| CTRI Number |
CTRI/2022/09/046043 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
29/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of Dynamic Cupping and Myofascial Release Technique in calf pain |
|
Scientific Title of Study
|
Comparison of Myofascial Trigger Point Dynamic Cupping and Myofascial Release Technique on Pain and Function of Chronic calf pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sagar Khurana |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar Deemed to be University
Ambala
HARYANA
133207
India |
| Phone |
7015531522 |
| Fax |
|
| Email |
sagarkhurana535@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamran Ali |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar Deemed to be University
Ambala
HARYANA
133207
India |
| Phone |
9540686786 |
| Fax |
|
| Email |
kamran.ali@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Vats |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and
Rehabilitation, Maharishi Markandeshwar Deemed to be University
Ambala
HARYANA
133207
India |
| Phone |
9992357385 |
| Fax |
|
| Email |
sakshi.vats@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal Physiotherapy Research Lab, Maharishi Markandeshwar Institute of
Physiotherapy, Maharishi Markandeshwar deemed to be University, Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Sagar Khurana |
| Address |
Musculoskeletal Physiotherapy Research Lab, Maharishi Markandeshwar Institute of
Physiotherapy, Maharishi Markandeshwar deemed to be University, Ambala, Haryana |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kamran Ali |
Musculoskeletal Physiotherapy Research Lab, Maharishi Markandeshwar Institute of
Physiotherapy, Maharishi Markandeshwar deemed to be University, Ambala, Haryana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sagar Khurana |
Maharishi Markandeshwar Hospital, Department of Musculoskeletal Physiotherapy |
Department of
Musculoskeletal
Physiotherapy,
Maharishi
Markandeshwar
Institute of
Physiotherapy and
Rehabilitation,
Maharishi
Markandeshwar
Deemed to be
University, Mullana
Ambala
HARYANA |
7015531522
sagarkhurana535@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the ethics committee |
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 |
| Intervention |
Dynamic Cupping Therapy |
In group A manual suction pump with one plastic cup will be utilized for intervention. The cup will be applied to the calf region with aqua gel for producing dynamic motion. For 6 sessions in 3 weeks that is 2 sessions a week for 5 minutes. |
| Comparator Agent |
Myofascial Release Technique |
In group B Myofascial Release technique for 6 sessions in 3 week that is 2 sessions a week for 5 minutes. Myofascial convention include releasing of trigger points over calf region with finger pad kneading and thumb kneading. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Adults(18-25years)
2. At least one or more trigger points in the calf muscles.
3. Both males and females.
4. Muscles associated with trigger points must be soleus and gastrocnemius.
5. Both limbs are given equal importance.
|
|
| ExclusionCriteria |
| Details |
1. Tumor, fracture, rheumatoid arthritis, osteoporosis, or any vascular condition in the lower limbs.
2. Previous surgery in the affected leg below the hip.
3. History of Deep vein thrombosis or varicose vein.
4. Contraindication to Cupping Therapy.
5. Pregnancy. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (NPRS)
Pain Pressure Thershold (PPH) |
2 times for 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Range of Motion of Ankle Joint
SF-36 Questionnaire |
2 times for 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
30/09/2022 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ethical approval of this study will be taken from the student project committee and ethical committee of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. Study will be done in accordance with Helsinki declaration revised 2013 and the National Ethical Guidelines for Biomedical Research involving Human Participants, 2017.
Recruitment and Intervention: The objective of the study is to find out the effectiveness of Cupping Therapy versus Myofascial Release Technique in patients with Chronic Calf Pain. Participants will be chosen from a group of 18-25 year-old who had been suffering from chronic calf pain for at least one trigger point in calf region. Each subject’s complete demographic information, including name, age, gender, weight, and height, will be recorded. For 3 weeks, treatment will be provided twice a week. The Numeric Pain Rating Scale and Pain Pressure Threshold (PPH) is used to assess pain intensity and Range of Motion and SF-36 Questionnaire is used to assess disability, and baseline measures will be done after the final intervention |