| CTRI Number |
CTRI/2024/05/066680 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To Study the Impact of Sliding and Gliding of Neve and Soft Tissue Release in Managing Pain and Function and Quality of life in Plantar Fascitis Patients |
|
Scientific Title of Study
|
Effectiveness of Neural Mobilization versus Myofascial Release on Pain, Function and Quality of Life in Patients with Plantar Fascitis - A Randomized Controlled Trail |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshika Thakur |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Sawangi Meghe |
| Address |
Department of Musculoskeletal Physiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7767975765 |
| Fax |
|
| Email |
anshika7057@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrat Samal |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Sawangi Meghe |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9370435611 |
| Fax |
|
| Email |
research4subrat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subrat Samal |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Sawangi Meghe |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9370435611 |
| Fax |
|
| Email |
research4subrat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research [Deemed to be University], Sawangi Meghe, Wardha, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Medical Sciences [Deemed to be University], Sawangi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anshika Thakur |
Acharya Vinobha Bhave Rural Hospital ,Sawangi Meghe |
Department of Musculoskeletal Physiotherapy, Physiotherapy OPD
Wardha
MAHARASHTRA |
7767975765
anshika7057@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Myofascial release along with conventional physiotherapy for plantar fascitis. |
The conventional exercises will be same as in intervention group.
Myofascial release:
Fascia Massage:
Therapist uses thumb or knuckles to slide pressure from heel to ball of foot.
2 sets of 60-second repetitions with a 10-second break.
Passive Toe Extension and Flexion:
Toes passively extended and flexed using the same technique.
Plantar Fascia Strokes:
Therapist applies 60 strokes on plantar fascia in 60 seconds.
Maintain consistent movement speed and rhythm of one stroke per second. |
| Intervention |
Neural mobilizations exercises along with conventional physiotherapy for plantar fascitis. |
1. Gastrosoleus stretching:
Lie in supine position with legs straight, a towel under the knee.
Push ankle up towards therapist, feel calf muscle stretch.
10 reps with 10 sec hold, stop at mild discomfort.
Duration: 1 week.
2.Towel curl up:
Sit with foot on end of towel, curl toes to bring towel towards body.
2 sets of 10 reps.
3. Toe Extension:
Sit with involved leg crossed over uninvolved leg.
Grasp toes, bend ankle upwards for arch and calf muscle stretch.
Perform deep massage along the arch.
Hold 10 sec, repeat for 2-3 minutes, 2-4 sessions/day.
4. Standing Calf Stretch:
Stand with hands on wall for support.
Place feet straight ahead, involved foot behind the other.
Shift forward, keeping back leg heel on ground for calf stretch.
Hold 45 sec, 2-3 times, repeat 4-6 times/day.
5. Ice Massage Arch Roll:
Rest involved foot on a frozen can, golf ball, or tennis ball.
Roll foot back and forth over the object.
Repeat for 3-5 minutes, 2 times/day.
6.Neural Mobilization for tibial nerve:
Patient in supine position, therapist beside.
5 sets of 10 reps with 1-min rest between sets.
Includes hip flexion at 45°, ankle dorsiflexion, foot eversion with knee extension.
Thrice a week. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed as chronic plantar fasciitis
2. Both male and female gender.
3. Above 25 – 40 years of age
4. Palpable discomfort in the medial plantar calcaneal area.
5. After a period of inactivity, the discomfort in the plantar medial heel is most obvious when the patient begins to walk again.
6. An increase in weight-bearing activities has led to an increase in heel discomfort.
7. Pain while palpating the plantar fascia insertion
8. Those willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Any deformity or rigidity of ankle
2. Patients with calcaneal spur or fractures
3. Patients with any recent surgeries of lower extremities
4. Patients taking any medications or steroids
5. Patients with vascular diseases of extremities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Foot Function Index Scale
Quality of Life |
Baseline after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life |
Baseline after 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
26/05/2024 |
| 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
|
The aim of the study is to evaluate the effect of neural mobilization and myofascial release on pain, function and quality of life in patients with plantar fasciitis. The objectives of my study are - 1. To determine the effect of neural mobilization along with conventional physiotherapy on pain, function and quality of life in patients with plantar fasciitis. 2. To determine the effect of myofascial release conventional physiotherapy on pain, function and quality of life patients with plantar fasciitis. 3. To compare the effect of neural mobilization versus myofascial release on pain, function and quality of life in patients with plantar fasciitis. 4. To compare the effect of neural mobilization versus myofascial release along with conventional therapy on pain, function and quality of life in patients with plantar fasciitis. |