| CTRI Number |
CTRI/2025/02/079985 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Matrix Rhythm Therapy on Tissue Changes in Non-Specific Neck Pain Evaluated Using
Ultrasound.
|
|
Scientific Title of Study
|
Effectiveness of Matrix Rhythm Therapy on Tissue Level Ultrasonographic Evaluation
in Non-Specific Neck Pain - A Randomized 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 |
Varun Naik |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy, Cardiovascular And Pulmonary Physiotherapy Department, JNMC Campus, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Lyarissa Carvalho |
| Designation |
Intern |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, OPD No.39, Department of Cardiovascular and Pulmonary Rehabilitation, Room No.6, Sagar Floor KLEs Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
91083 56985 |
| Fax |
|
| Email |
lyarissacarvalho12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varun Naik |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy, Cardiovascular And Pulmonary Physiotherapy Department, JNMC Campus, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9986497065 |
| Fax |
|
| Email |
varunnaik@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Dr.Prakbhakar Kore Hospital And Research Centre, Nehru Nagar, Belgaum-590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy, JNMC Campus, Nehru Nagar, Belgaum-590010, Karnataka, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Varun Naik |
KAHER Institute Of Physiotherapy |
KAHER Institute Of Physiotherapy, Cardiovascular And Pulmonary Physiotherapy Department (Room no:6), JNMC Campus, Nehru Nagar, Belgaum, -590010
Belgaum
KARNATAKA |
9986497065
varunnaik@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research And Ethical Committee KLEU Institue Of Physiotherapy Belgaum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A |
Conventional therapy (HMP, Stretching, Exercises and Manual myofascial release).
Hot Moist Pack: 15 mins,
Manual myofascial release,
Stretching of trapezius muscle,
Exercises.
|
| Intervention |
Group B |
Conventional therapy (HMP, Stretching, Exercises and Manual myofascial release) + Matrix rhythm therapy.
Hot Moist Pack: 15 mins,
Manual myofascial release,
Stretching of trapezius muscle,
Exercises,
1 session of Matrix rhythm therapy.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1 All genders from age group between 18years to 25years who are screened cases of non-specific neck pain without radiculopathy.
2 Subjects with a score between 5-24 points (mild to moderate) on Neck disability index
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed cases of injuries around the neck or any other musculoskeletal injuries.
2.Individuals contraindicated for MaRhyThe© like open wounds, DVT, Haemophilia, etc.
3.Unwilling individuals.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonography |
Thickness Of Upper Trapezius Muscle at Rest and on Contraction, Area of Trapezius will be assessed on day 0 and day 6
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain Pressure Algometer |
For Pain pre-assesment on day 0 & post- assessment on day 6 for group A
|
| Kinovea Software |
Craniovertebral angle on day 0 & day 6
|
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
16/02/2025 |
| 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="6"
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
|
Objective: To determine and compare the effect of Matrix rhythm therapy with conventional physiotherapy in non- specific neck pain with respect to pain, ROM and tissue level evaluation using algometer for pain pressure threshold, craniovertebral angle using goniometer and diagnostic ultrasonography respectively. Inclusion criteria: •All genders from age group between 18years to 25years who are screened cases of non-specific neck pain without radiculopathy. •Subjects with a score between 5-24 points (mild to moderate) on Neck disability index. Exclusion criteria: •Diagnosed cases of injuries around the neck or any other musculoskeletal injuries. • Individuals contraindicated for MaRhyThe© like open wounds, DVT, Haemophilia, etc. •Unwilling individuals. Brief Summary: The most prevalent cause for non-specific neck pain is trapezius discomfort which is a traditional form of stress pain. It was hypothesized that there will be difference in the effect of Matrix rhythm therapy with conventional physiotherapy with respect to pain, ROM and tissue level evaluation using algometer for pain pressure threshold, craniovertebral angle using goniometer and diagnostic ultrasonography respectively. The study will include total of 34 participants with non-specific neck pain in age group of 18 to 25 years. Outcome measures include pain pressure algometer for pain, ultrasonographic evaluation to measure thickness and area of trapezius muscle. The study is randomized controlled trial. Experimental group will receive 5 sessions of conventional therapy and 1 session of matrix rhythm therapy and control group will receive 5 sessions of conventional physiotherapy. |