| CTRI Number |
CTRI/2025/04/085784 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find out the effect of Instrument-Assisted Soft Tissue Mobilization on Neck Pain, Neck Movement, and Function in subjects with hypersensitive points present in Upper Trapezius Muscle |
|
Scientific Title of Study
|
Efficacy of Instrument Assisted Soft Tissue Mobilization on Pain Pressure Threshold, Range of Motion and Function in Latent Trigger Points of Upper Trapezius Muscle : A Single Blinded, Randomized Clinical 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 |
Sarasij Bit |
| Designation |
Physiotherapist |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room No. 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090
North Twentyfour Parganas WEST BENGAL 700090 India |
| Phone |
8910552677 |
| Fax |
|
| Email |
Physiobit14@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sarasij Bit |
| Designation |
Physiotherapist |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room No. 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090
North Twentyfour Parganas WEST BENGAL 700090 India |
| Phone |
8910552677 |
| Fax |
|
| Email |
Physiobit14@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sarasij Bit |
| Designation |
Physiotherapist |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room No. 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090
North Twentyfour Parganas WEST BENGAL 700090 India |
| Phone |
8910552677 |
| Fax |
|
| Email |
Physiobit14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090, India |
|
|
Primary Sponsor
|
| Name |
Sarasij Bit |
| Address |
National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090 |
| 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 Sarasij Bit PT |
National Institute for Locomotor Disabilities (Divyangjan) |
Room No. 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), Bon-hooghly, Kolkata - 700090, India North Twentyfour Parganas WEST BENGAL |
8910552677
Physiobit14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - National Institute for Locomotor Disabilities (Divyangjan) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects having Latent Trigger Points in their Upper Trapezius Muscle |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instrument Assisted Soft Tissue Mobilization (IASTM) |
Subject will be in a comfortable position. Emollient like Vaseline will be applied first to prevent skin irritation. Then IASTM will be applied over previously marked LTrPs of Upper Trapezius at 45° angle.
Each IASTM session included -
1 minute of Sweeping – Longitudinal strokes performed which is parallel to muscle fibres; 1 minute of Swivel – Pivoting or rotating back and forth with the knob directly over trigger point; 2 minute of Fanning – one end of instrument held in place and other end is moved in semi-circular pattern. |
| Comparator Agent |
Moist Hot Pack and Exercise |
Each Subject will get Moist Hot Pack (MHP) for 10 minutes.
Subjects will do Self-stretching of upper trapezius (30 sec hold for 5 times) and Neck isometric exercises (10 sec hold for 5 times) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having minimum one palpable nodule and hypersensitive tender spot in taut band in Upper Trapezius Muscle |
|
| ExclusionCriteria |
| Details |
1) Any active MTrPs present in Upper trapezius.
2) Diagnosed case of Fibromyalgia or Patients with symptoms of Neck pain, Cervical Radiculopathy or Cervical Myelopathy.
3) History of any musculoskeletal injury in Cervical spine including Road Traffic Accident, Fracture etc.
4) Rheumatoid disorders like Rheumatoid arthritis and Ankylosing Spondylitis.
5) Any vascular symptoms such as Basilar insufficiency, Thoracic outlet syndrome.
6) Diagnosed with Neurological conditions like Stroke, Neuropathy, etc.
7) Having undergone physiotherapy treatment last month.
8) Presence of red flags i.e. infection, malignancy.
9) Drug intake like NSAIDs and steroids during or 1 month before interventions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Pressure Threshold measured by Algometer (kg/cm2)
Cervical Contralateral Side Flexion Range of Motion measured by Goniometer (in degree)
Function measured by Neck Disability Index (in %) |
Pre-Intervention
Post-Intervention (the day after 10th Session) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/05/2025 |
| Date of Study Completion (India) |
10/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
A Myofascial Trigger Point (MTrP) is defined as a hypersensitive spot in a skeletal muscle associated with a taut band which is painful on compression and refers pain in characteristic pattern for each muscle. They can be activated directly by muscle overload, trauma, prolonged muscle contraction and nerve compression. This type of tissue dysfunctions in musculoskeletal system happens due to continuous exposure to abnormal, adverse physical conditions during rest or in job duty leading to pain and injury in body especially in neck and shoulder.
In accordance to clinical manifestation, MTrPs are classified into Active and Latent Trigger points. Latent Myofascial Trigger Points (LTrPs) are those in which local and referred pain do not produce any familiar or usual symptoms for the individual.
Upper Trapezius is a posture muscle and has a high susceptibility for overuse. Different studies already established the presence of latent trigger points in Upper Trapezius of symptomatic participants with shoulder pain, subacromial impingement, mechanical neck pain and chronic headaches
Instrument Assisted Soft Tissue Mobilization (IASTM) is a practical technique using specially designed instrument which is beveled in edges which minimizes the force applied by therapist but maximizes the force delivered to tissues. It provides therapist a mechanical advantage to treat with deeper force transmission and to detect altered tissue properties.
Different studies were conducted to find different manual technique and electrical modalities to treat Latent Trigger Point. But to best of our knowledge, there are no studies are available which was conducted to find the efficacy of IASTM in Latent Trigger Points.
Hence this study is designed to find out the efficacy of IASTM on Pain Pressure Threshold, Range of Motion and Function in Latent Trigger Points of Upper Trapezius muscle.
NULL HYPOTHESIS (H0): There is no statistically significant effect of IASTM along with Moist Hot Pack and Supervised Exercises on Pain Pressure Threshold, Range of Motion and Function in Latent Trigger Points in Upper Trapezius muscle.
ALTERNATE HYPOTHESIS (H1): There is statistically significant effect of IASTM along with Moist Hot Pack and Supervised Exercises on Pain Pressure Threshold, Range of Motion and Function in Latent Trigger Points in Upper Trapezius muscle. |