| CTRI Number |
CTRI/2025/06/088617 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To Study the Effects of Instrument-Assisted Soft Tissue Mobilization and Kinesio Taping on Pain levels, fear of movement, catastrophic thinking related to pain, and functional disability in patients with with Chronic Non-Specific Neck Pain |
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Scientific Title of Study
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Effect Of Instrument-Assisted Soft Tissue Mobilisation and Kinesio Taping on Pain, Kinesiophobia, Pain Catastrophizing, Functional Disability in Patients with Chronic Non Specific Neck Pain. |
| Trial Acronym |
nil |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Spoorthi Vittal Poojary |
| Designation |
Student |
| Affiliation |
SDM college of physiotherapy sattur Dharwad |
| Address |
OPD number 5 Orthopedic Physiotherapy Department SDM College
of Physiotherapy SDM College of Medical Sciences and Hospital
Manjushree Nagar Sattur Dharwad
Dharwad KARNATAKA 580009 India |
| Phone |
9326750861 |
| Fax |
|
| Email |
spoorthipoojary2001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Spoorthi Vittal Poojary |
| Designation |
student |
| Affiliation |
SDM college of physiotherapy sattur Dharwad |
| Address |
OPD number 5 Orthopedic Physiotherapy Department SDM College
of Physiotherapy SDM College of Medical Sciences and Hospital
Manjushree Nagar Sattur Dharwad
Dharwad KARNATAKA 580009 India |
| Phone |
9326750861 |
| Fax |
|
| Email |
spoorthipoojary2001@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sweta Kulkarni |
| Designation |
professor and pg guide |
| Affiliation |
SDM college of physiotherapy sattur Dharwad |
| Address |
OPD number 5 Orthopedic Physiotherapy Department SDM College
of Physiotherapy SDM College of Medical Sciences and Hospital
Manjushree Nagar Sattur Dharwad
Dharwad KARNATAKA 580009 India |
| Phone |
9886276543 |
| Fax |
|
| Email |
shweta.kulkarni@sdmuniversity.edu.in |
|
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Source of Monetary or Material Support
|
| nil |
| SDM College of physiotherapy Manjushree Nagar Sattur Dharwad |
|
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Primary Sponsor
|
| Name |
Spoorthi Vittal Poojary |
| Address |
SDM College of physiotherapy Manjushree Nagar Sattur Dharwad, 580009 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Spoorthi Vittal Poojary |
Shri Dharmasthala Manjunatheshwara hospita |
OPD number 5 Orthopedic Physiotherapy Department SDM College
of Physiotherapy SDM College of Medical Sciences and Hospital
Manjushree Nagar Sattur Dharwad Dharwad KARNATAKA |
9326750861
spoorthipoojary2001@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IASTM GROUP |
IASTM Technique for upper trapezius
While the patient is comfortably seated in a chair, lubricate(petroleum jelly) the treatment region. Apply IASTM at a 30- to 60-degree angle for 40 to 120 seconds, or until hyperemia occurs on the treatment site. Use ice packs to reduce hyperemia following treatment.
1)Hot Moist Pack for 10 mins will be given prior to the treatment .
2)Stretching exercise for cervical and scapular muscles
3)Strengthening exercise for cervical muscles(flexor, extensor, side flexor ,rotators )depending upon the assessment
Exercises will be tailored-made, depending upon the assessment the exercises will be progressed accordingly. Participants will be asked to maintain the diary for compliance for all the groups. |
| Comparator Agent |
K-TAPE GROUP |
Kineso Tape
1)Application of Y band
The bands will be cut for the taping procedure based on each persons neck measurement. All of the tapes corners will be given round forms throughout this procedure. This is done to keep the tape from lifting off the edges when the person is dressing, undressing, or moving around.Participants will be seated as a 5 cm broad by 0.6 mm thick strip of kinesiology tape was placed to the cervical spine. The cervical region of the neck will be used to apply each tail of the first strip (Y-strip, two-tailed)bending and rotating to the contralateral side. Two-thirds of the approximately 15 centimeters of kinesio tape will be sliced into a "Y" form. From the upper thoracic region (T1–T2) to the upper cervical region (C1–C2), the kinesio tape will be applied and the tape was stretched by 15–25%.2)Application of I band
The bands will be cut for the taping procedure based on each persons neck measurement. All of the tapes corners were given round forms throughout this procedure. This is done to keep the tape from lifting off the edges when the person is dressing, undressing, or moving around.24 With cervical flexion, the kinesio tape overlay (I band) was positioned perpendicular to the Y-strip, providing tension to the posterior neck structure. In order to absorb tension during cervical spine flexion, the I-shaped kinesio tape is stretched by 15–25% and applied to the mid-cervical region (C3–C6)1)Conventional treatment will be given after applying tape in K tape group.
