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CTRI Number  CTRI/2025/01/079105 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
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 physiotherapy in management of Frozen shoulder 
Scientific Title of Study   Comparison between Mulligan Mobilization and Scapular Mobilization versus Spencer Muscle Energy Technique and IASTM in the management of Frozen shoulder. 
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 Ayushi Jaiswal 
Designation  Research Scholar 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar Uttar Pradesh India

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  8708608881  
Fax    
Email  ayushijaiswal182@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjib Kumar Das 
Designation  Associate Professor 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar PIN 201313 Uttar Pradesh India

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  8879485847  
Fax    
Email  skdas@amity.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sanjib Kumar Das 
Designation  Associate Professor 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar PIN 201313 Uttar Pradesh India

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  8879485847  
Fax    
Email  skdas@amity.edu  
 
Source of Monetary or Material Support  
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh 201313 India 
 
Primary Sponsor  
Name  Ayushi Jaiswal 
Address  Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar Uttar Pradesh India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sanjib Kumar Das  Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar Uttar Pradesh India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ayushi Jaiswal  Amity Institute of Health Allied Sciences  Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH 		 8708608881

ayushijaiswal182@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional NTCC Committee Amity Institute of Health Allied Sciences Amity University Noida Uttar Pradesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mulligan mobilization with Scapular Mobilization  Mulligan Mobilization Techniques Mulligan mobilization involves the therapist passively controlling the accessory while the patient actively moves the arm in a painfree range. Improving Shoulder Movements Flexion The therapist stabilizes the scapula and clavicle while distracting the humerus laterally with a belt. The patient performs active flexion and applies passive overpressure at the end range. Internal and External Rotation The patient elbow and shoulder are in 90 degree flexion. The therapist uses a belt for lateral distraction and stabilizes the humerus. The patient actively moves and applies passive overpressure. Abduction A belt around the humeral head maintains glide. The therapist applies counterpressure to the scapula as the patient actively abducts their shoulder. Dosage Repetitions 3 sets of 10 Rest 1 minute between sets Frequency 3 times a week for 4 weeks Scapular Mobilization Scapular mobilization improves mobility relieves pain and restores function. Procedure Patient Position Lying on the unaffected side. Therapist Position In front of the patient hands on the scapula medial and superior borders. Movements Superior and Inferior Glide Rotation upward and downward Distraction using ulnar fingers under the scapula medial border. Dosage Repetitions 3 sets of 10 Rest 1 minute between sets Frequency 3 times a week for 4 weeks  
Comparator Agent  Spencer Muscle energy technique with IASTM  The Spencer Muscle Energy Technique (MET) is a structured approach to improve shoulder mobility and reduce pain. The patient lies on their unaffected side with the treated shoulder on top. The therapist stabilizes the superior shoulder girdle while performing the techniques seven steps Shoulder Extension with Elbow Flexion The therapist moves the patient arm into extension to the restricted barrier with a flexed elbow. Shoulder Flexion The arm is moved anteriorly into flexion, reaching the restricted barrier. Compression and Circumduction At 90 degree abduction the arm is rotated in small circles under compressive stress. Distraction and Circumduction With the arm at 90 degree abduction the therapist applies traction while rotating the arm in small circles. Abduction with Internal Rotation The patients hand rests on the therapist forearm performing abduction and internal rotation. The therapist rotates the elbow anteriorly with the hand dorsum behind the hip. Adduction and External Rotation The therapist guides the patient arm into adduction and external rotation with a flexed elbow. Tissue Pumping and Stretching The arm is extended with the hand on the therapist shoulder. The therapist stretches the deltoid. Dosage Repetitions 3 sets of 10 Rest 1 minute between sets Frequency 3 times per week for 4 weeks. IASTM enhances tissue flexibility reduces stiffness by breaking down scar tissue and adhesions improves circulation and promotes tissue healing. Dosimetry Frequency 3 times per week Duration: 5 to 15 minutes per session Sessions 3 times a week for 4 weeksIntensity Moderate pressure until mild redness (erythema) appears. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Individuals with (Grade 2) Frozen shoulder diagnosed by orthopaedic or clinically diagnosed by therapist.
2.Individuals between the age range of 40 -60 years
3.Both genders - male and female
4.Employed or Unemployed
5.Individuals presenting symptoms present for more than 3 months and restricted movements in ADLs.
6.Individuals whose onset of pathology is unknown or by metabolic disease (diabetes) will also be included
 
 
ExclusionCriteria 
Details  1. Any type of surgical history
2. Cancer
3. Pregnancy
4. Vertebral fracture
5. Nerve root irritation
6. Rotator cuff rupture
7. Open wound or skin infection
8. Shoulder Osteoarthritis
9. Any cognitive or neuromuscular disorder
10. History of trauma and fall

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain
Range of motion
Level of Functional disability
 		 Baseline Assessment Before intervention.
Follow up Assessment every 2 weeks
Post intervention after 4th week
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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   Phase 3 
Date of First Enrollment (India)   31/01/2025 
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="0"
Months="4"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ayushijaiswal182@gmail.com].

  6. For how long will this data be available start date provided 12-06-2025 and end date provided 11-05-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Need of study: 
This study is needed to address the existing gaps in knowledge regarding the most effective manual therapy techniques for treating frozen shoulder. By comparing Mulligan mobilization along with scapular mobilization and Spencer MET along with IASTM, the research will provide valuable insights into the best treatment combinations for improving range of motion, pain management, and functional independence. Ultimately, this could lead to more evidence-based and patient-centered interventions for individuals suffering from frozen shoulder

Aim: 
The study aims to evaluate and compare the impact of Mulligan mobilization and Spencer Muscle Energy Technique on pain reduction, functional improvement, and quality of life. 

Objectives:

1.   To compare the pain relief outcomes between Spencer MET and Mulligan mobilization in frozen shoulder.    2.  To evaluate the effect of Mulligan mobilization in improving shoulder Range of motion and QOL in frozen shoulder.      
3. To evaluate the effect of Spencer muscle energy in improving Range of motion and QOL in frozen shoulder. 

Hypothesis:

Null hypothesis:    
Ho1- There is no significant effect of Mulligan mobilization and Scapular Mobilization in improving shoulder Range of motion and QOL in frozen shoulder.

Ho2 – There is no significant effect of Spencer Muscle Energy Technique and IASTM in improving shoulder Range of motion and QOL in frozen shoulder.        

Alternate hypothesis:    
H11- There is significant effect of Mulligan mobilization and Scapular Mobilization in improving shoulder Range of motion and QOL in frozen shoulder.  
H12 – There is significant effect of Spencer Muscle Energy Technique and IASTM in improving shoulder Range of motion and QOL in frozen shoulder.     

      

 
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