| 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
|
|
|
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. |