| CTRI Number |
CTRI/2018/01/011127 [Registered on: 04/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Rehabilitation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to compare the final effects after 3 months between two groups of patients with Axial Spondyloarthritis,of which one group will be undergone Supervised Rehabilitation Programme,another group will be undergone therapeutic Home Exercise Progamme. |
|
Scientific Title of Study
|
A study to assess the effects of Supervised Rehabilitation Programme in Patients of Axial Spondyloarthritis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ARUPRATAN GHOSH |
| Designation |
TUTOR |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
Department of Physical Medicine and Rehabilitation,
Nilratan Sircar Medical College and Hospital,
138,A.J.C.Bose Road,Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
9830193132 |
| Fax |
|
| Email |
drarupratan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ARUPRATAN GHOSH |
| Designation |
TUTOR |
| Affiliation |
Nilratan Sircar Medical College |
| Address |
Department of Physical Medicine and Rehabilitation,
Nilratan Sircar Medical College and Hospital,
138,A.J.C.Bose Road,Kolkata
Kolkata
WEST BENGAL
700014
India |
| Phone |
9830193132 |
| Fax |
|
| Email |
drarupratan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Pankaj Kumar Mandal |
| Designation |
Professor and Head of the Department.Department of PMR,R.G.Kar MC |
| Affiliation |
R.G.Kar Medical College |
| Address |
Department of Physical Medicine and Rehabilitaton,
R.G.Kar Medical College,
1,Khudiram Bose Sarani,
Kolkata
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433915696 |
| Fax |
|
| Email |
drpkmpmr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| R.G.Kar Medical College and Hospital.
1,Khudiram Bose Sarani,
Kolkata-700004,West Bengal. |
|
|
Primary Sponsor
|
| Name |
Dr ARUPRATAN GHOSH |
| Address |
Currently;
Department of Physical Medicine and Rehabilitation.
Nilratan Sircar Medical College and hospital,
138,A.J.C.Bose Road,Kolkata-700014.
Previously;
Department of Physical Medicine and Rehabilitation,
R.G.Kar Medical College and Hospital,
1,Khudiram Bose Sarani
kolkata-700004 |
| Type of Sponsor |
Other [] |
|
|
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 ARUPRATAN GHOSH |
R.G.Kar Medical College and Hospital |
Department of Physical Medicine and Rehabilitation,
R.G.Kar Medical College and Hospital,
1,Khudiram Bose Sarani,
Kolkata-700004
Kolkata
WEST BENGAL |
9830193132
drarupratan@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R.G.Kar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Axial Spondyloarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Home Exercise Programme |
Multimodal Exercise Programme demonstrated monthly for 3 months ,
Lifestyle modification advises monthly for 3 months,
counseling monthly for 3 months,
environmental modification advises monthlyfor 3 months,
joint protection advises monthly for 3 months,
Energy conservation advises monthly for 3 months.
Physical Modalities for Pain management in Out patient basis as required for 3 months. |
| Intervention |
Supervised Rehabilitation Programme |
Supervised Multimodal Exercises thrice weekly for 3 months,
aggressive Lifestyle Modification with regular supervision thrice weekly for 3 months,
Group therapy classes thrice weekly for 3 months,
Counseling weekly for 3 months,
supervised Joint protection Technique weekly for 3 months,
Supervised Energy Conservation Technique weekly for 3 months,
active Environmental modification weekly for 3 months,
Cognitive Behavioral Therapy for pain management weekly follow up session for 3 months,
Physical modalities for Pain management as required for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling ASAS critria for Axial Spondyloarthritis. |
|
| ExclusionCriteria |
| Details |
1.Active non-inflammamatory Spinal Disease.
2.Pregnancy.
3.Hip and Knee deformity.
4.Past history of Orthopedic Surgery on Axial Skeleton and peripheral joints.
5.Psychiatric illness.
6.Hypertension.
7.Diabetes.
8.Past or present history of Tuberculosis.
9.patients on Biologic drugs for any ailment since last 1 year. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Physical function.
2.Spinal pain.
3.Spinal Mobility.
4.Patient Global assessment.
5.Stiffness.
6.Fatigue.
7.Disease activity. |
1.Physical function at 3 months.
2.Spinal pain at 3 months.
3.Spinal Mobility at 3 months.
4.Patient Global assessment at 3 months.
5.Stiffness at 3 months.
6.Fatigue at 3 months.
7.Disease activity at 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/09/2014 |
| Date of Study Completion (India) |
15/07/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/07/2015 |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Submitted at West Bengal University of Health Sciences,DD-36,Sector-1,Salt Lake,Kolkata-700064, as MD Thesis on November 2015. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study was a concurrent parallel Randomised Controlled Trial comparing the effects of a 3 month Supervised Rehabilitation Programme as intervention with Home exercise Programme as control in patients with Axial Spondyloarthritis conducted at R.G.Kar Medical College,Kolkata.
The Study outcomes were assessed by changes in Physical Function,Spinal Pain,Spinal Mobility,Spinal Stiffness,Patient Global Assessment,Fatigue and Disease activities before and after 3 months in both groups to determine the effects of supervised rehabilitation Programme in intervention group over the Home exercise Programme in control group.
|