| CTRI Number |
CTRI/2025/08/092471 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating SSMP Versus Eccentric Training: Outcomes in Chronic Rotator Cuff Tear Management |
|
Scientific Title of Study
|
Comparison of effectiveness of SSMP(shoulder symptom modification protocol) versus Eccentric training on
the outcome measure in chronic
rotator cuff tear: An experimental
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 |
Swathi S |
| Designation |
MPT( Physiotherapy) |
| Affiliation |
SDM college of physiotherapy |
| Address |
Room no-5 , orthopaedic physiotherapy department, SDM college of physiotherapy, SDM college of medical sciences and hospital, Manjushree Nagar, stature, dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8217082862 |
| Fax |
|
| Email |
shettyswathi324@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil K M |
| Designation |
MPT( Physiotherapy) |
| Affiliation |
SDM college of physiotherapy |
| Address |
Room no -5 , orthopaedic physiotherapy department, SDM college of physiotherapy, SDM college of medical sciences and hospital, Manjushree Nagar, stature, dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9880260626 |
| Fax |
|
| Email |
sunilkm789@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi S |
| Designation |
MPT( Physiotherapy) |
| Affiliation |
SDM college of physiotherapy |
| Address |
Room no-5, orthopaedic physiotherapy department, SDM college of physiotherapy, SDM college of medical sciences and hospital, Manjushree Nagar, stature, dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8217082862 |
| Fax |
|
| Email |
shettyswathi324@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of physiotherapy, Manjushree nagar, sattur, dharwad, karnataka - 580009 |
|
|
Primary Sponsor
|
| Name |
Swathi S |
| Address |
SDM college of physiotherapy, Manjushree nagar, sattur, dharwad |
| Type of Sponsor |
Other [] |
|
|
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 Swathi S |
SDM college of physiotherapy |
OPD no-5, orthopaedic physiotherapy department, SDM college of physiotherapy, SDM college of medical sciences and hospital, Manjushree Nagar, sattur, dharwad
Dharwad
KARNATAKA |
8217082862
shettyswathi324@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM college of medical sciences and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M751||Rotator cuff tear or rupture, notspecified as traumatic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A-Shoulder Symptom Modification Protocol |
Thoracic extension technique , Scapular elevation technique, Scapular retraction, Scapular posterior tilt, combination, eccentric flexion , eccentric abduction, external rotation, internal rotation, AP , PA techniques for 4 weeks |
| Comparator Agent |
GROUP B- ECCENTRIC TRAINING |
Sitting shoulder abduction, internal rotation, side lying external rotation, internal rotation, supine shoulder flexion, prone extension and wall push ups for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Shoulder pain persisting over 3 months. Participants diagnosed with chronic RC tear by orthopaeditian. |
|
| ExclusionCriteria |
| Details |
Participants with a history of significant shoulder trauma, Fractures, recurrent
shoulder dislocation, or recent shoulder surgery within the past year are excluded.
Individuals’ experiencing shoulder pain originating from the cervical spine or related to
specific disorders such as arthritis (e.g., Rheumatoid Arthitis (RA) are excluded. Individual’s with neurologic conditions (e.g., stroke) are excluded in this study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
ROM, MMT, NPRS, SPADI AND TSK-11
At baseline and after 4 weeks of intervention |
ROM, MMT, NPRS, SPADI AND TSK-11
At baseline and after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/09/2025 |
| 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 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
|
Rotator cuff (RC) tears are a common cause of persistent shoulder pain and functional limitations. The Shoulder Symptom Modification Protocol (SSMP) is a relatively recent, individualized, and patient-centered intervention focusing on immediate symptom reduction through postural, scapular, and humeral repositioning strategies. It has shown promising results in clinical settings. On the other hand, eccentric training has demonstrated effectiveness in promoting tendon remodeling, reducing pain, and improving function in chronic tendinopathies, including RC disorders. Comparing SSMP and eccentric training is crucial to determine which intervention provides superior outcomes in terms of pain relief, function, and long-term shoulder health in patients with chronic RC tears. These are studies- SSMP in chronic RC tear is effective, eccentric training in chronic RC tear is effective. To our knowledge there are no studies which has compared SSMP and eccentric training in chronic RC tear. Hence, the study was taken. This is one of the first experimental studies to directly compare Shoulder Symptom Modification Protocol (SSMP) versus eccentric training in patients with chronic rotator cuff tears. While both interventions are used clinically, no prior research has systematically evaluated their relative effectiveness, making this study a novel contribution to evidence-based conservative management of chronic RC tears. This study is expected to show how Shoulder Symptom Modification Protocol (SSMP) and eccentric training differ in their short-term effects on range of motion, muscle strength, pain intensity, kinesiophobia and disability in patients with chronic RC tear.
|