| CTRI Number  | 
    CTRI/2025/03/083526 [Registered on: 26/03/2025] Trial Registered Prospectively | 
    | Last Modified On: | 
    25/03/2025 | 
	
    | Post Graduate Thesis  | 
    Yes  | 
    | Type of Trial  | 
    Interventional  | 
    | 
    Type of Study
       
           | 
    Drug Medical Device Other (Specify) [DRY NEEDLING]   | 
    | Study Design  | 
    Randomized, Parallel Group Trial  | 
    | 
    Public Title of Study
                
                        
           
     
      | 
    A study is to compare the effectiveness of three different treatments for muscle pain in the neck and shoulder area: ultrasound therapy, dry needling, and corticosteroid injections.  | 
    | 
    Scientific Title of Study
                 
                        
           
           | 
    A comparative study of the efficacy of ultrasound therapy against dry needling and against corticosteroid topical injection in cervical and periscapular myofascial pain syndrome.  | 
    | Trial Acronym  | 
    NIL  | 
    | 
    Secondary IDs if Any
                 
                        
           
           | 
    
    
    
        | Secondary ID  | 
        Identifier  | 
     
            
            | NIL  | 
            NIL  | 
         
     
     
  | 
    | 
    Details of Principal Investigator or overall Trial Coordinator (multi-center study)
                 
                        
           
           | 
    
        
        
            | Name  | 
            SOUMEN KUMAR BISWAS  | 
         
	
            | Designation  | 
            POST GRADUATE TRANIEE  | 
         
	
            | Affiliation  | 
            SAMBHU NATH PANDIT HOSPITAL  | 
         
	
        
            | Address  | 
            DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, 2nd FLOOR,SAMBHUNATH PANDIT HOSPITAL, 11 LALA LAJPAT RAI STREET, KOLKATA 700020, WEST BENGAL.
  Kolkata WEST BENGAL 700020 India  | 
                 
        
            | Phone  | 
            9434619989   | 
                 
        
            | Fax  | 
               | 
                 
        
            | Email  | 
            soumen07biswas@gmail.com   | 
                         
         
      | 
    
    Details of Contact Person Scientific Query
                 
                        
           
           | 
    
        
        
            | Name  | 
            DR JAYANTA SAHA  | 
         
	
            | Designation  | 
            SENIOR CONSULTANT OF PMR  | 
         
	
            | Affiliation  | 
            SAMBHU NATH PANDIT HOSPITAL  | 
         
        
            | Address  | 
            DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, 2nd FLOOR,SAMBHUNATH PANDIT HOSPITAL, 11 LALA LAJPAT RAI STREET, KOLKATA 700020, WEST BENGAL. DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, 2nd FLOOR,SAMBHUNATH PANDIT HOSPITAL, 11 LALA LAJPAT RAI STREET, KOLKATA 700020, WEST BENGAL. Kolkata WEST BENGAL 700020 India  | 
                 
        
            | Phone  | 
            9433094843   | 
                 
        
            | Fax  | 
               | 
                 
        
            | Email  | 
            djayantas@yahoo.com   | 
                         
         
      | 
    
    Details of Contact Person Public Query
                  
                        
           
           | 
    
        
        
            | Name  | 
            DR JAYANTA SAHA  | 
         
		
            | Designation  | 
            SENIOR CONSULTANT OF PMR  | 
         
	
            | Affiliation  | 
            SAMBHU NATH PANDIT HOSPITAL  | 
         
        
            | Address  | 
            DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, 2nd FLOOR,SAMBHUNATH PANDIT HOSPITAL, 11 LALA LAJPAT RAI STREET, KOLKATA 700020, WEST BENGAL.
  Kolkata WEST BENGAL 700020 India  | 
                 
        
            | Phone  | 
            09433094843   | 
                 
        
            | Fax  | 
               | 
                 
        
            | Email  | 
            djayantas@yahoo.com   | 
                         
         
      | 
    | 
    Source of Monetary or Material Support
                  
                        
           
           | 
    
    
     
  | 
    | 
    Primary Sponsor
                  
                        
           
           | 
    
        
        
            | Name  | 
            SOUMEN KUMAR BISWAS  | 
                     
        
            | Address  | 
            DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, 2nd FLOOR,SAMBHUNATH PANDIT HOSPITAL, 11 LALA LAJPAT RAI STREET, KOLKATA 700020, WEST BENGAL.  | 
         
        
            | Type of Sponsor  | 
                        Other [SELF]  | 
         
         
      | 
    | 
    Details of Secondary Sponsor
                  
                        
           
           | 
    
        
      | 
    | 
    Countries of Recruitment
                  
                        
           
           | 
     
   India   | 
   
    | 
    Sites of Study
                  
                        
           
           | 
    
    	
    
           | No of Sites = 1   | 
     
    
        | Name of Principal
Investigator  | 
        Name of Site  | 
        Site Address  | 
        Phone/Fax/Email  | 
     
    	
        
        | DR JAYANTA SAHA  | 
        SAMBHU NATH PANDIT HOSPITAL   | 
        DEPARTMENT OF PHYSICAL MEDICINE AND REHABILITATION, 2nd FLOOR,SAMBHUNATH PANDIT HOSPITAL, 11 LALA LAJPAT RAI STREET, KOLKATA 700020, WEST BENGAL. Kolkata WEST BENGAL  | 
        9433094843
  djayantas@yahoo.com  | 
     
