| 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
|
|
|
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
|
|
|
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. |