2)Stretching exercise for cervical and scapular muscles
3)Strengthening exercise for cervical muscles(flexor, extensor, side flexor ,rotators )depending upon the assessment
Exercises will be tailored-made, depending upon the assessment the exercises will be progressed accordingly. Participants will be asked to maintain the diary for compliance for all the groups. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
a.Age- 20-55Year
b.Subject of either gender
c.Neck pain lasting for at least 12 week
d.Kinesiophobia on TSK more than 17 points
e.VAS more than 3
f.Not received any physical therapy treatment in last 6 month
g.Not undergone IASTM or K TAPE in last 6 month |
|
| ExclusionCriteria |
| Details |
a.Presence of allergies and skin disease
b.Cervical spondylosis with radiculopathy
c.Fracture of cervical spine or shoulder
d.History of previous neck trauma
e.Serious spinal abnormalities
f.Acute torticollis
g.Cervical radiculopathy
Surgeries in and around neck and shoulder past 6 month |
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Visual analouge scale,TAMPA scale of kinesiophobia,Pain catastrophizing scale,Neck disability index |
VAS used to measure pain pre and post treatment values will be noted at baseline and 6th week,TAMPA scale of kinesiophobia will be used to measure fear of movement pre and post treatment values will be noted at baseline and 6th week,PCS will measure catastrophizing pre and post treatment values wil be noted at baseline and 6th week,NDI will be used to measure functional disability pre and post treatment values will be noted at baseline and 6th week |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| CERVICAL RANGE OF MOTION (CROM) |
Baseline and after 6 weeks |
|
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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
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/06/2025 |
| 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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Over the past 10 years, technology has advanced at a quick pace, significantly altering people’s lifestyles, particularly those of young adults who lead physically inactive lifestyles1. Neck pain is a widespread musculoskeletal issue, impacting around 288.7 million people globally. In 2017 it led to an estimated 28.6 million years of disability making it a prominent cause of global impairment. Addressing this prevalent concern is vital for enhancing public health worldwide.In office workers, the estimated 1-year prevalence of neck pain was 45.5%; among healthcare professionals, it varied from 45.8% to 54.7%2. In 2010 neck pain ranked fourth in terms of years lived with disability, according to the global burden of illnesses. With the world’s population ageing, these figures could get worse in the future3.Based on the high-quality data that is currently available, persons who lead sedentary lifestyles are more likely to experience neck pain4.Recently, excessive use of computers and mobile phones, especially by young people, has increased the occurrence of neck pain. About two out of every three people will at some point in their life undergo at least a single episode of neck discomfort 1.A significant percentage of people never entirely heal from neck pain, yet only 6.3% of neck pain sufferers classify their condition as chronic.Moreover, pain that has persisted for at least three of the preceding six months is classified as chronic or persistent pain5. Studies indicate that between 50% and 85% of people who suffer discomfort are likely to have recurrent episodes of neck pain, which can lead to disability and chronic neck pain (CNP). According to reports, neck pain is more common overall in early adulthood than it is in children and adolescents5. Females are more impacted than males, and the prevalence increases in middle age. Prolonged cervical flexion and repetitive labor are risk factors. A minimal degree of incapacity is caused by mechanical neck pain. Compared to non-obese people, obese people may be more susceptible to neck pain for a variety of reasons, such as increased systemic inflammation, harmful structural changes, increased mechanical stress and ground reaction force, decreased muscle strength, more psychological problems, and greater disability related to kinesiophobia6.The fourth-ranking condition that causes disability is chronic neck pain. The major objectives of treatment are to improve the quality of life for patients with chronic neck pain, assure independence in everyday activities, and develop joint range of motion (ROM), muscle strength, endurance, and coordination. There are numerous established approaches of treating it. Physiotherapists choose exercise therapy since it is the most successful treatment option, although it does involve the patient’s active participation. In order to improve functions and lessen inflammation, pain, and muscle spasm brought on by nerve root irritation, passive treatment methods such as electrotherapy, hot-cold pack applications, manual therapy techniques, cervical traction, and neck collar are used 12 | The significant correlations have been shown between neck pain and psychosocial variables that affect pain perception, such