| CTRI Number |
CTRI/2022/10/046649 [Registered on: 20/10/2022] Trial Registered Prospectively |
| Last Modified On: |
12/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Combined Effect Of Education On Pain And Movement With Mobilization Technique In Individuals with knee Arthritis. |
|
Scientific Title of Study
|
Combined Effect Of Movement With Mobilization And Pain Neuroscience Education In Knee Osteoarthritis - A Randomised Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhura Shah |
| Designation |
PG Student |
| Affiliation |
KLE Institute Of Physiotherapy. |
| Address |
Gourishankar, no 424 , shivbasavanagar , near KPTCL hall, Belgaum
Belgaum
KARNATAKA
590001
India |
| Phone |
8329886133 |
| Fax |
|
| Email |
madhurashah22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anand Heggannavar |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute Of Physiotherapy. |
| Address |
KAHER Institute Of Physiotherapy , Orthopaedic Manual Therapy Department, JNMC Campus, Nehru Nagar, Belgum
Belgaum
KARNATAKA
590010
India |
| Phone |
994528296 |
| Fax |
|
| Email |
anandheggannavar@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anand Heggannavar |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute Of Physiotherapy. |
| Address |
KAHER Institute Of Physiotherapy , Orthopaedic Manual Therapy Department, JNMC Campus, Nehru Nagar, Belgum
KARNATAKA
590010
India |
| Phone |
994528296 |
| Fax |
|
| Email |
anandheggannavar@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Dr.Prabhakar Kore Hospital And Research Centre, Nehru Nagar ,Belgavi |
|
|
Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy , JNMC Campus, Nehru Nagar, Belgavi |
| 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 |
| Madhura Shah |
KAHER Institute Of Physiotherapy. |
KAHER Institute Of Physiotherapy, OPD 29 Orthopaedic Manual Therapy,Room 13 JNMC Campus, Nehru Nagar, Belgum
Belgaum
KARNATAKA |
8329886133
madhurashah22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Resarch And Ethical Committee KLEU Institute of Physiotherapy Belgavi |
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 |
| Intervention |
Movement with mobilization along with Pain Neuroscience Education group. |
Conventional Therapy Including TENS For 20 Min Along with Strengthening and Stretching Exercises And Movement With Mobilization.
Pain Neuroscience Education Will be Provided For 15 Min during Each Session. Total 6 sessions will be given 3 Sessions Per Week For 2 Weeks. |
| Comparator Agent |
Movement with mobilization group. |
Conventional Therapy Including TENS For 20 Min Along with Strengthening and Stretching Exercises And Movement With Mobilization will be given for 6 sessions. 3 Sessions Per Week For 2 Weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Symptoms Since Last 6 Months With Pain More Than 3 On Numerical Pain Rating Scale.
2.Individuals Classified As Grade 1,2 And 3 On Kellgren- Lawrence Grading For Osteoarthritis.
3.Radiologically Determined Osteoarthritis. |
|
| ExclusionCriteria |
| Details |
1.Previous Total Knee Replacement Surgery.
2.Pain In Knee Joint Referred From Another Region.
3.Any History Of Truma To Knee, Ligamentous Injuries.
4.Rheumatoid Arthritis.
5.Fracture Of Lower Extremity.
6.Terminal Illnesses. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale For Pain Assessment.
Central Sensitisation Inventory.
Pain Catastrophizing Scale.
Harris Mat Method For Measurement Of Plantar Pressure.
Timed Up And Go Test. |
Pre assessment will be taken on Day 1 and after 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
21/10/2022 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis Is Most Common Type Of Arthritis Which Commonly Affects The Knee. This Study Focuses On Combination Effect Of Movement With Mobilization And Pain Neuroscience Education Along With Conventional Physiotherapy On Pain, Functionality , Foot Pressure And Psychological Variables Such As Central Sensitisation And Pain Catastrophization In Individuals With Knee Osteoarthritis. |