CTRI Number |
CTRI/2025/04/085400 [Registered on: 23/04/2025] Trial Registered Prospectively |
Last Modified On: |
22/04/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Avoiding Surgery: The Role of Conservative Care in Neck Disc Issues |
Scientific Title of Study
|
To evaluate the effectiveness of conservative treatment in patients with cervical disc prolapse. |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Bharat R Dave |
Designation |
Principal Investigator and Spine Surgeon |
Affiliation |
Stavya Spine Hospital And Research Institute |
Address |
Room No-9, 2nd floor Annexe , Department-Research department
Stavya Spine hospital and Research Institute Mithakhali, Ellisbridge.
Ahmadabad GUJARAT 380006 India |
Phone |
9825019913 |
Fax |
07926408174 |
Email |
brd_172@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Bharat R Dave |
Designation |
Principal Investigator and Spine Surgeon |
Affiliation |
Stavya Spine Hospital And Research Institute |
Address |
Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Mithakhali, Ellisbridge.
Ahmadabad GUJARAT 380006 India |
Phone |
9825019913 |
Fax |
07926408174 |
Email |
brd_172@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Bharat R Dave |
Designation |
Principal Investigator and Spine Surgeon |
Affiliation |
Stavya Spine Hospital And Research Institute |
Address |
Room No-9, 2nd floor Annexe , Department-Research department
Stavya Spine hospital and Research Institute Mithakhali
Ellisbridge
Ahmadabad GUJARAT 380006 India |
Phone |
9825019913 |
Fax |
07926408174 |
Email |
brd_172@yahoo.com |
|
Source of Monetary or Material Support
|
Room No-9, 2nd floor Annexe , Department-Research department
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmadabad GUJARAT 380006 India |
|
Primary Sponsor
|
Name |
Stavya Spine Hospital and Research Institute |
Address |
Room No-9, 2nd floor Annexe , Department-Research department
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmadabad GUJARAT 380006 India |
Type of Sponsor |
Research institution and hospital |
|
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 Bharat R Dave |
Stavya Spine Hospital & Research Institute |
Room No-9, 2nd floor Annexe , Department-Research department
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmadabad GUJARAT 380006 India Ahmadabad GUJARAT |
09825019913 07926408174 brd_172@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Stavya Spine hospital & Research Institute IEC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S142||Injury of nerve root of cervical spine, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Nil |
Nil |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Age – 18 – 60 years
2.Presence of neck pain and radicular symptoms of a minimum duration of 1 month.
3.Diagnosis of cervical disc prolapse with associated nerve root compression, as confirmed by magnetic resonance imaging (MRI), corresponding to the clinical presentation of radicular symptoms. |
|
ExclusionCriteria |
Details |
1.Presence of neurological impairments or clinical evidence of myelopathy.
2.A documented history of prior cervical spine surgery.
3.Individuals demonstrating neurological deficits.
4.Individuals with a history of neuropsychiatric conditions.
5.Individuals with a history of traumatic injury to the cervical spine.
6.Individuals with significant comorbidities that may interfere with treatment outcomes (e.g., severe osteoporosis, malignancies, or systemic inflammatory disorders). |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
VAS score
Kernofsky performance score
NDI score |
Visits at 3 months,6 months and 12 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
07/05/2025 |
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="2" 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
|
Neck pain represents a significant global public health concern, with a wide range of etiologies. Among the various causes, cervical prolapsed intervertebral discs are one of the most prevalent contributors. Cervical disc prolapse arises when the nucleus pulposus, the inner gel-like component of the intervertebral disc, herniates and exerts pressure on the cervical spinal cord or nerve roots. This compression can lead to a range of neurological symptoms. The incidence of cervical disc herniation is approximately 1.79 per 1000 individuals per year , with the highest frequency observed in individuals during the fourth or fifth decade of life. Clinically, patients typically present with symptoms such as neck pain, arm pain, and sensory deficits, which often correspond to the dermatome of the affected cervical nerve root(s) .
Although there is a lack of universally accepted diagnostic criteria for cervical radiculopathy , the diagnosis is primarily established through a combination of clinical examination, patient history, and imaging, particularly magnetic resonance imaging (MRI). MRI serves as a valuable diagnostic tool, aiding in the visualization of disc herniation and the extent of nerve root or spinal cord involvement.
Treatment for cervical disc prolapse typically begins with conservative management, which includes pharmacological interventions, physical therapy, immobilization, cervical traction, and epidural steroid injections. In cases where conservative treatment fails to provide relief or in the presence of significant neurological deficits, myelopathy, or radiological evidence of spinal cord injury, surgical intervention may be indicated. Surgical options may include discectomy, fusion, or more advanced procedures, depending on the severity and location of the disc herniation. Further studies are needed to refine diagnostic criteria, optimize conservative treatment protocols, and evaluate long-term outcomes associated with both non-surgical and surgical management.
There is limited literature concerning the duration of conservative therapy for cervical disc prolapse, largely due to the unclear natural history of this condition. In our study, we aim to evaluate the efficacy of conservative treatment in patients diagnosed with cervical disc prolapse. |