| CTRI Number |
CTRI/2024/06/069038 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Hot and Cold Application to shoulder for Periarthritis Shoulder |
|
Scientific Title of Study
|
To evaluate the effect of Revulsive Compress
on pain and range of motion in Periarthritis
Shoulder-A Quasi Experimental Study |
| 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 K Jeyashree |
| Designation |
Post Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy medical sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy medical sciences, Faculty block, Ground floor ,Department of Naturopathy Kamarajar nagar, Chengalpattu, Kancheepuram,Tamilnadu-603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8667489513 |
| Fax |
|
| Email |
jeyashreedoctor97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of Department(Naturopathy) |
| Affiliation |
International Institute of Yoga and Naturopathy medical sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy medical sciences, Faculty block, Ground floor, Department of Naturopathy, Kamarajar nagar, Chengalpattu, Kancheepuram, Tamilnadu-603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Jeyashree |
| Designation |
Post Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy medical sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy medical sciences, Faculty block, Ground floor, Department of Naturopathy Kamarajar nagar, Chengalpattu, Kancheepuram, Tamilnadu-603001.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8667489513 |
| Fax |
|
| Email |
jeyashreedoctor97@gmail.com |
|
|
Source of Monetary or Material Support
|
| 184/4,International Institute of Yoga and Naturopathy medical sciences, Faculty block, Ground floor ,Department of Naturopathy Kamarajar nagar, Chengalpattu, Kancheepuram,Tamilnadu-603001 |
|
|
Primary Sponsor
|
| Name |
Dr K Jeyashree |
| Address |
184/4,International Institute of Yoga and Naturopathy medical sciences , Faculty Block(Ground Floor),Department of Naturopathy, Kamarajar Nagar, Chengalpattu, Kancheepuram, Tamilnadu - 603001 |
| 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 K Jeyashree |
International Institute of Yoga and Naturopathy medical sciences |
184/4,International Institute of Yoga and Naturopathy medical sciences, Faculty block, Ground floor, Department of Naturopathy, Kamarajar nagar, Chengalpattu, Kancheepuram, Tamilnadu-603001
Kancheepuram
TAMIL NADU |
8667489513
jeyashreedoctor97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
REVULSIVE COMPRESS |
study groupwill be given revulsive compress for 15 minutes in which a hot fomentation bag(98-104ï‚°F) / (36-40ï‚°C) will be applied over the shoulder joint for 4 min followed by a cold compress(55-65ï‚°F)/ (12-18ï‚°C) for 1 minute |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Pain at night, with inability to lie on the affected side among the age between 40 years and 65 years Both genders,Appreciable restriction of both active and passive range of motion especially external rotation,
abduction and flexion with Interscapular scratch test positive. |
|
| ExclusionCriteria |
| Details |
History of major shoulder injury or surgery,
Patients with shoulder dislocation, Presence of underlying fracture associated inflammatory arthritis, Painful arc between 60° and 120° abductions indicative of rotator cuff disease, Patients taking drugs such as NSAIDs or other pain killers, Patients undergoing other trials, Malignancy and Subacromial impingement |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain and its restriction |
Assessment of pain and its restriction a day before and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of range of motion |
Assessment of range of motion a day before & after intervention followed by primary outcome |
|
|
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)
|
28/06/2024 |
| 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="1"
Months="1"
Days="1" |
|
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
|
Periarthritis shoulder also called as frozen shoulder, adhesive capsulitis or painful stiff shoulder is an inflammatory painful musculoskeletal condition of the shoulder characterised by pain, stiffness and significant restriction of both active and passive range of motion particularly external rotation, abduction and flexion. It is more common in females than males. The condition usually exists in three stages. It begins with the painful stage lasting from 2 to 9 months characterised by pain worsening at night with gradual restriction in the range of motion. Second stage is frozen stage lasting till 12 months in which stiffness gets worse and the final stage is the thawing stage in which the symptom tends to resolve and last till 2 year. Usually the condition is characterised by pain followed by stiffness indicating the evolution of inflammation to fibrosis. The pathology of this condition is characterised by cytokine mediated synovial inflammation with fibroblastic proliferation which is responsible for the pain and the stiffness, the main characteristic feature of this condition. Naturopathy is a drugless system of medicine which encourages the self-healing process of the body. Hydrotherapy ,one of the treatments in the system of naturopathy uses water internally and externally in any form(water, steam, ice) to promote health and to treat diseases. Revulsive compress comes under external hydrotherapy which involves application of ice or water to the body. Revulsive compress is a treatment modality which involves alternate application of hot(98-104°F) / (36-40°C) immediately followed by cold(55-65°F)/ (12-18°C).This treatment produces revulsive, non-excitant analgesic effect. It also improves circulation thereby removing all toxins and metabolic wastes and inflammatory byproducts thereby easing pain, oedema, inflammation and helps in strengthening of connective tissue. It is known to increase the range of motion by increasing the extensibility of collagen rich tissues. In a study it is proved that revulsive compress works well on pain conditions, resulting in reduction of pain and increase in the range of motion |