| CTRI Number |
CTRI/2022/01/039267 [Registered on: 10/01/2022] Trial Registered Prospectively |
| Last Modified On: |
07/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of magnesium in treatment of patients with myofascial trigger points in upper trapezius |
|
Scientific Title of Study
|
Efficacy of magnesium in treatment of patients with myofascial trigger points in upper trapezius |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Mansatta |
| Designation |
Master of Physiotherapy |
| Affiliation |
NANAVATI SUPER SPECIALITY HOSPITAL |
| Address |
Department of physiotherapy Ground floor Nanavati Hospital SV Road vile parle(w) Mumbai(Suburban) MAHARASHTRA 400056
Department of Physiotherapy Ground floor Nanavati Hospital SV Road vile parle(w) Mumbai(Suburban) MAHARASHTRA 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9930380198 |
| Fax |
|
| Email |
pmansatta@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Bhartiya |
| Designation |
Master of Physiotherapy |
| Affiliation |
NANAVATI SUPER SPECIALITY HOSPITAL |
| Address |
Deparatment of physiotherapy Ground floor Nanavati Hospital SV Road vile parle(w) Mumbai(Suburban) MAHARASHTRA 400056
Department of Physiotherapy Ground floor Nanavati Hospital SV Road vile parle(w) Mumbai(Suburban) MAHARASHTRA 400056
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9930380198 |
| Fax |
|
| Email |
mansi.bhartiya@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Mansatta |
| Designation |
Master of Physiotherapy |
| Affiliation |
NANAVATI SUPER SPECIALITY HOSPITAL |
| Address |
Department of Physiotherapy ground floor Nanavati Hospital SV Road vile parle(w) Mumbai(Suburban) MAHARASHTRA 400056
Department of Physiotherapy ground floor
Nanavati Hospital SV Road vile parle(w) Mumbai(Suburban) MAHARASHTRA 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9930380198 |
| Fax |
|
| Email |
pmansatta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and sports medicine ground floor Nanavati Super Speciality Hospital Vile parle west Mumbai 400056 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy and sports medicine Nanavati Super Speciality Hospital |
| Address |
Department of Physiotherapy and sports medicine ground floor Nanavati Super Speciality Hospital Vile parle west Mumbai 400056 |
| Type of Sponsor |
Private medical college |
|
|
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 Ali Irani |
Dr. Balabhai Nanavati Hospital |
Department of physiotherapy ground floor SV Road, vile Parle west, Mumbai (suburban) Maharashtra
Mumbai (Suburban)
MAHARASHTRA |
02226172329
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics commitee,Dr. Balabhai Nanavati Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with trapezitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
efficacy of magnesium in treatment of patients with myofasical trigger points in upper trapezius. |
total duration: 6 sessions (30 mins)
Group A:- Treatment protocol for group A will be for duration of 6 sessions with the following exercises:-
• Steam (10 mins)
• Myofascial release along with ischemic compressions.
• Upper trapezius strengthening with shrugs (3 set of 10 reps with 5 seconds hold)
• MET- post isometric relaxation for upper trapezius ( 3 times with 7 seconds hold each)
Group B- Group B will receive magnesium spray in combination with the above-mentioned conventional treatment protocol.
|
| Comparator Agent |
magnesium oil |
After careful assessment and examination, the patient will be treated by magnesium spray after steam. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with active myofascial trigger points in upper trapezius. |
|
| ExclusionCriteria |
| Details |
(1) clinical evidence of cervical radiculopathy or myelopathy
(2) history of disc disease, degenerative joint disease, fracture, or dislocation of the cervical vertebrae
(3) cognitive deficits or psychiatric illness
(4) history of known hypersensitivity to magnesium were also excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.VAS (Visual Analogue Scale).
2.ROM (Range Of Motion).
3.Neck Disability Index (NDI).
4.Pressure pain threshold.
|
baseline, post 1 st session, post 6 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
10/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Efficacy of magnesium in treatment of
patients with myofascial trigger points in upper trapezius
Introduction: Myofascial
Trigger point (MTrP) has been defined as a highly localized and hyperirritable
spot in a palpable taut band of skeletal muscle fibres. Treatment of Myofascial trigger points often
requires a multidisciplinary approach. Steam- causes vasodilation, this
allows more blood, oxygen and nutrients to be delivered to the affected part
and accelerated removal of wastes. Ischemic compressions- causes
resurgence of local blood flow upon sudden release of digital pressure, most
probably from the spinal reflex mechanism, causes increase in pain pressure
threshold. The demand for Mg is likely to increase during accelerated metabolic
situations, thus, physically active individuals may have higher Mg requirements
in order to maintain optimal exercise performance as compared with their
inactive peers.
Aim: Comparison of effects of
magnesium with conventional physiotherapy in patients with myofascial trigger
points in upper trapezius.
Objectives:
To assess the effect of conventional therapy in myofascial trigger
points in upper trapezius with respect to pain through VAS, range of motion
using goniometer, pressure pain threshold using pain algometer and functional
status using Neck Disability Index (NDI).
Comparison of magnesium and conventional therapy in myofascial trigger
points in upper trapezius with respect to pain through VAS, range of motion
using goniometer, pressure pain threshold using pressure pain algometer and
functional status using Neck Disability Index (NDI).
Inclusion
Criteria: Subjects with active myofascial trigger points in upper
trapezius. Both male and female. Age group: 18-40 years
Exclusion Criteria: (1) clinical
evidence of cervical radiculopathy or myelopathy; (2) history of disc disease,
degenerative joint disease, fracture, or dislocation of the cervical vertebrae;
(3) cognitive deficits or psychiatric illness; (4) history of known
hypersensitivity to magnesium were also excluded.
Outcome measures:
VAS (Visual
Analogue Scale).
ROM (Range of
Motion).
Neck
Disability Index (NDI).
Pressure pain
threshold.
|