| CTRI Number |
CTRI/2024/03/064876 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| 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
|
Exploring the impact of mindfulness training in physiotherapy on pain, function and mindfulness in recreational long distance runners with patellofemoral pain syndrome |
|
Scientific Title of Study
|
Effect of mindfulness training in adjunct to conventional physiotherapy on pain, function and mindfulness attention awareness score in recreational long distance runners with patellofemoral pain syndrome: a randomized controlled 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 |
Dr Chaitali S Vikhe |
| Designation |
junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Sports Physiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(Deemed to be University),Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
8956738572 |
| Fax |
|
| Email |
chaitalivikhe619@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil U Ramteke |
| Designation |
Professor, Department of Sports Physiotherapy |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Sports Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(Deemed to be University),Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
7619941787 |
| Fax |
|
| Email |
swapnil123.com@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnil U Ramteke |
| Designation |
Professor, Department of Sports Physiotherapy |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Sports Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(Deemed to be University),Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
7619941787 |
| Fax |
|
| Email |
swapnil123.com@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (Deemed to be university), Sawangi (Meghe), Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department of Sports Physiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(Deemed to be University),Sawangi (Meghe) |
| 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 Chaitali S Vikhe |
Acharya Vinoba Bhave Rural Hospital |
Department of Sports Physiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(Deemed to be University),Sawangi (Meghe)
Wardha
MAHARASHTRA |
8956738572
chaitalivikhe619@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Physiotherapy |
The conventional treatment regimen for patellofemoral pain syndrome involves strengthening exercises for the hip adductors and lateral rotators, closed kinetic chain exercises like terminal knee extension, wall squats, leg press, and step-up exercises, stretching for the hamstrings, gastrocnemius-soleus complex, and iliotibial band, functional proprioceptive exercises on a tilt board, and McConnell patellar taping applied for three sessions over four weeks |
| Comparator Agent |
Mindfulness Training In Adjunct To Conventional Physiotherapy |
It includes strengthening, closed kinetic chain exercises, stretching, and McConnell patellar taping, while mindfulness training includes sitting meditation, body scan meditation, yoga exercises, walking meditation, and special sports meditation, with sessions lasting 30 minutes each conducted once weekly |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Long-distance running for more than half a year and having pain lasting longer than one month
Retro patellar knee pain, peripatellar or anterior on the following activity stair climbing, squatting, running.
Anterior knee pain non-traumatic
genu valgus
|
|
| ExclusionCriteria |
| Details |
Any pain following to Trauma
Laxity of articular ligament or meniscus injury of the knee,
Pressure pain foot tendon and patellar ligament,
Any history of dislocation of the patella or Recent fracture,
Effusion in the knee joint Any history of dislocation of patella or Recent fracture, Chondromalacia patella,
cardiovascular or osteoporosis deficits,
Any progressive neurological conditions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (NPRS),Mindfulness Attention Awareness Scale (MAAS)
|
Outcome will be taken at baseline baseline and at the end of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Knee Injury and Osteoarthritis Outcome Score (KOOS),Knee joint position sense by using goniometer
|
Outcome will be taken at baseline baseline and at the end of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/04/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To evaluate the effects of the interventions on functional outcomes, including improvements in pain (Numeric Pain Rating Scale), function (Knee Injury and Osteoarthritis Outcome Score), psychological well-being (Mindfulness Attention Awareness Scale), and overall physical function. To compare the Effect Of Mindfulness Training In adjuncts alone with Conventional Physiotherapy in recreational long-distance runners with patellofemoral pain syndrome. |