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CTRI Number  CTRI/2024/09/073474 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   To study the effect of IASTM vs Dry cupping on chronic mechanical low back pain 
Scientific Title of Study   Effect of IASTM vs Dry cupping on chronic mechanical low back pain - 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  Josiane Claudine Pinto 
Designation   
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KAHER INSTITUTE OF PHYSIOTHERAPY, Department of Orthopaedic Manual Physiotherapy,OPD No. 39, room no. 13,NEHRU NAGAR, BELAGAVI,KARNATAKA.

Belgaum
KARNATAKA
590010
India 
Phone  9284966830  
Fax    
Email  pintojosiane86@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ANAND HEGGANNAVAR 
Designation  Professor and Head of Department 
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KAHER INSTITUTE OF PHYSIOTHERAPY, Department of Orthopaedic Manual Physiotherapy,OPD No. 39, room no. 13,NEHRU NAGAR, BELAGAVI,KARNATAKA.

Belgaum
KARNATAKA
590010
India 
Phone  9945282896  
Fax    
Email  anandheggannavar@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  DR ANAND HEGGANNAVAR 
Designation  Professor and Head of Department 
Affiliation  KAHER INSTITUTE OF PHYSIOTHERAPY 
Address  KAHER INSTITUTE OF PHYSIOTHERAPY, Department of Orthopaedic Manual Physiotherapy,OPD No. 39, room no. 13,NEHRU NAGAR, BELAGAVI,KARNATAKA.


KARNATAKA
590010
India 
Phone  9945282896  
Fax    
Email  anandheggannavar@klekipt.edu.in  
 
Source of Monetary or Material Support  
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH, NEHRU NAGAR,BELAGAVI,KARNATAKA. 590010 
 
Primary Sponsor  
Name  KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH 
Address  KAHER INSTITUTE OF PHYSIOTHERAPY, Department of Orthopaedic Manual Physiotherapy,OPD No. 39, room no. 13,NEHRU NAGAR, BELAGAVI,KARNATAKA.590010  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anand Heggannavar  KLES Dr. Prabhakar Kore Hospital and Medical Research Centre  KAHER INSTITUTE OF PHYSIOTHERAPY, Department of Orthopaedic Manual Physiotherapy, OPD No. 39, room no. 13,NEHRU NAGAR, BELAGAVI,KARNATAKA.
Belgaum
KARNATAKA 		 9945282896

anandheggannavar@klekipt.edu.in 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DRY CUPPING  Dry cupping( static and dynamic) using fibre cups on affected area. 6-8 minutes 
Intervention  IASTM  IASTM will be performed using M2T blade, 15 strokes, to provide a mobilizing effect to the soft tissue to reduce pain and improve the range of motion and function. 5-7 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1)Participants of all genders, aged 18-45 years with low back pain.
2)Low back pain for 3 months or more
3)Willingness to participate in the study
4)Pain of 3 to 7 on VAS scale.
 
 
ExclusionCriteria 
Details  1)History of fractures within the past 6 months.
2)History of malignancies/cancer
3)History of previous spinal surgery
4)Disc herniation with radiculopathy
5)Peripheral vascular disease, bleeding disorders
6)Impaired sensation
7)Impaired ability to communicate/cognitive impairments

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Pain using Visual Analogue Scale (VAS)
2)Lumbar Flexibility Assessment using Modified Modified Schober’s Test
3)Core stability and muscle function using Sahrmann Core Stability Test
4)Assessment of physical disability caused by low back pain using Roland Morris Disability Questionnaire  		 At baseline, four weeks and eight weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2024 
Date of Study Completion (India) 14/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/03/2025 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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 : EFFECT OF IASTM VS DRY CUPPING ON CHRONIC MECHANICAL LOW BACK PAIN – RANDOMIZED CONTROLLED TRIAL.
Aim : To determine the effects of IASTM vs Dry Cupping along with core stabilization exercises in individuals with chronic mechanical low back pain.
Hypothesis :  Null Hypothesis (H0) : There will be no difference in effect of IASTM vs Dry Cupping along with core stabilization exercises on individuals with low back pain.
 Alternate Hypothesis (H1) : There will be a difference in effect of IASTM vs Dry Cupping along with core stabilization exercises on individuals with low back pain.
Inclusion Criteria : 1)  Participants of all genders, aged 18-45 years with low back pain.

2)  Low back pain for 3 months or more

3) Willingness to participate in the study

4)  Pain of 3 to 7 on VAS scale.

Exclusion Criteria : 1)  History of fractures within the past 6 months.

2)  History of malignancies/cancer

3)   History of previous spinal surgery

4)  Disc herniation with radiculopathy

5)   Peripheral vascular disease, bleeding disorders

6)    Impaired sensation

7)      Impaired ability to communicate/cognitive impairments

Procedure :

     Participants  will  be  briefed  about  the  purpose  of  the  study.    Participants  will  be  screened  based  on  the  inclusion  and  exclusion  criteria  prior  to  their  enrolment  in  the  study. A written Informed consent will be given to the participants in their own language and those consenting to participate in the study will be presented with the interventions. Participants  will  be  recruited  from  the  tertiary  care  hospitals  after  screening  them for mechanical low back pain using VAS scale.   Demographic  data  will  be documented. Participants will be randomly allocated into two groups using chit method. Post assessment of outcome measures will subsequently be done after one month of follow up.


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