| CTRI Number |
CTRI/2024/02/062699 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| 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
|
Management of Non-Specific Neck Pain in Housewives Using Self-Management Strategies |
|
Scientific Title of Study
|
Determining the Effect of Patient Education and Self-Management Strategies in Management of Non-Specific Neck Pain in Housewives |
| 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 Nehal Deepti |
| Designation |
Postgraduate student |
| Affiliation |
Amity Institute of Physiotherapy, Amity University, Noida |
| Address |
F-1 Block, LGF, Amity Institute of Physiotherapy, Amity University, Sector-125, Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8800964638 |
| Fax |
|
| Email |
nehal.deepti@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya |
| Designation |
Assistant Professor |
| Affiliation |
Amity Institute of Physiotherapy, Amity University, Noida |
| Address |
Room no.- 107A, First floor, Amity Institute of Physiotherapy, Amity University, Sector-125, Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9878529787 |
| Fax |
|
| Email |
pkumar24@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashish Chaudhary |
| Designation |
Physiotherapist |
| Affiliation |
Jyraj Clinic |
| Address |
Jyraj Clinic, Shop no.- 13, Ground floor tower, Paramount florence plaza, Sector 137, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201305
India |
| Phone |
8864962878 |
| Fax |
|
| Email |
kashish3005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jyraj Clinic, Shop no.- 13, Ground floor tower, Paramount florence plaza, Sector 137, Noida, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Nehal Deepti |
| Address |
304, Tower 3, Paramount Floraville, sector 137, Noida, Uttar Pradesh, India |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Nehal Deepti |
Jyraj Clinic |
Jyraj Clinic, Shop no.- 13, Ground floor tower, Paramount florence plaza, Sector 137, Noida, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH |
8800964638
nehal.deepti@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee, Amity Institute of Health Allied Sciences, Amity University, Uttar Pradesh |
Approved |
| NOC from Jyraj Clinic |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non-Specific Neck Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Combination of patient education intervention and self-management strategies |
Housewives will be receiving both patient education along with self-management strategies protocol
Duration: Two months |
| Intervention |
Patient education intervention |
• Educating the participants about non-specific neck pain
• Educational video [reassurance, basic advice about posture, early return to daily activities, pain relief methods (ice, heat)]
• Continuation of normal activities
• Advice given verbally (explanation fear of pain, acute pain expected, move as naturally as possible)
Duration: Two months |
| Intervention |
Self-management strategies |
Details of specific neck exercises:
• Upward and downward movement of eyes without moving the head and neck
• Downward and forward movement of eyes without moving the head and neck
• Chin tucks by bringing chin towards sternum
• Pressing the back of the head on the bed
Details of general neck exercises
• Moving the head up and down
• Rotating the head to the left then right as to see the shoulder
• Bending head to each side as trying to touch the shoulder with the ear
• Shoulder abduction
• Shoulder flexion
• Elbow flexed at 90° and forearm supinated, then take the hand away from the trunk
• Shoulder shrugging
Duration: Two months |
|
|
Inclusion Criteria
|
| Age From |
28.00 Year(s) |
| Age To |
48.00 Year(s) |
| Gender |
Female |
| Details |
Adults experiencing neck disorders, whether they were acute (lasting less than 30 days), sub-acute (30 to 90 days), or chronic (lasting more than 90 days), were classified under the category of neck disorders: neck pain, including non-specific (mechanical, simple) neck pain of unidentified aetiology.
NDI value less than 24 (mild to moderate disability scores on NDI) |
|
| ExclusionCriteria |
| Details |
1. Neurological disorders (i.e. irradiated pain) and headache as a consequence of specific headache diagnosis
2. Malignancy and infection
3. Trauma (i.e. fractures)
4. Cerebrovascular insufficiency
5. Chronic disease of the musculoskeletal system (e.g. polyarthritis, muscular disease)
6. Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disability with Neck Disability Index and Pain with Numeric Pain Rating Scale |
Two months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life with 36-Item Short Form Survey |
Two months |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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 2 |
|
Date of First Enrollment (India)
|
20/02/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Non-specific neck
pain (NSNP) is a common musculoskeletal condition that affects people globally
with symptoms such as pain, stiffness, and discomfort in the cervical region
without any identifiable underlying pathology. Its prevalence is generally
higher in women (5.8 %) than in men (4.0 %).
Need of the
study:
•
High
prevalence: Non-specific neck pain affects a large number of the population which
causes discomfort and quality of life gets affected. Approximately a quarter of
all physiotherapy outpatient appointments are related to this condition, which
has a lifetime occurrence rate of 12% to 70% in the general population.
•
Approximately
a quarter of all physiotherapy outpatient appointments are related to this
condition, which has a lifetime occurrence rate of 12% to 70% in the general
population
•
Empowerment of patients: Patient education
and self-management strategies make individuals more aware and they can take an
active role in their care, making them able to make informed decisions and
adopt changes in their healthy lifestyle.
•
Cost-effectiveness: Self-management
protocols can reduce healthcare costs by minimizing frequent medical visits and
long-term medication use.
•
Long-term benefits: Educating patients
about self-management techniques can lead to improvements in symptoms reducing
the burden of the condition in the long run.
Aim:
•
To
determine the effect of patient education and self-management strategies in
management of non-specific neck pain in housewives.
Objective:
- To
evaluate the effect of patient education, self-management strategies and
the combined effect of both the interventions.
•
To
investigate one month post intervention benefits of patient education and
self-management strategies into management of non-specific neck pain in
housewives.
|