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CTRI Number  CTRI/2025/09/094090 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of neck muscle training in reducing long-term shoulder pain caused by impingement of shoulder 
Scientific Title of Study   Effectiveness of deep cervical flexor endurance training in chronic subacromial impingement syndrome patients- A Randomized Control Trial 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  Dr Simran Naresh Vaswani  
Designation  Postgraduate Student 
Affiliation  Dr. G. D. Pol Foundation, YMT College Of Physiotherapy. 
Address  Dr. G. D. Pol Foundation, YMT College Of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar,Navi Mumbai, Maharashtra

Raigarh
MAHARASHTRA
410210
India 
Phone  8999345321  
Fax    
Email  simran12vaswani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ezhil Mathi (PT) 
Designation  Principal, Professor  
Affiliation  Principal at Dr. G. D. Pol Foundation, YMT College Of Physiotherapy. 
Address  Dr. G. D. Pol Foundation, YMT College Of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar,Navi Mumbai, Maharashtra

Raigarh
MAHARASHTRA
410210
India 
Phone  9920302664  
Fax    
Email  ezhilmathi48@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Simran Naresh Vaswani  
Designation  Postgraduate Student 
Affiliation  Dr. G. D. Pol Foundation, YMT College Of Physiotherapy. 
Address  Dr. G. D. Pol Foundation, YMT College Of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar,Navi Mumbai, Maharashtra

Raigarh
MAHARASHTRA
410210
India 
Phone  8999345321  
Fax    
Email  simran12vaswani@gmail.com  
 
Source of Monetary or Material Support  
Dr. G. D. Pol Foundation, YMT College Of Physiotherapy  
 
Primary Sponsor  
Name  Dr Simran Naresh Vaswani  
Address  Dr. G. D. Pol Foundation, YMT College Of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar,Navi Mumbai, Maharashtra 
Type of Sponsor  Other [Self] 
 
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 Simran Naresh Vaswani  YMT COLLEGE OF PHYSIOTHERAPY, KHARGHAR, NAVI MUMBAI  Room no. 305, Musculoskeletal OPD, DR.G.D POL FOUNDATION YMT COLLEGE OF PHYSIOTHERAPY INSTITUTIONAL AREA BELPADA ROAD SECTOR 4 KHARGHAR NAVI MUMBAI MAHARASHTRA 410210
Raigarh
MAHARASHTRA 
8999345321

simran12vaswani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. G. D. Pol Foundation, YMT COP Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M754||Impingement syndrome of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional training along with endurance training of deep cervical flexors with pressure bio feedback device   Conventional training along with endurance training of deep cervical flexors with pressure bio feedback device for 4 weeks, 3 days a week 
Intervention  Conventional training using IFT. Hot packs and exercises   Conventional training using IFT, hot packs and exercises for 4 weeks, 3 days a week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. shoulder pain persisting for over six
weeks.
2. Age group between 18-40 years. (stage I
and stage II patients)
3. A painful arc during shoulder flexion and
abduction (between 60° and 120°)
4. A positive Hawkins Kennedy and positive
neer impingement test.
5. Participants with history of neck pain
along with chronic subacromial
impingement syndrome and reduced
cervical flexor endurance. 
 
ExclusionCriteria 
Details  1) shoulder pain due to fractures,
dislocations.
2) cervical radiculopathy, a history of
surgical intervention or degenerative joint
disease of the shoulder joint complex, any
diagnosed rheumatic, systemic or
neurological diseases.
3) participants with history of heart attack
using pacemaker device.
4) participants with passive joint movement
limitation (Adhesive Capsulitis) are
excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Numerical Pain Rating Scale (NPRS) for Pain.
2) Shoulder Pain and Disability Index (SPADI) for Shoulder
Pain and Disability
3) Cranio-cervical Flexion Test using the pressure bio feedback device for deep cervical flexors endurance  
At baseline and after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   15/09/2025 
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="0"
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  

Subacromial Impingement Syndrome (SIS) is the most frequent diagnosis in shoulder pain, accounting for up to 65% of shoulder complaints, and is strongly associated with impairments in posture, scapular control, and cervical spine function. While current rehabilitation emphasizes scapular stabilization and shoulder mechanics, poor cervical posture and reduced deep cervical flexor (DCF) endurance may contribute to altered scapular kinematics and persistent dysfunction. This randomized controlled trial aims to evaluate the additional benefit of DCF endurance training, using a pressure biofeedback device, alongside conventional physiotherapy. Thirty-six patients aged 18–40 years with chronic SIS were randomly assigned to two groups: Group A received conventional therapy (hot packs, IFT, and shoulder strengthening), while Group B received the same plus DCF endurance training performed three times per week for four weeks. Pain (NPRS), disability (SPADI), and cervical endurance (CCFT) were measured pre- and post-intervention. It is hypothesized that DCF training will produce greater reductions in pain and disability and improve cervical endurance compared to conventional therapy alone. The study addresses a gap in SIS management by considering the role of cervical stabilization, potentially offering a more comprehensive rehabilitation approach for patients.

 
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