FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
NIL 
 
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  
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 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  
Status 
Not Applicable 
 
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.  

 
Close