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CTRI Number  CTRI/2018/03/012887 [Registered on: 27/03/2018] Trial Registered Retrospectively
Last Modified On: 26/03/2018
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   The effect of two manual therapy techniques on sacroiliac joint dysfunction  
Scientific Title of Study   Effect of Mulligan Taping Technique as an adjunct to Mulligan mobilization versus Manipulation in anterior innominate dysfunction- A randomized clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saviola Ribeiro 
Designation  Post-graduate student, Orthopaedic manual therapy 
Affiliation  KAHER Institute of Physiotherapy, Belagavi. 
Address  JNMC Campus, Nehru nagar, belagavi- karnataka
KAHER Institute of Physiotherapy, Nehru nagar, Belagavi.
Belgaum
KARNATAKA
590010
India 
Phone    
Fax    
Email  ribeiro.gayle@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anand Heggannavar 
Designation  Associate Professor, Orthopaedic manual therapy, department 13 
Affiliation  Associate Professor, Orthopaedic Manual therapy, Institute of Physiotherapy, Belagavi. 
Address  KLE Academy of Higher Education and Research, Nehru nagar, Belagavi- Karnataka
KAHER Institute of Physiotherapy, Nehru nagar, Belagavi.
Belgaum
KARNATAKA
590010
India 
Phone  9945282896  
Fax  0831-2474727  
Email  anandhegs@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Saviola Ribeiro 
Designation  Post-graduate student, Orthopaedic manual therapy 
Affiliation  KAHER Institute of Physiotherapy, Belagavi. 
Address  JNMC Campus, Nehru nagar, belagavi- karnataka
KAHER Institute of Physiotherapy, Nehru nagar, Belagavi.
Belgaum
KARNATAKA
590010
India 
Phone    
Fax    
Email  ribeiro.gayle@gmail.com  
 
Source of Monetary or Material Support  
Saviola Ribeiro Post-graduate student under Orthopaedic Manual Therapy, KAHER Institute of Physiotherapy Belagavi 
 
Primary Sponsor  
Name  Saviola Ribeiro 
Address  KAHER Institute of Physiotherapy Nehru nagar, Belagavi ,karnataka 
Type of Sponsor  Other [Self funded] 
 
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 
Saviola G Ribeiro  KLE Hospital and Research Centre, Belagavi  KLE Hospital and Research centre, Nehru nagar, Belagavi
Belgaum
KARNATAKA 		 9945522521

ribeiro.gayle@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and ethics committee, KLEU Institute of Physiotherapy, Belagavi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Anterior Innominate Sacroiliac joint dysfunction.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A - Postero-medial sacroiliac joint Mulligan mobilization and mulligan taping technique plus conventional treatment (therapeutic ultrasound) Group B - Sacroiliac joint Manipulation and mulligan taping technique plus conventional treatment (therapeutic ultrasound)  Group A:- Mulligan mobilization (6 min), mulligan taping technique (3 min), therapeutic ultrasound (5 min) Group B:- Sacroiliac joint manipulation (6 min), mulligan taping technique (3 min), therapeutic ultrasound (5 min) 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Acute/Sub-acute pain within 4-12 weeks of onset.

Atleast three of four clinical tests (supine to long sitting test, prone knee flexion test, standing flexion test and passive straight leg raise test) positive for anterior innominate dysfunction
 
 
ExclusionCriteria 
Details  Subjects with clinical conditions contraindicating to ultrasound therapy such as metal implants, malignancy.

Red flags to high velocity low amplitude thrust such as osteoporosis, gross instability.

Red flags to sacroiliac mobilization such as hyper mobility.

Specific to sacroiliac joint syndrome, differential diagnosis- ankylosing spondylitis, gout, psoriasis, reiters, rheumatoid.

Pregnancy

Hypersensitive skin over the pelvic area
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Modified Oswestry Disability Questionnaire
2. Modified Schober’s Lumbar Range Of Motion
3. Pelvic inclinometer scale 		 Pre treatment (day 1)- Post treatment (day 6) 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analogue Scale  Pre treatment (day 1)- Post treatment (day 6) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   30/05/2017 
Date of Study Completion (India) 22/01/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The study was done to find out the effects of mulligan taping technique as an adjunct to Mulligan mobilization technique versus manipulation in anterior innominate dysfunction on a population aged between 25-55 years. The outcome measures used were visual analogue scale, modified oswetery disability questionnaire, modified schober’s lumbar range of motion and pelvic inclinometer scale. 30 samples were recruited and randomized into two groups for a duration of 6 consecutive days. The study was a one year duration study. Both the groups showed improvement but the group that received mulligan mobilzation and taping with conventional treatment was found to be more beneficial than manipulation and taping with conventional treatment group.No side effects were seen under this side. 
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