| CTRI Number |
CTRI/2025/04/083814 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
effectiveness of novel physiotherapy intervention that is PNF (Sprinter pattern and Crunch exercises) to improve lower back function in patients with chronic low back pain. |
|
Scientific Title of Study
|
Efficacy of Proprioceptive Neuromuscular Facilitation on Pain, Quality of life and Dynamic Balance among patients with chronic low back pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Katiyar |
| Designation |
Student |
| Affiliation |
SCHOOL OF HEALTH SCIENCES CHHATRAPATI SHAHUJI MAHARAJ UNIVERCITY KANPUR |
| Address |
Department of Physiotherapy, SHS 106 CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8052648677 |
| Fax |
|
| Email |
kati.003nidhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Digvijay Sharma |
| Designation |
Director |
| Affiliation |
SCHOOL OF HEALTH SCIENCES CHHATRAPATI SHAHUJI MAHARAJ UNIVERCITY KANPUR |
| Address |
Department of Physiotherapy, SHS 106 CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9839217108 |
| Fax |
|
| Email |
digvijaysharma@csjmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Digvijay Sharma |
| Designation |
Director |
| Affiliation |
SCHOOL OF HEALTH SCIENCES CHHATRAPATI SHAHUJI MAHARAJ UNIVERCITY KANPUR |
| Address |
Department of Physiotherapy, SHS 106 CSJMU Kanpur
Kanpur Nagar
UTTAR PRADESH
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9839217108 |
| Fax |
|
| Email |
digvijaysharma@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Health Sciences, Department of physiotherapy SHS 106 CSJMU Kanpur UTTAR PRADESH 208024 India |
|
|
Primary Sponsor
|
| Name |
School of Health Sciences |
| Address |
School of Health Sciences, Chhatrapati Shahuji Maharaj University Kanpur UP India 208012 |
| 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 Digvijay Sharma |
SCHOOL OF HEALTH SCIENCES PHYSIOTHERAPY OPD |
SHS 106 DEPARTMENT OF PHYSIOTHERAPY,SCHOOL OF HEALTH SCIENCES, CHHATRAPATI SHAHU JI MAHARAJ UNIVERSITY,
KANPUR NAGAR
UTTAR PRADESH
208024
INDIA
Kanpur Nagar
UTTAR PRADESH |
09839217108
digvijaysharma@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHHATRAPATI SHAHU JI MAHARAJ UNIVERSITY, KANPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Proprioceptive Neuromuscular Facilitation (Sprinter pattern and crunch exercises) |
Provided for 6 days/week for 2 weeks. 20 minutes of sprinter pattern and 20 minutes of crunch exercises with 30 seconds of rest. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
primary complaints of low back pain(more than month), mechanical low back pain, signed informed consent |
|
| ExclusionCriteria |
| Details |
acute low back pain, history of surgery on the spine, pathological record(disease) of the spine, orthopedic and neurological injuries, seizures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg balance scale,
Mc Gill pain index scale,
Modified Oswestry disability index(MODI) |
at baseline, 2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
30/04/2025 |
| 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
|
INTRODUCTION- Chronic low back pain (CLBP) is one of the most common musculoskeletal problem. More than 80% of world population experiences low back pain at least 15% of 80% suffer from chronic low back pain. Proprioceptive neuromuscular facilitation (PNF) has been widely used in the clinical treatment of the present study will therefore investigate the effect of PNF training on pain, quality of life and dynamic balance patients satisfaction in patients with CLBP. METHODS- This will be Quasi Experimental Design of Study. Sample size was calculated using G power software. 46 participants will be enrolled this study according to selection criteria. Lower back function pain, quality of life and dynamic balance will be assessed at baseline before and after 2 weeks of intervention using Mc gill pain index scale, modified Oswestry disability index, berg balance. Intervention will be PNF (sprinter pattern and crunch exercises) provided 6 days/week for 40 minutes. 20 minutes for sprinter pattern and 20 minutes for crunch exercises. DATA ANALYSIS- Data will be normalized and presented in the form of descriptive statistics data will be analysed using SPSS software and parametric test will be applied. P value less then 0.005 will be considered statistically significant than the result will be published. DISCUSSION- The result of this study will be provide significant insights in to neurorehabilitation of chronic low back pain patients. |