| CTRI Number |
CTRI/2025/01/079333 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits Of Dry Cupping And Spinal Adjustments On Lower Back Movements And Skin Temperature |
|
Scientific Title of Study
|
Immediate Effects Of Dry Cupping And Spinal Manipulation On Restricted Lumbar Range Of Motion and Cutaneous Temperature In Asymptomatic Individuals: A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand Heggannavar |
| Designation |
Head of the department in orthopaedic manual therapy |
| Affiliation |
KAHER Institute of Physiotherapy Belagavi |
| Address |
KLE Prabhakar kore hospital and research centre Physiotherapy opd no. 39 sagar wards, orthopedic manual therapy opd no. 13 Belagavi Karnataka, 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9945282896 |
| Fax |
|
| Email |
anandheggannavar@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Heggannavar |
| Designation |
Head of the department in orthopaedic manual therapy |
| Affiliation |
KAHER Institute of Physiotherapy Belagavi |
| Address |
KLE Prabhakar kore hospital and research centre Physiotherapy opd no. 39 sagar wards, orthopedic manual therapy opd no. 13 Belagavi Karnataka, 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9945282896 |
| Fax |
|
| Email |
anandheggannavar@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kunal Tegginmani |
| Designation |
Post graduate 1st year |
| Affiliation |
KAHER Institute of Physiotherapy Belagavi |
| Address |
KLE Prabhakar kore hospital and research centre Physiotherapy opd no. 39 sagar wards, orthopedic manual therapy opd no. 13 Belagavi Karnataka, 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
6360613315 |
| Fax |
|
| Email |
kunaltegginmani123@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of physiotherapy, near KLE hospital, Nehru nagar, Belagavi Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Kunal V Tegginmani |
| Address |
KAHER INSTITUTE OF PHYSIOTHERAPY
KARNATAKA 590010 |
| Type of Sponsor |
Other [Self sponsored project] |
|
|
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 Kunal V Tegginmani |
KLES Dr Prabhakar Kore Hospital and Research Centre |
KLE Prabhakar kore hospital and research centre Physiotherapy opd no. 39 sagar wards, orthopedic manual therapy opd no. 13 Belagavi Karnataka, 590010
Belgaum
KARNATAKA |
6360613315
kunaltegginmani123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASYMPTOMATIC INDIVIDUALS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry Cupping |
Single session of Dry cupping for 10 minutes |
| Comparator Agent |
Spinal Manipulation |
Single session of Spinal manipulation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy males and females.
Between the ages of 18 to 30 years.
Less than 5 centimetre increase in length determined by modified modified schobers test.
Subjects willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
History of low back pain.
cold, and or any thermogenic disease, that could affect their cutaneous temperature.
Open wounds and inflamed or infected tissue.
Any individual with a confirmed or suspected blood/blood clotting disorder (i.e.,hemophiliac).
History of fractures within the past 6 months.
Radicular pain or radiculopathy, or both, with the presence of neurologic signs. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Double inclinometer
Infrared laser thermometer |
Double inclinometer and Infrared laser thermometer will be assessed baseline and immediately post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified modified Schobers test |
Modified modified Schobers test will be assessed baseline & post intervention |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2025 |
| Date of Study Completion (India) |
30/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
TITLE: Immediate effects of of dry cupping and spinal manipulation on restricted lumbar range of motion and cutaneous temperature in asymptomatic individuals: A Randomized Clinical Trial
OBJECTIVE: To compare the effects of dry cupping and spinal manipulation on restricted lumbar range
of motion using double inclinometer, modified modified Schober’s test and cutaneous
temperature with infrared thermometer in asymptomatic individuals.
INCLUSION CRITERIA: - Apparently healthy males and females. - Between the ages of 18 - 30 years. - Less than 5cm increase in length determined by modified modified schober’s test. - Subjects willing to participate in the study.
EXCLUSION CRITERIA: - History of low back pain - cold, and/or any thermogenic disease, that could affect their cutaneous
temperature. - Open wounds and inflamed or infected tissue. - Any individual with a confirmed or suspected blood/blood clotting disorder (i.e.,
hemophiliac). - History of fractures within the past 6 months. - Radicular pain or radiculopathy, or both, with the presence of neurologic signs
OUTCOME MEASURES: - Infrared laser thermometer - Double inclinometers - Modified modified schober’s test
PROCEDURE: Group A will receive a single session of Dry cupping for 10 minutes Group B will receive a single session of High velocity low amplitude spinal manipulation
The pre- and post- data will be collected, tabulated and analyzed. |