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CTRI Number  CTRI/2025/04/083872 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of Elastic Band Training on Painful Shoulder 
Scientific Title of Study   Effects of Tissue Flossing on Pain, Range of Motion, and Functional outcomes in Frozen Shoulder Patients: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jaya P 
Designation  Assistant Professor 
Affiliation  Father Muller College of Physiotherapy 
Address  Father Muller College of Physiotherapy, A Unit of Father Muller Charitable Institutions, Father Muller Road, Kankanady, Mangalore-575002

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9611057292  
Fax    
Email  jayakulal55@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saumya Srivastava 
Designation  Associate Professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Musculoskeletal sciences, Nitte Institute of Physiotherapy, Deralakatte, Mangalore.

Dakshina Kannada
KARNATAKA
575022
India 
Phone  7007337186  
Fax    
Email  saumyasri2000@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Saumya Srivastava 
Designation  Associate Professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Musculoskeletal sciences, Nitte Institute of Physiotherapy, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575022
India 
Phone  7007337186  
Fax    
Email  saumyasri2000@nitte.edu.in  
 
Source of Monetary or Material Support  
Father Muller Medical College Hospital, A unit of Father Muller Charitable Institutions, Father Muller Road, Kankanady, Mangalore-575002, Dakshina Kannada, Karnataka, India 
 
Primary Sponsor  
Name  Father Muller Medical College Hospital 
Address  Kankanady, Mangalore-575002 
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 
Jaya P  Father Muller Medical College Hospital  A Unit of Father Muller Charitable Institutions, Father Muller Road, Kankanady, Mangalore-575002, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA 		 9611057292

jayakulal55@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
NITTE Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Physical therapy  Stretch into ER at 0° of abduction: The patient is in supine, with the shoulder supported on a foam wedge in 0° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral ER Stretch into ER at 45° of abduction: The patient is in supine, with the shoulder supported on a foam wedge in 45° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral ER Stretch into ER at 90° of abduction: The patient is in prone, with the shoulder at 90° of abduction and the forearm resting on a foam wedge, maintaining the intended stretch into glenohumeral ER Stretch into IR at 30° of abduction: The patient is in sidelying, with the shoulder supported on a foam wedge in 30° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral IR Stretch into IR at 60° of abduction: The patient is in sidelying, with the shoulder supported on a foam wedge in 60° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral IR Stretch into IR at 90° of abduction: The patient is in sidelying, with the shoulder supported on a foam wedge in 90° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral IR.20 All the exercises given for (5 bouts of 1 to 5 seconds) stretching, twice a week for 6 weeks.  
Intervention  Tissue Flossing with standard physical therapy  After the pre-test, patients affected hand will be passively lifted and laid on the t0herapist’s shoulder. The start of the flossing tape (Lime Green; Sanctband Flossband) will be applied at the point of attachment of deltoid muscle (deltoid tuberosity) and wound on the shoulder area with its winding inwards and with an 0overlap of individual turns by half of the width of the flossing tape. The application will be performed with the same force (50% tension) by an experienced therapist.21 Stretch into ER at 0° of abduction: The patient is in supine, with the shoulder supported on a foam wedge in 0° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral ER Stretch into ER at 45° of abduction: The patient is in supine, with the shoulder supported on a foam wedge in 45° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral ER Stretch into ER at 90° of abduction: The patient is in prone, with the shoulder at 90° of abduction and the forearm resting on a foam wedge, maintaining the intended stretch into glenohumeral ER Stretch into IR at 30° of abduction: The patient is in sidelying, with the shoulder supported on a foam wedge in 30° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral IR Stretch into IR at 60° of abduction: The patient is in sidelying, with the shoulder supported on a foam wedge in 60° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral IR Stretch into IR at 90° of abduction: The patient is in sidelying, with the shoulder supported on a foam wedge in 90° of abduction in the scapular plane, allowing gravity to produce the intended stretch into glenohumeral IR.20 All the exercises given for (5 bouts of 1 to 5 seconds) stretching, twice a week for 6 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient age is between 40 and 65 years of both the gender
Loss of passive external rotation greater than 50 percent when compared to the uninvolved shoulder or less than 45 degree of external rotation
ROM loss of greater than 25 percent in at least 2 movement planes in comparison to the uninvolved shoulder
Pain and restricted movement present and reaching a plateau or worsening for at least 1 month Volunteers must be willing to follow the study protocol attend sessions and provide informed consent
 
 
ExclusionCriteria 
Details  History of shoulder surgery example rotator cuff repair shoulder arthroplasty or recent trauma example fractures dislocations
Other shoulder joint pathologies like osteoarthritis rotator cuff tears or labral tears
Corticosteroid injections in the past 6 months
Shoulder mobility defects accompanying neurological damage such as in stroke or Parkinson disease
Open wounds, infections, rashes, or other skin conditions.
Chronic joint or connective tissue disorders (e.g., rheumatoid arthritis, lupus, or other autoimmune diseases).
History of heart disease or vascular disorders.
Allergic reactions to latex.
Generalized pain syndromes (e.g., fibromyalgia) to avoid confounding effects from diffuse pain unrelated to adhesive capsulitis.
Infection or Malignancy. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain
Shoulder Range of motion
Function 		 baseline and 6 weeks post 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/04/2025 
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="2"
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   tissue flossing is a newer intervention, where elastic band will be applied in and around joint or soft tissue to improve range, pain and strength. tissue flossing found to be effective in other musculoskeletal conditions of lower limbs such as knee, ankle and hip region. its effectiveness on upper limb especially in shoulder region yet to be studied. hence hypothesis of current study to investigate effects of tissue flossing on pain, range and functional outcomes in frozen shoulder patients. 
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