| CTRI Number |
CTRI/2025/07/090346 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| 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
|
Effect of Physiotherapy techniques on pain foot functions and quality of life in middle aged heel patients |
|
Scientific Title of Study
|
Efficacy of Combined Physiotherapy Approaches on Pain Pressure Threshold Foot Functions and Quality of life in middle aged patients with Plantar Fasciitis- A Randomised 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 |
Bhumika Arora |
| Designation |
Ph.D. scholar |
| Affiliation |
|
| Address |
Room no E003 Department of Physiotherapy Galgotias University Sec 17A Noida Expressway Gautam Buddha Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711055066 |
| Fax |
|
| Email |
bhumikaarora210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Reddy Vajrala |
| Designation |
|
| Affiliation |
|
| Address |
Room no E003 Department of Physiotherapy Galgotias University Sec 17A Noida Expressway Gautam Buddha Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
|
| Fax |
|
| Email |
krishnareddympt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhumika Arora |
| Designation |
Ph.D. scholar |
| Affiliation |
|
| Address |
Room no E003 Department of Physiotherapy Galgotias University Sec 17A Noida Expressway Gautam Buddha Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711055066 |
| Fax |
|
| Email |
bhumikaarora210@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no E003 Department of Physiotherapy Galgotias University Sec 17A Noida Expressway Gautam Buddha Nagar Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Room no E003 Department of Physiotherapy Galgotias University Sec 17A Noida Expressway Gautam Buddha Nagar Uttar Pradesh |
| Type of Sponsor |
Research institution |
|
|
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 Bhumika Arora |
Galgotias University |
Room no E003 physiotherapy OPD department of physiotherapy galgotias university sec 17A Yamuna Expressway Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9711055066
bhumikaarora210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, (2) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
Phonophoresis
Propioceptive Neuromuscular Fascilitation
Ischaemic compression therapy |
Phonophoresis 10 mins
Propioceptive Neuromuscular Fascilitation 10 mins
Ischaemic compression therapy 10 mins |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Chronic Plantar Fasciitis having pain from last 3 months
Age from 30 to 55years
All sexes
Bilateral and unilateral foot
|
|
| ExclusionCriteria |
| Details |
Acute Plantar Fasciitis
History of ankle and foot surgeries
Patient having pathological or stress fractures of calcaneum
Tumor of ankle and foot
Patient having neurological conditions (Tarsal Tunnel Syndrome Diabetes Peripheral Neuropathy)
Other musculoskeletal conditions such as rheumatoid arthritis fibromyalgia Ankylosing Spondylitis Systematic lupus erythematous Sever’s disease pes cavus pes planus
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Pressure Threshold
Foot Functions |
Baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline and 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
30/07/2025 |
| 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="0"
Months="1"
Days="20" |
|
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
|
Background: Plantar fasciitis is one of the most common cause of heel pain and gait difficulties in Indian population. Patients with Plantar fasciitis tend to walk more slowly than healthy individuals, They show significant reduction in cadence, gait speed, stride length .An abnormal biomechanical parameter is considered as the risk factor for plantar fasciitis. Strengthening Exercises and Stretching are widely used for reduction of pain and improving biomechanical parameters. Methodology: Participants having Plantar fasciitis are randomly allocated into Group A and Group B, Group A receives invertors and evertors strengthening with resistive bands along with therapeutic ultrasound for 3 sessions per week for 4 weeks and Group B receives stretching of Plantar fascia along with Therapeutic Ultrasound for 3 sessions per week for 4 weeks. Outcome measures are Pain which is assessed by VAS, Foot functions which is assessed by Foot function Index and Gait Parameters(stride length, step length,) which are assessed by Footprint method. Result: 30 participants are allocated into Group A and Group B, Group A will show significant reduction in pain and improvement in gait parameters. Conclusion: Both strengthening exercises and stretching programs will be helpful in reducing pain and in improving foot functions and gait parameters in patients with Plantar fasciitis. Keywords: Foot functions, Pain,Plantar fasciitis,Strengthening Exercises,Stretching |