CTRI Number |
CTRI/2022/04/041985 [Registered on: 20/04/2022] Trial Registered Prospectively |
Last Modified On: |
26/02/2024 |
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
|
Instant Effect of Maitland Mobilization Techniques versus Scapular Proprioceptive Neuromuscular Facilitation and Glenohumeral Mobilization in Adhesive Capsulitis- A Randomized Controlled Trial |
Scientific Title of Study
|
Immediate Effect of Grade III or IV Maitland Mobilization Techniques versus Scapular Proprioceptive Neuromuscular Facilitation and Glenohumeral Mobilization in Adhesive Capsulitis- A Randomized Controlled trial |
Trial Acronym |
RCT |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Neha Nandakumar Shet |
Designation |
Second Year Master of Physiotherapy in Musculoskeletal Disorders and Sports Medicine |
Affiliation |
Allied Health Science Courses, Goa Medical College, Bambolim, Goa |
Address |
Department of Orthopaedic Surgery, Goa Medical College, Bambolim- Goa
North Goa GOA 403512 India |
Phone |
09588493861 |
Fax |
|
Email |
nehashet10@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Alisha Lilia Gracias PT |
Designation |
Lecturer in Physiotherapy |
Affiliation |
Allied Health Science Courses, Goa Medical College, Bambolim, Goa |
Address |
Department of Orthopaedic Surgery, Goa Medical College, Bambolim- Goa
North Goa GOA 403512 India |
Phone |
09588493861 |
Fax |
|
Email |
alisha.gracias@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Neha Nandakumar Shet |
Designation |
Second Year Master of Physiotherapy in Musculoskeletal Disorders and Sports Medicine |
Affiliation |
Allied Health Science Courses, Goa Medical College, Bambolim, Goa |
Address |
Department of Orthopaedic Surgery, Goa Medical College, Bambolim- Goa
North Goa GOA 403512 India |
Phone |
09588493861 |
Fax |
|
Email |
nehashet10@gmail.com |
|
Source of Monetary or Material Support
|
Goa Medical College, Bambolim- Goa, India |
|
Primary Sponsor
|
Name |
Nil |
Address |
Nil |
Type of Sponsor |
Other [Nil ] |
|
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 |
Neha Shet |
Goa Medical College |
Department of Orthopaedic Surgery North Goa GOA |
09588493861
nehashet10@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Goa Medical College Institutional Ethics Committee |
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 |
Intervention |
Maitland end-range glenohumeral mobilization and scapular mobilization |
Scaption plane glenohumeral mobilization and superior, inferior glides; upward, downward rotations, distraction
Frequency: 2 treatment sessions
Duration: 1 hour
Frequency |
Comparator Agent |
Scapular proprioceptive neuromuscular facilitation and Maitland glenohumeral mobilization |
Anterior elevation and posterior depression for scapula and caudal glide, caudal glide progression, postero-anterior glide for glenohumeral joint
Frequency: 2 treatment sessions
Duration: 1 hour |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Diagnosed with adhesive capsulitis within 3-9 months
Capsular restriction of movement
Visiting Goa Medical College
2021 - 2022 |
|
ExclusionCriteria |
Details |
Shoulder surgery
Corticosteroid injection
Shoulder impingement
Trauma to shoulder or scapula
Hypermobile joints
Neurological disorders
Migration |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Visual Analog Scale
Disabilities of Arm, Shoulder and Hand Questionnaire
Lateral Scapular Slide Test
Glenohumeral Range of Motion |
Baseline, immediately following treatment and post 1 week following treatment |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
27/04/2022 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
My thesis compares end range glenohumeral mobilization and scapular mobilization versus glenohumeral mobilization and scapular proprioceptive neuromuscular facilitation technique to measure which technique will have better effect in adhesive capsulitis to decrease pain and to improve range of motion and functional disability in patients with adhesive capsulitis.
Summary The study concluded that scapular mobilization with Maitland glenohumeral mobilization and scapular PNF with Maitland glenohumeral mobilization are both effective in improving pain, functional disability, glenohumeral joint ROM and scapular dyskinesis in post treatment in patients with adhesive capsulitis but won’t have effect post 1 week. Also, the effect size is small.
|