| CTRI Number |
CTRI/2020/03/023780 [Registered on: 05/03/2020] Trial Registered Prospectively |
| Last Modified On: |
29/02/2020 |
| 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
|
A comparative study to see the effect of Elastic band exercise and regular physical therapy programme on pain and disability in patient with knee osteoarthritis |
|
Scientific Title of Study
|
A comparative study to analyze the efficacy of theraband exercises and conventional physiotherapy protocol on pain and disability in patient with knee osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shabnam Joshi |
| Designation |
Assistant professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shabnam Joshi |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shabnam Joshi |
| Designation |
Assistant professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parvesh Arya Department of Physiotherapy
Guru Jambheshwar university of science and technology Hisar |
|
|
Primary Sponsor
|
| Name |
Parvesh Arya |
| Address |
Department of Physiotherapy
Guru Jambheshwar University of Science and Technology |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Parvesh Arya |
Guru Jambheshwar University of Science and Technology, Department of Physiotherapy |
Room no. 4 Ground floor Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA |
7988887406
parvesh234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group (B) |
Hotpack and isometric exercise will be given 3 session per week. Total duration- 4 weeks |
| Intervention |
Theraband exercise (A) |
Theraband exercise will be given 3 sessions per week. Total duration-4 weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient having primary osteoarthritis of knee (unilateral/bilateral) |
|
| ExclusionCriteria |
| Details |
Patient having trauma to lower extremity in the past,
Patient with neurological disorder,
Patient with severe cardiopulmonary disorder,
Patient with any musculoskeletal disorder except OA knee |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Knee Injury and Osteoarthritis Outcome Score
2. Visual Analogue Scale |
From baseline and after 4 weeks of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disability |
End of 1st, 2nd, 3rd, 4th week |
|
|
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)
|
09/03/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis (OA) is a chronic joint disorder
in which there is progressive softening and disintegration of articular
cartilage occurs. The term ‘Osteoarthritis’ was coined by John spendon. This
progressive degenerative diseases is known to affect various changes in
articular cartilage, bone, synovium, and joint capsule. It is the one of the
most common musculoskeletal disorder. It is characterized by pain, articular
cartilage deterioration and joint space narrowing and reduced muscle strength. The participants will be
selected according to the inclusion and exclusion criteria. The selected
participants will be evaluated by KOOS scale for disability and VAS for pain.
Two groups will be divided. One group will be given conventional therapy which
includes hotpack and isometric exercises and another group will be given
theraband exercises in different position which includes supine position, prone
and standing position, according to the strength of the patient. Different
types of resistance theraband will be used. Each patient will undergo 3 session per week and protocol will be of 4
weeks. |