| CTRI Number |
CTRI/2020/11/029023 [Registered on: 10/11/2020] Trial Registered Prospectively |
| Last Modified On: |
06/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare 2 different therapies to improve pain and function in individuals with heel pain |
|
Scientific Title of Study
|
Effect of Myofascial release versus Cupping therapy on pain and function in individuals with plantar heel pain: A comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manisha Masand PT |
| Designation |
Student MPT1 Masters in Musculoskeletal Physiotherapy |
| Affiliation |
Sancheti institute College of physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy 12 Thube Park Shivajinagar Pune
Sancheti institute for orthopaedic and rehabilitation college of physiotherapy Pune Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9820215450 |
| Fax |
|
| Email |
masandmanisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilima Bedekar |
| Designation |
HOD and Professor Department of musculoskeletal physiotherapy |
| Affiliation |
Sancheti institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy 12 Thube Park Shivajinagar Pune
Sancheti institute for orthopaedic and rehabilitation college of physiotherapy Pune Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nssbedekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilima Bedekar |
| Designation |
HOD and Professor Department of musculoskeletal physiotherapy |
| Affiliation |
Sancheti institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy 12 Thube Park Shivajinagar Pune
Sancheti institute for orthopaedic and rehabilitation college of physiotherapy Pune Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nssbedekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute College of Physiotherapy Sancheti Institute College of Physiotherapy, 12, Thube Park, Shivajinagar Pune -411005Â Â |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy 12 Thube Park Shivajinagar Pune 411005Â |
| 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 |
| Dr Manisha Masand PT |
Sancheti Hospital - Institute for Orthopaedics and Rehabilitation |
Physiotherapy OPD- musculoskeletal department
Pune
MAHARASHTRA |
9820215450
masandmanisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for Orthopedics and Rehabilitation |
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 |
| Intervention |
Dry cupping therapy with exercises |
5 sessions in 15 days
Followed by exercises and home program
|
| Intervention |
Myofascial release with exercises |
5 sessions in 15 days followed by exercises and home program |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Heel pain: most noticeable with initial steps after a period of inactivity but also worse following prolonged weight bearing
2. Tenderness over medial tubercle of calcaneus
3. Trigger points over the calf and foot.
|
|
| ExclusionCriteria |
| Details |
1.A history of surgery to the ankle, foot or lower leg
2. Severe vascular disease
3. Neurological involvement
4. Had received conservative treatment (i.e. physical therapy, acupuncture, massage therapy, chiropractic treatment or local steroid injections) for PHP in the previous 4 weeks
5. Rheumatoid arthritis
6. Fracture in the past 6 months [lower limb] |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pressure algometry at 3 points-
A.Over most tender point on the heel
B.Gastrocnemii middle point over the belly
C.Soleus centered point of the muscle belly at 10 cm over Achilles tendon
2. Visual analog scale
3. Foot function index
|
Pre assessment week 0
Post assessment after 2nd week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
17/11/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a comparative single blinded study studying the effects of Myofascial release versus Cupping therapy on pain and function in patients with plantar heel pain. Patients will be allocated to either the myofascial release group or the cupping therapy group intervention will be given for 5 sessions over 2 week, apart from either of these techniques the patients will receive exercise therapy based on the institutional protocol. The primary outcome measures shall be assessed at day 1 and after 2 weeks, it includes pressure algometry, visual analog scale and foot function index. This will be followed by statistical analysis within and between groups |