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CTRI Number  CTRI/2026/03/105439 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 05/03/2026
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   Exercise and Pain Education to Reduce Pain and Improve Shoulder Movement in People with Frozen Shoulder and Type 2 Diabetes 
Scientific Title of Study   Effectiveness of Multimodal Physiotherapy Combined with Pain Neuroscience Education on Pain Disability and Quality of Life in Type 2 Diabetes Mellitus Patients with Frozen Shoulder 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  Dr Shivani Patil 
Designation  Assistant Professor, PhD Scholar 
Affiliation  KLE College of Physiotherapy 
Address  KLE college of physiotherapy Hubballi
KLE Hospital and Medical Research Centre, Gabbur Cross Hubballi
Dharwad
KARNATAKA
580028
India 
Phone  8369721874  
Fax    
Email  drshivanip24@kledeemeduniversity.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashant Mukkannavar 
Designation  Principal, Professor and HOD Orthopedic Physiotherapy 
Affiliation  KLE College of Physiotherapy Hubballi. 
Address  KLE college of physiotherapy Hubballi KLE Hospital and Medical Research Centre, Gabbur Cross Hubballi

Dharwad
KARNATAKA
580028
India 
Phone  9448231520  
Fax    
Email  drprashantm@kledeemeduniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Prashant Mukkannavar 
Designation  Principal, Professor and HOD Orthopedic Physiotherapy 
Affiliation  KLE College of Physiotherapy Hubballi. 
Address  KLE college of physiotherapy Hubballi KLE Hospital and Medical Research Centre, Gabbur Cross Hubballi

Dharwad
KARNATAKA
580028
India 
Phone  9448231520  
Fax    
Email  drprashantm@kledeemeduniversity.edu.in  
 
Source of Monetary or Material Support  
KLE Hospital and Medical Research Centre near Gabbur Hubballi 580028 Karnataka India 
 
Primary Sponsor  
Name  Dr Shivani Patil 
Address  KLE College of Physiotherapy, Hubballi 580028 
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 Shivani Patil  KLE Physiotherapy OPD  KLE Hospital and Medical Research Centre Department of Neurophysiotherapy OPD Number 1 Gabbur Hubballi 5800028
Dharwad
KARNATAKA 		 8369721874

drshivanip24@kledeemeduniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethical Committee KLE Institute of Dental Sciences, Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Patient Education Group  Conventional Education Group: The therapist will deliver the education intervention to participants in the conventional education group. Participants in this group will receive Conventional Patient Education, Graded Motor Imagery, Portable Transcutaneous Electrical Nerve Stimulation, Mulligan Mobilization, and structured shoulder exercises. The intervention will be delivered three days per week with a total duration of 60 minutes per session in the outpatient department. The face to face intervention will be provided for six weeks resulting in a total of 18 supervised sessions. During the seventh and eighth weeks, a non face to face home program will be continued. Participants will be provided with educational booklets and video links related to shoulder exercises for home practice. Total duration of intervention Eight weeks including six weeks of supervised treatment and two weeks of home based program. 
Intervention  Pain neuroscience education (PNE)  Pain Neuroscience Education PNE The therapist will deliver the pain education intervention to participants in the PNE group. Participants in this group will receive Pain Neuroscience Patient Education, Graded Motor Imagery, Portable Transcutaneous Electrical Nerve Stimulation, Mulligan Mobilization, and structured shoulder exercises. The intervention will be delivered three days per week with a total duration of 60 minutes per session in the outpatient department. The face to face intervention will be provided for six weeks resulting in a total of 18 supervised sessions. During the seventh and eighth weeks, a non face to face home program will be continued. Participants will receive educational booklets and video links related to Pain Neuroscience Education and shoulder exercises for home practice. Total duration of intervention Eight weeks including six weeks of supervised treatment and two weeks of home based program. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Participant provides written informed consent and agrees to voluntary participation in the study.

Male and female participants aged 18 to 70 years.

Medically diagnosed with Type 2 Diabetes Mellitus.

Diagnosed with Frozen Shoulder also known as Adhesive Capsulitis based on the following:

Shoulder pain of at least 3 centimeters on the Visual Analog Scale at rest or during activity for more than three months.

Restriction in both active and passive shoulder range of motion.

Normal shoulder radiographs.

Individuals in Phase One or Phase Two of Frozen Shoulder.

Vividness of Visual Imagery Questionnaire score between 16 and 48. 
 
ExclusionCriteria 
Details  Patients presenting with shoulder dislocation, arthritis, fracture, avascular necrosis, or osteoporosis.

History of surgery involving the neck or affected shoulder.

Participants who have undergone any treatment such as corticosteroid injection in the shoulder or physiotherapy within the past one year.

Douleur Neuropathique Four Questionnaire score of four or more.

History of stroke or other neurological disorders affecting upper limb function.

Participants with impaired sensation who may be unable to provide appropriate feedback regarding Transcutaneous Electrical Nerve Stimulation intensity.

Participants with pacemaker or epilepsy, as these are contraindications for Transcutaneous Electrical Nerve Stimulation.

Severe cardiac or respiratory illness that may interfere with physical activity.

Diagnosed psychiatric illness or cognitive impairment that may interfere with study participation. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. The Visual Analog Scale (VAS)
2.Short-Form 36-Item Health Survey (SF-36)
3. The Shoulder Pain and Disability Index (SPADI) 		 Baseline,6 weeks, 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Tampa Scale of Kinesiophobia (TSK)
The Pain Catastrophizing Scale (PCS)
Universal Goniometer 		 Baseline,6 weeks, 8 weeks 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   31/03/2026 
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="5"
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  

This randomized controlled trial aims to evaluate the effectiveness of multimodal physiotherapy combined with pain neuroscience education in patients with Type 2 Diabetes Mellitus having frozen shoulder. The study will compare this combined intervention with standard physiotherapy to determine its effect on pain reduction, functional disability, and quality of life. The findings may help identify an improved rehabilitation approach for managing diabetes-associated frozen shoulder.

 
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