| CTRI Number |
CTRI/2024/09/073314 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Cupping Therapy on calf muscle in patients with Plantarfasciitis |
|
Scientific Title of Study
|
Effectiveness of Cupping Therapy on cross-sectional area of gastrocnemius in patients with Plantarfasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Ranjan |
| Designation |
PG student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room Number 03, Orthopedics OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
07454836645 |
| Fax |
|
| Email |
prachiranjan7454@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simranjeet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room Number 03, Orthopedics OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9877144498 |
| Fax |
|
| Email |
dr.simranjeet.kaur@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Ranjan |
| Designation |
PG student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room Number 03, Orthopedics OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
07454836645 |
| Fax |
|
| Email |
prachiranjan7454@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilittion, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala,Haryana,133207 |
|
|
Primary Sponsor
|
| Name |
Prachi Ranjan |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala, Haryana, 133207 |
| 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 |
| Dr Simranjeet kaur |
Maharishi Markandeshwar Super Speciality Hospital Ambala |
Room Number 03, Orthopedics OPD, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be University), Mullana-Ambala, Haryana
Ambala
HARYANA |
9877144498
dr.simranjeet.kaur@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MMIMSR,Mullana,Ambala |
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 |
| Intervention |
Cupping therapy |
The patient will be recruited in a single group. Outcome measures like the VAS and Elastograhy Ultrasound with B-mode linear probe high frequency 7-12MHz will be used to assess the subject pre- intervention and post- intervention. Plantar fasciitis patient with gastrocnemius tightness will receive one session of dynamic cupping therapy with pressure +1mmhg for 10 mins. The period of time between pre-intervention assessment and post intervention assessment will be 3 days. |
| Comparator Agent |
Not applicable |
Not applicable
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with plantarfasciitis associated with tightness of gastrocnemius muscles male and female both age between 14 to 45 years, VAS greatear than 5,Patient who was able to follow simple verbal commands
|
|
| ExclusionCriteria |
| Details |
Diagnosis of another heel pain releated problems (calcaneal stress fracture, plantar fascia neoplasm)
Any metal implant in leg and foot
Vascular diseases and neurological condition
Any types of skin disorders
Degenerative disorder
Participants were excluded that had diabetes or were on blood thinners, as these are contraindicated for the cupping therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonography |
The period of time between pre-intervention assessment and post intervention assessment will be 3 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue scale |
The period of time between pre-intervention assessment & post intervention assessment will be 3 days. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
16/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="25"
Months="3"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study anticipates the Plantar fasciitis patients with gastrocnemius tightness. Patients will be recruited on the basis of the aforementioned criteria. All subject will be informed about the study procedure and treatment protocol and written informed consent will be procured. The therapist will provide patients and their caregivers with an information sheet that explains the study protocol as well as the risks and benefits. The patient will be recruited in a single group. Outcome measures like the VAS and Ultrasonography with B-mode linear probe high frequency 7-12MHz will be used to assess the subject pre- intervention and post- intervention. Plantar fasciitis patient with gastrocnemius tightness will receive one session of dynamic cupping therapy with pressure +1mmhg for 10 mins. The period of time between pre-intervention assessment and post intervention assessment will be 3 days. |