FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066323 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 04/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   “A experimental study of Instrument Assisted Soft Tissue Mobilization versus Myofascial Release in Neck Pain in Dentists” 
Scientific Title of Study   “A Comparative study of Instrument Assisted Soft Tissue Mobilization (IASTM) versus Myofascial Release for the Treatment of Mechanical Neck Pain in Dentists” 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vanshika Tandon 
Designation  MPT Student  
Affiliation  Dr. D.Y. Patil College of Physiotherapy 
Address  Dr. D.Y. Patil College of Physiotherapy, Electrotherapy Department, Lab No. 02, 3rd floor, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad

Pune
MAHARASHTRA
411018
India 
Phone  8962836497  
Fax    
Email  vanshikatandon38@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumik Basu  
Designation  Associate Professor 
Affiliation  Dr. D.Y Patil College of Physiotherapy 
Address  Dr. D.Y. Patil College of Physiotherapy, Electrotherapy Department, Lab no.02, 3rd floor, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad

Pune
MAHARASHTRA
411018
India 
Phone  9762165015  
Fax    
Email  soumik.basu@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Soumik Basu 
Designation  Associate Professor 
Affiliation  Dr. D.Y Patil College of Physiotherapy 
Address  Dr. D.Y. Patil College of Physiotherapy, Electrotherapy Department, Lab No. 02, 3rd floor, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad

Pune
MAHARASHTRA
411018
India 
Phone  9762165015  
Fax    
Email  soumik.basu@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr. D.Y. Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri colony, Pimpri-Chinchwad, Maharashtra 411018 
 
Primary Sponsor  
Name  Vanshika Tandon 
Address  Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad  
Type of Sponsor  Other [self] 
 
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 
Dr Vanshika Tandon  Dr. D Y Patil College Of Physiotherapy,Pune  Dr. D. Y. Patil College of Physiotherapy, OPD Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA 		 8962836497

vanshikatandon38@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committe of Dr. D.Y. Patil College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Dentist with mechanical neck pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A- Instrument assisted soft tissue mobilisation IASTM + exercise.   Subjects will receive IASTM using M2T blade for upper trapezius, levator scapulae and suboccipitalis muscle and routine physical therapy. The general principle is a six-step technique comprising examination, warm-up, IASTM, stretching, strengthening and icing. Each treatment session will be of 35 minutes every alternate day for 2 weeks for all the muscles. The protocol is for 2 weeks and the study will be for 8 months 
Comparator Agent  Group B- Myofascial Release (MFR) + exercise  Subjects will receive myofascial release and exercise followed by cold pack, every alternate day for 2 weeks. The protocol is for 2 weeks and the study will be for 8 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Dentists age from 20-40 years
2.Both genders
3.Mechanical Neck pain diagnosed by orthopaedician
4.Pain referring unilaterally
5.Restricted neck range of motion 
 
ExclusionCriteria 
Details  1.Any recent head and neck surgery, ankylosing spondylitis
2.skin sensitivity
3.Open wounds
4.Local infection
5.History of cervical fracture 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.)Numeric Pain Rating Scale
2.)Neck Disability Index Scale.
3.)Cervical range of motion using inclinometer
4.) Head neck posture by Craniovertebral angle (CVA) using MB ruler  		 1.) At start of the study and end of the study (after 2 weeks)
2.) At start of the study and end of the study (after 2 weeks)
3.) At start of the study and end of the study (after 2 weeks)
4.) At start of the study and end of the study (after 2 weeks)
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) 16/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 16/12/2024 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 In process 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

AIM:

To assess the effects of Instrument-Assisted Soft Tissue Mobilization vs myofascial release on neck range of motion, pain, cervical spine posture and disability in the treatment of neck pain in dental practioners.

OBJECTIVES:

1. To assess the effects of Instrument-Assisted Soft Tissue Mobilization vs manual Myofascial release on pain using NPRS

2. To assess the effects of Instrument-Assisted Soft Tissue Mobilization vs manual Myofascial release on cervical spine ROM using inclinometer.

3. To assess the effects of Instrument-Assisted Soft Tissue Mobilization vs manual Myofascial release on function using NDI

4. To assess the effects of Instrument-Assisted Soft Tissue Mobilization vs manual Myofascial release on posture using CV angle.

Need of the study

1.Dental professionals often experience mechanical neck pain due to prolonged periods of working in awkward postures, such as bending over patients during dental procedures. 

2. Study suggests that dentist flex their neck > 30⁰ (85% of the time). Neck flexion angle >20 ⁰ induce severe stress on the neck which may result in forward head posture, neck pain and discomfort. 

3.IASTM is a unique technique that allows therapists to quickly and precisely detect and treat soft tissue injuries. Adhesions formed as a result of repeated strain can be broken down, allowing for the painless restoration of range of motion and function.

4. Very few studies have been done on comparing IASTM vs MFR however, Studies relating to IASTM vs MFR in dentists who are involved in sustained neck bending postures for prolonged period of time specifically have not been done.

5. Thus, this study proposes to find the effect of IASTM in comparison with myofascial release in pain, range of motion, head posture and functional ability on dentist having restricted neck range of motion and neck pain.

NULL HYPOTHESIS-

H0- IASTM and Myofascial release both have equal effect on neck pain, range of motion, head and neck posture and neck disability in the treatment of dental practioners.

 

ALTERNATIVE HYPOTHESIS –

H1- IASTM is more effective than Myofascial release on neck pain, range of motion, head and neck posture and neck disability in the treatment of dental practioners.

H2- Myofascial release is more effective than IASTM release on neck pain, range of motion, head and neck posture and neck disability in the treatment of dental practioners.


Potential Subjects will be screened (72 subjects)

Pre assessment will be done for Craniovertebral angle (CV angle), pain, cervical range and neck dysfunction. 

Group A: IASTM + exercise

Group B: MFR + exercise

Post assessment will be done for Craniovertebral angle (CV angle), pain, cervical range and neck dysfunction after 2 weeks. Stastical analysis and result formation will be done after the treatment phase is complete.


 
Close