| CTRI Number |
CTRI/2023/10/058599 [Registered on: 12/10/2023] Trial Registered Prospectively |
| Last Modified On: |
06/10/2023 |
| 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
|
Effects of magnesium along with exercises in treatment for patients with knee pain |
|
Scientific Title of Study
|
Effects of magnesium in physiotherapy treatment for patients with knee osteoarthritis |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khadija Lokhandwala |
| Designation |
MPT Student |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Department of Physiotherapy, Ground floor, Nanavati Max Super Speciality Hospital, LIC Colony, Suresh Colony, Vile Parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9820741652 |
| Fax |
|
| Email |
khadijalokhandwala2799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Parulekar |
| Designation |
Assistant Professor- Physiotherapy |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science SVKMs, Bhaktivedanta Road, Vile parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9821820233 |
| Fax |
|
| Email |
poonam.parulekar@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Parulekar |
| Designation |
Assistant Professor- Physiotherapy |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science SVKMs, Bhaktivedanta Road, Vile parle West
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9821820233 |
| Fax |
|
| Email |
poonam.parulekar@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, Ground floor, Nanavati Max Super Specality Hospital, SV Road, Vile
Parle West, Mumbai-400056 |
|
|
Primary Sponsor
|
| Name |
Dr Khadija Lokhandwala |
| Address |
Sunandan Divatia School of Science, SVKMs, Bhaktivedanta Road, Vile Parle West, Mumbai-400056 |
| 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 Poonam Parulekar |
Nanavati Max Super Specality Hospital |
Department of
Physiotherapy, Ground
floor, Nanavati Max
Super Specality Hospital,
SV Road, Vile Parle West, Mumbai-400056
Mumbai (Suburban)
MAHARASHTRA |
02226172329
poonam.parulekar@nmims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nanavati Max Super Speciality Hospital |
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 |
| Comparator Agent |
Conventional therapy- Exercises and warm water foot soak |
Exercise protocol will be followed for eight sessions over a duration of two weeks, with progression in exercises after each two sessions comprising of knee strengthening exercises- Quadriceps, Hamstrings, Hip flexors, extensors, abductors, adductors, stretching of tendoachilles, hamstring, adductors, gluteals, piriformis, iliopsoas, balance training. In addition warm water foot soak for 20 minutes will be done at home. |
| Intervention |
Magnesium and exercise |
Topical application of magnesium oil and immersion in Epsom salt foot soak will be done for all the eight sessions over a duration of two weeks. 2 sachet of Epsom salt 50 grams will be given for all the eight sessions to do the foot soak at home for 20 minutes each. Along with the magnesium application exercise protocol will be followed. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Knee Osteoarthritis |
|
| ExclusionCriteria |
| Details |
1.Subjects with other known musculoskeletal conditions of knee
2.Having other joint pathologies (for example, rheumatoid arthritis, severe osteoporosis, or fracture)
3.Uncontrolled blood pressure, diabetes mellitus or suspected diseases that may restrict exercise
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Visual Analog Scale (VAS)- On Rest
2)Visual Analog Scale (VAS)- On Activity
3)Western Ontario and McMaster Universities Arthritis Index (WOMAC)
4)Timed up and go test (TUG)
5)Stair Climb Test
|
Pre intervention before the first session and post intervention after the eight session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Quadriceps strength
2)Knee Range of motion
|
Pre intervention before the first session and post intervention after the eight session |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/10/2023 |
| 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
|
TITLE OF THE STUDY-
Effects of magnesium in physiotherapy treatment for patients with knee osteoarthritis
INTRODUCTION- Osteoarthritis is a complex joint disorder characterized by articular cartilage degradation, abnormal mineralization and inflammation. Knee osteoarthritis predominantly affecting the medial tibiofemoral compartment, is a major public health problem. Magnesium deficiency is considered to be a major risk factor for osteoarthritis development and progression. Magnesium deficiency is active in several pathways that have been implicated in osteoarthritis, including increased inflammatory mediators, cartilage damage, defective chondrocyte biosynthesis, aberrant calcification and a weakened effect of analgesics. Oral magnesium presents unique challenges for many individuals to effectively restore intracellular magnesium levels. To completely comprehend the possible advantages of magnesium for osteoarthritis, more research is nonetheless required. Hence this study will be conducted to provide further data on the effect of transdermal magnesium (through topical application of magnesium oil and immersion in Epsom salt foot soak) on patients with knee osteoarthritis.
AIM - To determine the therapeutic effects of Magnesium in physiotherapy treatment for patients with knee osteoarthritis. OBJECTIVE -
1. To assess the effects of conventional therapy in osteoarthritis on pain and functional mobility.
2. To assess the effects of Magnesium as an adjunct to conventional therapy in osteoarthritis.
3. Comparison of the above two groups.
Inclusion Criteria- - Subjects diagnosed with knee osteoarthritis
- Age group 40-70 years
Exclusion Criteria-
1. Subjects with other known musculoskeletal conditions of knee
2. Having other joint pathologies (for example, rheumatoid arthritis, severe osteoporosis, or fracture)
3. Uncontrolled blood pressure,diabetes mellitusor suspected diseases that may restrict exercise
OUTCOME MEASURES- 1. Pain assessment
a) Visual Analog Scale (VAS) On Rest On Activity
2. Functional Mobility assessment
a) Western Ontario and McMaster Universities Arthritis Index (WOMAC)
b) Timed up and go test (TUG)
c) Stair Climb Test
PROCEDURE-
· · An
interventional study will be conducted after seeking approval of the ethical
committee.
· Registration
will be done with CTRI.
· The
subjects will be selected according to the inclusion and exclusion criteria.
· Subjects
will be explained about the study and an informed consent will be filled by
them who satisfy the inclusion criteria.
·
Simple
random sampling of subjects into two groups and outcome measures assessed.
·
Group
A- Conventional
therapy + Warm water foot soak
·
Group
B- Conventional
therapy + Epsom salt foot soak + Magnesium oil application
·
Intervention of 8 sessions will be given, outcome measures repeated
post completion of intervention period and data analysis will be done.
|