| CTRI Number |
CTRI/2024/12/078119 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Impact of Matrix Rhythm Therapy vs. Muscle Energy Technique on Pain, Range of Motion, and Neck Muscle Strength in Chronic Neck Pain: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effectiveness of Matrix Rhythm Therapy vs Muscle Energy Technique on Pain, Range of Motion and neck muscle Strength in participants with chronic neck pain: A Single Blinded Randomized Controlled Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vrushali Dod |
| Designation |
MPT First year Musculoskeletal science |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
Department of musculoskeletal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar MAHARASHTRA
414111 India Ahmadnagar MAHARASHTRA India
Department of musculoskeletal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar MAHARASHTRA
414111 India Ahmadnagar MAHARASHTRA India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9284490462 |
| Fax |
|
| Email |
vrushalidod111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vrushali Dod |
| Designation |
MPT First year Musculoskeletal science |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
Department of musculoskeletal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar MAHARASHTRA
414111 India Ahmadnagar MAHARASHTRA India
Department of musculoskeletal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar MAHARASHTRA
414111 India Ahmadnagar MAHARASHTRA India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9284490462 |
| Fax |
|
| Email |
vrushalidod111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Anap |
| Designation |
HOD Musculoskeletal sciences |
| Affiliation |
|
| Address |
Department of musculoskeltal physiotherapy basement Dr Vithalrao
Vikhe Patil college of physiotherapy Ahmednagar MAHARASHTRA
414111
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890200972 |
| Fax |
|
| Email |
deepak.anap@hotmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy Ahmednagar |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy |
| Address |
Department of musculoskeletal sciences Block 1 basement DVVPFs
college of physiotherapy Oppo Govt Milk Dairy MIDC 414111
Ahmadnagar MAHARASHTRA |
| Type of Sponsor |
Private medical college |
|
|
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 Vrushali Dod |
D V V P Fs College of Physiotherapy |
Vitthalrao vikhe patil
memorial hospital
Ahmednagar
Ahmadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
09284490462
vrushalidod111@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFS College of Physiotherapy Institutional ethical Committe Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Matrix Rhythm Therapy |
1) Matrix is a cell biological therapy which activates and rebalances specific physiological vibrations of skeletal muscle and nervous system. Matrix reactivates the cell metabolism and normalizes the physiological process by depth-effective rhythmical phase synchronous magneto mechanical oscillations. The frequency of matrix is modulated between 8 and 12 Hz given for 1 sessions/day for 2 week. In this process the cells are stimulated and the entire tissue is rhythmically resynchronized. |
| Comparator Agent |
Muscle Energy Technique (MET) |
Muscle Energy Technique (MET) is an active manual technique in which the physiotherapist does not control corrective force. The patient, in fact, should be able to produce oriented voluntary contraction of varying intensity. In 1989, Greenman PE described isometric, concentric and eccentric contractions as types of muscle contraction to perform in MET. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
51.00 Year(s) |
| Gender |
Both |
| Details |
18 years to 50 years both male and female,1. Having a neck pain for at least 3 months |
|
| ExclusionCriteria |
| Details |
Cervical radiculopathy or myelopathy, Undergoing surgical operation for neck pathologies |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Range of Motion and neck muscle Strength |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain, Range of Motion & neck muscle Strength |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
23/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/12/2024 |
| 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)
|
Open to Recruitment |
| 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
|
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Brief Summary
|
Matrix Rhythm Therapy was extensively used in Orthopedic, Neurological and vascular conditions. A new therapeutic and clinical modality matrix rhythm therapy was developed by Dr. Ulrich Georg Randoll is based on research carried out in 1989-1997 at the department of oral and maxillofacial surgery and trauma surgery of Erlangen University Muscle Energy Technique (MET) is an active manual technique in which the physiotherapist does not control corrective force. The patient, in fact, should be able to produce oriented voluntary contraction of varying intensity. we need to identify whether matrix rhythm therapy and muscle energy techniques will have a significant effect on pain, range of motion, and strength in patients with neck pain. So, this study will be carried out with the aim of comparing the effectiveness of matrix rhythm therapy and muscle energy technique (MET) on pain, ROM, and neck muscle strength in patients with neck pain.
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