| CTRI Number |
CTRI/2022/02/040016 [Registered on: 04/02/2022] Trial Registered Prospectively |
| Last Modified On: |
31/01/2022 |
| 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
|
Comparing the effects of actively releasing versus comfortably releasing plantar fasciitis |
|
Scientific Title of Study
|
comparing the effects of active release technique versus positional release technique in patients with plantar fasciitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachana Prathamesh Punekar |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Sunandan Divatia School Of Science, NMIMS University. |
| Address |
Department of Physiotherapy, Ground floor Nanavati Super
Speciality Hospital SV Road, Vile Parle(W)
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
8108645349 |
| Fax |
|
| Email |
rachanapunekar50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Bhartiya |
| Designation |
Professor |
| Affiliation |
Sunandan divatia school of science, NMIMS University |
| Address |
Department of Physiotherapy, Ground floor Nanavati Super
Speciality Hospital SV Road, Vile Parle(W)
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9867512415 |
| Fax |
|
| Email |
mansi.bhartiya@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rachana Prathamesh Punekar |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Sunandan Divatia School Of Science, NMIMS University. |
| Address |
Department of Physiotherapy, Ground floor Nanavati Super
Speciality Hospital SV Road, Vile Parle(W)
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
8108645349 |
| Fax |
|
| Email |
rachanapunekar50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy & Sports Medicine, Nanavati Super Speciality Hospital |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NIl] |
|
|
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 Ali Irani |
Department of Physiotherapy & Sports Medicine, Nanavati Super Specialty Hospital |
Department of Physiotherapy, Ground floor Nanavati Super
Speciality Hospital SV Road, Vile Parle(W)
Mumbai (Suburban)
MAHARASHTRA |
02226172329
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr Balabhai Nanavati 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 |
| Comparator Agent |
Active release technique versus Positional release technique |
One group will be given active release technique with conventional treatment and the other group will be given positional release technique with conventional treatment. Both the groups will be compared and results will analysed |
| Intervention |
Comparing the effects of Active release technique versus Positional release technique in subjects with Plantar Fasciitis |
Subjects with plantar fasciitis will be randomly grouped in 2 groups.
Group A- Active release technique with conventional therapy
Group B- Positional release technique with conventional therapy
Treatment will be given for 30-40 minutes for 10 sessions
Outcome measures will be assessed pre treatment on the first day and post treatment on the last day
Pre and post intervention findings will be calculated and data will be statistically analyzed.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Acute plantar fasciitis,
Age above 18 years,
Windlass test- positive. |
|
| ExclusionCriteria |
| Details |
Dermatitis,
History of fracture or any trauma around the foot complex. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale- first step pain, at rest, on activity
Pressure algometer
Foot and ankle ability measure
Ankle ROM- Dorsiflexion (goniometer)
|
Baseline and after 10 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
12/02/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Comparing the effects of Active release technique versus
Positional release technique in subjects with Plantar Fasciitis. Introduction: Plantar fasciitis is one
of the most common causes of foot pain. Over the years plantar fasciitis
is been treated with rest, stretching, myofascial release, etc. Also
electrotherapeutic modalities in the form of ultrasound, phonophoresis, laser,
microwave diathermy, iontophoresis, cryotherapy, contrast bath have been given
in the past. Active Release
Techniques (ART) is a soft-tissue technique that locates and breaks down the
scar tissue and adhesions which cause pain, stiffness, weakness, abnormal
sensations, including mechanical dysfunction in the muscles, fascia, and soft
tissue. ART is used for the treatment of Repetitive strain injuries, as well as
for the improvement of athletic performance. Positional release
therapy (PRT) includes placing the involved tissue in an ideal position of
comfort. The purpose of position of comfort is to reduce the irritability of
tender point and to normalize the tissues associated with dysfunction. This
technique is proposed to increase muscle flexibility by placing the muscle in a
shortened position to promote muscle relaxation. Active release
technique and Positional release technique has been proved separately to be
effective for the treatment of plantar fasciitis in previous studies. But there
is limited study done comparing these two techniques i.e ART and PRT for
plantar fasciitis. Hence, the aim of our study is to compare the effectiveness
of Active release technique and Positional release technique in subjects with
plantar fasciitis. Aim: To compare the effects of active release technique versus
positional release technique in subjects with plantar fasciitis. Objectives: 1. To assess the effects of active release technique versus
positional release technique on numerical pain rating scale, pressure
algometer, foot and ankle ability measure and ankle dorsiflexion range of
motion in patients with plantar fasciitis. 2. Comparison of both groups. Inclusion criteria: Acute Plantar Fasciitis, Age above 18 years, Windlass test- positive. Exclusion criteria: Dermatitis, History of surgery or any trauma around the foot complex. Outcome measures: 1. Numerical Pain Rating Scale- first step pain, at rest, on
activity 2. Pressure algometer 3. Foot and ankle ability measure
4. Ankle ROM- Dorsiflexion (goniometer) |