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CTRI Number  CTRI/2024/10/074617 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effectiveness of Kinesio-Taping and Stabilization Exercises on Pain and Disability in Middle-aged Women with Sacroiliac Joint Dsyfunction 
Scientific Title of Study   Effectiveness of Kinesio-Taping and Lumbopelvic Stabilization Exercises on Pain and Disability in Middle-aged Women with Sacroiliac Joint Dsyfunction: An Experimental Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chitroda Hetvi Manojbhai 
Designation  Post Graduate Student 
Affiliation  School of Physiotherapy, RK Univeristy 
Address  Research Department, Room no. 207, School of Physiotherapy, RK University Kasturbadham Rajkot-Bhavnagar Highway, Rajkot

Rajkot
GUJARAT
360020
India 
Phone  8758901111  
Fax    
Email  hchitroda283@rku.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Namrata Sojitra MPT 
Designation  Assistant Professor, School of Physiotherapy, RK University 
Affiliation  School of Physiotherapy, RK University 
Address  Research Department, Room no. 207, School of Physiotherapy, RK University Kasturbadham Rajkot- Bhavnagar Highway, Rajkot

Rajkot
GUJARAT
360020
India 
Phone  7984098112  
Fax    
Email  namrata.sojitra@rku.ac.in  
 
Details of Contact Person
Public Query  
Name  Chitroda Hetvi Manojbhai 
Designation  Post Graduate Student 
Affiliation  School of Physiotherapy, RK Univeristy 
Address  Research Department, Room no. 207, School of Physiotherapy, RK University Kasturbadham Rajkot-Bhavnagar Highway, Rajkot

Rajkot
GUJARAT
360020
India 
Phone  8758901111  
Fax    
Email  hchitroda283@rku.ac.in  
 
Source of Monetary or Material Support
Modification(s)  
Chitroda Hetvi Manojbhai School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot-360020, Gujarat, India  
 
Primary Sponsor
Modification(s)  
Name  Chitroda Hetvi Manojbhai 
Address  School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot-360020, Gujarat, India 
Type of Sponsor  Other [Self] 
 
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 
Dr Hetvi Chitroda PT  RK Physiotherapy Rehabilitation and Research Center  Physiotherapy Department, Room no.1, opp Meghani rang bhuvan, Bhaktinagar Circle, Rajkot, Gujarat, India
Rajkot
GUJARAT 		 8758901111

hchitroda283@rku.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, School of Physiotherapy, RK University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kinesio-Taping and Lumbopelvic Stabilization Exercises  Kinesio-Taping for piriformis muscle ("I" strip) and lumbopelvic region ("star" technique) and Lumbopelvic Stabilization Exercises (bridging, cat-camel, child pose, dead-bird, plank, pointer and side plank) will be given 10 repetitions, 3 sets for 3 days per week for 3 weeks. 
Comparator Agent  Lumbopelvic Stabilization Exercises  Lumbopelvic Stabilization Exercises (bridging, cat-camel, child pose, dead-bird, plank, pointer and side plank) will be given 10 repetitions, 3 sets for 3 days per week for 3 weeks. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1) Lower Back Pain with Sacroiliac Joint Dysfunction
2) FABER Test Positive
3) Piriformis Test Positive
4) Oswestry Disability Questionnaire score 5-14 Mild Disability 
 
ExclusionCriteria 
Details  1) Neurological Pain in the Lower Limb
2) Previous or Scheduled Surgeries in the Lumbopelvic Region
3) Pelvic Bone Fracture
4) Malignant Site
5) Skin Allergies
6) Infected Site
7) Open Wound
8) Not willing to sign informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Numerical Pain Rating Scale
2)Oswestry Disability Questionnaire  		 Pre Outcome at Baseline (first day of training)
Post Outcome After 3 weeks (last day of training) 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   02/12/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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: Effectiveness of Kinesio-Taping and Lumbopelvic Stabilization Exercises on Pain and Disability in Middle-aged Women with Sacroiliac Joint Dysfunction: An Experimental Study
Introduction: Sacroiliac joint dysfunction (SIJD) is the most common cause of nondiscogenic pain. Mechanical SIJD is mainly characterized by pain in the sacroiliac joint (SIJ) area due to stiffness and decreased mobility of SIJ, also called hypomobility. SIJD, which may lead to biomechanical alterations in the structures around the pelvis, is the most common source of lower back pain affecting 70%–85% of adults. Accordingly, 13%–30% of patients with lower back pain have SIJD.
Need of Study: Despite the availability of various treatment options for sacroiliac joint dysfunction (SIJD), many studies have focused on long duration (4-12 weeks) interventions. It has been shown that different exercise protocols can significantly improve SIJD. Understanding how these interventions work together could lead to enhanced treatment protocols that effectively address both pain and disability. However, there has been insufficient study on combining two interventions, kinesio-taping with lumbopelvic stabilization exercises. Therefore, there is a need for a study to evaluate the effectiveness of kinesio-taping and lumbopelvic stabilization exercises in middle-aged women with sacroiliac joint dysfunction using a 3-week intervention, to determine if a shorter duration of intervention can be effective in reducing pain and disability.
Aim: Effectiveness of kinesio-taping and lumbopelvic stabilization exercises on pain and disability in middle-aged women with sacroiliac joint dysfunction.
Objectives: 1. To evaluate the effectiveness of kinesio-taping in middle-aged women with sacroiliac joint dysfunction. 2. To evaluate the effectiveness of lumbopelvic stabilization exercises in middle-aged women with sacroiliac joint dysfunction. 3. To evaluate and compare the effectiveness of kinesio-taping along with lumbopelvic stabilization exercises among middle-aged women with sacroiliac joint dysfunction.
Methodology: The population will be women 30-40 years old. Subjects will be screened using purposive sampling and included in the study based on inclusion criteria. Written consent will be obtained from subjects. Group A will receive kinesio-taping and lumbopelvic stabilization exercises for 3 weeks, and group B will receive lumbopelvic stabilization exercises for 3 weeks. Pre and post data will be assessed with Numerical Pain Rating Scale and Oswestry Disability Questionnaire.

 
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