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CTRI Number  CTRI/2025/05/087738 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 12/05/2025
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   Effect of customised shoulder movement on Functionality and Capsular Thickness in patients with Diabetic Frozen Shoulder. 
Scientific Title of Study   Efficacy of Mechanical Diagnosis and Treatment on Functionality and Capsular Thickness in Patients with Stage 2 Diabetic Adhesive Capsulitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sheena Arora 
Designation  PhD Student 
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  QG 08, Physiotherapy OPD, Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies

Faridabad
HARYANA
121004
India 
Phone  8820744801  
Fax    
Email  sheena.arora.81989@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Moattar Raza Rizvi 
Designation  Professor 
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  QG 08, Physiotherapy OPD, Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies

Faridabad
HARYANA
121004
India 
Phone  9312048470  
Fax    
Email  rajrizvi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sheena Arora 
Designation  PhD Student 
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  QG 08, Physiotherapy OPD, Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies

Faridabad
HARYANA
121004
India 
Phone  8820744801  
Fax    
Email  sheena.arora.81989@gmail.com  
 
Source of Monetary or Material Support  
Manav Rachna International Institute of Research and Studies, Manav Rachna Campus Road, Gadakhor Basti Village, Sector 43, Faridabad, Haryana - 121004, India 
 
Primary Sponsor  
Name  Manav Rachna International Institute of Research and Studies 
Address  Manav Rachna Campus Road, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004  
Type of Sponsor  Other [Private University] 
 
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 Sheena Arora  Manav Rachna International Institute of Research and Studies  QG 08, Physiotherapy OPD, Q-Block, Department of Physiotherapy, Manav Rachna International Institute of Research and Studies, Manav Rachna Campus Road, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004, India
Faridabad
HARYANA 
8820744801

sheena.arora.81989@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Committee  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 
Comparator Agent  Conventional Therapy  These include shoulder range of motion exercises and stretches that are usually given in the present condition. The total duration of supervised conventional intervention would be 2 weeks. The follow-up would be done at 6th week and 10th week. 
Intervention  Mechanical Diagnosis and Treatment  It is a type of therapy that is used to classify symptoms according to their presentation as given by "McKenzie" and treat them accordingly. The total duration of supervised intervention would be 2 weeks. The follow-up would be done at 6th week and 10th week. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed case of type 2 diabetes mellitus with atleast 12 months duration having glycosylated haemoglobin (HbA1c) values between 5.5 to 12 percentage treated by diet, oral hypoglycaemic agents or insulin therapy.

Stage 2 adhesive capsulitis symptoms for atleast three months with greater than 25 percent restriction in PROM of the shoulder for atleast two directions (shoulder-abduction, -flexion, internal and external rotation) compared to the opposite shoulder. 
 
ExclusionCriteria 
Details  Patients with secondary adhesive capsulitis (e.g. traumatic adhesive capsulitis)

Subject in inflammatory or chemical stage of adhesive capsulitis (If any 3 of following are present the participant would be excluded: VAS greater than 6, Night pain, redness, increased local temperature morning symptoms).

Inflammatory arthritis of the shoulder, polyarthritis, rheumatoid arthritis.

Bony deformity or pre-existing musculoskeletal disorders of the shoulder joint (rotator cuff injury, impingement disorder etc).

History of shoulder trauma (fractures or dislocations) or ligament injury for less than 6 months.

Weakness of shoulder girdle muscles associated with neurological deficits.

Injection to shoulder pain, invasive procedures or surgeries in the affected shoulder.

Cervical spondylosis or radiculopathy.

Uncontrolled comorbidities (moderate to severe anaemia, cardiovascular impairment, nephropathy etc) affecting the study outcomes.

Subjects with infections and coagulation disorders.

On medication for adhesive capsulitis. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Upper Extremity Functional Index

Range of Motion

Visual Analog Scale

Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

Capsular thickness and coracohumeral ligament (CHL) thickness

Standardized Quality of Life (QoL) Assessment through SF 36 
The outcome will be assessed at baseline, 2nd week, 6th week and 10th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   09/06/2025 
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  
Detailed demographic information, medical history, and baseline outcome measures will be collected from each participant to establish a comprehensive understanding of their condition. The participants in both with controlled (Group A1 and A2) and uncontrolled (Group B1 and B2) diabetic adhesive capsulitis groups will be assessed using the MDT assessment sheet. This will include history taking, observation of posture, range of motion testing, and repetitive movement testing and special tests. Groups A1 and B1, i.e., control groups 1 and 2, will be advised to follow exercise programs with conventional treatment (i.e. shoulder exercises, pamphlets will be given for the same) along with hot water fomentation as a home program. The participants in groups A2 and B2, i.e., experimental groups 1 and 2, will further be assessed according to the MDT approach.

Participants of all the groups would revisit the hospital to report changes the next day. The treatment would be modified if needed, or else he/she will be advised to continue until the symptoms diminish, i.e., pain and disability are decreased, and range of motion is increased. Pre-assessment and post-treatment outcome measures will be taken at 2 weeks to evaluate the effectiveness of the interventions. After completing the treatment, participants will be given a home exercise program for prophylaxis. Follow-up assessments will be conducted at 6 and 10 weeks, with outcome measures taken to evaluate the sustainability of treatment effects.
 
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