| CTRI Number |
CTRI/2024/12/078642 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| 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
|
Foot massager machine for pain and function in plantar fasciitis patients |
|
Scientific Title of Study
|
Effect of mechanical foot massager on pain and function in individuals with plantar fascitis: A pilot randomised control 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 |
Apeksha C Gore |
| Designation |
Post graduate |
| Affiliation |
kaher Institute of physiotherapy , belgavi |
| Address |
Room no. 18, OPD no. 18, G-1 Floor, DEPARTMENT OF ORTHOPEDIC PHYSIOTHERAPY, KLES DR PRABHAKAR KORE HOSPITAL, NEHRU NAGAR, BELAGAVI, INDIA
ROOM no. 18, OPD no. 18, G-1 Floor, DEPARTMENT OF ORTHOPEDIC PHYSIOTHERAPY, KLES DR PRABHAKAR KORE HOSPITAL, NEHRU NAGAR, BELAGAVI, 590010 INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
8433896665 |
| Fax |
|
| Email |
drapekshagore@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Aarti Welling |
| Designation |
Associate Professor |
| Affiliation |
kaher Institute of physiotherapy, belgavi |
| Address |
DEPARTMENT OF ORTHOAPEDIC PHYSIOTHERAPY OPD NO 18, ADVANCED PHYSIOTHERAPY CENTRE,KLES DR PRABHAKAR KORE HOSPITAL AND MRC, NEHRU NAGAR, BELGAVI, INDIA
DEPARTMENT OF ORTHOPEDIC PHYSIOTHERAPY OPD NO 18, ADVANCED PHYSIOTHERAPY CENTRE, KLES DR PRABHAKAR KORE HOSPITAL AND MRC, NEHRU NAGAR, BELAGAVI, INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwelling@klekipt.edu.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Aarti Welling |
| Designation |
Associate Professor |
| Affiliation |
kaher Institute of physiotherapy, belgavi |
| Address |
Room no. 18, OPD no. 18, G-1 Floor, DEPARTMENT OF ORTHOPEDIC PHYSIOTHERAPY, KLES DR PRABHAKAR KORE HOSPITAL, NEHRU NAGAR, BELAGAVI, INDIA
Room no. 18, OPD no. 18, G-1 Floor, DEPARTMENT OF ORTHOPEDIC PHYSIOTHERAPY, KLES DR PRABHAKAR KORE HOSPITAL, NEHRU NAGAR, BELAGAVI, INDIA
Belgaum
KARNATAKA
590010
India |
| Phone |
9448814569 |
| Fax |
|
| Email |
aartiwelling@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of physiotherapy, Nehru Nagar, Belagavi, Karnataka 590010 |
|
Primary Sponsor
Modification(s)
|
| Name |
Apeksha C Gore |
| Address |
KLES Dr.Prabhakar
Kore Hospital and MRC, Advanced Physiotherapy Center, Orthopaedic Department, Room No. 18 Nehru Nagar, Belagavi 590010 |
| 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 |
| dr Apeksha C Gore |
KLES DR PRABHAKAR KORE HOSPITAL |
KLES Dr Prabhakar Kore Hospital Advanced Physiotherapy Center Room no 39 Orthopaedic physiotherapy Department KLES Dr Prabhakar Kore Hospital and Medical Research centre, Nehru Nagar, 590010
Belgaum
KARNATAKA |
8433896665
drapekshagore@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kle academy of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Plantar fasciitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
Individuals will receive conventional therapy which includes exercises such as foot gym exercises and heel raises for 10 repetitions /3 sets and calf stretch and towel stretch for 30 seconds hold. |
| Intervention |
Mechanical foot massager |
Individuals will receive mechanical foot massager and exercises for 5 sessions over a period of 2 weeks.The participant will be instructed to sit in a comfortable chair with the feet aligned to the mechanical foot massage.
The therapist will select the mode using control panel and adjust the speed and intensity as needed. Then the therapist will be instructing the participant to place the ankle and foot in the air compression bags.
Ensuring both the feet are properly positioned for a balanced massage. The mechanical foot massager will be set up for 15 minutes per session and automatically turns off after the set duration. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All gender subjects aged between 35 to 65 years of age.
Participants with a confirmatory diagnosis of plantar fasciitis by performing windlass test .
Individuals with BMI range of 18.5 - 24.9 .
Willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Individuals with diabetic neuropathy , foot infections , foot ulcers, pregnancy and vascular disorders.
Individuals with a history of foot tumors, , arthritis and impaired circulation to lower extremity.
Allergic reactions or skin conditions to the foot and ankle .
Individuals with the intake of corticosteroids in the treatment of plantar fasciitis. Features of vascular involvement like pallor, cyanosis and edema.
Individuals with a psychiatric and cognitive disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale |
Pain/Numeric Pain Rating Scale will be assessed PRE and POST after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Foot function/Foot Function Index |
Before the treatment, pre -assessment will be taken and after the treatment, post assessment will be done. |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/01/2025 |
| Date of Study Completion (India) |
18/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title: Effect of Mechanical foot massager on pain and function in individuals with plantar fasciitis: pilot randomised controlled trial. This study helps to understand the effectiveness of using a mechanical foot massager for managing pain and improving function in individuals with plantar fasciitis.Participants will be divided into experimental and control groups, with the experimental group receiving foot massager therapy. A pre -assessment and post assessment will be done before and after the treatment protocol. |