| CTRI Number |
CTRI/2025/02/080929 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| 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
|
To study the effect of Magnesium oil applied over the skin along with physiotherapy exercises, on fear of performing movements in patients having low back pain for more than 3 months. |
|
Scientific Title of Study
|
Effect of Transdermal Magnesium oil application along with conventional protocol versus conventional protocol on Kinesiophobia in chronic low back pain patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khyati Thakker |
| Designation |
Post Graduate Student |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Department of Physiotherapy, Ground floor, Nanavati Max Super Speciality Hospital, S.V road, Bhaidas Sabhagriha Building, Vile Parle (W), Mumbai, Maharashtra 400056, India
Sunandan Divatia School of Science, Department of Physiotherapy
7th floor Mithibai College Building, Vile Parle
West
Mumbai
MAHARASHTRA
400056
India
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
8600091068 |
| Fax |
|
| Email |
khyatithakkery2k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mansi Bhartiya |
| Designation |
Assistant Professor |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science, Department of Physiotherapy
7th floor Mithibai College Building, Bhaktivedanta Road, Vile Parle (West)
Mumbai
MAHARASHTRA
400056
India
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9867512415 |
| Fax |
|
| Email |
mansi.bhartiya@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Bhartiya |
| Designation |
Assistant Professor |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science, Department of Physiotherapy
7th floor Mithibai College Building, Bhaktivedanta Road, Vile Parle (West)
Mumbai
MAHARASHTRA
400056
India
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9867512415 |
| Fax |
|
| Email |
mansi.bhartiya@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Nanavati Max Super Speciality Hospital.
Department of Physiotherapy, Ground floor, Nanavati Max Super Speciality Hospital, S.V road, Bhaidas Sabhagriha Building, Vile Parle (W), Mumbai, Maharashtra 400056, India |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Mansi Bhartiya |
Physiotherapy OPD, Nanavati Max Super Speciality Hospital |
Department of Physiotherapy, Ground floor, Nanavati Max Super Speciality Hospital, S.V road, Bhaidas Sabhagriha Building, Bhaktivedanta Swami Marg, Vile Parle (W), Mumbai, Maharashtra 400056, India
Mumbai (Suburban)
MAHARASHTRA |
02261347560
Mansi.bhartiya@nmims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Dr. Balabhai Nanavati Hospital. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Physiotherapy Low Back Pain Protocol and given Magnesium as comparative agent. |
Both the groups are given Conventional physiotherapy low back pain protocol for 12 sessions over a period of 2 weeks.
1 group is given transdermal application of Magnesium oil.
Total duration of this study is 6 months. |
| Comparator Agent |
Transdermal Magnesium oil application is given as comparator agent to 1 of the 2 groups |
Transdermal application of Magnesium oil is given to the participants of one group for all 12 sessions which will take place over a period of 2 weeks along with the conventional physiotherapy exercises given to the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females having low back pain for more than 12 weeks and in the age group of 18-50 years, are included in the study. |
|
| ExclusionCriteria |
| Details |
1) Patients who have undergone derangement syndrome such as listhesis or spine injury.
2) Patients who have underwent fracture or spine injury in a period of last 12 weeks.
3) Patients suffering from other systemic conditions (CNS, RS, CVS). |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Oswestry Disability Index (ODI)
2) Tampa Scale of Kinesiophobia (TSK)
|
Pre
Post 6 sessions
Post 12 sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Numerical Pain Rating Scale (NPRS)
2) Pelvic Inclinometer
3) Anterior Pelvic Tilt
4) Posterior Pelvic Tilt
5) Lumbar flexion and extension using modified schobers test
6) Lumbar side flexion of both the sides
7) Sit and Reach Distance
8) EMG Biofeedback Peak value |
Pre
Post 6 sessions
Post 12 sessions |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
26/02/2025 |
| 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 Applicable |
| 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
|
Low Back Pain is the most common Musculoskeletal problem that affects the population indiscriminately. Magnesium has been found to be deficient in most of the population in various studies. Magnesium is an NMDA receptor antagonist and helps to reduce central sensitization, thus reducing pain. Kinesiophobia gets in the way of physiotherapy treatment as movement and exercise is the mainstay of physiotherapy treatment. As pain and fear are related, this study is done to check the change in kinesiophobia following transdermal magnesium oil application along with conventional physiotherapy exercises in chronic non-specific low bak pain patients. |