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CTRI Number  CTRI/2018/02/012048 [Registered on: 21/02/2018] Trial Registered Retrospectively
Last Modified On: 23/04/2019
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   Effect of specific exercises on patients with neck pain. 
Scientific Title of Study   Effect of Scapular Stabilization with Upper Limb Proprioceptive Training in Chronic Non specific Neck Pain Patients on Function and Related Parameters 
Trial Acronym  SSULPT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Zubia Veqar 
Designation  Assistant professor 
Affiliation  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia 
Address  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Zubia Veqar 
Designation  Assistant professor 
Affiliation  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia 
Address  room no 204, second floor Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  veqar.zubia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anam fatima 
Designation  Student  
Affiliation  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia 
Address  Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia Islamia

South
DELHI
110025
India 
Phone  9958993486  
Fax    
Email  anam93fatima@gmail.com  
 
Source of Monetary or Material Support  
Jamia Millia Islamia, Maulana mohd Ali gauhar marg,Okhla, Delhi, India 
 
Primary Sponsor  
Name  Jamia Millia Islamia 
Address  okhla 
Type of Sponsor  Other [Central university] 
 
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 Zubia Veqar  centre for Physiotherapy and rehabilitaton sciences  Physiotherapy clinic, ground floor,Centre For Physiotherapy and Rehabilitation Scienced Jamia Millia Islamia
South
DELHI 
9958993486

veqar.zubia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, JAMIA MILLIA ISLAMIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Physiotherapy  Cervical Stabilization Exercises. The following will be a four week protocol. It will begin with postural education that will include teaching the subjects to sit with front and side mirror views and to maintain a neutral balanced position of the lumbar, thoracic, and cervical spine. This will be followed by Cervical Stabilization Exercise Program A. The cervical bracing technique performed in neurodevelopment stages, and then extremity range of motion exercises. B. Cervical dynamic isometric exercises: Will be performed directly forward, obliquely, toward right and left, and directly backward by maintaining stabile spine and progressed with elastic resistive bands.  
Intervention  Physiotherapy  Scapulothoracic and Upper limb proprioceptive exercises It will be a four week protocol. These will be Scapular orientation exercise; that will include Isometrics; Scapular pinches, Low Row Wall isometrics and isotonics ; Prone shoulder, Horizontal abduction and progress into Resistive exercises i.e. Scapular pinches using theraband, Dynamic Hug, Cheerleader Exercise, Manually Resisted Scapular Strengthening, Scaption with external rotation, and Side-lying external Dumbbell. Upper extremity proprioceptive training will include, Mirroring Upper Extremity, Duplicating Position, Double and Single Arm Balancing and Ball Balancing with eyes open and eyes closed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  •Subjects with chronic (≥3months) nonspecific neck pain of mechanical origin with symptoms provoked by neck postures, movements, or palpation.
•Males/females between 18 to 59 years of age.
•Subjects willing to attend a 4 week treatment program
•Numerical pain rating scale score ≤ 6 and ≥ 2.
•Working knowledge of English to complete the questionnaires.
•A score of more than 6 in Pittsburgh Sleep Quality Index
 
 
ExclusionCriteria 
Details  1. Subjects with cervical spine surgery or any previous history of cervical spine fracture or spinal stenosis.
2.Subjects suffering from debility any other co morbid conditions.
3.Subjects with bilateral upper extremity symptoms, positive radicular signs consistent with nerve root compression.
•Subjects having vertebrobasilar insufficiency symptoms.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Neck pain and Disability
Scapular muscles strength
Upper limb proprioception (Constant error)
Sleep
Quality of life
 
4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Neck Disability
Sleep
Quality of life 
4 weeks 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2018 
Date of Study Completion (India) 30/04/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2018 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction: Neck pain is a world-wide health problem and is one of the causes of individual suffering and a large burden for the society.  It is counted among the most common musculoskeletal problem in health care. Pain results in sleep disturbances affecting sleep maintenance, sleep latency and is responsible for wakefulness.  Pain triggers certain mechanisms that worsen the sleep quality.Groups will receive specific exercises with a set standardization of parameters and type which are internationally accepted. The main musculatures involved in chronic neck pain are Upper trapezius, Middle Trapezius and Lower Trapezius, Serratus Anterior, Pectolaris Minor, Levator Scapulae and Rhomboids. Goal directed movements and position matching acuity are found to be affected in chronic nonspecific neck pain patients. Upper limb acuity i.e. position matching was found to be reduced in people with chronic neck pain patients. Active joint repositioning training utilizes the procedure that is used for testing purposes of joint position sense. Here, the starting angle and target angles are selected which are the most vulnerable to injuries. Then the patient moves from the beginning position to the target angle and holds at that position for approximately for five seconds. This is done first with eyes open followed by eyes closed .A combined effect of upper limb proprioceptive exercises and stabilization exercises is the corner stone of this study. Stability and goal directed movements training induced changes will be examined at the end of the programme.

Objective: To find the Effects of scapular stabilization with upper limb proprioception training on pain, functional disability, QOL and Sleep of patients with chronic nonspecific neck pain.

Significance of the study: This study will help us to develop Scapular Stabilization with Upper limb Proprioceptive Training as a better therapeutic measure for the Chronic Neck Pain patients with disturbed Sleep, Quality Of Life and Functional Disability and Pain.

Method: Total of 28 sample of (14=GroupA, 14=Group B) will be taken from Jamia Millia Islamia, New Dellhi.

Research design: A randomized, therapy-controlled trial.

Procedure: Subjects will be divided randomly into two groups: Group 1: Conventional physiotherapy only; Group 2: Scapular stabilization with upper extremity proprioceptive Training including conventional exercises. All identifying information on the consent form and demographic/injury history questionnaire will be kept confidential by assigning number to each subject.Data will be collected on 1st day and at the 4th week of intervention.

 
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