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CTRI Number  CTRI/2024/06/068324 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing kinesio tape and exercises versus ultrasonic therapy for neck pain and forward head posture 
Scientific Title of Study   To compare the Effects of Kinesio tape with Postural Corrective Exercises Versus Scapular Stabilisation exercises with Ultrasonic (Phonophoresis) on patients with Forward Head posture and Neck Pain.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muskan Aggarwal 
Designation  Post Graduate Student 
Affiliation  shri guru ram rai university ,school of paramedical and allied health sciences 
Address  Room No-04, Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun

Dehradun
UTTARANCHAL
248001
India 
Phone  9756677767  
Fax    
Email  aggarwalmuskan4176@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shama praveen 
Designation  assistant professor 
Affiliation  shri mahant indresh hospital ,patel nagar dehradun 
Address  Room No-04, Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun


UTTARANCHAL
248001
India 
Phone  8006965111  
Fax    
Email  shamapraveen@sgrrmc.com  
 
Details of Contact Person
Public Query  
Name  Dr Shama praveen 
Designation  assistant professor 
Affiliation  shri mahant indresh hospital ,patel nagar dehradun 
Address  Room No-03, Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun


UTTARANCHAL
248001
India 
Phone  8006965111  
Fax    
Email  shamapraveen@sgrrmc.com  
 
Source of Monetary or Material Support  
Shri Mahant Indresh Hospital, Dehradun,248001,uttrakhand,india  
 
Primary Sponsor  
Name  Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences 
Address  Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun,uttrakhand 248001 ,india  
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 
Dr Shama Praveen  Shri Mahant Indresh Hospital  Room No-03, Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun
Dehradun
UTTARANCHAL 		 8006965111

shamapraveen@sgrrmc.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun  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 
Intervention  k-tape with postural corrective exercises  Participants will be guided through a series of movements designed to target specific muscle groups effectively. They will engage in chin tucks, holding the position for several seconds before relaxing and repeating the exercise, whether in a supine or sitting position. Strengthening exercises for the shoulder retractors will be conducted standing, utilizing resistance bands to pull the shoulders back and bring the shoulder blades together. Additionally, stretching routines will focus on the pectoralis and SCM muscles, with therapists providing guidance and assistance as needed. Participants will follow instructions to achieve optimal positioning and perform movements to stretch these muscles, ensuring flexibility and reducing tightness. Through consistent practice of these exercises, individuals will experience improvements in posture and overall musculoskeletal health, laying the foundation for long-term well-being. k-tape will be applied on upper traps from insertion to origin and treatment duration will be 30-35 minutes per seesion for 5 days in a week for 4 weeks  
Comparator Agent  scapular stabilisation exercises with ultrasonic   In the forward flexion exercise, individuals will lie on their side with shoulders in a neutral position, then perform forward flexion in the horizontal plane to a 135-degree angle. Side-lying external rotation exercises will involve lying on the side with the shoulder in a neutral position, elbow flexed to 90 degrees, and performing external rotation while ensuring proper form with a towel to prevent compensatory movements. Scaption exercises will be conducted in a sitting position with knees flexed at 90 degrees, lifting dumbbells laterally while maintaining scapular height below 80 degrees. Finally, participants will engage in quadripod position exercises, lifting their arms alternately with shoulder abduction and 120 degrees flexion while in a four-point kneeling position. These exercises will be instrumental in enhancing shoulder mobility, stability, and overall function, contributing to improved physical performance and well-being. ultrasonic therapy will be given on upper traps muscle for 5 minutes in continous mode . this session will last for 30-35 minutes in a day for 5 days a week for 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.CV angle less than 50 degrees
2.Suffered atleast 3 months of neck pain
3.No Cervical or shoulder neurological movement disorder
4.Shoulder flexion atleast 130 degrees or more
 
 
ExclusionCriteria 
Details  • 1. Scoliosis
2. Cervical fractures
3. Thoracic fractures
4. Have had previous shoulder surgery
5. Diagnosis of fibromyalgia syndrome
6. Diagnosis of psychiatric disorders such as anxiety and depression
7. Any metabolic disease
8. Any heart disease
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale (VAS)  Baseline Data
Mid Week
Fourth Week
 
 
Secondary Outcome  
Outcome  TimePoints 
Neck disability index   Baseline Data
Mid Week
Fourth Week 
Craniovertebral angle   Baseline Data
Mid Week
Fourth Week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   16/06/2024 
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="2"
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  

I will do a comparative study to find out the effects  between the use of Kinesio Tape with postural corrective exercises Versus scapular stabilsation exercises with Ultrasonic(phonophoresis) on patients with Forward Head Posture and neck pain .

Total 30 patients will be included in the study by convenient sampling method.

Subjects will be divided into 2 groups in which one will be group A and another will be group B and both the groups will be experimental. Each group containing 15 subjects each.

Group A will receive K-taping on the upper fibres of Trapezius muscle (inhibition technique)(from the acromion process to the hairline)(insertion to origin) along with postural corrective exercises whereas group B will recieve Scapular stabilisation exercises along with ULTRASONIC on the upper fibres of traps muscle.

The patients will be accorded from the OPD of Physiotherapy Department of Shri Mahant Indresh Hospital,Patel Nagar, Dehradun .The subjects will be undertaken according to the inclusion as well as exclusion criteria and a written informed consent will be obtained .All the participants  will be briefed about the purpose and the method of the study .

 
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