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CTRI Trial Data

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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 00:57:17 GMT) 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 EFFECTIVENESS OF PECTORALIS MINOR RELEASE TECHNIQUES ON STRUCTURAL Study ADAPTATIONS IN SUBJECTS WITH ADHESIVE CAPSULITIS Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name RAYUDU GEETHA MOUNIKA Trial Coordinator (multi-center study) 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 [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name RAYUDU GEETHA MOUNIKA Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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 page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in East Godavari ANDHRA PRADESH 533293 India Phone 9666376705 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Swatantra Institute of Physiotherapy and Rehabilitation NH-16,laxmipurm,rajanagaram,533296. Primary Sponsor Primary Sponsor Details 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 Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator geetha mounika Swatantra institute of NH-16,rajahmundry 9666376705 physiotherapy and East Godavari rehabilitation ANDHRA PRADESH mounikarayudu.92@gm ail.com Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? institutional ethics Approved 12/02/2020 No committee,gsl medical college and general hospital Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Other soft tissue disorders related to use, overuse and pressure Intervention / Type Name Details Comparator Agent Intervention pectoralis minor release 3 times a week for 6 weeks of techniques like IASTM and duration. proprioceptive neuromuscular facilitation stretching. Comparator Agent conventional exercises like hot 3 times a week for 6 weeks of pack,TENS,therapeutic duration. ultrasound, stretching and strengthening exercises Inclusion Criteria Inclusion Criteria Age From 40.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1. Subjects with stage 2 Adhesive Capsulitis<br/> 2. Pain in the shoulder for at least 3months<br/> 3. PMI less than 7.44<br/> page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Exclusion Criteria Exclusion Criteria 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 Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Alternation Concealment Blinding/Masking Participant Blinded Primary Outcome Outcome Timepoints PRIMARY OUTCOME-Ultrasonography- To Ultrasonography- To measure the thickness of measure the thickness of Pectoralis Minor Pectoralis Minor -BASELINE AND POST TEST SPADI-FUCTIONAL ABILITY SPADI-BASELINE,3RD WEEK AND POST TEST Secondary Outcome Outcome Timepoints 1.VAS- Pain VAS- Pain-pre 1st week 2nd week 3rd week 4th 2.ROM- Universal Goniometer week 5th week post 3.TSD- Rounded Shoulder Posture ROM- Universal Goniometer-pre 3rd week and 4.PMI-Length of the muscle 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 27/07/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details NIL 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. page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in 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 page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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