| CTRI Number |
CTRI/2025/08/093420 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| 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
|
Effect of neck exercise on goldsmith workers of rajkot |
|
Scientific Title of Study
|
A study to compare 4 weeks effect of McKenzie exercises and Indirect Cervical stabilization exercises on neck pain intensity, flexibility and strength among goldsmith workers of Rajkot: - A randomized control trial”
|
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Paragbhai Ashar |
| Designation |
PG Scholar |
| Affiliation |
Marwadi university |
| Address |
MB 557, Faculty of physiotherapy, Marwadi University Morbi Rajkot highway At and PO Gauridad, Rajkot
Rajkot GUJARAT 360003 India |
| Phone |
08200452435 |
| Fax |
|
| Email |
nidhi.ashar123790@marwadiuniversity.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Nidhi Paragbhai Ashar |
| Designation |
PG Scholar |
| Affiliation |
Marwadi university |
| Address |
MB 557, Faculty of physiotherapy, Marwadi University Morbi Rajkot highway At and PO Gauridad, Rajkot
GUJARAT 360003 India |
| Phone |
08200452435 |
| Fax |
|
| Email |
nidhi.ashar123790@marwadiuniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Ashika gordhanbhai Tanna |
| Designation |
assistant professor |
| Affiliation |
Marwadi university |
| Address |
MB 557, Faculty of physiotherapy, Marwadi University Morbi Rajkot highway At and PO Gauridad, Rajkot
Rajkot GUJARAT 360003 India |
| Phone |
08200452435 |
| Fax |
|
| Email |
ashika.tanna@marwadieducation.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIDHI PARAGBHAI ASHAR |
| Address |
Marwadi University Morbi Rajkot highway At and PO Gauridad, Rajkot |
| Type of Sponsor |
Other [MYSELF] |
|
|
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 Ashish Kakkad |
Physiotherapy OPD |
MCS001, Marwadi University campus OPD Rajkot GUJARAT |
09824415797
ashish.kakkad@marwadieducation.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Marwadi University Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indirect Cervical stability exercises |
Participants will perform postural correction exercises, chin tucks, and scapular stabilization drills. Week 1 emphasizes posture awareness and scapular control. Week 2 introduces deep neck flexor activation with supine nods and stretching. Week 3 integrates cervical isometrics for strength and ergonomic training. Week 4 builds functional stability through dynamic balance and core engagement. Each session lasts 30–45 minutes and is delivered under supervision or guided home-based format. Progress is monitored weekly. |
| Intervention |
McKenzie exercises |
A set of directional preference-based repeated movements and postural correction exercises targeting cervical spine dysfunction. Administered for 4 weeks, 5 days per week, under physiotherapist supervision. Each session includes extension, retraction, lateral movements, and posture education as per McKenzie protocol. |
| Comparator Agent |
standard treatment |
week 1
Neck flexion(5-6 reps).
Neck extension(5-6 reps).
Neck lateral flexion(5-6 reps.)
TENS – continuous mode for 10mins.
week2
Neck flexion(5-6 reps).
Neck extension(5-6 reps).
Neck lateral flexion(5-6 reps).
Chin tuck(5-6 reps, 10sec hold).
TENS- continuous mode for 10mins
week3
Same as 2nd week with increases in repetations and hold.
week 4
Same as 3rd week with increase in repetations along with chin tuck and neck extension.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Male and female both.
Age- 18-50years.
Working as goldsmith for more than 4hrs per day for more than 1 year.
Having neck pain for more than 3 months.
|
|
| ExclusionCriteria |
| Details |
Spinal fracture.
Spinal deformity.
Trauma around neck and shoulder region.
Ankylosing spondylitis.
Any neurological involvement.
Surgery around neck.
Rheumatological conditions.
Severe adhesive capsulitis.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neck pain intensity, Cervical flexibility, Cervical muscle strength and functional load |
baseline and end of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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)
|
01/10/2025 |
| 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
|
A study to compare 4 weeks effect of McKenzie exercises and Indirect Cervical stabilization exercises on neck pain intensity, flexibility and strength among goldsmith workers of Rajkot: - A randomized control trialStudy aims to compare the effects of McKenzie exercises and indirect cervical stabilization exercises on neck pain intensity, flexibility, and strength in goldsmith workers of Rajkot over a 4-week period. Goldsmiths often adopt poor postures due to the nature of their work, leading to musculoskeletal problems, especially chronic neck pain. This randomized controlled trial will help determine which protocol offers more benefit to this occupational group. Eligible participants will be randomly allocated into three groups: Group A will receive McKenzie exercises; Group B will receive indirect cervical stabilization exercises and Group C will receive conventional therapy. All interventions will be provided 5 days a week for 4 weeks. Pre- and post-intervention assessments will be done using the Numeric Pain Rating Scale (NPRS), cervical range of motion (ROM) via goniometer, muscle strength via Lafayette dynamometer and Pain Pressure Threshold (PPT). |