| CTRI Number |
CTRI/2020/04/024638 [Registered on: 15/04/2020] Trial Registered Prospectively |
| Last Modified On: |
01/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
physiotherapy treatment to pectoralis minor in subjects with shoulder pain |
|
Scientific Title of Study
|
EFFECTIVENESS OF PECTORALIS MINOR RELEASE TECHNIQUES ON STRUCTURAL ADAPTATIONS IN SUBJECTS WITH ADHESIVE CAPSULITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAYUDU GEETHA MOUNIKA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SWATANTRA INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION |
| Address |
c/o GSL MEDICAL COLLEGE
COLLEGE OF PHYSIOTHERAPY
NH-16
RAJANAGARAM
533296
c/o GSL MEDICAL COLLEGE
COLLEGE OF PHYSIOTHERAPY
NH-16
RAJANAGARAM
533296
East Godavari
ANDHRA PRADESH
533293
India |
| Phone |
9666376705 |
| Fax |
|
| Email |
mounikarayudu.92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAYUDU GEETHA MOUNIKA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SWATANTRA INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION |
| Address |
c/o GSL MEDICAL COLLEGE
COLLEGE OF PHYSIOTHERAPY
NH-16
RAJANAGARAM
533296
c/o GSL MEDICAL COLLEGE
COLLEGE OF PHYSIOTHERAPY
NH-16
RAJANAGARAM
533296
East Godavari
ANDHRA PRADESH
533293
India |
| Phone |
9666376705 |
| Fax |
|
| Email |
mounikarayudu.92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAYUDU GEETHA MOUNIKA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SWATANTRA INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION |
| Address |
c/o GSL MEDICAL COLLEGE
COLLEGE OF PHYSIOTHERAPY
NH-16
RAJANAGARAM
533296
c/o GSL MEDICAL COLLEGE
COLLEGE OF PHYSIOTHERAPY
NH-16
RAJANAGARAM
533296
East Godavari
ANDHRA PRADESH
533293
India |
| Phone |
9666376705 |
| Fax |
|
| Email |
mounikarayudu.92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swatantra Institute of Physiotherapy and Rehabilitation NH-16,laxmipurm,rajanagaram,533296. |
|
|
Primary Sponsor
|
| Name |
RAYUDU GEETHA MOUNIKA |
| Address |
D.NO:4-118,mirthipadu,rajahmundry rural,seethanagaram mandal, east godavari district. |
| 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 |
| geetha mounika |
Swatantra institute of physiotherapy and rehabilitation |
NH-16,rajahmundry
East Godavari
ANDHRA PRADESH |
9666376705
mounikarayudu.92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee,gsl medical college and general hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional exercises like hot pack,TENS,therapeutic ultrasound, stretching and strengthening exercises |
3 times a week for 6 weeks of duration. |
| Intervention |
pectoralis minor release techniques like IASTM and proprioceptive neuromuscular facilitation stretching. |
3 times a week for 6 weeks of duration. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with stage 2 Adhesive Capsulitis
2. Pain in the shoulder for at least 3months
3. PMI less than 7.44
|
|
| ExclusionCriteria |
| Details |
1. Reported a previous history of Cancer, Severe Vascular disease, Upper extremity fracture, Rheumatoid arthritis and Osteoporosis.
2. History of trauma or surgery to the shoulder
3. Skin infections, open wounds on the
shoulder
4. Neurological disorders.
5. Psychological disorders
6. Patients under steroids
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME-Ultrasonography- To measure the thickness of Pectoralis Minor
SPADI-FUCTIONAL ABILITY
|
Ultrasonography- To measure the thickness of Pectoralis Minor -BASELINE AND POST TEST
SPADI-BASELINE,3RD WEEK AND POST TEST |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.VAS- Pain
2.ROM- Universal Goniometer
3.TSD- Rounded Shoulder Posture
4.PMI-Length of the muscle
|
VAS- Pain-pre 1st week 2nd week 3rd week 4th week 5th week post
ROM- Universal Goniometer-pre 3rd week and post
PMI-Baseline,3rd week and post test
TSD- Rounded Shoulder Posture pre and post |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
27/07/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
NEED OF THE STUDY Altered Glenohumeral mechanics are major cause for functional restrictions in patients with Adhesive Capsulitis. In most of the Physiotherapy approaches are targeted towards glenohumeral mobilization and Scapulothoracic rehabilitation. But Pectoralis minor shortening is one of the unaddressed portion in the management of Adhesive Capsulitis. So, shortening of pectoralis minor can limit glenohumeral joint functioning to the full extent. It could be the reason behind long term disability. Failure to address this problem could results in incomplete recovery in adhesive capsulitis. So, the need of the study arises to see the effectiveness of pectoralis minor release techniques on structural adaptations in subjects with adhesive capsulitis.
HYPOTHESIS Hypothesis (H1): Pectoralis minor release techniques may have significant effect than Conventional exercises on Pain, ROM, Function and Structural changes in subjects with Adhesive Capsulitis.
Null hypothesis (H0): Pectoralis minor release techniques may not have significant effect than Conventional exercise on pain, ROM, function and Structural changes in subjects with Adhesive Capsulitis
|