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CTRI Number  CTRI/2025/04/085784 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to find out the effect of Instrument-Assisted Soft Tissue Mobilization on Neck Pain, Neck Movement, and Function in subjects with hypersensitive points present in Upper Trapezius Muscle 
Scientific Title of Study   Efficacy of Instrument Assisted Soft Tissue Mobilization on Pain Pressure Threshold, Range of Motion and Function in Latent Trigger Points of Upper Trapezius Muscle : A Single Blinded, Randomized Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarasij Bit 
Designation  Physiotherapist 
Affiliation  National Institute for Locomotor Disabilities (Divyangjan) 
Address  Room No. 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090

North Twentyfour Parganas
WEST BENGAL
700090
India 
Phone  8910552677  
Fax    
Email  Physiobit14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sarasij Bit 
Designation  Physiotherapist 
Affiliation  National Institute for Locomotor Disabilities (Divyangjan) 
Address  Room No. 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090

North Twentyfour Parganas
WEST BENGAL
700090
India 
Phone  8910552677  
Fax    
Email  Physiobit14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sarasij Bit 
Designation  Physiotherapist 
Affiliation  National Institute for Locomotor Disabilities (Divyangjan) 
Address  Room No. 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090

North Twentyfour Parganas
WEST BENGAL
700090
India 
Phone  8910552677  
Fax    
Email  Physiobit14@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090, India 
 
Primary Sponsor  
Name  Sarasij Bit 
Address  National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090 
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 Sarasij Bit PT  National Institute for Locomotor Disabilities (Divyangjan)  Room No. 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090, India
North Twentyfour Parganas
WEST BENGAL 
8910552677

Physiobit14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee - National Institute for Locomotor Disabilities (Divyangjan)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects having Latent Trigger Points in their Upper Trapezius Muscle 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Instrument Assisted Soft Tissue Mobilization (IASTM)  Subject will be in a comfortable position. Emollient like Vaseline will be applied first to prevent skin irritation. Then IASTM will be applied over previously marked LTrPs of Upper Trapezius at 45° angle. Each IASTM session included - 1 minute of Sweeping – Longitudinal strokes performed which is parallel to muscle fibres; 1 minute of Swivel – Pivoting or rotating back and forth with the knob directly over trigger point; 2 minute of Fanning – one end of instrument held in place and other end is moved in semi-circular pattern. 
Comparator Agent  Moist Hot Pack and Exercise  Each Subject will get Moist Hot Pack (MHP) for 10 minutes. Subjects will do Self-stretching of upper trapezius (30 sec hold for 5 times) and Neck isometric exercises (10 sec hold for 5 times) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Subjects having minimum one palpable nodule and hypersensitive tender spot in taut band in Upper Trapezius Muscle 
 
ExclusionCriteria 
Details  1) Any active MTrPs present in Upper trapezius.
2) Diagnosed case of Fibromyalgia or Patients with symptoms of Neck pain, Cervical Radiculopathy or Cervical Myelopathy.
3) History of any musculoskeletal injury in Cervical spine including Road Traffic Accident, Fracture etc.
4) Rheumatoid disorders like Rheumatoid arthritis and Ankylosing Spondylitis.
5) Any vascular symptoms such as Basilar insufficiency, Thoracic outlet syndrome.
6) Diagnosed with Neurological conditions like Stroke, Neuropathy, etc.
7) Having undergone physiotherapy treatment last month.
8) Presence of red flags i.e. infection, malignancy.
9) Drug intake like NSAIDs and steroids during or 1 month before interventions.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain Pressure Threshold measured by Algometer (kg/cm2)
Cervical Contralateral Side Flexion Range of Motion measured by Goniometer (in degree)
Function measured by Neck Disability Index (in %) 
Pre-Intervention
Post-Intervention (the day after 10th Session) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   12/05/2025 
Date of Study Completion (India) 10/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
A Myofascial Trigger Point (MTrP) is defined as a hypersensitive spot in a skeletal muscle associated with a taut band which is painful on compression and refers pain in characteristic pattern for each muscle. They can be activated directly by muscle overload, trauma, prolonged muscle contraction and nerve compression. This type of tissue dysfunctions in musculoskeletal system happens due to continuous exposure to abnormal, adverse physical conditions during rest or in job duty leading to pain and injury in body especially in neck and shoulder. 

In accordance to clinical manifestation, MTrPs are classified into Active and Latent Trigger points. Latent Myofascial Trigger Points (LTrPs) are those in which local and referred pain do not produce any familiar or usual symptoms for the individual. 

Upper Trapezius is a posture muscle and has a high susceptibility for overuse. Different studies already established the presence of latent trigger points in Upper Trapezius of symptomatic participants with shoulder pain, subacromial impingement, mechanical neck pain and chronic headaches

Instrument Assisted Soft Tissue Mobilization (IASTM) is a practical technique using specially designed instrument which is beveled in edges which minimizes the force applied by therapist but maximizes the force delivered to tissues. It provides therapist a mechanical advantage to treat with deeper force transmission and to detect altered tissue properties.

Different studies were conducted to find different manual technique and electrical modalities to treat Latent Trigger Point. But to best of our knowledge, there are no studies are available which was conducted to find the efficacy of IASTM in Latent Trigger Points. 

Hence this study is designed to find out the efficacy of IASTM on Pain Pressure Threshold, Range of Motion and Function in Latent Trigger Points of Upper Trapezius muscle.

NULL HYPOTHESIS (H0): There is no statistically significant effect of IASTM along with Moist Hot Pack and Supervised Exercises on Pain Pressure Threshold, Range of Motion and Function in Latent Trigger Points in Upper Trapezius muscle.

ALTERNATE HYPOTHESIS (H1): There is statistically significant effect of IASTM along with Moist Hot Pack and Supervised Exercises on Pain Pressure Threshold, Range of Motion and Function in Latent Trigger Points in Upper Trapezius muscle.
 
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