| CTRI Number |
CTRI/2023/07/054698 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
03/07/2023 |
| 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 ankle joint mobilization along with foot core strengthening to improve functional status in patients with plantar fasciitis: A randomised controlled trial. |
|
Scientific Title of Study
|
Effectiveness of subtalar joint mobilization along with Foot core strengthening on pain and functional status in patients with plantar fasciitis: A randomised controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ketaki Patil |
| Designation |
PG student |
| Affiliation |
|
| Address |
Pravara Institute of Medical Sciences
OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY
Dr APJ Abdul Kalam College of Physiotherapy
TAL RAHATA DIST AHMEDNAGAR
LONI MAHARSHTRA
413736
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9970796007 |
| Fax |
|
| Email |
ketakipatil61298@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rakesh K Sinha |
| Designation |
PROFESSOR AND PRINCIPAL |
| Affiliation |
|
| Address |
Pravara Institute of Medical Sciences
OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY
Dr APJ Abdul Kalam College of Physiotherapy
TAL RAHATA DIST AHMEDNAGAR
LONI MAHARSHTRA
413736
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9799783783 |
| Fax |
|
| Email |
smartphysio@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ketaki Patil |
| Designation |
PG student |
| Affiliation |
|
| Address |
Pravara Institute of Medical Sciences
OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY
Dr APJ Abdul Kalam College of Physiotherapy
TAL RAHATA DIST AHMEDNAGAR
LONI MAHARSHTRA
413736
Ahmadnagar MAHARASHTRA 413736 India |
| Phone |
9970796007 |
| Fax |
|
| Email |
ketakipatil61298@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pravara Institute of Medical Sciences Dr APJ Abdul Kalam College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Dr APJ Abdul Kalam College of Physiotherapy |
| Address |
Pravara Institute of Medical Sciences
OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY
Dr APJ Abdul Kalam College of Physiotherapy
TAL RAHATA DIST AHMEDNAGAR
LONI MAHARSHTRA
413736 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| KETAKI PATIL |
PRAVARA INSTITUTE OF MEDICAL SCIENCES |
Dr APJ Abdul Kalam College of Physiotherapy
OPD NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY
TAL RAHATA
DIST AHMEDNAGAR
LONI MAHARSHTRA
413736 Ahmadnagar MAHARASHTRA |
9970796007
ketakipatil61298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Dr APJ Abdul kalam COPT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL THERAPY
|
THERAPEUTIC ULTRASOUND 50 PERCENT PULSE MODE 1 MHZ FREQUENCY 1.5WATT PER CENTERMETER SQ. INTENSITY
STRETCHING EXERCISES FOR FOLLOWING MUSCLES
GASTRONEMIUS
SOLEUS
PLANTAR FASCIA
3 REPETATIONS WITH 30 SECOND HOLD 3 TIMES PER WEEK |
| Intervention |
Subtalar joint mobilization Foot
core strengthening |
1.Subtalar joint mobilization
3sets with 6-10sec for 3 times per
week
2.Foot core strengthening
toe spread out
first toe
extension
second to fifth toe
extension
short foot exercise
3sec for 4sets with 15repetition 3 times per week
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group 40-60years
Both Male and Female
Patients with positive windlass test
Diagnosed case of plantar fasciitis
Patients with navicular drop |
|
| ExclusionCriteria |
| Details |
History of ankle or foot surgery
Patients with any congenital/acquired deformity of foot
Patients with any neurological condition
Refuse to participate or sign informed consent |
|
|
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 |
Visual analogue scale
foot function index |
Baseline to 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
13/07/2023 |
| 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="2" Months="0" Days="0" |
|
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
|
|
Plantar
fasciitis (PF; also known as “plantar heel painâ€) is a common foot disorder
in adults secondary to an inflammatory response caused by repetitive
micro-trauma.(1)a localized inflammation of the plantar
aponeurosis, is reported to be the most common cause of heel pain. An
estimated 1 in 10 people will develop the condition over a lifetime.(2)
Complaint is usually of an insidious sharp pain in the medial heel along the
medial plantar fascia at the insertion at the medial tuberosity of the
calcaneum on weight bearing after a period of non-weight bearing.(3)Typically,
this pain is described as “burningâ€, “aching†and, occasionally,
“lancinatingâ€.(1) The typical pain of PF is located at the
hindfoot,(4) medial tubercle of the calcaneus and normally occurs
during the first few steps in the morning or after a prolonged non-weight
bearing activity.(5) And can often be a challenge for clinicians
to treat successfully. It occurs over a wide age range and is seen in both
sedentary and athletic individuals.(4,6) PF may affect >1
million people worldwide per year. The exact prevalence of PF is not known.
