| 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
|
|
|
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
|
|
|
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. |