| CTRI Number |
CTRI/2025/09/094418 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| 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
|
Effects of two different modalities on neck pain |
|
Scientific Title of Study
|
Short term effects of Laser therapy and Kinesio Taping on Myofascial trigger points of upper trapezius in Young adults - A Randomised 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 |
Misba Bagban |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD No. 5 Ortho Physiotherapy Department, SDM College of Physiotherapy, Sattur SDM College of Medical Sciences, Manjushree Nagar, Sattur Dharwad KARNATAKA 580009 India |
| Phone |
09740173874 |
| Fax |
|
| Email |
misbabagaban6595@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Misba Bagban |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD No. 5 Ortho Physiotherapy Department, SDM College of Physiotherapy, Sattur SDM College of Medical Sciences, Manjushree Nagar, Sattur
KARNATAKA 580009 India |
| Phone |
09740173874 |
| Fax |
|
| Email |
misbabagaban6595@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ravi Savadatti |
| Designation |
Professor and PG guide , SDM College of Physiotherapy |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD No. 5 Ortho Physiotherapy Department, SDM College of Physiotherapy, Sattur SDM College of Medical Sciences, Manjushree Nagar, Sattur Dharwad KARNATAKA 580009 India |
| Phone |
09740173874 |
| Fax |
|
| Email |
raviraj09199@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Medical sciences and hospital SDM College Physiotherapy Manjushree Nagar Sattur Dharwad Karnataka 580009 India |
|
|
Primary Sponsor
|
| Name |
Misba Bagban |
| Address |
SDM College of Medical sciences and hospital SDM College Physiotherapy Manjushree Nagar Sattur Dharwad Karnataka 580009 India |
| 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 |
| Misba Bagban |
Shri Dharmasthala Manjunatheshwar Hospital |
OPD No. 5 Ortho Physiotherapy Department, SDM College of Physiotherapy, Sattur
SDM College of Medical Sciences, Manjushree Nagar, Sattur
Dharwad Dharwad KARNATAKA |
09740173874
misbabagaban6595@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Medical Sciences and Hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M62||Other disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laser therapy |
Group a is the laser therapy group. Patient position is prone lying with hands on forehead and head tilted to other side affected area to
be exposed. Both the patient and the therapist will be using protective eyewear. Calculation of laser dose will be done. The dose of laser therapy will be determined by the area to be treated. The target dose is 10 joules per centimeter square. Mode of laser used will be stochastic mode. Technique of application is laser probe will be held perpendicular to the skin surface. Contact method of application will be
used. Group b laser therapy and additional to that kinesio taping will be done. Laser therapy procedure will be same as mentioned above. Followed by laser therapy application kinesio taping will be done by certified taping therapist. Kinesio taping star taping technique will be used. Patient position will be comfortable sitting on chair.
Four i-shaped bands will be taken, all of the tapes corners will be given round forms throughout the procedure. This is done to prevent the tape from lifting off the edges when the
person is dressing, undressing or moving around. The same length i bands, between 15 and 20 cm, will be taped on top of the trigger point. After the first i tape is adhered, the second i tape will be
adhered at 90 degrees. Then, the 3rd and 4th i bands will adhered at 45 degrees to obtain a star appearance. The tapes will be applied with the patient in the resting position without tension at the ends. Dosage is the intervention program will be given of total 4 sessions with 2 days gap between each session, for 2 weeks, in physiotherapy outpatient department. Pre and post evaluation will be done for pain, cervical range of motion and disability using visual analogue scale, universal goniometer and neck disability index scale respectively. |
| Intervention |
Laser therapy |
Group a is the laser therapy group. Patient position is prone lying with hands on forehead and head tilted to other side affected area to be exposed. Both the patient and the therapist will be using protective eyewear. Calculation of laser dose will be done. The dose of laser therapy will be determined by the area to be treated. The target dose is 10 joules per centimeter square. Mode of laser used will be stochastic mode. Technique of application is laser probe will be held perpendicular to the skin surface. Contact method of application will be used. Group b laser therapy and additional to that kinesio taping will be done. Laser therapy procedure will be same as mentioned above. Followed by laser therapy application kinesio taping will be done by certified taping therapist. Kinesio taping star taping technique will be used. Patient position will be comfortable sitting on chair. Four i-shaped bands will be taken, all of the tapes corners will be given round forms throughout the procedure. This is done to prevent the tape from lifting off the edges when the person is dressing, undressing or moving around. The same length i bands, between 15 and 20 cm, will be taped on top of the trigger point. After the first i tape is adhered, the second i tape will be adhered at 90 degrees. Then, the 3rd and 4th i bands will adhered at 45 degrees to obtain a star appearance. The tapes will be applied with the patient in the resting position without tension at the ends. Dosage is the intervention program will be given of total 4 sessions with 2 days gap between each session, for 2 weeks, in physiotherapy outpatient department. Pre and post evaluation will be done for pain, cervical range of motion and disability using visual analogue scale, universal goniometer and neck disability index scale respectively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 18 to 35 years.