The lifetime prevalence may reach 10% of the general population worldwide.
Affect all the age groups, sexes, and ethnicities, with a higher prevalence
noted in females aged 40–60 years. (1) There is no clear consensus
on the etiology of plantar fasciitis, but overuse due to prolonged
weightbearing or unaccustomed activity, obesity, and limited dorsiflexion
range of motion have all been implicated as contributing factors.(2) After the initial inflammatory response and
repetitive micro-trauma of plantar aponeurosis, myxoid degeneration with PF
fragmentation as well as vascular ectasia in bone marrow, are the most common
histologic findings. Therefore, PF may be considered a degenerative fasciosis
in the absence of inflammation.(1) Plantar heel pain also results in mild
disability and decrease in quality of life of an individual.(3) .
Diagnosis of PF can be made through the patient history, clinical symptoms,
and objective assessments such as pain level, palpation, muscle tightness,
joint range of motion, or muscle strength. In addition, diagnostic imaging
may be used to exclude other causes of pain such as heel spurs or tissue
inflammation.(5) . Patients with PF who have painful episodes at
the heel commonly avoid weight bearing on the symptomatic foot and are at
risk for developing antalgic gait. Patients with PF tend to walk more slowly
than healthy individuals in order to avoid or reduce pain. They show
significant decreases in cadence, gait speed, stride length, and increases in
stride time.(5) Conservative treatments for PF usually include
rest, anti-inflammatory drugs, shoe inserts, shoe wear modification,
stretching exercises, and physical therapy. Examples of physical therapy are
massage, mobilization, therapeutic ultrasound, and taping.(5)
|
One of the reasons of heel pain may be due
to Subtalar joint dysfunction that will affect the movement of calcaneus and
thus potentially affect the tension in plantar fascia.(3) Subtalar
joint mobilization is a manual therapy intervention that increases the
mobility of the calcaneum that contributes an increased pronation and thus
increased tensile stress through the plantar fascia.(7) Studies
have shown substantial benefit from manual therapy on conditions like
Osteoarthritis knee, neck pain, and cervicogenic headaches. There exists less
evidence to support the use of manual therapy intervention and their
effectiveness in subjects diagnosed with PF.(3,8)
|
The foot is a highly
complex structure with many articulations and multiple degrees of freedom that play
an important role in static posture and dynamic activities.(9,10) The
foot core system consists of a complex foot structure, including active,
passive, and neural subsystems, providing stability and flexibility when coping
with changing foot demands.(11) The theoretical basis of
lumbopelvic-hip core stability is applied to the foot core system.(12)The
passive subsystem of the foot core consists of the bones, ligaments and joint
capsules that maintain the various arches of the foot. The active subsystem
consists of the muscles and tendons that attach on the foot. The local
stabilizers of the foot are the plantar intrinsic muscles that both originate
and insert on the foot, whereas the global movers are the extrinsic muscles
that originate in the lower leg, cross the ankle and insert on the foot. The
neural subsystem consists of the sensory receptors in the plantar fascia,
ligaments, joint capsules, muscles and tendons involved in the active and
passive subsystems. (9) The intrinsic foot muscles and extrinsic
foot muscles, which constitute the foot active subsystem, also play an active
role in maintaining foot core stability.
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