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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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