| CTRI Number |
CTRI/2024/04/065958 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Relieving Neck Nerve Pain with Stretching and Movement |
|
Scientific Title of Study
|
Effect of PNF stretching and mobilization on pain, hand grip strength and quality of life in patient with cervical radiculopathy: A clinical Trial. |
| Trial Acronym |
A Clinical trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalpana |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, School of Allied Health Science Galgotias University Plot No.2 Yamuna expr Opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6202763753 |
| Fax |
|
| Email |
kalpana.20smas1010082@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surbhi kaura |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
b319 Block B,School of Allied Health sciences Galgotias university Plot No.2 Yamuna Expr Opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8527389589 |
| Fax |
|
| Email |
physiosurbhi123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surbhi kaura |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
b319 Block B,School of Allied Health sciences Galgotias university Plot No.2 Yamuna Expr Opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8527389589 |
| Fax |
|
| Email |
physiosurbhi123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development cell, Room No B-319, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar |
|
|
Primary Sponsor
|
| Name |
Research and Development cell Galgotias University |
| Address |
Room No B-319, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar |
| 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 |
| KALPANA |
Galgotias University |
Room No E003 Department Of Physiotherapy School Of Allied Health Sciences Galgotias University Plot2 Yamuna Expr Opposite Of Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
6202763753
kalpana.20smas1010082@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DEPARTMENTAL RESEARCH COMMITTEE DEPARTMENT OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G542||Cervical root disorders, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Isometric exercises |
In this group conservative treatment will be given which include cervical isometrics exercises of 10 -12 repetition in each direction with 5 second of hold in every isometric movement of 3sets.
Isometric exercises will be performed in sitting position and TENSE will be used for pain management.
|
| Intervention |
PNF Stretching (Hold Relax )
Mobilization ( P-A mobilization) |
Hold relax - The subject will be made to lie in supine position. Therapist will be standing above the head side of bed. the therapist will rotate neck of subject passively and instruct the subject to hold neck in that position for 10 sec and then relax (repeat the same in each angle and direction).
Mobilization (P-A)- Subject will be lie in prone position and therapist will be standing above the head side of bed and The tips of the thumbs will be positioned in an opposition at the level of the cervical vertebras facet joint (for unilateral PA) or spinous process (for central PA). the treating therapist will apply grade two and three oscillatory pressure at the most excruciating level for 2 min and 3 sets will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Radiating symptoms of cervical radiculopathy
Patient with numbness in affected side
If positive result were found in minimum three test Spurling test, Upper limb neurodynamic test 1 and Foramen Compression test and Distraction test |
|
| ExclusionCriteria |
| Details |
Cervical Surgery
Carpel Tunnel Syndrome
Cervical Circulatory Disorder
Traumatic history
Malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain rating scale
Dynamometer
|
Baseline, 4th week and follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| World Health organization quality of life -BREF, The upper extremity functional index. |
Baseline, 4th week and follow up |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
Background Research that has examined the effects of PNF stretching and Mobilization on pain, Hand grip strength and quality of life in patient with cervical radiculopathy. The aim of this study is to examine or Methods Fifty participants with radiating cervical pain with numbness in affected side were randomly allocated to 1- Experimental group (Pre- Hot pack, TENS, PNF stretching hold relax) and 2- control or conventional group (Pre hot pack, TENS isometric exercise) for 4 consecutive weeks. Numeric Pain Rate Scale for pain, Dynamometer for Hand grip strength measurement , WHOQOF-BREF , The upper extremity functional index are measured at baseline, and after completion of session (4week). Keyword – Cervical radiculopathy, PNF stretching, Mobilization
|