| CTRI Number |
CTRI/2025/03/082117 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Manual physiotherapy techniques for shoulder pain among hill driving taxi drivers |
|
Scientific Title of Study
|
Comparison of Maitland Manipulation versus Conventional Shoulder Exercises in Middle Aged Hill Station Taxi Drivers having Periarthritis shoulder - an 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 S Senthil Kumar |
| Designation |
Associate Professor |
| Affiliation |
Saveetha college of physiotherapy |
| Address |
Saveetha College of Physiotherapy,
Saveetha Institute of Medical and Technical Sciences
Chennai
TAMIL NADU
602105
India |
| Phone |
9840784295 |
| Fax |
|
| Email |
drsenthilmptbds@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Senthil Kumar |
| Designation |
Associate Professor |
| Affiliation |
Saveetha college of physiotherapy |
| Address |
Saveetha College of Physiotherapy,
Saveetha Institute of Medical and Technical Sciences
Chennai
TAMIL NADU
602105
India |
| Phone |
9840784295 |
| Fax |
|
| Email |
drsenthilmptbds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Senthil Kumar |
| Designation |
Associate Professor |
| Affiliation |
Saveetha college of physiotherapy |
| Address |
Saveetha College of Physiotherapy,
Saveetha Institute of Medical and Technical Sciences
Chennai
TAMIL NADU
602105
India |
| Phone |
9840784295 |
| Fax |
|
| Email |
drsenthilmptbds@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Noah Selvaraj |
| Address |
Santosh College of Physiotherapy, 15B, GST Road, Tirunagar, Madurai.625006, TamilNadu. |
| 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 |
| Noah Selvaraj |
Santosh College of Physiotherapy |
Room no 1, Santosh College of Physiotherapy OPD,15B, GST Road, Tirunagar, Madurai. 625006
Madurai
TAMIL NADU |
9843111114
scpmadurai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee biomedical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periarthritis shoulder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Shoulder Exercises |
Group B will undergo Conventional Therapy (shoulder exercises): Ultra sound therapy, frequency-1MHz, intensity–0.8W/cm2, for 7min., Cryotherapy for 10 min. Exercises: Codman’s pendulum exercises 10 repetitions each, Capsular Stretches 30 sec hold, 5 repetitions, Shoulder mobility exercises. |
| Intervention |
Maitland Manipulation |
Group A will undergo Maitland Manipulation , using glides involves performing movements where the distal aspect of the limb is free and not fixed to an object, allowing isolated joint movements. And Ultrasound therapy,frequency-1MHz, intensity–0.8W/cm2, for 7min. will be given.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with periarthritis shoulder and who are willing to participate in the study.
Special test positive subject. (shrug test)
Diabetes mellitus with periarthritis under regular treatment.
Middle Aged Hill Station Taxi drivers
|
|
| ExclusionCriteria |
| Details |
Subjects having any other pathology.
Un cooperative subjects.
Subjects undergone any shoulder surgery
Mal union
Congenital deformities of shoulder
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shoulder Pain and Disability Index
Range of motion
|
Data collection 3 months
Data analysis and discussion 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/04/2025 |
| 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="6"
Days="0" |
|
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
|
Frozen shoulder also termed as periarthritis shoulder or adhesive capsulitis of shoulder, is one of the common cause of shoulder pain and stiffness in day to day practice. It is a self-limiting condition resolving over 2-3 years. The various treatment options available include simple physiotherapy, intra articular injections. Manipulation under general anaesthesia and surgical intervention. Professional drivers are at high risk of developing musculoskeletal pain (MSP) due to risk factors such as prolonged sitting, whole body vibration, awkward posture, and repetitive actions. Work-related musculoskeletal disorders (WRMD) in physiological illness may develop over a long period due to prolonged mechanical stresses imposed on the musculoskeletal system. Drivers have the highest prevalence of MSDs, in comparison with other jobs. Drivers are in fixed postures for long time therefore they would suffer from musculoskeletal disorders because of the forces on their joints such as lumbar vertebra, knees, neck, shoulders, wrists, elbows, ankles, and almost all the joints of body. Conventional treatment of periarthritis shoulder – Pendulum exercise, active assisted range of motion-limited symptoms free available range, rope and pulley exercises, various types of mobility exercises, pain relieving modalities- ultrasound cryotherapy , transcutaneous electrical stimulation, high voltage galvanic stimulation , strengthening exercise. The international Maitland Teachers Association (IMTA) defines the Maitland concept as a process of examination, assessment and treatment of neuro musculoskeletal disorder by manipulative physiotherapy. Maitland mobilization (MM) is a manual technique commonly used in order to decrease pain and stiffness in the shoulder joint. Maitland’s rhythmic oscillations’ ability to reduce inflammation. |