| CTRI Number |
CTRI/2025/07/091468 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Neck Muscle activity in individuals undergoing cervical spine surgery |
|
Scientific Title of Study
|
Neck muscle activity in individuals undergoing cervical spine surgery—a single-group pre-post 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 |
Preeti S Agrawal |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
6260246811 |
| Fax |
|
| Email |
preeti.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Manikandan Natarajan |
| Designation |
HOD |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Apoorva M Shankarnarayana |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9591976213 |
| Fax |
|
| Email |
apoorva.s@manipal.edu |
|
|
Source of Monetary or Material Support
|
| 3rd floor, Dhanvantri, Baliga Block, Kasturba Hospital, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Preeti S Agrawal |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal - 576104 |
| Type of Sponsor |
Other [] |
|
|
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 Preeti S Agrawal |
Kasturba Hospital |
3rd floor, Neurorehabilitation Physiotherapy Unit, Baliga block, , Dhanvantari, Kasturba hospital, manipal, Karnataka 576104
Udupi
KARNATAKA |
6260246811
preeti.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G988||Other disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for cervical spine surgery
Medically stable
Age range of 18-65 years
|
|
| ExclusionCriteria |
| Details |
NThis study will include patients undergoing elective cervical spine surgery. However, individuals will be excluded if they have a pain score of six or above on the numerical pain rating scale, a history of prior neck surgeries, or coexisting neurological or musculoskeletal conditions that affect the neck muscles. Patients with skin conditions that prevent the application of EMG electrodes, those presenting with cervical vertebral trauma, and individuals with congenital cervical deformities will also be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage maximum voluntary contraction from EMG and Numerical Pain Rating Scale (NPRS)
|
1 day before surgery(baseline) and
2 days after surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
04/08/2025 |
| 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="1"
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
|
Title
Neck Muscle Activity in Individuals Undergoing Cervical Spine Surgery – A Single Group Pre Post Study
Type of Study
Prospective cross sectional study
Aim and Objective
To assess neck muscle activity in terms of percentage maximum voluntary contraction before and after cervical spine surgery using surface electromyography
Justification
There is limited research on isometric neck muscle activity before and after surgery. Using surface electromyography provides objective data to guide postoperative rehabilitation and improve patient recovery
Study Period
April 2025 to March 2026
Sample Size
37 participants including 20 percent dropout rate
Inclusion Criteria
Adults aged 18 to 65 years scheduled for elective cervical spine surgery and medically stable
Exclusion Criteria
Severe pain score 6 or above on the numerical pain rating scale
History of prior neck surgery
Cervical trauma or congenital deformity
Neurological or musculoskeletal conditions affecting the neck
Skin conditions interfering with electrode placement
Tools Used
Surface electromyography and numerical pain rating scale
Procedure
Muscle activity of the trapezius and sternocleidomastoid will be recorded preoperatively and on the second postoperative day using surface electrodes during specific isometric tasks. Data will be averaged from three trials and compared
Outcome Measures
Percentage maximum voluntary contraction and pain score
Statistical Analysis
Descriptive statistics, normality testing using Shapiro Wilk test
Paired t test or Wilcoxon signed rank test will be used
Significance level set at p less than 0 point zero five
Potential Risks
Minimal risk involving slight discomfort or fatigue
Benefits
Helps design effective rehabilitation protocols
Improves neck strength, function, and overall recovery
Ethical Considerations
Institutional ethics committee approval
Informed consent and confidentiality ensured
Participant safety will be prioritized
Literature Review
Previous studies show changes in neck muscle function after cervical spine surgery. Muscle loss and altered activity patterns are linked to poor outcomes. Early identification and rehabilitation are essential to improve patient recovery and quality of life. |