| CTRI Number |
CTRI/2024/08/072182 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [sesame oil massage and Epsom salt hot water application ] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Compare the effect of sesame oil massage with Epsom salt hot water application and combination of sesame oil massage, Epsom salt hot water application in managing knee joint pain among homemakers. |
|
Scientific Title of Study
|
Intergroup comparative evaluation of the efficacy of sesame oil massage Epsom salt hot water application and combination of both in the management of knee joint pain among homemakers.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaya Vijay Khandar |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
09665177982 |
| Fax |
|
| Email |
Jayamasane4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
09527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
09527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research sawangi meghe wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Sawangi Meghe Wardha
442001 |
| 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 |
| Jaya Khandar |
Datta Meghe Institute of Higher Education and Research |
Department of Community Health Nursing, Ground Floor, SRMMCON Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9665177982
jayamasane4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Combination of Epsom salt hot water application and sesame oil massage |
Combination of Epsom salt hot water application and sesame oil massage will be provided to knee joint pain patients for 6 weeks |
| Comparator Agent |
Epsom salt hot water application |
Homemakers with knee joint pain will be provided with Epsom salt hot water application 6 weeks. |
| Intervention |
Sesame oil massage |
Homemakers with knee joint pain will be provided with Sesame oil massage for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Participants who have mild and moderate knee joint pain due to osteoarthritis
2. Participant between above 40 to 60 years of age |
|
| ExclusionCriteria |
| Details |
1. Participants with severe neuropathies, burns, skin lesion on the joints.
2. Participants with complicated like facilities, neuropathies, vascular Compromise, and systemic lupus erythematous.
3. Participants who has mental illness
4. Participants who has allergies to Epsom salt and sesame oil on knee joint pain due to osteoarthritis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in Pain Intensity and
Improved Physical Function
|
Assessments will be done at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Joint Stiffness and Physical Activity Levels
|
Assessments will be done at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="2"
Months="0"
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
|
The study is
designed as a randomized 3-arm parallel active control trial to assess the
efficacy of various treatments for managing knee joint pain among homemakers.
Specifically, it aims to evaluate the effectiveness of sesame oil massage,
Epsom salt hot water application, and a combined approach incorporating both
treatments.
The
primary objective is
To identify
which intervention or combination thereof offers the most effective relief for
knee joint pain within this particular group.
This research will provide valuable insights into optimizing pain management strategies for homemakers
experiencing knee joint discomfort.
The study may include assessing factors such as
improvement in joint flexibility, reduced inflammation markers, changes in pain
intensity scores over time, and participants’ overall satisfaction and
adherence to the treatment protocols. |