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CTRI Number  CTRI/2022/10/046776 [Registered on: 25/10/2022] Trial Registered Prospectively
Last Modified On: 20/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   "To assess the combined effect of therapeutic ultrasound and trigger point release in alleviating neck pain and improving functional disabilities among professional computer users 
Scientific Title of Study   "To assess the combined effect of therapeutic ultrasound and trigger point release in alleviating neck pain and improving functional disabilities among professional computer users: A quasi experimental study" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankit kumar 
Designation  Mpt student  
Affiliation  Maharishi Markandeshwar institute of physiotherapy and rehabilitation 
Address  Maharishi Markandeshwar institute of physiotherapy and rehabilitation Maharishi Markandeshwar deemed to be University Mullana, Ambala, Haryana India

Ambala
HARYANA
133207
India 
Phone  8685081383  
Fax    
Email  ankitgojra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aksh chahal  
Designation  Professor  
Affiliation  Maharishi Markandeshwar institute of physiotherapy and rehabilitation 
Address  Maharishi Markandeshwar institute of physiotherapy and rehabilitation Maharishi Markandeshwar deemed to be University Mullana, Ambala, Haryana India

Ambala
HARYANA
133207
India 
Phone    
Fax    
Email  drakshchahal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ankit kumar 
Designation  Mpt student  
Affiliation  Maharishi Markandeshwar institute of physiotherapy and rehabilitation 
Address  Maharishi Markandeshwar institute of physiotherapy and rehabilitation Maharishi Markandeshwar deemed to be University Mullana, Ambala, Haryana India

Ambala
HARYANA
133207
India 
Phone  8685081383  
Fax    
Email  ankitgojra@gmail.com  
 
Source of Monetary or Material Support  
Musculoskeletal physiotherapy Research Lab, Maharishi Markandeshwar institute of physiotherapy and rehabilitation, Maharishi Markandeshwar deemed to be University, Ambala, Haryana  
 
Primary Sponsor  
Name  Ankit  
Address  Maharishi Markandeshwar institute of physiotherapy and rehabilitation, Maharishi Markandeshwar deemed to be University, Ambala, Haryana 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Aksh chahal   Maharishi Markandeshwar institute of physiotherapy and rehabilitation, Maharishi Markandeshwar deemed to be University, Ambala, Haryana 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ankit Kumar   Maharishi Markandeshwar Hospital Department of Musculoskeletal Physiotherapy  Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana Ambala HARYANA
Ambala
HARYANA 		 8685081383

ankitgojra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of the decision of the ethics committee Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana Ambala HARYANA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable   Not applicable  
Intervention  Therapeutic ultrasound and trigger point release   The subjects will be treated with continuous mode ultrasound (3MHz, 1W/cm²) 6 days regularly. Subjects will also receive trigger point release for neck pain. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Individuals with neck pain for more than 3 month duration

2.Individuals willing to be a part of the proposed study

•Posing atleast one trigger point in neck region

•Male and females

Age group 20 to 40 years 
 
ExclusionCriteria 
Details  1.Acute neck pain 

2.Previous history of trauma or fracture past 6 months 
3.Individuals with Cervical PIVD

Inflammatory pathology, malignancy, previous spinal surgery, history of cardiovascular and pregnant females 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS)
 		 2 times that is pre intervention and post intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
Neck disability index   2 times that is pre intervention and post intervention  
Cervical ROM  2 times that is pre intervention and post intervention  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 1 
Date of First Enrollment (India)   31/10/2022 
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="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The objective of this study is to assess the combined effect of therapeutic ultrasound and trigger point release in alleviating neck pain and improving functional disabilities among professional computer users. Participants will be chosen from a group of 20–40-year-old who had been suffering from neck pain for at least 4 weeks. Each subject’s complete demographic information including name, age, gender will be recorded. Treatment will be provided for 6 days regularly. The Visual Analouge Scale will be used to assess pain intensity, the Cervical Range Of Motion will be assessed with the help of goniometer and the Neck Disability Index Questionnaire is used to assess disabilities of neck, and outcome will be measured pre and post intervention. 
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