| CTRI Number |
CTRI/2024/07/070261 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Cervical position sense, Muscle activity patterns and available Neck movement range in patients after 6 months of Neck decompression surgery |
|
Scientific Title of Study
|
Cervical Proprioception, Muscle activity patterns and Range of motion in patients after 6 months of decompression surgery |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A Mangala gowri |
| Designation |
Post Graduate |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Medical Sciences and Hospital, Multispeciality building, 1st floor, Neuro-Physiotherapy department, Sattur, Dharwad, Karnataka, India, 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9538973049 |
| Fax |
|
| Email |
mangalagowri3105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudhir Bhatbolan |
| Designation |
Professor |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Medical Sciences and Hospital, Multispeciality building 1st floor, Neuro-Physiotherapy department Sattur, Dharwad, Karnataka, India, 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9538973049 |
| Fax |
|
| Email |
sudhirbhatbolan@sdmuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
A Mangala gowri |
| Designation |
Post Graduate |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM College of Medical Sciences and Hospital, Multispeciality building, 1st floor, Neuro-Physiotherapy department, Sattur, Dharwad, Karnataka, India, 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9538973049 |
| Fax |
|
| Email |
mangalagowri3105@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Physiotherapy, Sattur, Dharwad, India, 580009 |
|
|
Primary Sponsor
|
| Name |
A Mangala gowri |
| Address |
ward no:14, Door no:81/3, Rupanagudi Narappa street, Millerpet, Ballari, 583101 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| A Mangala gowri |
SDM College of Medical sciences |
Neuro-Physiotherapy OPD, 1st floor Multispeciality building
Dharwad
KARNATAKA |
9538973049
mangalagowri3105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM College of Medical Sciences and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Any gender
2. Aged between 25 to 55 years
3. Patients diagnosed with cervical radiculopathy, spondylosis; who have undergone decompressive surgical procedure at least six months back.
Inclusion Criteria: Healthy volunteers
1. Apparently healthy individuals of same age category and any gender
|
|
| ExclusionCriteria |
| Details |
1. Patient who has undergone spinal decompressive surgery more than once
2. Any localised infection, inflammation around cervical area
3. If patient reports persistent, debilitative recurrence of neck pain or other symptoms.
4. Patient who is not consenting to participate
5. Patient with any other neurological condition like Parkinsons, stroke etc. that could affect the mobility or muscle recruitment around cervical area
6. Patients who have undergone cervical surgical procedure for radiculopathy due to vertebral fracture dislocation, vertebral collapse, trauma to cervical roots with avulsion or radiation injury, Infiltrative, neoplastic, infectious, Para infectious and metabolic conditions.
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
inclinometer
joint position error test
Electromyograph |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Inclinometer
Joint position error test
Electromyograph |
6 months |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="41" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| 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
Modification(s)
|
Cervical Radiculopathy (CR) is broadly defined as “Pain in a radicular pattern in one or both upper extremities related to compression and/or irritation of one or more cervical nerve roots. Frequent signs and symptoms include varying degrees of sensory, motor, and reflex changes as well as dysesthesias and paresthesia’s related to nerve roots without evidence of spinal cord dysfunctionâ€.
In the patients who do not respond to conservative treatment are referred for surgery. The indications for surgical management include individuals with growing motor weakening, or unremitting radicular pain after 6 to 12 weeks of conservative treatment.
After cervical discectomy, patients had neck pain, significantly lower ROM especially the extension to a greater extent followed by flexion and rotation range of motion restriction. Muscle strength was also reported to be lowest in rotators, lower in extensors and low in flexor group and hand muscles. Patients after ACDF surgery were also reported with decreased neck muscle endurance and balance.
A basic Cervico-Cephalic sensitivity test was developed by Revel et al. with the goal of identifying changes in Cervical proprioception. In particular, this method assesses the subject’s capacity to precisely move their heads to a subjective straight-ahead posture while wearing blindfolds.
The muscle strength/ activation remains as a significant domain of Cervical activity and requires to be assessed. A gold standard to achieve this is the Electromyography (EMG) recording. Two of the biggest and most visible muscles in the cervical region is the sternocleidomastoid muscle (SCM) and the upper trapezius muscle (UT). Accurate motions of the head and neck require proper cooperation and coordination between those two muscles.
Patient follow up post-surgery, focus is on symptoms especially pain/ tingling/ radiation; while ROM and Muscle activation parameters are frequently missed, while proprioception which has an important role in maintenance of postural reactions, balance etc due to linkage to the vestibular, visual connections remains as the least addressed component.
These evaluations may be difficult to perform in the initial days/ weeks post-surgery due to the presence of kinesiophobia, localised pain at surgical site and muscle guarding Thus, assessing a patient at an interval of atleast 6 months post-surgery which allows for natural course of recovery is viable and could provide vital insights and is therefore justified.
Scoping through the available literature reveals a literature gap in comprehensively and collectively analyzing the components of Proprioception, muscle activation and ROM post-decompression surgery for Cervical radiculopathy at a longer follow up period like 6 months. An objective understanding in this regard, further should help in improving the patient care and recovery by adopting early guided strategies in the course of rehabilitation. Thus, there is a strong and justified need to perform this proposed study.
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