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CTRI Number  CTRI/2025/07/092097 [Registered on: 31/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of PENS Vs Dry Needling in patients with Trigger Points 
Scientific Title of Study   Comparative Evaluation of Effectiveness of Percutaneous Electrical Nerve Stimulation (PENS) and Dry Needling on ph of trigger point, Pain Pressure Threshold and Quality of Life as against Conventional Treatment in patients with Levator Scapulae Trigger Point in Medical Professionals: A Three Arm Parallel Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MAITHILI DESHPANDE 
Designation  Assistant Professor 
Affiliation  Ravi Nair Physiotherapy College 
Address  Sawangi Wardha
Ravi Nair Physiotherapy college, sawangi wardha
Wardha
MAHARASHTRA
440025
India 
Phone  09082955722  
Fax    
Email  deshpandemaithili5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MAITHILI DESHPANDE 
Designation  Assistant Professor 
Affiliation  Ravi Nair Physiotherapy College 
Address  Ravi Nair Physiotherapy college, sawangi wardha
Ravi Nair Physiotherapy college, sawangi wardha
Wardha
MAHARASHTRA
440025
India 
Phone  09082955722  
Fax    
Email  deshpandemaithili5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MAITHILI DESHPANDE 
Designation  Assistant Professor 
Affiliation  Ravi Nair Physiotherapy College 
Address  Ravi Nair Physiotherapy college, sawangi wardha
Ravi Nair Physiotherapy college, sawangi wardha
Wardha
MAHARASHTRA
440025
India 
Phone  09082955722  
Fax    
Email  deshpandemaithili5@gmail.com  
 
Source of Monetary or Material Support  
Ravi Nair Physiotherapy college, MSK OPD, Sawangi wardha 
 
Primary Sponsor  
Name  Ravi Nair Physiotherapy College 
Address  Ravi Nair Physiotherapy college, sawangi wardha 442005 
Type of Sponsor  Private medical college 
 
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 
Maithili Deshpande  Ravi Nair Physiotherapy college MSK OPD  MSK OPD Sawangi Wardha
Wardha
MAHARASHTRA 
09082955722

deshpandemaithili5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ravi Nair Physiotherapy College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Treatment  After the treatment session, stretching to the Levator scapulae muscle and icing will be given to avoid muscle soreness. 
Intervention  PENS, Dry Needling  After the ethical clearance from the University, participants with chronic neck pain with myofascial trigger point in Levator scapulae muscle will be recruited from Physiotherapy OPD of Acharya Vinoba Bhave Rural Hospital, Sawangi Wardha and OPD of Ravi Nair Physiotherapy College, Salod, Wardha. Once given consent and assent, these participants will be divided into two groups by simple random sampling by chit method. All the patients will be initially questioned about age, gender, and duration of pain. Then all subjects will be evaluated for ph of trigger point, Pain Pressure threshold and Quality of life method will be used on session 1 pre-treatment and on session 9 post-treatment. The treatment procedure will be conducted 3 times a week excluding weekends, for total of 9 sessions for 15-20 mins per session. GROUP A: In the group A, Percutaneous electrical nerve stimulation will then applied to the trigger point in Levator scapulae muscle. Patient will be in prone position lying with both arm in abduction and head resting over the hands to relax the muscle that enables easy palpation of the muscle bulk. Head will be in neutral position. The needle of 40-50mm will be inserted. The needle Probe were connected to the alligator electrodes, with each lead connected to one positive and one negative probe. The leads were connected to the electrical generator with frequency of 15Hz and 30 Hz. After the treatment session, stretching to the Levator scapulae muscle and icing will be given to avoid muscle soreness. GROUP B: In the group A, Dry Needling will then applied to the trigger point in Levator scapulae muscle. Patient will be in prone position lying with both arm in abduction and head resting over the hands to relax the muscle that enables easy palpation of the muscle bulk. Head will be in neutral position. The needle of 40-50mm will be inserted. The patient will be aware that Levator scapulae muscle will respond strongly and strong twitch response will be felt. After the treatment session, stretching to the Levator scapulae muscle and icing will be given to avoid muscle soreness. day 1 pre treatment and day 21 post treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. A minimum of 1 palpable trigger point in Levator scapulae muscle.
2. Individual aging between 18-40 yrs.
3. Positive jump sign characterized by patient vocalization or withdrawal.
 
