| CTRI Number |
CTRI/2024/08/072984 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| 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
|
To compare Slider Neurodynamic Mobilisation and Mulligan Bent Leg Raise Technique in chronic discogenic sciatica |
|
Scientific Title of Study
|
Slider Neurodynamic Mobilisation Versus Mulligan Bent Leg Raise Technique on Chronic Discogenic Sciatica A Comparative 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 |
Muskan Kapoor |
| Designation |
MPT MUSCULOSKELETAL Student |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculoskeletal physiotherapy department
Banarsidas Chandiwala Institute of Physiotherapy Chandiwala estate maa anandmai marg kalkaji , New Delhi
South DELHI 110019 India |
| Phone |
8447581683 |
| Fax |
|
| Email |
mk6682515@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Niti Khurana |
| Designation |
Assistant Professor |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculosketal physiotherapy department ,chandiwala estate Maa Anandmai Marg Kallkaji New Delhi
South West DELHI 110019 India |
| Phone |
9811052132 |
| Fax |
|
| Email |
nitikhurana@bcip.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Avi chaudhary |
| Designation |
Senior Assistant Professor |
| Affiliation |
Banarsidas Chandiwala Institute of Physiotherapy |
| Address |
Musculosketal physiotherapy department chandiwala estate maa Anandmai Marg Kalakji , New Delhi
South West DELHI 110019 India |
| Phone |
9717763533 |
| Fax |
|
| Email |
avichaudhary@bcip.ac.in |
|
|
Source of Monetary or Material Support
|
| Banarsidas Chandiwala institute of Physiotherapy , Musculosketal physiotherapy department , chandiwala estate Maa anandmai marg , Kalkaji New Delhi ,110019 |
|
|
Primary Sponsor
|
| Name |
Muskan Kapoor |
| Address |
1A/183 NIT Faridabad , Haryana , 121001 |
| Type of Sponsor |
Other [self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Niti Khurana |
Banarsidas Chandiwala Institute of Physiotherapy |
Musculoskeletal physiotherapy department ,Banarsidas Chandiwala Institute of Physiotherapy, Chandiwala Estate, Maa Anandmai marg, kalkaji, 110019 South West DELHI |
9811052132
nitikhurana@bcip.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banarsidas chandiwala institute of physiotherapy Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mulligan bent leg raise technique |
Mulligan bent leg raise technique is a manual therapy technique developed by Brian Mulligan use to treat sciatica. Treatment will be given for three sessions per week for four weeks on alternate basis. |
| Intervention |
Slider Neurodynamic Mobilisation |
Slider Neurodynamic Mobilisation is a therapeutic technique use to treat condition involving nerve entrapment such as sciatica. Treatment will be given for three sessions per week for four weeks on alternate basis .
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of discogenic sciatica reffered by orthopedic surgeon.
ï‚· BMI less than 30 . 28
ï‚· Age 35-55years. 5
ï‚· Both male and females.
ï‚· History of sciatica for more than 12 weeks or at least 3 episodes of intermittent sciatica each last for more than 1 week.
ï‚· Positive slump test and SLR test(limited to 30-70 degree) with reproduction of neurological symptoms.
|
|
| ExclusionCriteria |
| Details |
ï‚· Spinal condition such as infection, tumors secondary metastases, osteoporosis, and spinal fracture.
ï‚· Piriformis Syndrome, SI Joint arthropathies , Hamstring tightness
ï‚· LBP caused by systemic or organic diseases, or central nervous system involvement
ï‚· systemic disease as diabetes or neurological condition that alters the function of the nervous system.
ï‚· Diagnosed nerve lesions of the lower limb
ï‚· Hip or knee or ankle joints pathology causing limitation of movement
ï‚· Pregnant females ,post partum (upto 6 months post cesarean section) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain using VAS score
Quality of life using Modified Oswestry low back pain disability questionnaire |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range Of motion using Measuring tape & Goniometer |
1 year |
|
|
Target Sample Size
|
Total Sample Size="82" Sample Size from India="82"
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)
|
03/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" 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
|
For patients with discogenic sciatica, slider neurodynamic mobilisation technique produces sliding movement of the neural tissue in relation to its adjacent structures, which distributes tension and compression along the nervous system instead of one specific region is very effective in reducing symptoms and limitations. MBLR is a useful method for releasing adhesions between the gluteus maximus, hamstring, and sciatic nerve. As a result, the sciatic nerve will be mobilized relative to these muscles without the nerve being stretched which have significant clinical outcomes regarding pain alleviation and restoring sciatic nerve mobility. After reviewing the available previous published studies, it is found that there is no previous study which directly compared both techniques in case of chronic discogenic sciatica, although both techniques are found to induce good clinical outcomes when studied separately , so we will conduct this study to examine the superiority of effectiveness of them. |