| CTRI Number |
CTRI/2024/09/073944 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out effect of proprioceptive training and neural mobilization on lumber radiculopathy. |
|
Scientific Title of Study
|
Effect of Proprioceptive Training and Neural Mobilization
on Pain Disability Quality of Life and Psychological status among patient with lumbar radiculopathy A quasi experimental trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Paritosh Dwivedi |
| Designation |
Student |
| Affiliation |
Chhatrapati Shauji Maharaj University Kanpur |
| Address |
Room No 102,Chhatrapati Shauji
Maharaj University, School of health Sciences, Kalyanpur Kanpur Nagar.
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
6386497885 |
| Fax |
|
| Email |
sd589031@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adarsh Kumar Srivastav |
| Designation |
Assistant Professor |
| Affiliation |
Chhatrapati Shauji Maharaj University Kanpur |
| Address |
Room No 144,Chhatrapati Shauji
Maharaj University, School of health Sciences, Kalyanpur Kanpur Nagar.
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8618889003 |
| Fax |
|
| Email |
adarshkumarsrivastava@csjmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adarsh Kumar Srivastav |
| Designation |
Assistant Professor |
| Affiliation |
Chhatrapati Shauji Maharaj University Kanpur |
| Address |
Room No 144,Chhatrapati Shauji
Maharaj University, School of health Sciences, Kalyanpur Kanpur Nagar.
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8618889003 |
| Fax |
|
| Email |
adarshkumarsrivastava@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Health Sciences,
Chhatrapati Sahuji Maharaj University Kalyanpur Kanpur Nagar 208024 Uttarpradesh India |
|
|
Primary Sponsor
|
| Name |
School of Health Sciences |
| Address |
School of Health Sciences, Chhatrapati ShahuJi Maharaj University Kanpur UP India 208024 |
| Type of Sponsor |
Research institution |
|
|
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 Adarsh Kumar Srivastava |
Chhatrapati Shahuji Maharaj University Kanpur |
Room No 106 School of Health Sciences, Chhatrapati Shahuji Maharaj University Kanpur
Kanpur Nagar
UTTAR PRADESH |
8618889003
adarshkumarsrivastav@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Commitee,Chhatrapati Shahuji Maharaj University Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neural Mobilization |
Participant will go for Neural mobilization exercises include slump stretch, sciatic nerve glide, standing hamstring stretch individual perform 3 sessions per week for up to 2 weeks. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Proprioceptive Training |
Protocol involve 5 min warm up exercises include single leg balance exercise, lumbar stabilization exercise participating individual perform 3 sessions per week for up to 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Positive straight leg raising
positive slump test
abnormal reflexes
muscle weakness
|
|
| ExclusionCriteria |
| Details |
History of any back surgery in last 6 months.
Any neurological Impairement such as dementia or
cognitive Impairement.
presence of psychological disorders
Spinal injury
tumor
fracture |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain, Disability, Quality of Life, Psychological Status
|
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
27/09/2024 |
| 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="1"
Months="0"
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
|
Introduction- Lumbar Radiculopathy is described as any pain originating either due to lumbar disc herniation occurring at any level or compression of sciatic nerve along its course. Symptoms of lumbar radiculopathy include pain, paresthesia and numbness along the dermatome and myotome. It is highly prevalent in our society and patients suffering from it experience greater work related absentism and higher disability affected days of living (DALY’s). The objective of this study will be to identify the effect of proprioceptive training and neuralmobilization on pain, disability, quality of life and psychological status in patients with lumbar radiculopathy. Hypothesis of this study will that combine treatment will produce significant results.
Methods- sample size was calculated using G Power. 32 participants will be enrolled in this study. Pain will be assessed using Numeric Pain Rating Scale, Disability will be assessed using oswestry disability scale, Quality of life will be assessed using Short form 36 and psychological status will be assessed using pain catastrophizing scale. Data will be recorded at baseline and after 2 weeks of intervention. Data will be normalized. Data will be analyzed using SPSS software and expressed in the form of descriptive statistics. P value of 0.005 will be considered statistically significant.
Results- results of this study will provide insights into rehabilitation of patients using novel technique of proprioception and neural mobilization. |