| CTRI Number |
CTRI/2025/07/091385 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Russian Current and Exercise Therapy on Neck Pain Due to Mobile Overuse |
|
Scientific Title of Study
|
Combined Effect of Russian current and strengthening exercise in patient with text neck syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suraj Pradhan |
| Designation |
MPT student |
| Affiliation |
Maharshi Markendeshwar institute of Physiotherapy and Rehabilitation |
| Address |
Room No.2 Ground Floor Department of physiotherapy, Maharishi Markendeshwar (deemed to be University), Mullana
Ambala
Haryana
133207
India
Ambala
HARYANA
133207
India |
| Phone |
8305344214 |
| Fax |
|
| Email |
surajctri24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Professor |
| Affiliation |
Maharshi Markendeshwar institute of Physiotherapy and Rehabilitation |
| Address |
Room No.2 Ground Floor Department of physiotherapy, Maharishi Markendeshwar (deemed to be University), Mullana
Ambala
Haryana
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Sharma |
| Designation |
Professor |
| Affiliation |
Maharshi Markendeshwar institute of Physiotherapy and Rehabilitation |
| Address |
Room No.2 Ground Floor Department of physiotherapy, Maharishi Markendeshwar (deemed to be University), Mullana
Ambala
Haryana
133207
India
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Orthopedic physiotherapy Research Laboratory, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana, India, 133207 |
|
|
Primary Sponsor
|
| Name |
Suraj Pradhan |
| Address |
Maharshi Markendeshwar Institute of Physiotherapy and Rehabilitation, Maharshi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sunita Sharma |
Maharshi Markendeshwar Institute of Physiotherapy and Rehabilitation, Maharshi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suraj Pradhan |
Maharishi Markandeshwar super speciality hospital |
Ground Floor, Room no. 2 Department of physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markendeshwar (deemed to be University), Mullana, Ambala, 133207, 1India
Ambala
HARYANA |
08305344214
surajctri24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana-Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Russian Current and Strengthening Exercises |
Russian therapy with frequency Frequency= 2500Hz will be used for treating patients with text neck syndrome. Treatment time = 10 min (10 sec on and 50sec off) along with strengthening exercises foe 3 days a week for 4 weeks |
| Comparator Agent |
Sham Treatment |
Placebo russian current along with Strengthening exercises along with for 3 days in a week for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-30 years
Both male and female VAS more than 5
Neck pain at least more than 1 weeks
Tenderness on the trapezius levator scapulae |
|
| ExclusionCriteria |
| Details |
Diagnosis of other cervical pathology (cervical radiculopathy cervical canal
stenosis cervical spondylosis cervical pivd etc)
Vascular diseases and neurological condition
Degenerative disorder
Any type of skin disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale for Pain
Pressure Bio-feedback for Strength |
Pre, Post (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neck Disability Index For Neck Disability
SF-36 for Quality of Life |
Pre, Post (4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
02/08/2025 |
| 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="0"
Months="8"
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
|
Neck pain is a prevalent health problem, largely reported in adult patients.
However, very recent data show that new technologies are inducing a shift in the
prevalence of this relevant issue from adulthood to all of the paediatric ages. In fact, the
precocious and inappropriate use of personal computers and especially cell phones might
be related to the development of a complex cluster of clinical symptoms commonly
defined as “text neck syndrome”. To find out the effect of Russian current therapy along with among patients with text
neck syndrome on their pain, tenderness and cervical function.Patient recruited ranged in age from 18 to 45 on the basis of inclusion and
exclusion criteria. Using Sequentially Numbered Opaque Sealed Envelope (SNOSE). The
patient will be randomly allocated to group A and B. All demographic information about
each subject will be recorded. The group A will receive Russian current and strengthening
exercise and group B will receive shams therapy. Outcome measures like Visual Analogue
Scale (VAS) for pain intensity and pressure algometry for tenderness and Foot Function
Index (FFI) will be used to assess patients’ pre-intervention and post-intervention.The purpose of this study is to evaluate the effect of Russian current therapy and
strengthening exercise in comparison to classical physiotherapy alone in treating patients with
text neck syndrome. In this study, the effect of the above-mentioned modalities will be
compared in terms of pain intensity, tenderness and quality of life. There is no literature that
evaluates the effect of Russian current therapy and strengthening exercise therapy on patients
with text neck syndrome. |