| CTRI Number |
CTRI/2024/08/071837 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the effects of diffetent modalities such as Interferential theray, LASER and cervical pain exercises
on Neck Pain in Computer Users |
|
Scientific Title of Study
|
Comparative effects of different therapeutic modalities and Conventional Physiotherapy
Intervention on Neck Pain in Computer Users 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 |
Manvi Gautam |
| Designation |
Student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Physiotherapy OPD, Room No. 510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7876744266 |
| Fax |
|
| Email |
gautammanvi591@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali Kaul |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Physiotherapy OPD, Room No. 510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
78018518005 |
| Fax |
|
| Email |
drgeetanjalikaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Kaul |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Physiotherapy OPD, Room No. 510, Kumarhatti, Solan
HIMACHAL PRADESH
173229
India |
| Phone |
78018518005 |
| Fax |
|
| Email |
drgeetanjalikaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshawar Medical College and Hospital Kumarhatti Solan Himachal Pradesh 173229 India |
|
|
Primary Sponsor
|
| Name |
Manvi Gautam |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Physiotherapy OPD, Room No. 510, Kumarhatti, Solan |
| Type of Sponsor |
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 Geetanjali Kaul |
Maharishi Markandeshwar University |
Maharishi Markandeshwar Medical College and Hospital, Department of Physiotherapy, Physiotherapy OPD, Room No. 510, Kumarhatti, Solan
Solan
HIMACHAL PRADESH |
7018518005
drgeetanjalikaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ehical Committee MM Medical College and Hospital |
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 |
| Comparator Agent |
cervical exercises |
At the beginning of treatment, a pre-assessment of the patient will be taken by using NPRS, CROM and NDI. Following the evaluation, the patient will be given moist heat pack for which
patient will be in prone lying position then apply the moist heat pack directly over the cervical
region for 10-15 minutes. After application of the moist heat pack, the patient will be instructed
to do stretching exercises such as trapezius, Levator scapula, and pectoralis. Stretching
exercises will be performed 3 times for 30 seconds. After the stretching exercises, the patient
will be instructed to do cervical strengthening exercises such as cervical flexor isometrics, cervical extensors isometrics, and cervical lateral flexor isometrics. Isometrics Exercises will
be performed 5 repetition, 10 seconds hold and 2 sets. There will be ten sessions
distributed over two weeks of treatment. After two weeks of treatment, the patients will undergo
post-treatment evaluation using the NPRS, NDI, and C-ROM |
| Intervention |
Class- IV laser |
At the beginning of treatment, a pre-assessment of the patient will be taken by using NPRS, CROM and NDI. After the assessment patient will receive Class IV laser therapy. The patient
will be in prone lying or sitting comfortably. The therapist will assess the patient to make sure
there are no contraindications of high intensity laser before starting therapy. The therapist will
be wearing protective goggles to prevent direct eye contact with the laser beam and the laser
probe will be placed in contact with the skin and perpendicular to the treated area. Laser
scanning will be done on the neck region, internal surfaces of the scapula, upper trapezius,
bilateral paraspinal muscles, and the neck region in both transverse and longitudinal directions.
The treatment will be given in continuous mode and in the analgesic phase, with an energy of
8.0 W, a dose of 5 J / cm², a frequency of 25 Hz, and a total energy of 125 joules. The durationof one session will be approximately 15 minutes. After receiving laser therapy, the patient
will be given instructions to perform stretches for the pectoralis, Levator scapula, and trapezius.
Stretching exercises will be performed 3 times for 30 seconds. Exercises for strengthening
the neck muscles, such as cervical flexor, cervical extensor, and cervical lateral flexor
isometrics, would be prescribed to the patient after the stretching session these isometrics
exercises will be performed 5 repetition, 10 seconds hold and 2 sets. There will be ten
sessions distributed over two weeks of treatment. After two weeks of treatment, the patients
will undergo post-treatment evaluation using the NPRS, NDI, and C-ROM. |
| Intervention |
Interferential therapy group |
Baseline assessment of the patient will be recorded with NPRS, C-ROM, NDI. Following the
evaluation, moist heat pack will be given to the patient in prone for 10-15 minutes. Thereafter
IFT will be given to the patient in prone lying position. Therapist will examine the patient to
make sure they had no contraindications for IFT. Four carbon rubber electrodes will be placed
in the neck region in quadripolar method. The IFTs parameters will be established as follows:
Duration will be 20 minutes, intensity will be on the basis of patients tolerance. Throughout
the period of the therapy, a proper check will be kept and the frequency will be 90-120 Hz
(rhythmic). After receiving IFT, the patient will be given instructions to perform stretches
for the pectoralis, Levator scapula, and trapezius these stretching exercises will be performed
3 times for 30 seconds. After the stretching exercises, the patient will be instructed to do
cervical strengthening exercises such as, cervical flexor isometrics, cervical extensors
isometrics, and cervical lateral flexor isometrics. These isometrics exercises will be performed
5 repetition, 10 seconds hold and 2 sets.There will be ten sessions distributed over two
weeks of treatment. After two weeks of treatment, the patients will undergo post-treatment
evaluation using the NPRS, NDI, and C-ROM. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female
2. Age between 18-35years
3. Neck pain from at least last 2 weeks
4. Desktop/laptop use 4-6 hours /day from last minimum 3 months
|
|
| ExclusionCriteria |
| Details |
1. Patient taking physiotherapy treatment in previous 3 months
2. Cervical spondylosis and Radiculopathy
3. Dizziness, tinnitus
4. Vertigo, blurred/disturbed vision and nystagmus
5. Any neck and ear surgery
6. Malignancy & spinal tumor
7. Forward head posture
8. Upper cross syndrome
9. Any spinal surgery |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Numeric pain rating scale
2. Neck disability index |
at baseline and at 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cervical range of motion |
at baseline and at 14th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 defined as the pain felt in an area circumscribed inferiorly by an
imaginary transverse line passing through the T1 spinous process, laterally by the neck’s
lateral borders, and superiorly by the superior nuchal line. Individuals with neck pain
typically have reduced cervical range of motion (ROM) and point soreness in addition to
localized and/or transferred pain. Neck pain was linked to computer usage for at least four hours periods without a break. It is reported that not having computer screen at eye level as
a risk factor for developing neck pain. Computer users have a relatively high incidence of
neck pain i.e 72%, commonly between 20 – 45 years of age. Because of extended static postures, repetitive movements and poor ergonomic
practices, neck pain is a prevalent problem among computer users. For the treatment of neck
discomfort, a variety of therapeutic techniques are available, such as electrotherapy, exercise
therapy and ergonomic modifications. The need of the present study is to assess and contrast
the efficacy of different therapeutic modalities and conventional physiotherapy intervention
and to find out which is more beneficial. Comparative research can be used to determine in
what circumstances which therapies work effectively. |