 
ExclusionCriteria 
Details  1. History of fracture of neck and upper back region.
2. History of referred pain due to cervical pathology.
3. Dermatitis over upper back region.
4. Un-cooperative patient.
5. Subjects with Needle Phobia.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Ph of trigger point, pain pressure threshold, Quality of life  pre on day 1 and post day 21 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  outcome assessed on day 1 pre treatment & day 21 post treatment 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   20/08/2025 
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="5"
Days="0" 
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  

Myofascial pain, which is brought on by myofascial trigger points, is a typical source of musculoskeletal pain (MTrPs). Myofascial pain symptoms are caused by MTrPs, which are described as excruciatingly sensitive places in discrete taut bands of stiffened muscle. MTrPs can be deactivated by manual methods, spray and stretch, and trigger point needling. When necessary, MTrPs inactivation may be supplemented with ergonomic guidance, active workouts, posture correction, and relaxation. Rarely do comprehensive assessments of the effectiveness of conservative therapies in individuals with neck pain include the treatment of MTrPs. Although well-designed controlled studies are lacking, a few of case studies have suggested that treating MTrPs in patients with neck discomfort may be useful.

Chronic nerve pain, including headaches and post-operative pain, is also treated using percutaneous electrical nerve stimulation (PENS) which is a skilled technique where electrical stimulation is applied via small needles which penetrate the skin.

Intra muscular manual therapy or Dry Needling (DN) is an adept intervention used by physical therapists that treats neuromusculoskeletal pain and mobility problems by inserting a small filiform needle into the skin and stimulating the underlying myofascial trigger points, muscles, and connective tissues.

Trigger points have the potential to refer pain to far-off areas of the body. To release/inactivate the trigger points and alleviate pain, physical therapists use Dry Needling. Dry Needling, according to preliminary study, enhances pain management, lessens muscular tension, normalizes biochemical and electrical dysfunction of motor endplates, and speeds up the transition back to active rehabilitation.

There is limited evidence that compare the efficacy of the two therapy modalities, even though all the above-mentioned procedures are successful in managing myofascial pain. As a result, this study proposes to compare the effects of Percutaneous Electrical Stimulation and Dry Needling in the Management of Levator scapulae Trigger point in Dental Students.

After the ethical clearance from the University, participants with chronic neck pain with myofascial trigger point in Levator scapulae muscle will be recruited from Physiotherapy OPD of Acharya Vinoba Bhave Rural Hospital, Sawangi Wardha and OPD of Ravi Nair Physiotherapy College, Salod, Wardha. Once given consent and assent, these participants will be divided into two groups by simple random sampling by chit method.

All the patients will be initially questioned about age, gender, and duration of pain. Then all subjects will be evaluated for ph of trigger point, Pain Pressure threshold and Quality of life method will be used on session 1 pre-treatment and on session 9 post-treatment.

The treatment procedure will be conducted 3 times a week excluding weekends, for total of 9 sessions for 15-20 mins per session.

 

 

GROUP A: In the group A, Percutaneous electrical nerve stimulation will then applied to the trigger point in Levator scapulae muscle. Patient will be in prone position lying with both arm in abduction and head resting over the hands to relax the muscle that enables easy palpation of the muscle bulk. Head will be in neutral position. The needle of 40-50mm will be inserted. The needle Probe were connected to the alligator electrodes, with each lead connected to one positive and one negative probe. The leads were connected to the electrical generator with frequency of 15Hz and 30 Hz. After the treatment session, stretching to the Levator scapulae muscle and icing will be given to avoid muscle soreness.

 

 

GROUP B: In the group A, Dry Needling will then applied to the trigger point in Levator scapulae muscle. Patient will be in prone position lying with both arm in abduction and head resting over the hands to relax the muscle that enables easy palpation of the muscle bulk. Head will be in neutral position. The needle of 40-50mm will be inserted. The patient will be aware that Levator scapulae muscle will respond strongly and strong twitch response will be felt. After the treatment session, stretching to the Levator scapulae muscle and icing will be given to avoid muscle soreness.

 

Patient will be advised not to take any analgesics during the treatment session. The pre and post treatment ph of Trigger point, Pain Pressure Threshold and Quality of Life measurements will be analyzed statistically.

 

 

 
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