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CTRI Number  CTRI/2025/03/081660 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Dentistry
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of kinesiotape in facial muscle pain.  
Scientific Title of Study   Evaluation of efficacy of kinesiotape as first line therapy in myofascial masticatory pain.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pushpa 
Designation  Post Graduate student 
Affiliation  PGIDS ROHTAK 
Address  Room no 11 , department of oral medicine and radiology , PGIDS Rohtak.
Room no 11, department of oral medicine and radiology,PGIDS Rohtak.
Rohtak
HARYANA
124001
India 
Phone  8168233314  
Fax    
Email  Drpushpabadal95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR. Lavina Arya 
Designation  Associate Professor 
Affiliation  PGIDS ROHTAK 
Address  Room no 11, department of oral medicine and radiology,PGIDS Rohtak.
Room no 11, department of oral medicine and radiology,PGIDS Rohtak.
Rohtak
HARYANA
124001
India 
Phone  8168233314  
Fax    
Email  Aryalavina@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pushpa 
Designation  Post Graduate student 
Affiliation  PGIDS ROHTAK 
Address  Room no 11, department of oral medicine and radiology,PGIDS Rohtak.
Room no 11, department of oral medicine and radiology,PGIDS Rohtak.
Rohtak
HARYANA
124001
India 
Phone  8168233314  
Fax    
Email  Drpushpabadal95@gmail.com  
 
Source of Monetary or Material Support  
PGIDS ROHTAK 
 
Primary Sponsor  
Name  PGIDS ROHTAK 
Address  Room no 11 , department of oral medicine and radiology , PGIDS Rohtak. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pushpa  PGIDS Rohtak  Room no 11, department of oral medicine and radiology,PGIDS Rohtak.
Rohtak
HARYANA 		 8168233314

Drpushpabadal95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BHRC, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KINESIOLOGY TAPE  TWO APPLICATIONS OF KINESIOLOGY TAPE WILL BE APPLIED TO MASSETER MUSCLE FOR 3 DAYS EACH FOR ONE WEEK 
Comparator Agent  NSAIDS AND MUSCLE RELAXANT  NSAIDS AND MUSCLE RELAXANT WILL BE GIVEN TWICE DAILY FOR 7 DAYS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with Myofascial masticatory pain according to recent RDC Criteria.

2. Patients consent for participation in this study.
 
 
ExclusionCriteria 
Details  1. Patients with history of trauma in
temporomandibular joint.
2 Patients 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.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS assessment of pain.  Baseline, 1st week, 2nd week and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the change in masticatory efficiency in both groups.
To evaluate the treatment satisfaction in both groups.
Adverse side effects associated with treatment in both groups.
To evaluate changes in pain related disability and functional limitation
 		 One year 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

.

 

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.


 
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