                
         
      | 
    | 
    Details of Ethics Committee
                  
                        
           
           | 
    
        
    
           | No of Ethics Committees= 1   | 
     
           
                | Name of Committee  | 
                Approval Status  | 
               
             
            
                | IPGME&R RESEARCH OVERSIGHT COMMITTEE  | 
                Approved  | 
              
                     
         
      | 
    | 
    Regulatory Clearance Status from DCGI
                  
                        
           
           | 
        
        
      | 
    | 
    Health Condition / Problems Studied
                  
                        
           
           | 
    
        
            
                | Health Type  | 
                Condition  | 
             
	
    		| Patients  | 
    		(1) ICD-10 Condition: M791||Myalgia,   | 
  	 
	
         
      | 
    | 
    Intervention / Comparator Agent
                  
                        
           
           | 
    
        
            
                | Type  | 
                Name  | 
                Details  | 
             
  
    | Intervention  | 
    Corticosteroid injection  | 
    Patients will receive Injection of 2ml of a suspension containing 20mg Triamcinoloneacetonide(0.5 ml) and 2% solution of lignocaine (1.5 ml) without adrenaline near the origin of pain followed by therapeutic stretching exercise  and analgesic as paracetamol 500mg sos.  | 
   
    
    | Intervention  | 
    Dry needling  | 
     Patients will receive dry needling at trigger point followed by therapeutic stareching exercise and analgesic as paracetamol (500mg) sos.  | 
   
    
    | Comparator Agent  | 
    Therapeutic Ultrasound   | 
     Patients will receive Therapeutic Ultrasound for 2 weeks followed by therapeutic starching exercise and analgesic as paracetamol (500mg) sos. Duration – 6days/week x 2Weeks, 3 minutes on region of pain each session. Intensity- 2 watt/cm2 Frequency- 1 MHZ Mode- continuous mode  | 
   
           
      | 
    | 
    Inclusion Criteria
                  
                        
           
                | 
    
        
            
                | Age From  | 
                30.00 Year(s) | 
             
            
                | Age To  | 
                70.00 Year(s) | 
             
                        
                | Gender  | 
                Both  | 
                    
            
                | Details  | 
                1)Aduld Trigger point pain who had not responded to conservative treatment. 
 2) Recurrent pain inspite of local steroid injection at least for two epiosodes. 
3) Age Group: 30-70 years 
4) Both Sexes 
  | 
                  
         
      | 
    | ExclusionCriteria  | 
    
        
	            
            
                               
            
                | Details  | 
                1] Patients who are not willing or not in a sound mental state to give consent 
2] Bony deformities 
3] Uncontrolled Diabetes Mellitus 
4] Uncontrolled Hypertension 
5] Patients with neurological deficits (motor, sensory) 
6] Patients with bleeding disorders 
7] Local sepsis 
8] Patients with Psychiatric disorders 
9] Patients with implanted pacemaker 
10] Patients with skin disease 
11] Known hypersensitivity to lignocaine 
12] Gout 
13] Rheumatoid arthritis 
14] Pregnancy 
15] Patients on anticoagulants 
16] Previous steroid injections within past 6 months 
17] Immuno suppressed patient 
  | 
                  
         
      | 
    | 
    Method of Generating Random Sequence
                  
                        
           
           | 
    Other  | 
    | 
    Method of Concealment
                  
                        
           
           | 
    Not Applicable  | 
    | 
    Blinding/Masking
                  
                        
           
           | 
    Open Label  | 
    | 
    Primary Outcome
                  
                        
           
           | 
    
        
             
                | Outcome  | 
                TimePoints  |                 
             
            
                | 1. Compare the effectiveness and results of three distinct treatment approaches, such as  ultrasound therapy (UST), ,dry needling and local steroid injection to identify trigger sites in the clinical course of myofascial pain syndrome.                     2. To propose early rehabilitation and identify the area needing further clinical research.  | 
                1stvisit (0week), 2nd (6weeks), 3rd (12weeks)   | 
             
         
      | 
    | 
    Secondary Outcome
                  
                        
           
           | 
    
        
             
                | Outcome  | 
                TimePoints  |                 
             
                
                |  To propose early rehabilitation & identify the area needing further clinical research.  | 
                1stvisit (0week), 2nd (6weeks), 3rd (12weeks)  | 
             
         
      | 
    | 
    Target Sample Size
                  
                        
           
           | 
    Total Sample Size="120" Sample Size from India="120"   
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)
                  
                        
           
           | 
    07/04/2025  | 
	
| 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="0" Months="7" Days="15"  | 
    | 
    Recruitment Status of Trial (Global)
                  
                        
           
           | 
    Not Yet Recruiting  | 
    | 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
                  
                        
           
           | 
                 A musculoskeletal ailment known as
myofascial pain is characterised by discomfort in the region of a muscle in
the body as well as the fascia, or surrounding connective tissue. In
addition to being local or regional, the pain may have several trigger
locations. Trigger points are extremely sensitive, touch-sensitive muscle foci
that radiate pain throughout the surrounding tissue.                                      These are tiny, sensitive spots
in the muscle that, either on their own or in reaction to compression, produce
a local twitch response and pain in a distant area known as the “referred pain
zone”.                                                                                                                                                             
             The muscles in the neck, shoulders
—such as the trapezius, scalene, sternocleidomastoid, levator scapulae, —are
frequently impacted. The cause of the discomfort, which can be either acute or
chronic, is either muscle injuries, postural abnormalities, or overuse. 
              A patient with myofascial pain
syndrome mainly attended in clinics with:- 
      1.Severe discomfort in certain muscle
locations 
      2. Pain that increases with stretching or
straining the injured muscle  
      3. 
Pain that worsens over time or does not go better with the presence of
excruciating knots in    the muscles                                                                                      
 
      4.
When pressed, cause excruciating localised or referred pain weak, stiff,
inflexible,                       
       5. with a reduced range of motion of the
affected joint, mood or sleep disturbances 
              Palpation is the basic method of
diagnosis . Therefore, history and clinical examination play an important
role in identifying trigger points in MPS.  
   |