| CTRI Number |
CTRI/2024/10/075194 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| 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
|
Cyriax Physiotherapy or Exercise? Evaluating Their Impact on Supraspinatus Tendinitis |
|
Scientific Title of Study
|
Comparison of Cyriax Physiotherapy versus exercise program on pain and range of motion in supraspinatus tendinitis: A comparative 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 Jyoti Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
8057366428 |
| Fax |
|
| Email |
jyoti.yadav@galgotiasuniversity.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyoti Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, OPD Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
UTTAR PRADESH 203201 India |
| Phone |
8057366428 |
| Fax |
|
| Email |
jyoti.yadav@galgotiasuniversity.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Anas Ahmad |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Department of physiotherapy, OPD Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
7042227085 |
| Fax |
|
| Email |
anasjminagar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and development cell Galgotias University, Uttar pradesh, gautam budhh nagar pincode 203201. India |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| Type of Sponsor |
Research institution |
|
|
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 Shahiduz Zafar |
OPD of Physiotherapy department, Room no: E003, Galgotias university |
Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 Gautam Buddha Nagar UTTAR PRADESH |
9811701345
Shahiduz.zafar@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, School of health and allied sciences, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cyriax physiotherapy |
Deep transverse frictional massage
Duration: 10 min per session
Frequency: 3 times per week
For four weeks |
| Comparator Agent |
Exercise program |
1. Anterior and posterior capsule stretching
duration: 5 min per session
frequency : 5 times per week
2. Theraband exercises for shoulder abduction, internal and external rotation.
Duration : 20 min per session
frequency: 5 times per week
for four weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with supraspinatus tendinitis
Patient having Pain with resisted overhead movement of arm |
|
| ExclusionCriteria |
| Details |
Any recent surgery done around shoulder region
Previous surgery done around cervical region |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS Scale |
four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The shoulder pain and disability index (SPADI) |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="0" Months="1" Days="15" |
|
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
|
Pain and dysfunction of the shoulder is common causes of impaired quality of life in the general population. Two per cent of the age group 42-46 years report shoulder pain. Studies from primary care show that 16% of the general population suffers with shoulder pain. This rises to 21% in elderly hospital and community populations. Supraspinatus tendinitis was the most common cause of shoulder pain found in the various studies.(1) Supraspinatus tendinitis is a common and disabling condition that becomes more prevalent after middle age (2) and is a common cause of shoulder pain (3). A predisposing factor is resistive overuse. The supraspinatus tendon of the rotator cuff is involved and affected tendons of the musculoskeletal system and becomes degenerated, most often as a result of repetitive stresses and overloading during sports or occupational activities.(4) (5) (6) The supraspinatus muscle is of the greatest practical importance in the rotator cuff, it derives its innervation from the suprascapular nerve and stabilizes the shoulder, externally rotates and helps abduct the arm, by initiating the abduction of the humerus on the scapula(7) Any friction between the tendon and the acromion is normally reduced by the subacromial bursa.Supraspinatus tendinopathy is a common source of shoulder pain in athletes that participate in overhead sports. |