| CTRI Number |
CTRI/2024/03/064616 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Pain Education along with Conventional Physiotherapy in Chronic Plantar Fasciitis |
|
Scientific Title of Study
|
Efficacy of Pain Neuroscience Education as an adjunct to Conventional Physiotherapy in patients with Chronic Plantar Fasciitis: A two group Pretest Posttest Experimental Design |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Kalra |
| Designation |
MPT student, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, |
| Affiliation |
MPT student, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, |
| Address |
Orthopedics lab, Ground floor, Room no 8, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana - Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7082123862 |
| Fax |
|
| Email |
riyakalra14oct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Goyal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana - Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu Goyal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana - Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Mullana - Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Riya Kalra |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana - Ambala, Haryana |
| 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 |
| Riya Kalra |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Orthopaedics Physiotherapy Lab, Ground floor, Room no 8
Ambala
HARYANA |
7082123862
riyakalra14oct@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, MMIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Conventional Physiotherapy will be given for 45 minutes for 2 sessions per week. |
| Intervention |
Pain Neuroscience Education (PNE) and Conventional Physiotherapy |
Under PNE, Participant will given education about the condition with the help of examples and metaphors. Conventional Physiotherapy for 45 minutes and PNE for 15 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having unilateral and bilateral chronic Plantar Fasciitis |
|
| ExclusionCriteria |
| Details |
Recent trauma and fracture at ankle and foot in the last 6 months
Any referred pain in the plantar aspect of foot
Impaired Cognition |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot and Ankle Disability Index(FADI)
Numeric Rating Scale(NRS)
Tampa Scale of Kinesiophobia (TSK) |
baseline, 3rd week and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain Catastrophizing Scale(PCS) |
Baseline, 3rd week, 6th week |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/04/2024 |
| 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="3"
Days="10" |
|
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
|
Participants who are willing to participate and suitable according to inclusion criteria will be recruited for the study. Participants will be divided into Experimental group and Control group. Experimental group will receive Pain Neuroscience Education along with Conventional Physiotherapy and Control group will receive Conventional Physiotherapy. Outcome measures will be taken at baseline and upon completion of the intervention after 6 weeks. |