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CTRI Number  CTRI/2025/04/084919 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   The Impact of Sacroiliac Joint Mobilization on Pain, Function, and Disability in Patients with Lumbar Disc Herniation. 
Scientific Title of Study   The Efficacy of Sacroiliac Joint Mobilization on Pain, Function and Disability in Patient with Lumbar Prolapse Intervertebral Disc. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aarunee Srivastava 
Designation  MPT Student 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy And Rehabilitation 
Address  Department of Physiothrapy, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  8920561804  
Fax    
Email  aaunee.srivastava@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sandeep Pattnaik 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy And Rehabilitation 
Address  Department of Physiothrapy, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  9348096886  
Fax    
Email  physiosandeep94@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sandeep Pattnaik 
Designation  Assistant Professor 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy And Rehabilitation 
Address  Department of Physiothrapy, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  9348096886  
Fax    
Email  physiosandeep94@gmail.com  
 
Source of Monetary or Material Support  
Orthopedic Physiotherapy Research Laboratory, Maharishi Markandeshwar Institute of Medical Sciences and Research, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala,Haryana, 133207 
 
Primary Sponsor  
Name  Aarunee Srivastava 
Address  Maharishi Markandeshwar Institute Of Physiotherapy And Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala, Haryana, 133207. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sandeep Pattnaik  Maharishi Markandeshwar Institute Of Physiotherapy And Rehabilitation, Maharishi Markandeshwar (Deemed to be University) Mullana-Ambala, Haryana, 133207. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aarunee Srivastava  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation  Room No.2, Ground floor, Department of Physiotherapy, Maharishi Markandeshwar (Deemed to be University), Mullana,
Ambala
HARYANA 
8920561804

aarunee.srivastava@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee, Maharishi Markandeshwar Institute of Medical Sciences And Research, Mullana-Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M489||Spondylopathy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Sacroiliac Joint Mobilization: Posterior-anterior glides and glides in the direction of lumbar extension. 2. Core Strengthening Exercises: Small-arc pelvic bridging, Adductor ball squeeze and Abductor resistance band strengthening.   1. Sacroiliac Joint Mobilization: Maitland Rhythmic Mobilization techniques will be employed, specifically posterior-anterior glides and glides in the direction of lumbar extension. Each set will consist of 30 glides, performed three times with a 30-second rest period between sets. 2. Core Strengthening Exercises: Exercises will include: Small-arc pelvic bridging: 10 repetitions, holding each repetition for 10 seconds. Adductor ball squeeze: 10 repetitions, holding each repetition for 10 seconds. Abductor resistance band strengthening: 10 repetitions, holding each repetition for 10 seconds.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Participants must be between 30 and 50 years of age.
2. Both male and female participants are eligible.
3. Acute cases of PIVD, that is onset in less than three months will be considered.
4. Unilateral lumbar PIVD, as confirmed by MRI findings, will be considered.
5. Only paracentral, foraminal, and extraforaminal disc bulges or prolapses will be included;
6. Participants must exhibit unilateral radiating pain without associated motor or sensory deficits.
 
 
ExclusionCriteria 
Details  1. Participants younger than 30 years or older than 50 years will be excluded.
2. Chronic cases of PIVD, that are diagnosed for more than 3 months will be excluded.
3. Central bulges, Extruded or sequestrated discs, and spinal stenosis will be excluded.
4. Low back pain due to any other cause.
5. Individuals with motor or sensory deficits will be excluded.
6. Individuals who have undergone any physiotherapy or surgical intervention to address lumbar PIVD in the last 3 months.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Visual Analog Scale (VAS)
2. Time Up and Go test (TUG)
3. Oswestry Disability Index (ODI)
 
At:
1. Pre-intervention (Immediately after recruitment)
2. Post-intervention (After 6 sessions of intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 2 
Date of First Enrollment (India)   01/05/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The lumbar-pelvic-hip complex, including the sacroiliac joint (SIJ), constitutes an interconnected anatomical unit. Dysfunctions within one region can often manifest as symptoms in others. Extensive research has established a significant association between lumbar prolapsed intervertebral disc (PIVD), a prevalent cause of low back pain, and SIJ abnormalities. Notably, up to 30.7% of individuals presenting with sciatica and low back pain exhibit concomitant SIJ dysfunction. While SIJ mobilization offers a promising therapeutic approach, further rigorous investigation is imperative to elucidate its efficacy for lumbar PIVD, particularly considering the potential risks associated with spinal and SIJ manipulation in this patient population. To find the efficacy of SIJ mobilization on pain, function and disability in patients with lumbar prolapse intervertebral disc. A total of 45 participants will be recruited based on predefined inclusion and exclusion criteria. A single-group, pre-test-post-test quasi-experimental design will be employed. Participants will receive SI joint mobilization utilizing a postero-anterior glide technique and lumbar extension, in conjunction with core muscle strengthening exercises. Pre- and post-intervention assessments will be conducted using the Visual Analogue Scale, Timed Up and Go Test, and the Oswestry Disability Index. Data Normality will be assessed using the Shapiro-Wilk test. For normally distributed data, paired t-tests will be used to analyze within-group differences. If the data is not normally distributed, the Wilcoxon Signed-Rank test will be used for within-group comparisons. This research aligns with a patient-centered approach, fostering a deeper understanding of the efficacy of SIJ mobilization on pain, function, and disability in patients with lumber PIVD.

 
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