as catastrophizing, stress, anxiety, and depression7.Inappropriate pain cognitions, such as (kinesiophobic)movement apprehension pain catastrophizing, and hypervigilance, are also common in CNP patients. According to studies, the best factors that predict persistent musculoskeletal pain over a six-month period are fear and movement avoidance. Prolonged pain and impairment are also thought to be caused by pain catastrophizing, the fear-avoidance beliefs factor, and movement avoidance as a result of reluctance to risk of pain or harm.Because of this, when working with patients who have long-term disabilities, healthcare professionals should take psychological variables into account and recognize their importance8. The methods for treating neck discomfort include applying heat, receiving manual treatment, engaging in physical activity, etc. A recent addition to the toolkit of physiotherapists is kinesio taping. Kinesio tape supports and stabilises muscles and joints without limiting range of motion, aiding in the body’s natural healing process. 4.Kinesio taping technique (KT) has gained popularity in addition to all of these therapeutic modalities, particularly for musculoskeletal issues. The KT was created by Kenzo Kase, but earlier the usage was less compared usage of it has increased recently.The following are some of the hypotheses put up regarding the effects of KT: pain inhibition; blood circulation stimulation; oedema reduction through increased lymph circulation; and joint position correction by the provision of muscular relaxation, support, and stability to muscles and joints without restricting range of motion12.The application of the tape was done in the following shapes: I, Y, X, Octopus, Donut, and Star. Utilizing it improves muscular function and reduces pain by activating cutaneous mechanoreceptors on skin tissues as well as blood and lymph circulation. This is achieved through the pain gate theory16. By reducing excessive muscle tension and enhancing joint function, these actions enable the damaged fascia and muscles to recover to normal functioning.In addition to being sticky, kinesiotape is thin, air permeable, and water resistant.Because of its skin-like adhesion qualities, it applies steady shear to the skin and can be left on for three to four days without needing to be removed. 13 Another treatment has proved to be effective in treatment of chronic mechanical neck pain is Instrument-assisted soft tissue mobilisation (IASTM).It has become a common therapeutic modality for myofascial limitation, used in conjunction with traditional treatments for chronic pain. Numerous IASTM instruments, including hawk grips, graston, adhesion breakers, functional and kinetic treatment, and fascial abrasion technique, each have their unique method of treatment and design, including the material and form of the instruments19. IASTM is carried out with the use of tools made especially to mobilize soft tissue (such as scar tissue and myofascial adhesion) in order to lessen discomfort and enhance function and range of motion. By using these tools, the tissue can be treated in a targeted location and with a deeper penetration17. The goal of IASTM therapy is to encourage collagen secondary to fibroblast recruited healing by resorbing excess fibroses and so promoting the restart of connective tissues. Thus, scar tissues, adhesion, and fascial restrictions are loosened and disintegrated18. | Various treatment approaches are available for the treatment of chronic non specific neck pain recently IASTM and K Tape addition along with routine physiotherapy has given better results.IASTM helps in releasing the soft tissue while K tape helps to support and stabilize the soft tissue and joint. Studies done previously where IASTM and K tape are compared with conventional treatment, Manual therapy, Mulligan mobilization, McKenzie mobilization have proved to be beneficial in treatment of neck pain, trapeizitis and trigger points. But most of these studies done have seen immediate effect or short term effect i.e 48 hours or one week .Most of these(IASTM and K Tape) studies have failed to asses the sustained effect of these treatment technique. Studies done on K tape have not mentioned precise stretch of tape on soft tissue. And these chronic neck pain studies have not addressed other components of chronic pain such as kinesophobia and catastrophizing they have only considered pain severity, function and disability. Also studies are lacking where they have compared between IASTM and K tape in chronic non specific neck pain, but done in chronic low back pain, where they have proved both groups were improved equally and the limitations of this study was that the effects were not observed after certain period of time. Both of these treatment technique are effective in treatment of fascia and also K tape helps to treat tissue bellow fascia but still studies are lacking. As the studies lack in so many areas there arises a strong need to conduct a study which aims to compare The effect of IASTM and K tape on pain , kinesophobia, pain catastrophizing, functional disability in patient with non specific chronic neck pain.
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