| CTRI Number |
CTRI/2025/03/082547 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two muscle releasing technique in neck pain
|
|
Scientific Title of Study
|
Comparing the effectiveness of myofascial release and positional release technique with kinesio taping on non-specific neck pain
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himanshi Sen |
| Designation |
MPT Student |
| Affiliation |
Gurugram University |
| Address |
Department of Physiotherapy, Sector-87,Kankrola Village, Gurugram University
Gurgaon HARYANA 122505 India |
| Phone |
09643630642 |
| Fax |
|
| Email |
senhimanshi599@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gurpreet Singh |
| Designation |
Assistant Professor |
| Affiliation |
Gurugram University |
| Address |
Department of Physiotherapy, Sector-87, Kankrola Village, Gurugram University
Gurgaon HARYANA 122505 India |
| Phone |
9350567096 |
| Fax |
|
| Email |
physio11r@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gurpreet Singh |
| Designation |
Assistant Professor |
| Affiliation |
Gurugram University |
| Address |
Department of Physiotherapy, Sector-87,Kankrola Village, Gurugram University
Gurgaon HARYANA 122505 India |
| Phone |
9350567096 |
| Fax |
|
| Email |
physio11r@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Physiotherapy, Gurugram University,sector-87, Kankrola Village, Gurugram |
|
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Primary Sponsor
|
| Name |
Gurugram University |
| Address |
Sector-87,Kankrola Village, Gurugram (Haryana) |
| Type of Sponsor |
Other [Gurugram University] |
|
|
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 |
| Dr Himanshi Sen |
Quality physio Advanced Chiropractor Physiotherapy and Rehabilitation center |
Sector 52, Gurugram 122018, Haryana Gurgaon HARYANA |
09643630642
senhimanshi599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Department of physiotherapy, Gurugram University |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R299||Unspecified symptoms and signs involving the nervous and musculoskeletal systems, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myofascial Release(MFR)
Kinesio Taping
Neck Strengthening Exercises |
MFR- The patient will be seated or supine with the head supported. Light pressure will be applied to areas of tension, and the pressure will gradually rise as the tissue softens. Hold: 90 seconds
Repetition: 3 Repetition with 20-second rest interval in between.
Kinesio Taping- The patient will be seated with the neck slightly extended or rotated away from the affected side. Y-tape will be used for support and I-tape for pain relief.
Neck strengthening Exercises-Chin Tuck, Neck Isometric and Resistance exercises.
•Hold-10 seconds
•Repetition-10 repetitions with 20-second short intervals in between, two times a day.
|
| Comparator Agent |
Positional Release Technique(PRT)
Kinesio Taping
Neck Strengthening Exercises |
PRT- The patient will lie supine with the neck in a neutral position. Gentle pressure will be applied to the trigger point.
•Hold: 90 seconds
•Repetition: 3 Repetition with 20-second rest interval in between.
Kinesio Taping- The patient will be seated with the neck slightly extended or rotated away from the affected side. Y-tape will be used for support and I-tape for pain relief.
Neck strengthening Exercises-Chin Tuck, Neck Isometric and Resistance exercise
•Hold-10 seconds
•Repetition-10 repetitions with 20-second short intervals in between, two times a day. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Non-specific neck pain for more than 3 weeks
2. Subjects with neck pain (grade 4 or higher) (Numeric Pain Rating Scale)
3. Subjects aged 25 to 32 years
4. Subjects with forward head posture (less than 48-50 degrees) (Craniovertebral angle)
5. Male and female participants
|
|
| ExclusionCriteria |
| Details |
1. Subjects with a history of an accident, fracture, neck or upper back surgeries, or psychological condition during the last 6 months.
2. Subjects with migraine, Inflammatory pathology, Cervical tumor, and Cervical pathologies like radiculopathy and myelopathy within the past 6 months.
3. Spine deformities such as scoliosis and kyphosis.
4. Severe spasticity such as torticollis.
5. Pregnant women
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Goniometer
Numeric Pain Rating Scale
|
At baseline(day 0) ,post intervention (week 4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neck Disability Index
Craniovertebral angle |
At baseline(day 0) ,post intervention (week 4) |
|
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Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
28/03/2025 |
| 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="2" Days="28" |
|
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
|
Worldwide, nonspecific neck pain (NSNP) is a major health issue that contributes to significant debility. 30-50% of the general population is impacted by NSNP, which frequently results in severe impairment. Non-specific neck Pain (NSNP) is characterised by cervical pain with an indefinite underlying cause. Additionally, using a laptop or smartphone during a pandemic lockdown has increased neck pain. It is frequently noted that the forward head position (FHP) is linked to neck pain. Often referred to as "hunched," an FHP. Generally, a tight band of muscle can be palpated, and these palpable masses are often referred to as “trigger points”. In previous studies, it is concluded that most of the causes of neck pain have a complex relationship between the individual and their occupation, in which they maintain poor postures and experience repetitive stress. It is also found that using the suboccipital release technique along with conventional treatment significantly improves neck pain, disability, and range of motion in forward head posture and on the other, also the effect of the Positional Release Technique has been enhanced in Improving Range of Motion and Pain Pressure in patients with Myofascial Trigger Points in the Upper Trapezius Muscle (Rubi Yadav et al., 2024). Kinesio tape application provides additional benefits to the conventional physiotherapy method in terms of treatment satisfaction (Hilal Dogan et al.,2022). However, there are no comparative studies on how well myofascial release and positional release, combined with kinesio taping, address this issue. Therefore, the purpose of the current study is to evaluate the effectiveness of Myofascial release and Positional release techniques combined with Kinesio Taping in reducing pain and improving cervical range of motion, improving forward head posture by addressing related weak neck muscles. |