| CTRI Number |
CTRI/2024/10/075082 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of neural mobilization versus kinetic chain activation with blood flow restriction training in cervical radiculopathy |
|
Scientific Title of Study
|
Comparing The Effectiveness Of Neural Mobilization And Kinetic Chain Activation Technique Combined With Blood Flow Restriction Training On Pain, ROM, Grip Strength And Functional Disability In Cervical Radiculopathy- A Randomized Clinical 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 |
Smruti Keskar |
| Designation |
PG Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy ,Department of Orthopaedic Physiotherapy, OPD No 39,Room No 18,Nehru Nagar, Belgavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8378972501 |
| Fax |
|
| Email |
keskarsmruti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Peeyoosha Gurudut |
| Designation |
Professor and Head of Orthopaedic Department |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy ,Department of Orthopaedic Physiotherapy, OPD No 39,Room No 18,Nehru Nagar, Belgavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Peeyoosha Gurudut |
| Designation |
Professor and Head of Orthopaedic Department |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy ,Department of Orthopaedic Physiotherapy, OPD No 39,Room No 18,Nehru Nagar, Belgavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research Center,Belgavi,Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research Center |
| Address |
Nehru Nagar, Belgavi |
| Type of Sponsor |
Private medical college |
|
|
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 Peeyoosha Gurudut |
KLE Dr. Prabhakar Kore Hospital and Medical Research Center |
Orthopaedic Physiotherapy,OPD No. 39, KLE Dr. Prabhakar Kore hospital and Medical Research Centre, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA |
9844821355
peeyooshagurudut@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kinetic Chain Activation Technique and Blood Flow Restriction |
Kinetic Chain Activation Technique combined with Blood Flow Restriction will be given for 2 weeks on alternate days, 5 sessions in total |
| Intervention |
Neural Mobilization and Blood Flow Restriction |
Neural Mobilization combined with Blood Flow Restriction will be given for 2 weeks on alternate days, 5 sessions in total |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants positive for at least one of the following clinical tests: upper limb nerve tension test (ULNTT), Spurling test and Distraction test
Pain intensity greater than 3/10 on the NPRS |
|
| ExclusionCriteria |
| Details |
Patients with previous cervical surgeries and having traumatic history like cervical fractures, dislocation, whiplash injuries
History of carcinoma
Neurological deficits like stroke, SCI, PNI, myelopathy, multiple sclerosis. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain using Numeric Pain Rating Scale, functional disability using Neck Disability Index Scale, grip strength using handheld dynamometer, ROM using goniometer |
Outcome will be assessed at baseline and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
COMPARING THE EFFECTIVENESS OF NEURAL MOBILIZATION AND KINETIC CHAIN ACTIVATION TECHNIQUE COMBINED WITH BLOOD FLOW RESTRICTION TRAINING ON PAIN, ROM, GRIP STRENGTH AND FUNCTIONAL DISABILITY IN CERVICAL RADICULOPATHY- A RANDOMIZED CLINICAL TRIAL Aim of the study-To determine and compare the effectiveness of neural mobilization and KCAT combined with BFR training in cervical radiculopathy. Inclusion criteria: Participants- Between age group 18-60.Presence of unilateral symptoms of arm pain, paraesthesia or numbness in the upper limb.Participants’ positive for at least one of the following clinical tests: upper limb nerve tension test (ULNTT), Spurling test and Distraction test. Pain intensity greater than 3/10 on the NPRS Exclusion criteria: Paricipants-Patients with previous cervical surgeries and having traumatic history like cervical fractures , dislocation, whiplash injuries..History of carcinoma.Neurological deficits like stroke, SCI, PNI, myelopathy, MS.Skin disorders like open wounds, active infection, allergic conditions
Outcome Measures: NPRS, NDI,Handheld dynamometer, Goniometer
Procedure Participants will be divided into two groups. Group A will be given BFR and neural mobilization and group B will be given BFR and KCAT. Participants will be given 5 sessions on alternate days for 2 weeks. Participants will be assessed pre and post intervention.
|