| CTRI Number |
CTRI/2025/08/093001 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Muscle Relaxation Technique on Neck Pain, Movement, and Function in patients with Upper Back Muscle Stiffness |
|
Scientific Title of Study
|
Effectiveness of Integrated Neuromuscular
Inhibition Technique on pain pressure threshold, Cervical range of motion and
functionality in patient with upper trapezius trigger point: An Experimental
Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NISHAD SIDDHARTH |
| Designation |
PG STUDENT |
| Affiliation |
SPB Physiotherapy college surat |
| Address |
SPB Physiotherapy College OPD (Musculoskeletal Department) Ugat Bhesan Road Morabhagal Surat SPB Physiotherapy College OPD (Musculoskeletal Department) Ugat Bhesan Road Morabhagal Surat Surat GUJARAT 395009 India |
| Phone |
7359785061 |
| Fax |
|
| Email |
siddharthnishad73@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR BHUMIKA PARMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SPB PHYSIOTHERAPY COLLEGE |
| Address |
SPB Physiotherapy College OPD (Musculoskeletal Department) Ugat Bhesan Road Morabhagal Surat SPB Physiotherapy College OPD (Musculoskeletal Department) Ugat Bhesan Road Morabhagal Surat Surat GUJARAT 395005 India |
| Phone |
7738360449 |
| Fax |
|
| Email |
bhumikapatelmpt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR BHUMIKA PARMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SPB PHYSIOTHERAPY COLLEGE |
| Address |
SPB Physiotherapy College OPD (Musculoskeletal Department) Ugat Bhesan Road Morabhagal Surat SPB Physiotherapy College OPD (Musculoskeletal Department) Ugat Bhesan Road Morabhagal Surat Surat GUJARAT 395005 India |
| Phone |
7738360449 |
| Fax |
|
| Email |
bhumikapatelmpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| SPB Physiotherapy College OPD Ugat Bhesan Road Morabhagal Surat Gujarat India 395005 |
|
|
Primary Sponsor
|
| Name |
NISHAD SIDDHARTH |
| Address |
SPB Physiotherapy College OPD Ugat Bhesan Road Morabhagal Surat Gujarat India 395005 |
| 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 |
| NISHAD SIDDHARTH |
SPB Physiotherapy College |
SPB Physiotherapy College OPD (Musculoskeletal Department)Ughat Bhesan Road Morabhagal Surat Gujarat India 395005 Surat GUJARAT |
7359785061
siddharthnishad73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SPB Physiotherapy College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M624||Contracture of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional treatment |
Conventional treatment for neck and upper back dysfunction often includes a combination of chin tuck exercises, active neck movements, neck isometrics, shoulder bracing, and trapezius self-stretching. This approach focuses on improving posture, reducing muscle tension, and enhancing strength and flexibility. Chin tucks help in correcting forward head posture by strengthening deep neck flexors, while active neck movements promote mobility and reduce stiffness. Neck isometrics involve static muscle contractions to build strength without joint movement, ideal for early rehabilitation. Shoulder bracing supports proper shoulder alignment and reduces strain on neck muscles. Lastly, trapezius self-stretching targets tight upper trapezius muscles, relieving tension and improving range of motion. duration is 10min |
| Intervention |
Integrated Neuromuscular Inhibition Technique |
The Integrated Neuromuscular Inhibition Technique (INIT) is a manual therapy approach used in physiotherapy to manage muscle pain, tightness, and dysfunction, particularly involving myofascial trigger points. It combines three soft tissue techniques: Ischemic Compression , Muscle Energy Technique (MET), and Strain-Counterstrain (SCS). TPR involves applying pressure to deactivate painful trigger points; MET uses the patient’s voluntary muscle contractions against resistance to relax and lengthen tight muscles; and SCS is a passive technique that places the muscle in a position of comfort to reduce spasm and reset muscle spindle activity. By integrating these methods, INIT helps reduce pain, release muscle tension, improve range of motion, and restore neuromuscular balance. It is commonly used for conditions like neck and back pain, myofascial pain syndrome, postural issues, and sports injuries, offering a safe, effective, and non-invasive treatment option. Duration is 20min |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females, Patients with bilateral trapezitis, Presence of active MTrPs identifiable by spot tenderness in a taut, muscular band, Patients with grade 3 and 4 trapezius muscle Tenderness, and Pain pressure threshold in upper trapezius less than or equal to 2.5 kg/cm |
|
| ExclusionCriteria |
| Details |
Patients with Cervicogenic headache, Patients who have history of any traumatic brain injury, whiplash injury and cervical spine surgery, Patients with fibromyalgia and other musculoskeletal disorders such as ankylosing spondylitis, rheumatoid arthritis, Patients with any deformity e.g. spasmodic torticollis, Sprengel’s deformity, scoliosis, Patients undergoing any other treatment for the same condition from any other health practitioner. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Pressure Threshold, Cervical Range of Motion, Functionality |
At Baseline, 4 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/10/2025 |
| 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 Applicable |
| 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
|
Title : Effectiveness of Integrated Neuromuscular Inhibition Technique on Pain Pressure Threshold, Cervical Range of Motion and Functionality in Patients with Upper Trapezius Trigger Points: An Experimental Study Trapezitis is defined as inflammation of trapezius muscle. The upper trapezius muscle is designated as postural muscle and it is highly susceptible to over use. The pain is present even during rest and is aggravated by activity; it may be referred to other area from the site of primary inflammation. The Integrated Neuromuscular Inhibition Technique (INIT) is a manual therapy approach used in physiotherapy to manage muscle pain, tightness, and dysfunction, particularly involving myofascial trigger points. It combines three soft tissue techniques: Ischemic Compression , Muscle Energy Technique (MET), and Strain-Counterstrain (SCS). TPR involves applying pressure to deactivate painful trigger points; MET uses the patient’s voluntary muscle contractions against resistance to relax and lengthen tight muscles; and SCS is a passive technique that places the muscle in a position of comfort to reduce spasm and reset muscle spindle activity. The purpose of the study is to check the effect of this techniques in patients with upper trapezius trigger points and to study its effectiveness on PPT, Cervical ROM and functionality in the patients with Upper Trapezius Trigger points. Patients with Upper Trapezius Trigger points of age 18 to 35years, both males and females, Presence of active MTrPs identifiable by spot tenderness in a taut, muscular band. The patient will be screened on the basis of inclusion and exclusion criteria and their demographic data will be taken by an assessment Performa. Prior to the commencement of the study, detailed procedure of the study will be explained to the patients and assigned informed consent form will be taken from them. Then the patient will be randomly assigned to a 4-week intervention protocol and allocated randomly to Group A and Group B. Group A = Integrated Neuromuscular Inhibition Technique (INIT) + Conventional treatment (total duration – 20 mins) In INIT includes 3 techniques i.e Ischemic compression, Positional release technique and Muscle energy technique. GroupB = Control group. Conventional treatment (total duration-10 mins) SPSS Version 29.0 will be used for statistical analysis and Microsoft Excel 2019 will be used for tabulation and graphical presentation of data. Based on the normality of distribution, either parametric/non parametric test will be used, for analysis of intergroup and intragroup differences. |