| CTRI Number |
CTRI/2024/05/067766 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| 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
|
Comparing effectiveness of Dry Needling and Dry cupping in the treatment of plantar fasciitis. |
|
Scientific Title of Study
|
Efficacy of Dry Needling versus Dry Cupping on calf muscles with conventional therapy in the treatment of plantar fasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kiran Mulchandani |
| Designation |
MPT student |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy, Electrotherapy Department, Lab No. 02, 3rd floor, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad
Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9518340142 |
| Fax |
|
| Email |
kiranmulchandani17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumik Basu |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy, Electrotherapy Department, Lab No. 02, 3rd floor, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad
Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9762165015 |
| Fax |
|
| Email |
soumik.basu@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumik Basu |
| Designation |
Associate Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Dr. D.Y. Patil College of Physiotherapy, Electrotherapy Department, Lab No. 02, 3rd floor, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad
Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9762165015 |
| Fax |
|
| Email |
soumik.basu@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri colony, Pimpri-Chinchwad, Maharashtra 411018. |
|
|
Primary Sponsor
|
| Name |
Kiran Mulchandani |
| Address |
Dr. D.Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Kiran Mulchandani |
Dr. D.Y. Patil College Of Physiotherapy,Pune. |
OPD of Dr. D.Y. Patil College of Physiotherapy, electrotherapy department Sant Tukaram Nagar, Pimpri, Pune 18.
Pune
MAHARASHTRA |
9518340142
kiranmulchandani17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe of Dr. D.Y. Patil Vidhyapeeth, Pune 18. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with chronic unilateral plantar fasciitis. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A : Dry Needling, Stretches, Icing. |
All participants will receive short explanation about the procedure. They would be positioned in prone position for the technique application. Myofascial Trigger Points will be evaluated using Travel and Simons. The muscles selected would be gastrocnemius, & coleus. Needle with the length of 30-50mm & diameter of 0.6mm will be used followed with icing for 5mins and stretching after the removal of needles. Self stretching exercises will be taught. The treatment period will be 2 weeks with 3 sessions of dry needling in a week. |
| Comparator Agent |
Group B : Dry Cupping, Stretches, Icing. |
All the participants will receive information regarding the initial sensation of suction, potential occurrence of bruising at the application site. The technique will be applied for 10mins, and will target the painful area. Icing and Stretches will be followed after the removal of cups. The treatment period will be 2 weeks with 3 sessions of Dry Needling in a week. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants with chronic unilateral plantar fasciitis diagnosed by orthopaedician.
Ability to understand the study and informed consent, as well as having signed consent form. |
|
| ExclusionCriteria |
| Details |
Needle phobia.
Needle Allergy or hypersensitivity to metals.
Receiving or implementing any form of treatment for plantar fasciitis.
Recent trauma or bone injury. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Ultrasonography measuring Plantar fascia thickness. |
1. At start of the study and end of the study (after 2 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pressure- pain algometer.
2. Foot and Ankle Disability Index. |
At start of the study and end of the study (after 2 weeks)
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2024 |
| 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="0"
Months="8"
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
|
Need of Study : The management of plantar fasciitis involves a variety of interventions, addressing the symptoms the condition and enhancing the overall function of the foot. Therefore, the purpose of this study is the compare the added effect of Dry Needling or Dry Cupping with Conventional Therapy in the treatment of Plantar fasciitis.
AIM : To study Dry Needling, Dry Cupping with Conventional therapy in the treatment of Plantar Fasciitis.
OBJECTIVES : 1. To study the added effect of Dry Needling, Dry Cupping with conventional therapy, on plantar thickness (measured by USG). 2. To study the added effect of Dry Needling, Dry Cupping with conventional therapy, on pain using pressure pain algometer. 3. To study the added effect of Dry Needling, Dry Cupping with conventional therapy, on functional limitations of foot & ankle using FADI (Foot and Ankle Disability Index).
Null Hypothesis : H0 : There will be no difference in the effect of Dry Needling and Dry Cupping in the treatment of Plantar fasciitis.
Alternate Hypothesis : H1 : Dry Needling will be more effective than Dry Cupping in the treatment of plantar fasciitis. H2 : Dry Cupping will be more effective than Dry Needling in the treatment of plantar fasciitis. |