| CTRI Number |
CTRI/2024/07/071347 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercise Protocol for Improving Shoulder Range of Motion in Impingement Syndrome Patients |
|
Scientific Title of Study
|
Comparison of Efficacy of Mulligan Technique with Ultrasound Therapy versus Mulligan Technique with Interferential Therapy on Patients with Subacromial Impingement Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Tiwari |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Room No-04, Department of Physiotherapy,North Block,Lower Ground,Shri Mahant Indresh Hospital,Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8433032102 |
| Fax |
|
| Email |
tiwarinisha826@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof (Dr )Niraj Kumar |
| Designation |
Professor |
| Affiliation |
Shri Mahant Indresh Hospital,Patel Nagar,Dehradun |
| Address |
Room No-04, Department of Physiotherapy,North Block,Lower Ground,Shri Mahant Indresh Hospital,Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895795277 |
| Fax |
|
| Email |
drnirajkumar25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof (Dr)Niraj Kumar |
| Designation |
Professor |
| Affiliation |
Shri Mahant Indresh Hospital,Patel Nagar,Dehradun |
| Address |
Room No-04, Department of Physiotherapy,North Block,Lower Ground,Shri Mahant Indresh Hospital,Patel Nagar,Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895795277 |
| Fax |
|
| Email |
drnirajkumar25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Mahant Indresh Hospital, Patel Nagar, Dehradun, Uttrakhand, 248001 |
|
|
Primary Sponsor
|
| Name |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Department of Physiotherapy North BLock,Lower Ground , Shri Mahant Indresh Hospital Patel Nagar, Dehradun, Uttrakhand |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Nisha Tiwari |
Shri Mahant Indresh Hospital |
Department of Physiotherapy,North Block,Lower Ground,Patel Nagar,Dehradun
Dehradun
UTTARANCHAL |
8433032102
tiwarinisha826@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Shri Guru Ram Rai Institute of Medical and Health Sciences,Patel Nagar,Dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M754||Impingement syndrome of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mulligan Technique with Interferential therapy |
Subjects will first receive IFT (Interferential Therapy) with Amplitude: -80-150Hz for 20 minutes.
Moist hot pack will be given prior to the technique.
1.The Mulligan MWM for shoulder internal/external rotation technique:- will involve by placing patient in supine lying with affected shoulder and elbow in 90 degree of flexion.Mobilising belt will be secured around the therapist waist and should be close to the joint line.Therapist will grab the distal end of humerus and maintain a sustain lateral glide and the patient will actively rotate thier shoulder either internally or externally while belt maintains lateral distraction.
3 sets of 5 repetitions with rest interval of 30 seconds between each set.
2.Posterolateral MWM for shoulder pain: -Subject seated at the edge of the chair with arm in external rotation. Therapist will stand laterally to the unaffected shoulder. Therapist will stabilize the affected shoulder of the subject and thenar eminence of the other hand is placed medial to the head of humerus and glides the humeral head in posterior-lateral-inferior direction with thenar eminence of his hand and ask the subject to do active shoulder flexion.3 sets of 5 repetitions with rest interval of 30 seconds between each set.
3.Posterolateral MWM for flexion with belt: -Subject position will be sitting upright at the edge of the chair. Therapist will stand behind the affected side in postero lateral direction. Therapist loops the mobilization belt around the patients affected shoulder and around his pelvis and give sustained posterolateral glide. Maintain the glide by moving pelvis. Ask the patient to do flexion in boxing or a punching manner.3 sets of 5 repetitions with rest interval of 30 seconds between each set. |
| Intervention |
Mulligan Technique with Ultrasound Therapy |
Subjects will first receive ultrasound therapy with Intensity: -1.5W/cm2for 8 minutes.
Moist hot pack will be given prior to the technique.
1.The Mulligan MWM for shoulder internal/external rotation technique:- will involve by placing patient in supine lying with affected shoulder and elbow in 90 degree of flexion.Mobilising belt will be secured around the therapist waist and should be close to the joint line.Therapist will grab the distal end of humerus and maintain a sustain lateral glide and the patient will actively rotate thier shoulder either internally or externally while belt maintains lateral distraction.
3 sets of 5 repetitions with rest interval of 30 seconds between each set.
2.Posterolateral MWM for shoulder pain: -Subject seated at the edge of the chair with arm in external rotation. Therapist will stand laterally to the unaffected shoulder. Therapist will stabilize the affected shoulder of the subject and thenar eminence of the other hand is placed medial to the head of humerus and glides the humeral head in posterior-lateral-inferior direction with thenar eminence of his hand and ask the subject to do active shoulder flexion.3 sets of 5 repetitions with rest interval of 30 seconds between each set.
3.Posterolateral MWM for flexion with belt: -Subject position will be sitting upright at the edge of the chair. Therapist will stand behind the affected side in postero lateral direction. Therapist loops the mobilization belt around the patients affected shoulder and around his pelvis and give sustained posterolateral glide. Maintain the glide by moving pelvis. Ask the patient to do flexion in boxing or a punching manner.3 sets of 5 repetitions with rest interval of 30 seconds between each set. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Having continuous unilateral shoulder pain.
2. Patients with positive Neer’s test, Hawkin’s test |
|
| ExclusionCriteria |
| Details |
1.Patients having adhesive capsulitis
2.Major rotator cuff tears
3.Sensory and muscular deficits
4.Muscle atrophy or weakness
5. Patients with history of any shoulder trauma or surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Numerical Pain Rating Scale
2.Universal Goniometer |
Baseline data
6th week data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SPADI Questionnaire |
Baseline data
6th week data |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/08/2024 |
| 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="14" |
|
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
|
This study aims to compare the effectiveness of two treatment protocols, Mulligan Technique with Ultrasound Therapy versus Mulligan Technique with Interferential Therapy on Patients with Subacromial Impingement Syndrome. The objectives include assessing the effectiveness of each technique and therapeutic modalities individually and determining which protocol yields faster results.
The study proposes an alternate hypothesis suggesting a significant difference in the effects of the two techniques and therapeutic modalities , while the null hypothesis indicates no significant difference. |