CTRI Number |
CTRI/2025/05/086842 [Registered on: 13/05/2025] Trial Registered Prospectively |
Last Modified On: |
06/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Studying How Mental Practice Affects Neck Awareness, Movement Confidence, and Daily Function in Women with Long-Term Neck Pain |
Scientific Title of Study
|
Impact of Motor Imagery Intervention on Cervical Proprioceptive Accuracy and Kinesiophobia and Disability in Females with Chronic Non-Specific Neck Pain: A Randomized 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 |
Shumaila Khan |
Designation |
Post Graduate Scholar |
Affiliation |
Jamia Hamdard |
Address |
Room No.8, Rehabilitation Centre, Department of Physiotherapy, Jamia Hamdard, Hamdard Nagar, New Delhi
South DELHI 110062 India |
Phone |
6388246009 |
Fax |
|
Email |
770shumailakhan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Zuheb Ahmed Siddiqui |
Designation |
Assistant Professor |
Affiliation |
Jamia Hamdard |
Address |
Room No. 534, 5th Floor, Central Library Building, Department of Physiotherapy, Jamia Hamdard, Hamdard Nagar, New Delhi
South DELHI 110062 India |
Phone |
9810744297 |
Fax |
|
Email |
zuhebahmedsiddiqui@jamiahamdard.ac.in |
|
Details of Contact Person Public Query
|
Name |
Zuheb Ahmed Siddiqui |
Designation |
Assistant Professor |
Affiliation |
Jamia Hamdard |
Address |
Room No. 534, 5th Floor, Central Library Building, Department of Physiotherapy, Jamia Hamdard, Hamdard Nagar, New Delhi
DELHI 110062 India |
Phone |
9810744297 |
Fax |
|
Email |
zuhebahmedsiddiqui@jamiahamdard.ac.in |
|
Source of Monetary or Material Support
|
Jamia Hamdard, Hamdard Nagar, New Delhi - 110062 |
|
Primary Sponsor
|
Name |
Jamia Hamdard |
Address |
Hamdard Nagar, New Delhi - 110062 |
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 Zuheb Ahmed Siddiqui |
Jamia Hamdard |
Room No.8, Rehabilitation Centre,Jamia Hamdard, Hamdard Nagar, New Delhi - 110062 South DELHI |
9810744297
zuhebahmedsiddiqui@jamiahamdard.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Jamia Hamdard Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Conventional Exercises |
• Traditional intervention [Neck stabilization exercises].
• The cervical bracing technique will be performed [24]. The exercises would include workouts using the bracing technique in the neurodevelopment phase (prone, supine, bipedal, quadrupedal) for the cervical spine.
• The contraction will be 10 seconds in each position, with 8 repetitions.
• Then, cervical isometric exercises will be implemented with 10 repetitions and a hold time of 6 to 10 seconds each [24]. NSE will be performed once a day (three days per week, for six weeks)
|
Intervention |
Motor Imagery Exercises |
• The three phases of the motor imagery intervention will be implemented one after the other, in order, for 6 weeks: a) kinesthetic imagery (first and the second week); b) internal visual imagery (third and fourth weeks); and c) external visual imagery along with laterality discrimination (fifth and sixth week). The motor imagery training will be given for a maximum of 25 min, 3 days a week for 6 weeks. |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Female |
Details |
1.Female subjects aged between 30 to 50 years.
2.Diagnosed with non specific chronic neck pain for more than three months.
3.Chronic neck pain having not less than 3 cms on Visual Analogue Scale causing pain, impairment of function and physical disability.
|
|
ExclusionCriteria |
Details |
1.Subjects with a diagnosed cervical radiculopathy or any nerve root involvement.
2.Subjects with a history of osteoporosis
3.Subjects having undergone neck surgery during the past twelve months.
4.Subjects with uncontrolled diabetes with and without peripheral neuropathy.
5.Subjects with diagnosed visual, vestibular & balance impairments.
6.Recent history of injury or trauma to the upper limb.
7.Subjects having any drug abuse.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Neck Pain, Head Repositioning Accuracy, Kinesiophobia |
Baseline, After 4 weeks and after 6 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Neck Disability Index |
Baseline, After 4 weeks and after 6 weeks |
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
19/05/2025 |
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="0" Months="6" Days="15" |
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
|
This randomized controlled trial will be conducted at the Rehabilitation Centre, Department of Physiotherapy, Jamia Hamdard, New Delhi, over a duration of six months. A total of 75 female participants (aged 30–50 years) diagnosed with non-specific chronic neck pain (NSCNP) for over three months will be recruited and randomly allocated into three groups: -
Group A (Control Group): Neck Stabilization Exercises (NSE) -
Group B (Motor Imagery Group): Motor Imagery (MI) Training -
Group C (Combined Group): NSE + MI Intervention Protocol Group A (Control Group): -
Neck stabilization exercises (cervical bracing in different postures) -
Cervical isometrics (10 repetitions, 5-10 sec hold) -
Stretching exercises for upper trapezius, sternocleidomastoid, and levator scapulae (5 reps, 10 sec hold) -
Hot fermentation for 10 minutes Group B (Motor Imagery Group): -
Weeks 1-2: Kinesthetic Imagery – Participants imagine performing neck stabilization exercises with verbal guidance. -
Weeks 3-4: Internal Visual Imagery – Participants watch recorded videos of exercises and mentally rehearse them. -
Weeks 5-6: External Visual Imagery – Participants perform exercises while observing themselves in a mirror. -
Laterality discrimination training with head/neck images (identifying left/right positions). -
MI training duration: 25 minutes, 3 times per week for six weeks. Group C (Combined Group): Outcome Measures Assessments will be conducted at baseline and post-intervention using: -
Pain: Visual Analogue Scale (VAS) -
Kinesiophobia: Tampa Scale of Kinesiophobia (TSK) -
Cervical Proprioception: Head Repositioning Accuracy Test (HRAT) -
Disability: Neck Disability Index (NDI) Data Collection & Analysis -
Data will be recorded using the Nordic Musculoskeletal Questionnaire and manually entered into a pre-planned format. -
Ethical approval will be obtained, and informed consent will be taken from all participants. -
A statistician will analyze the data using appropriate statistical methods. |