noncompliant during screening period.
7. Pain attributable to recent facial trauma, dental surgery or placement of a dental appliance.
8. Allergy to tape, open wounds ,acne or skin infection or skin disease in area of application.
9. Patient with fibromyalgia.
10. Patient taking analgesics or muscle relaxant regularly for any indication.

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  Sample Size: Sample size of 35 patients to be taken in each group with age range from 18 to 75 years.

Methodology:

The participants will be randomized in to experimental and control group. Kinesiotaping will be applied to the experimental group till 1 week. Each application lasts for 3 days. BOLDFIT Kinesiology tape with a width of 5.5cm will be used. The skin will be cleaned with alcohol prior to the application in order to remove oils. Lotions and moisture which might limit the adhesive ability to adhere to the skin. Shaving of the area to be treated will be provided when necessary. Taping tecnique described by  KENZO et al. for TMJ will be performed as follows. A Y shaped kinesiotape will be prepared  according to measurement for each individual. Patient will be asked to open and close his /her jaw in order to locate the TMJ. The base of the  Y strip will be placed  slightly posterior to the TMJ with no tension. The superior tail of the strip will be applied with very light tension(20-25%) of available after pulling the skin from TMJ to the nose. Later on, inferior tail of the Y strip will be applied by using the same technique

ü   Control group will be given drug Acelofenac(100mg) + chlorzoxazone(500mg)+paracetamol(325) twice daily for 7days.

ü  Follow up will be done at baseline, first, second and 4 weeks in both groups.

ü  If patient still having pain, additional drug will be permitted in test group and record will be maintained.