| CTRI Number |
CTRI/2017/03/008073 [Registered on: 14/03/2017] Trial Registered Prospectively |
| Last Modified On: |
14/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study of the effects of a physiotherapy treatment technique known as Mulligan technique in people suffering from knee pain over a prolonged period, i.e, more than 3 months |
|
Scientific Title of Study
|
Immediate effects of Mulligan techniques on Pain and Functional mobility in individuals 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 |
Madhura Bhagat |
| Designation |
Physiotherapy Postgraduate Student (MPT) |
| Affiliation |
SOAHS, Manipal |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9071589663 |
| Fax |
|
| Email |
madhura.bhagat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranganath Gangavelli |
| Designation |
Associate Professor |
| Affiliation |
SOAHS Manipal |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9844372252 |
| Fax |
|
| Email |
ranganath.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Anupama Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
SOAHS Manipal |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
anupama.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Madhura Bhagat,Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal- 576104 |
|
|
Primary Sponsor
|
| Name |
Madhura Bhagat |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Mnanipal |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Madhura Bhagat |
Kasturba Hospital |
Department of Physiotherapy, Manipal University, Manipal, Udupi - 576104
Udupi
KARNATAKA |
9071589663
madhura.bhagat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Knee Osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulligan Techniques |
Mulligan technique involves "glides"or forces delivered by a physiotherapist, causing accessory joint movements, while the subject performs active movement. |
| Comparator Agent |
Sham technique/ Placebo |
Hand placement mimicking the treatment technique without actually delivering the gliding force |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Radiologically diagnosed degenerative tibiofemoral osteoarthritis with bilateral involvement, grades 1 to 3 according to the Kellgren and Lawrence classification
2.Duration of the condition: >3 months
|
|
| ExclusionCriteria |
| Details |
1. Systemic or Local Infection
2. Osteoarthritis secondary to rheumatoid and other inflammatory and autoimmune conditions
3. Acute trauma and fractures
4, Difficulties in comprehension
5. Patellofemoral pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale |
Immediate pre and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up and Go test |
Immediate pre and post intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/03/2017 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study aims to investigate the immediate effects of Mulligan techniques on pain and functional mobility in individuals with knee osteoarthritis. Mulligan technique is a manual therapy technique which involves the physiotherapist administering a force causing accessory joint movements, called gliding force, and the manouvre is called a glide, while the participant actively performs the offending movement. The primary outcome measure will be pain score on Numerical Pain rating scale and the secondary outcome measure will be time taken to complete the Timed Up and Go test. This randomized, parallel group design placebo controlled trial will be conducted in a single centre, where 30 participants will be randomized in two groups of 15 members each, the experimental group receiving Mulligan technique and the control group receiving placebo which involves a mere hand placement mimicking the glide without an actual gliding force. Pre and post intervention outcome measures will be recorded after obtaining informed consent from eligible subjects, and both group members will receive conventional physiotherapy treatment post data collection. |