2.Symptoms persisting more than 3 months.
3.Presence of atleast 1 trigger point in upper trapezius.
4.Pain intensity more than 4 on visual analogue scale.
5.Painful and sensitive points in
muscle at 25 newton per centimeter square. |
|
| ExclusionCriteria |
| Details |
1.Presence of any neurological condition (sensory
abnormalities, spinal root compression, cervical
spondylosis, cervical stenosis).
2.Cervical radiculopathy.
3.Cervical canal stenosis.
4.Local anesthetics, or steroid injections into the trigger point within last 6 months.
5.Cervical spine surgery.
6.Malignancy.
7.Fibromyalgia syndrome.
8.Pregnancy.
9.Any shoulder pathologies.
10.Presence of kyphosis or scoliosis.
11.Patient on anticoagulant drug.
12.Patients allergic to kinesio tape.
13.Patients unwilling to participate. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Visual analogue scale(VAS)
2.Range of motion with goniometer
3.Neck disability index (NDI) |
At 0th day and 2nd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
25/09/2025 |
| 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 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 one of the most common musculoskeletal disorders. It is characterized by localized or referred pain, tenderness at specific points, and limited Cervical range of Motion (CROM). Chronic neck pain (CNP) persists for over 3 months, significantly affecting quality of life. The primary cause is often myofascial pain in the upper trapezius. Simons defined myofascial pain syndrome as a complex of sensory, motor and autonomic symptoms that are caused by myofascial trigger points. It often results from prolonged poor posture, repetitive strain, and muscle overuse, leading to functional limitations and decreased quality of life. The myofascial trigger points are more commonly observed in the postural muscles, especially the upper trapezius muscle.Need of the study while various technique exists, there is growing interest in non-invasive and patient friendly care. Class 4 diode laser is a high-power laser that penetrates deeper into tissues, promoting anti- inflammatory effects, improved circulation, and pain relief. While kinesio tape support soft tissue structures, reduces the local pressure, and improves lymph drainage. Class 4 diode laser therapy (high-power laser) has gained attention for its deep tissue penetration, anti-inflammatory effects, pain modulation, and enhanced microcirculation, promoting muscle healing and relaxation. Kinesiology taping, on the other hand, is widely used to provide proprioceptive feedback, support soft tissue structures, reduce muscle strain, and improve circulation. While Class 4 laser can help in reducing pain and inflammation at a cellular level, kinesiology taping can provide mechanical support and facilitate muscle function. Novelty our study includes both subjective (VAS for pain) and objective measures (PPT, cervical ROM), it enhances the novelty by providing quantifiable data on impact of intervention. This research is unique in its focus on young adults aged 18-35 years, a demographic often overlooked in prior studies. Null hypothesis laser therapy with kinesio tape will not show any significant difference on pain, cervical range of motion and disability in young adults with myofascial trigger points in upper trapezius. Alternate hypothesis laser therapy with kinesio tape will show significant difference on pain, cervical range of motion and disability in young adults with myofascial trigger points in upper trapezius. Primary objective to evaluate the effects of laser therapy and kinesio taping on pain in myofascial trigger points of upper trapezius in young adults, to determine the effects of laser therapy and kinesio taping on cervical range of motion in myofascial trigger points of upper trapezius in young adults, to determine the effects of laser therapy and kinesio taping on disability in myofascial trigger points of upper trapezius in young adults. Methodology 36 participants will be selected based on inclusion and exclusion criteria mentioned above. Participants will be randomly allocated to 2 groups, group a laser therapy and group b taping additional to laser therapy will be given. Outcomes will be measured pre and post intervention on 0th day and end of 4th session will be taken, pain will be taken on visual analogue scale, range of motion on universal goniometer and disability with neck disability index. Data analysis descriptive data will be analyzed by mean, standard deviation, frequencies and percentage. Paired t-test will be administered to compare within the groups. Independent t-test will be administered to compare between the groups. p value significance will be less than 0.05. |