| CTRI Number |
CTRI/2025/02/080536 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of foot reflex pressure on shoulder pain |
|
Scientific Title of Study
|
Effect of foot reflexology on pain and disability in patients with periarthritis of the shoulder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasanthambigai |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai-600106
Department of Acupuncture and Energy Medicine,Second floor, Government Yoga and Naturopathy Medical College and Hospital,PG Block, Arumbakkam,Chennai-600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9600233612 |
| Fax |
|
| Email |
vasanthambigaibnys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Moovendhan |
| Designation |
Assistant Medical Officer cum Lecturer grade 2 |
| Affiliation |
Government yoga and naturopathy medical College and hospital |
| Address |
Department of Research, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai-106
Department of Research, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasanthambigai |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai-106
Department of Acupuncture and Energy Medicine, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9600233612 |
| Fax |
|
| Email |
vasanthambigaibnys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital, Arignar anna Indian Medicine campus, Arumbakkam, Chennai-106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai. |
| Type of Sponsor |
Government 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 Vasanthambigai V |
Government Yoga and Naturopathy Medical College and Hospital |
Department of Acupuncture and Energy Medicine, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai
Chennai
TAMIL NADU |
9600233612
vasanthambigaibnys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government yoga and naturopathy medical College and hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foot reflexology in both foot using Rwo shur method |
foot reflexology in both foot using Rwo shur method for 15 minutes at shoulder region along with solar plexus point once a day, 5 days a week for 2 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
People who have shoulder pain elicited by the movement of the arm
Positive empty can test
|
|
| ExclusionCriteria |
| Details |
People who had steroid injections
Psychiatric illness
Auto immune diseases and neoplastic diseases.
Women who are pregnant, lactating and during menstruation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain and disability will be done using Shoulder pain and disability index (SPADI). |
Shoulder pain and disability index (SPADI) will be measured before and after intervention Of duration 20 minutes for 2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of range of motion of shoulder joint will be performed using goniometer. |
Assessment of range of motion of shoulder joint will be performed using goniometer before & after intervention of 20 minutes duration for 2 Weeks. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/03/2025 |
| 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="1"
Months="5"
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
|
A single group pre-test
and post-test study design will be adopted for this study. All the
eligible subjects will be receiving foot reflexology in both foot using Rwo
shur method for 15 minutes at shoulder region along with
solar plexus point once a day, 5 days a week
for 2 weeks. Assessment
of pain and disability will be done using Shoulder
pain and disability index (SPADI). Assessment of range of motion of shoulder joint will
be performed using goniometer.
|