| CTRI Number |
CTRI/2024/05/067750 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Motor imagery with conventional treatment in patients with chronic neck pain |
|
Scientific Title of Study
|
Comparison of conventional treatment versus conventional treatment with motor imagery in patients with chronic neck pain : A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipti Geete |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
OPD Room No. 5, Physiotherapy Department (402), P.T. School and
Centre, Seth Dhurmal Bajaj Orthopaedic Centre and Research
Institute, KEM Hospital, Acharya Donde Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
dipti_geete@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dipti Geete |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai |
| Address |
OPD Room No. 5, Physiotherapy Department (402), P.T. School and
Centre, Seth Dhurmal Bajaj Orthopaedic Centre and Research
Institute, KEM Hospital, Acharya Donde Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
dipti_geete@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhargavi Unhale |
| Designation |
Master of Physiotherapy (Musculoskeletal Sciences) |
| Affiliation |
PT School and Centre, Seth GSMC and KEMH |
| Address |
OPD Room No. 5, Physiotherapy Department (402), P.T. School and
Centre, Seth Dhurmal Bajaj Orthopaedic Centre and Research
Institute, KEM Hospital, Acharya Donde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224143435 |
| Fax |
|
| Email |
bhargavissu03@gmail.com |
|
|
Source of Monetary or Material Support
|
| P. T. School and Centre, Seth GS Medical College and KEM Hospital. |
|
|
Primary Sponsor
|
| Name |
Dipti Geete |
| Address |
P. T. School and Centre, Seth GS Medical College and KEM
Hospital. |
| Type of Sponsor |
Other [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 |
| Dr Dipti Geete |
Seth GS Medical College and KEM Hospital |
OPD Room No. 5,
Physiotherapy
Department (402), Seth
Dhurmal Bajaj
Orthopaedic Centre and
Research Institute,
KEM Hospital, Acharya
Donde Marg, Parel.
Mumbai
MAHARASHTRA |
02224143435
dipti_geete@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Seth GS Medical College and KEM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
The subjects will be called 3 times a week for a period of 3 week (Frequency) and they will perform 3 sets of 10 repetitions twice a day of the following
conventional therapy exercises:
Range of Motion exercises
1.Cervical flexion, extension
2.Side flexion
3.Lateral rotation
Head nods
Prone Head lifts
Serratus anterior activation
Shoulder shrugs |
| Intervention |
Motor imagery |
Frequency -10 repetitions, 2 times /day 3 days /week.
Duration for each patient- 3 weeks.
Patient will be asked to be in relaxed position(sitting).
He/she will be asked to fill Patient Specific Functional Scale.
According to this scale patient is asked to name any 3 most painful activities in
descending order.
Then they will be asked to close their eyes and imagine the 3 painful activities which
they have mentioned in Patient Specific Functional Scale.After this, the patient will be then asked to imagine the following exercises: ROM, Head
nods, Prone head lifts.
Subsequently, the patient will be asked to perform the same conventional treatment
exercises as mentioned for control group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.The participants who were willing to participate in the study.
2.Men and women aged between 18 and 45 years
3.Subjects having neck pain for more than 3 months.
|
|
| ExclusionCriteria |
| Details |
Any history of trauma or spine surgery
Cervical myelopathy
Neurological disorders such as Parkinsons disease, multiple sclerosis, stroke, etc
Metabolic disorders
Thoracic Outlet syndrome
•Pregnancy, rheumatoid arthritis, ankylosing spondylitis
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Numerical pain rating scale for pain
2.Neck disability index for assessing disability of neck
3.TAMPA scale of kinesiophobia -11 for assessing fear of movement.
4.Inclinomter for measuring cervical ROM
5.Patient Specific Functional Scale |
Assessment will be done at baseline and at the end of 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Specific Functional Scale |
Assessment will be done at baseline and at the end of 3rd week |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="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
|
Chronic neck pain is the pain that the patient experiences for longer than 12 weeks. According to Childs et al., 10%–20% of people report having neck issues at any one moment, with 54% of people reporting experiencing neck pain in the previous six months. Patients with chronic neck pain experience maladaptive neuroplasticity in the primary somatosensory cortex along with this, it causes changes in cortical proprioceptive representations that facilitates the execution, coordination and planning there by leading to impaired motor performance of individuals. Hence, focusing on these changes as a result of chronic pain is important to enhance the motor performance of patients. This study aims to assess the effectiveness of adding motor imagery to conventional treatment on pain intensity, disability, kinesiophobia and ROM in the patients with Chronic neck pain. 52 patients with chronic neck pain fulfilling the inclusion criteria will be recruited in the study and will be assessed for the following parameters which include Pain using Numerical Pain Rating Scale, cervical range of motion using Inclinometer, Disability using Neck Disability Index, and Kinesiophobia using Tampa Scale of Kinesiophobia -11. Patients will be randomized into 2 groups : 1)Experimental group receiving motor imagery(imagining painful activities mentioned in PSFS and head nods, prone head lifts and ROM exercises) with conventional treatment exercises and 2)Control group receiving conventional treatment (ROM exercises, Prone head lifts, head nods, serratus anterior strengthening and shoulder shrugs). Patients in both groups will be called for 3 times a week for a period of 3 week and they will perform 3 sets of 10 repetitions and 2 times a day of the given exercise. Post assessment will be taken at the end of 3rd week. All of data will be collected and compared. Categorical data will be summarized using frequency and percentage. Normality will be checked using Shapiro Wilk Test. Inter Group Analysis depending on normality, Independent T Test (Parametric) or Mann Whitney (Non Parametric) will be used to compare Pain (Numerical Pain Rating Scale), Kinesiophobia (TAMPA scale), Disability (Neck Disability Index) and Cervical ROM (Inclinometer). Intra Group Analysis depending on normality, Paired T Test (Parametric) or Wilcoxon Signed Rank test (Non-Parametric) will be used to compare Pain (Numerical Pain Rating Scale), Kinesiophobia (TAMPA scale), Disability (Neck Disability Index) and Cervical ROM (Inclinometer). A 2-tailed P < 0.05 will be considered to be statistically significant. Statistical analysis will be performed by appropriate statistical tests using IBM SPSS v26 (statistical package for social sciences) software. |