| CTRI Number |
CTRI/2024/11/077323 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring Treatment and recovery in Cervical Radiculopathy |
|
Scientific Title of Study
|
Fate and Recovery: An Exploration of Treatment and rehabilitation strategies in cervical radiculopathy patients – A Prospective Cohort 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 |
Sriram K |
| Designation |
Ph D Scholar |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD NO.05
Neuro physiotherapy Department
SDM College of Medical Science and Hospital
Manjushree Nagar
Sattur
Dharwad
Karnataka-580009
INDIA
OPD NO.05
Neuro physiotherapy Department
SDM College of Medical Science and Hospital
Manjushree Nagar
Sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
9487662107 |
| Fax |
|
| Email |
sreeramkarunakaran12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JYOTI S JEEVANNAVAR |
| Designation |
Professor and Ph.D guide |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Physiotherapy Manjushree Nagar
Sattur
Dharwad 580009
Karnataka
INDIA
OPD NO.05
Neuro physiotherapy Department
SDM College of Medical Science and Hospital
Manjushree Nagar
Sattur
Dharwad
Karnataka-580009
INDIA
Dharwad
KARNATAKA
580009
India |
| Phone |
9972189767 |
| Fax |
|
| Email |
jyoti.jeevannavar@sdmuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sriram K |
| Designation |
Ph D Scholar |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD NO.05
Neuro physiotherapy Department
SDM College of Medical Science and Hospital
Manjushree Nagar
Sattur
Dharwad
Karnataka-580009
INDIA
OPD NO.05
Neuro physiotherapy Department
SDM College of Medical Science and Hospital
Manjushree Nagar
Sattur
Dharwad
Karnataka-580009
INDIA
Dharwad
KARNATAKA
580009
India |
| Phone |
9487662107 |
| Fax |
|
| Email |
sreeramkarunakaran12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SDM College of Physiotherapy |
| Address |
SDM College of Physiotherapy Manjushree Nagar, Sattur, Dharwad - 580 009. Karnataka, INDIA. |
| 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 |
| Sriram k |
SDM College of Medical sciences and Hospital |
OPD NO.05
Neuro physiotherapy Department
SDM College of Medical Science and Hospital
Manjushree Nagar
Sattur-580009
INDIA
Dharwad
KARNATAKA |
9487662107
sreeramkarunakaran12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMIEC |
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 |
PHYSIOTHERAPY |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of any gender between 18 to 60 years of age
2. Patients diagnosed with cervical radiculopathy by medical practitioner, associated with or without herniated disc, spondylosis, and/or degenerated disc |
|
| ExclusionCriteria |
| Details |
1.Patients Diagnosed with cervical myelopathy
2.Patients with history of Shoulder disorders like Peri arthritic shoulder /frozen shoulder, reflex sympathetic dystrophy of upper limb, shoulder dislocation and acute fractures
3.Patient who are on active treatment for Malignancy, Rheumatoid Arthritis, Ankylotic spondylosis, systemic Infections, and polyneuropathy
4.Patient with history of cervical spinal surgery will be excluded while other spinal surgeries in the previous 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
NUMERICAL PAIN RATING SCALE
NECKPAIN DISABILITY INDEX
THE WHOQOL BREF
CERVICAL RADICULOPATHY IMPACT SCALE
DYNAMOMETER
INCLINOMETER
NINE HOLE PEG TEST |
1st point of enrollment
2nd at time of discharge
3rd at 6 month follow-up
4th at 1 year follow-up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
DYNAMOMETER
INCLINOMETER
NINE HOLE PEG TEST |
1st point of enrollment
2nd at time of discharge
3rd at 6 month follow-up
4th at 1 year follow-up
|
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
09/12/2024 |
| 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="8"
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
|
Studying the fate and progression of cervical radiculopathy is crucial for several reasons. Understanding how the condition evolves over time can help health care providers to make informed decisions regarding treatment strategies and interventions. The study will help the researchers to identify various factors that may influence the duration and severity of the symptoms, as well as the potential risk factors for disease progression. This knowledge can lead to development of more effective management approaches and personalized treatment plan for individuals with cervical radiculopathy. Additionally, it may contribute to advancement of medical knowledge and improve patient outcomes in the long run. The results obtained from the study will improve the understanding of the therapists in view of the prognosis of the condition and help in planning and provision of more effective rehabilitation strategies in patients with cervical radiculopathy. The data will help in understanding the long-term effects of conservative management, and the impact of environmental factors like occupation and life style on the development and progression of cervical radiculopathy along with the impending influence on quality of life. Various studies have reported a low to moderate Sensitivity and specificity of various clinical diagnostic techniques like ULTT, Spurling’s test, compression test and distraction test individually. The data obtained from this study may provide insides into these metrics of such tests |