| CTRI Number |
CTRI/2025/09/094244 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| 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
|
Positional release technique and active release technique on foot function among plantar fasciitis |
|
Scientific Title of Study
|
Effect of positional release technique and active release technique on selective biomechanical changes and function of the foot among subjects with plantar fasciitis |
| Trial Acronym |
PAFP Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sony George |
| Designation |
Physiotherapist |
| Affiliation |
P.N.N.M Hospital |
| Address |
A V. Nivas, Inchavila, PO.
Kollam, Kerala.
Kollam
KERALA
691601
India |
| Phone |
09400522321 |
| Fax |
|
| Email |
sonyvinujee80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJibi Paul |
| Designation |
Professor |
| Affiliation |
Dr. M.G.R. Educational and Research Institute, Chennai |
| Address |
Faculty of Physiotherapy
Dr.M.G.R. Educational and Research Institute, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9061470448 |
| Fax |
|
| Email |
jibipaul74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJibi Paul |
| Designation |
Professor |
| Affiliation |
Dr. M.G.R. Educational and Research Institute, Chennai |
| Address |
Faculty of Physiotherapy
Dr.M.G.R. Educational and Research Institute, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9061470448 |
| Fax |
|
| Email |
jibipaul74@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sony George |
| Address |
AV. Nivas
inchavila P. O.
Perinad, Kollam, Kerala. |
| 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 |
| DrJibi Paul |
A.C.S Medical College and Hospital. |
chennai,
Tamil Nadu
Chennai
TAMIL NADU |
09061470448
jibipaul74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A.C.S. Medical College and Hospital |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Active Release Technique
Group B Positional Release Technique
Group C ConventionalT reatment |
Active Release Technique
ART performed from a long sitting position. and the ankle is maintained in plantar flexion so that the plantar fascia is shortened. Therapists should apply deep manual pressure on the trigger point, and while sustaining it, the subject actively moves the ankle from plantar flexion to dorsiflexion (from a shortened to a lengthened position). The placement of a contact point near the lesion causes the patient to move in a manner that produces a longitudinal sliding motion of soft tissues. Fifteen repetitions were performed. Repeat the Active Release Technique for ten minutes for three days a week for four weeks.
2. Positional release technique
The patient is made to lie prone and then given mechanical pressure on the tender point with one fingertip in order to determine tenderness. The foot should then be positioned into pure plantar flexion and gently fine-tuned with force directed posterior, superior, and lateral with optimum pain maintained for ninety seconds with three repetitions (two hundred and seventy seconds), until the pain reduces by at least 70%. Repeat the positional release technique for 10 minutes for three days a week for four weeks.
3. Plantar fascia stretching
The patient is lying supine; the therapist grasped the patient’s heel with one hand and maintained the subtalar joint in a neutral position, with the other hand grasping the metatarsal region, then gently applying pressure back toward the shin until feeling a stretch in the arch or plantar fascia. Holding the position for thirty seconds, followed by thirty seconds of rest. Repeat ten times.
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with Plantar Fasciitis
Plantar Fasciitis for more than 12 Weeks
|
|
| ExclusionCriteria |
| Details |
Acute Plantar Fasciitis
Dermatitis
Diabetes
Congenital foot deformities
Corticosteroid injection in the heel for the past 3 months
Neurological pain, like sciatica.
History of fracture in foot and Patients under medication |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure pain.
To measure the plantar fascia thickness.
To measure the Calcaneal Pitch Angle
To assess the function of the foot. |
After one month of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse the effect of Active Release Technique on pain, plantar fascial thickness, calcaneal pitch angle & foot function in plantar fasciitis.
To analyse the effect of the Positional Release Technique on pain, plantar fascial thickness, calcaneal pitch angle & foot function in plantar fasciitis.
To analyse the effect of conventional treatment on pain, plantar fascial thickness, calcaneal pitch angle, & foot function in plantar fasciitis.
|
three days a week for a total of four weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
All participants diagnosed with plantar fasciitis will be selected for the study. They are briefed about the nature of the study and interventions. Consent was obtained from all participants before they were randomly divided into three equal groups using a random sampling method. The demographic data of each patient, including age, sex, side affected, and duration of the condition, were all noted. Pain levels were assessed using pressure algometry, calcaneal pitch angle from X-ray, plantar fascia thickness measured from ultrasound, and foot function using the foot function index scale. Data were collected before and after the interventions. All the participants received the designated interventions 30 minutes per day on 3 days per week for a total of 4 weeks. Collected data were analysed to evaluate the outcome of the study. |