| CTRI Number |
CTRI/2024/09/073564 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| 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
|
Rehabilitation protocols after surgey among patients of shoulder injury |
|
Scientific Title of Study
|
Comparative Effect of different Rehabilitation protocols among patients of Large to Massive Rotator Cuff Arthroscopic Repair involving Subscapularis tendon tear: A Randomized Contolled 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 |
Ajit Kumar |
| Designation |
Senior Physiotherapist |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Physical Rehabiltation and Medicine PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9781717579 |
| Fax |
|
| Email |
kumar_ajit4004@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Kumar Chouhan |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Orthopaedics
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8360057338 |
| Fax |
|
| Email |
drdevnim@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajit Kumar |
| Designation |
Senior Physiotherapist |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Physical Rehabiltation and Medicine PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9781717579 |
| Fax |
|
| Email |
kumar_ajit4004@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PGIMER Chandigarh 160012 INDIA |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research, Sector 12 , Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Devendra Kumar Chouhan |
PGIMER Chandigarh |
Department of Orthopedics
PGIMER Chandigarh 160012 INDIA
Chandigarh
CHANDIGARH |
8360057338
drdevnim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER,CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Delayed mobilization group |
In intervention Group 2 active assisted exercises will be started at 12 weeks post op and active exercises will be done at 16 weeks |
| Intervention |
early mobilization group |
In the early mobilization group pendulum exercises and passive forward arm flexion will start on the first postoperative day and in the delayed mobilization group, after 6 weeks postop In intervention Group-1, active assisted exercises will start at 2 weeks post-op and active exercises will be done at 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving informed consent
Age between 18 to 70 years
Recent MRI findings and clinical tests suggestive of large to massive rotator cuff tear with involvement of Subscapularis muscle
Rotator tears amenable to arthroscopic repair
|
|
| ExclusionCriteria |
| Details |
Small to medium size tear size 1 to 3 cm
Previous history of shoulder surgery infection and rotator cuff arthropathy
Open rotator cuff repair
Glenohumeral arthritis and inflammatory arthritis
SLAP lesion Bankart lesion Shoulder instability
Patients with grade 4 and 5 of Hamada classification based on AHI
Irreparable rotator cuff tear Atrophy
Occupation ratio
retraction
Patte classification
fatty infiltration grade 3 and grade 4 of rotator cuff muscles based on Goutallier classification
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional parameter in the terms of ROM ADL Pain Strength in the study population in early and delayed group and their correlation |
At 2 weeks 4 weeks 6 weeks 3 months 4 months 5 months 6 months 9 months and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiological parameters quality of life and physiological morbidity in the terms of retear sleep pattern anxiety and depression in the study population in early and delayed group and their correlation Proportion of subscapularis tear among cases of large to massive rotator cuff tear prevalence of functional limitation psychological morbidity social functioning deficits and night pain severity in the study population and their improvement after rehabilitation |
At 2 weeks 4 weeks 6 weeks 3 months 4 months 5 months 6 months 9 months and 12 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/09/2024 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
The present parallel group RCT will be conducted in the Department of
Orthopedics and Department of Physical Rehabilitation and Medicine at PGIMER
Chandigarh with the following OBJECTIVE -
To
compare the functional parameters among patients of arthroscopic repair of
large to massive rotator cuff involving subscapularis tear in early
mobilization and delayed mobilization group vs the patients without
subscapularis involvement.
All
enrolled patients will undergo arthroscopic repair for large to massive rotator
cuff tear by an Orthopaedics surgeon of PGIMER Chandigarh. After arthroscopic confirmation, the
patients with involvement of subscapularis, will be randomized into two groups,
Early mobilization group (Intervention-1) and Delayed mobilization group
(Intervention-2) i.e. after surgical procedure. The randomization will be done
by simple randomization techniques by nursing officer working in the
Orthopaedics ward. After arthroscopic repair, these patients will go for
rehabilitation protocol (early and delayed rehabilitation protocol). The patients without subscapularis involvement will be
provided routine care in the hospital. They will also be kept under
observation.
All the patients will
be assessed for clinical outcome score measurement. All
above mentioned patients will go for arthroscopic repair and post operative
rehabilitation after CTRI registration and Ethical approval from Institute
Ethical Committee, PGIMER, Chandigarh.
The
participants, intervention, comparator and outcome variable (PICO) are
described as follows:
PICO
Statement of the trial
P
(Participant) = Patients of arthroscopic repair of large to massive rotator
cuff involving the subscapularis tear.
I
(Intervention) = early mobilization group; allocation ratio 1:1
C
(Comparator) = Delayed mobilization group |