| CTRI Number |
CTRI/2024/10/076033 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| 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
|
Effectiveness of Codmans Paradoxical Movements versus Capsular Stretching in Managing Adhesive Capsulitis |
|
Scientific Title of Study
|
Effect of Codmans Paradoxical Movement v/s Capsular Stretching in Patient with 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 |
Nitanshi Jain |
| Designation |
MPT student |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
GLAGOTIAS UNIVERSITY
room no. 228 , department of physiotherapy
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8810399613 |
| Fax |
|
| Email |
nitanshijain05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Taruna Verma |
| Designation |
Associate professor |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
Room no. 228 , department of physiotherapy Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7988151951 |
| Fax |
|
| Email |
drtarunaverma21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Taruna Verma |
| Designation |
Associate professor |
| Affiliation |
GALGOTIAS UNIVERSITY |
| Address |
Room no. 228 , department of physiotherapy Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7988151951 |
| Fax |
|
| Email |
drtarunaverma21@gmail.com |
|
|
Source of Monetary or Material Support
|
| GALGOTAIS UNIVERSITY
School of Allied and Health Science , Department of physiotherapy , E-003, Physiotherapy OPD ,Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
|
|
|
Primary Sponsor
|
| Name |
GALGOTIAS UNIVERSITY |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Taruna Verma PT |
Galgotias University |
School of Allied and Health Science , Department of physiotherapy , E-003, Physiotherapy OPD ,Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
7988151951
drtarunaverma21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Departmental 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 |
CAPSULAR STRETCHING |
anterior and posterior capsular stretching
5 repetitions , 30 second hold each time , 5 sets per session 5 days in a week for 3 weeks |
| Intervention |
CODMANS PARADOXICAL MOVEMENT |
Patient will be positioned in supine lying in a treatment couch with adequate exposure of the involved shoulder. His upper limb will be positioned parallel to trunk with palm facing medically and thumb pointing anteriorly, his arm will be elevated passively up to pain tolerable ROM in the plane of flexion (sagittal plane) and when the pain reaches maximum tolerable, the arm is abducted and descended in the frontal plane to place parallel to trunk with palm facing outward and thumb pointing posteriorly. This movement pattern will be repeated for 5 times per set,3 sets in a session, and 5 sessions in a week the intervention is done for 3 weeks and the assessment is done every week after the intervention |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Must have adhesive capsulitis
must have informed consent
middle aged group |
|
| ExclusionCriteria |
| Details |
Any neurological condition : cerebral palsy , stroke , DMD
Any major surgery : cervical spine , shoulder joint , elbow
Any Trauma within last 6 months : whiplash , RTA
Any Cardiac Condition : PTA , bypass surgery
Taking Medications : NSAIDs, Muscle Relaxant |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Range of Motion
2.Functional mobility
|
assessment day 0, followed every week. For 3 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.pain
|
assessment day 0, followed every week. For 3 weeks
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/11/2024 |
| 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="0"
Days="21" |
|
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
|
Frozen shoulder, sometimes referred to as adhesive capsulitis, is a disorder that impairs shoulder mobility and has a major negative impact on quality of life. It is more common (19%) among people with type II diabetes and affects 2% to 5% of the general population. The disorder impairs vital shoulder functions required for day-to-day tasks by limiting both active and passive range of motion. NSAIDs, or non-steroidal anti-inflammatory medicines, are common conservative therapies. Oral or intra-articular injections of glucocorticoids. Physical therapy has been shown to be successful in reducing pain and regaining range of motion. NSAIDs and physical therapy together have proven to be more effective than NSAIDs alone. Physical therapy is essential for rehabilitation, but there is little data on the specific application of Codman’s paradoxical motions in the treatment of adhesive capsulitis.Manipulation under anesthesia (MUA) with Codman’s paradox has been shown to reduce pain and improve function, but there is little evidence for non-anesthetic modeling of same movements. Shoulder stiffness can result from tightness in the intra-articular capsule or muscle-tendon units, or from adhesions in the shoulder’s range of motion areas. complete physical examination is necessary to determine the source of stiffness. Passive stretching routines have shown to be successful and can be included in at-home workout plans, helping to enhance joint flexibility and enhance external rotation. Stretching out tight soft tissues, in addition to the adherent capsule, could aid in the healing process for patients with chronic frozen shoulder. Further research is needed to explore the effectiveness of passive Codman’s paradoxical movements in conservative rehabilitation for adhesive capsulitis, particularly for patients unable to undergo more invasive treatments. A Randomized controlled trial study aim to analyze the effect of codmans paradoxical movement vs capsular stretching in patients with adhesive capsulitis |