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CTRI Number  CTRI/2023/10/058709 [Registered on: 16/10/2023] Trial Registered Prospectively
Last Modified On: 13/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Immediate effects of Percutaneous Electrical Nerve Stimulation versus Ischemic Compression on pain, pressure pain tolerance and side bend in individuals with one side neck pain of short duration 
Scientific Title of Study   Immediate effects of Percutaneous Electrical Nerve Stimulation versus Ischemic Compression on pain, pressure pain threshold and lateral flexion in individuals with acute unilateral neck pain: An Experimental 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  Tamanna Nurai 
Designation  Master of Physiotherapy Student 
Affiliation  K J Somaiya college of physiotherapy 
Address  OPD 4 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7887711448  
Fax    
Email  tamanna.nurai@somaiya.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Supriya Dhumale 
Designation  Associate Professor 
Affiliation  K J Somaiya college of physiotherapy 
Address  OPD 4 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8369542247  
Fax    
Email  supriya@somaiya.edu  
 
Details of Contact Person
Public Query  
Name  Tamanna Nurai 
Designation  Master of Physiotherapy Student 
Affiliation  K J Somaiya college of physiotherapy 
Address  OPD 4 Musculoskeletal Department K J Somaiya college of physiotherapy Eastern express highway Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7887711448  
Fax    
Email  tamanna.nurai@somaiya.edu  
 
Source of Monetary or Material Support  
OPD 4 Musculoskeletal department K J Somaiya College of Physiotherapy Eastern Express Highway Sion Mumbai 
 
Primary Sponsor  
Name  K J Somaiya college of physiotherapy 
Address  OPD 4 Musculoskeletal Department K J Somaiya College of Physiotherapy Eastern express highway Sion Mumbai 
Type of Sponsor  Research institution and hospital 
 
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 Tamanna Nurai  K J Somaiya College of Physiotherapy  OPD 4 Musculoskeletal Department K J Somaiya College of Physiotherapy Eastern Express Highway Sion Mumbai
Mumbai
MAHARASHTRA 		 7887711448

tamanna.nurai@somaiya.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee K J Somaiya College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ischemic Compression  Ischemic compression is the application of progressively strong, painful pressure on trigger point to eliminate trigger points. It is performed by compressing the trigger points with tolerable pain intensity using thumb pressure, and as the degree of pain decreases the intensity of compression is increased simultaneously. Ischemic compression should be followed by lengthening of muscle.  
Intervention  Percutaneous electrical nerve stimulation  Percutaneous Electrical Nerve Stimulation is a modified form of traditional acupuncture in which an electrical current is applied between pairs of acupuncture needles by using a device that controls the frequency and strength of the electrical current which was being delivered. PENS is the application of a low-intensity current through an acupuncture needle. It is a combination of Dry Needling and TENS. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  a) unilateral neck pain, less than 7 days
b) active myofascial trigger point diagnosed as per Gerwin and Simon criteria
c) numerical pain rating scale score of 4-7 points. 
 
ExclusionCriteria 
Details  a) Patient having needle phobia
b) Patient on anticoagulant therapy and/or bleeding disorder
c) Tumour
d) Migraine
e) Any cervical surgery
f) Any cervical pathology such as spondylosis, spondylolysis, disc prolapse,
spinal stenosis, ankylosing spondylitis, fracture, cervicogenic dizziness, etc.
g) Pregnancy
h) Compromised immune therapy
i) Diabetes
j) Epilepsy
k) Vascular disease
l) Temporomandibular joint dysfunction
m) Conditions with thoracic spine involvement
n) Infective conditions (neck abscess, osteomyelitis, pott’s spine, TB lung) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Pressure Pain threshold
2. Numerical Pain Rating Scale
3. Lateral Flexion 		 Pre-intervention: Baseline assessment
post-intervention: immediately after 1st session 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   23/10/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Approval is obtained from Institutional Ethics Committee. Participants fitting the inclusion criteria will be recruited and a written informed consent will be obtained in the language best understood by them. Participants will be randomly allocated by SNOSE (sequentially numbered, opaque, sealed envelope) technique using computer generated numbers into two groups: Group A(study group)- Percutaneous Electrical Nerve Stimulation and Stretching, Group B (control group)- Ischemic Compression Technique and Stretching. Explanation to the treatment, Baseline information in case record form and Pre-treatment assessment will be done for pain, pressure pain threshold (mean of 3 readings) and range of motion for cervical side flexion to opposite side. Single session will be given. Immediate treatment, assessment will be done using numerical pain rating scale, pressure algometer and goniometer. Statistical analysis will be done by paired t test for intragroup analysis and unpaired t test for intergroup analysis.

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