| CTRI Number |
CTRI/2024/12/078103 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of IASTM versus Posterolateral Movement with Mobilization on Range of Motion in Overhead Athletes with Posterior Shoulder Tightness: A RCT. |
|
Scientific Title of Study
|
Effect of Instrument Assisted Soft Tissue Mobilization versus Posterolateral MWM on Range of Motion in Overhead Athletes with Posterior Shoulder Tightness: A RCT. |
| 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 Santosh metgud |
| Designation |
Professor and Vice Principal |
| Affiliation |
KLE Institute of Physiotherapy, Belagavi. |
| Address |
Advanced Physiotherapy, room no. 39,Department of Orthopedic Manual Therapy, room no. 13, Sagar floor, KLE Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka- 590010, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh metgud |
| Designation |
Professor and Vice Principal |
| Affiliation |
KLE Institute of Physiotherapy, Belagavi. |
| Address |
Advanced Physiotherapy, room no. 39,Department of Orthopedic Manual Therapy, room no. 13, Sagar floor, KLE Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka- 590010, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vanya Afonso |
| Designation |
Post Graduate |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy, room no. 39,Department of Orthopedic Manual Therapy, room no. 13, Sagar floor, KLE Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka- 590010, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9011799389 |
| Fax |
|
| Email |
vanya14afonso@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belagavi-590010,Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Vanya Afonso |
| Address |
Advanced Physiotherapy, room no. 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka- 590010, India |
| 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 |
| Vanya Afonso |
KLE Dr. Prabhakar Kore Hospital, Belagavi |
Advanced Physiotherapy, room no. 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belagavi, Karnataka- 590010, India
Belgaum
KARNATAKA |
9011799389
vanya14afonso@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research & Ethical Committee, KLEU Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Posterior Shoulder Tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A:
Posterolateral Mobilization with movement, conventional treatment
|
Patient position: Patient stands facing a wall with hands supported against it.
Therapist position: Standing posterior-lateral to the patient.
Hand placement: Therapist places one hand over scapula (such that the belt passes between the thumb and index finger) to stabilize the scapula.
Other hand is placed anteriorly over the belt on the head of the humerus.
Belt placement: Positioning the belt in such a way that it lies in anteromedial aspect of the affected glenohumeral joint.
Mobilization: Gentle, sustained, posterior-lateral-inferior glide by pulling the mobilizing belt.
Patient bends forward from the pelvis by drawing his hips backward to attain more shoulder flexion.
The volume of intervention will consist of 3 sets of 10 repetitions of MWM with an interval of 60 s between sets.
1 session of posterolateral MWM, 3 sets of 10 repetitions +cross body stretch with 30 sec hold, 5 reps
|
| Comparator Agent |
GROUP B:
IASTM and conventional treatment
|
Participant will be lying prone on the treatment table, with their dominant throwing arm positioned in neutral rotation, 90° of elbow flexion, and 90° of shoulder abduction. To make sure the participants humerus stays in level with the acromion process, a towel will be placed underneath it.
A lubricant (Vaseline) will be applied to the skin around the posterior shoulder area prior to treatment and the M2T blade will be cleaned with an alcohol pad. The M2T blade will be used, at an angle of 45° to apply slow strokes along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique) for approximately three minutes.
The treatment strokes will be applied both perpendicularly and parallel to the posterior axillary border muscle fibers, which include the posterior deltoid, latissimus dorsi, teres major, teres minor, and infraspinatus.
After treatment, if any hyperemia or burning reaction occurs, the participants will be asked to put an ice pack on the area. The skin will be cleaned and wiped with tissues and the tool will be cleaned with alcohol.
1 session of instrument assisted soft tissue release,
total treatment time 3 minutes and cross body stretch with 30 sec hold, 5 reps.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Apparently healthy individuals of both genders aged 18 to 30 years, playing overhead sport and who are willing to participate.
2. Participants with a 10 degree or greater difference in internal rotation on their dominant and non-dominant shoulder measured at 90 degrees of abduction.
|
|
| ExclusionCriteria |
| Details |
1. Presence of known any orthopedic or neurologic pathology, or current pain in the shoulder, cervical, or thoracic regions.
2. A history of fracture or surgery of the humerus, scapula, or clavicula in the past 6 months.
3. Any kind of neurological disorders which affect movement system.
4. Positive Neer, Hawkins-Kennedy, and apprehension tests (to rule out rotator cuff disease and glenohumeral instability).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Range of motion using Digital inclinometer:
Range of motion assessed will be horizontal adduction, shoulder internal and external rotation. |
Pre assessment and Post assessment of outcome measures will be done immediately post intervention and after 1 week of follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder mobility using Apley’s scratch test |
Pre assessment and Post assessment of outcome measures will be done immediately post intervention and after 1 week of follow up. |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Posterior Shoulder Tightness has been associated with adaptive structural alterations in the osseous (such as humeral retroversion) and/or soft tissues(such as capsuloligamentous or muscular tightness) of the glenohumeral (GH) joint due to the high demands and excessive overload of activities that are performed overhead repeatedly. It is hypothesized there will be a difference in the effect of Instrument Assisted Soft Tissue Mobilization and posterolateral MWM on range of motion and shoulder mobility in overhead athletes with posterior shoulder tightness using a digital inclinometer and Apley’s scratch test. The study will include a total of 52 participants based on inclusion criteria who are apparently healthy individuals with posterior shoulder tightness in the age group of 18-30 years. Outcome measures include ROM using digital inclinometer and shoulder mobility using Apley’s scratch test. Random allocation will be done by chit method. The study is randomized clinical trial. Group A will receive 1 session of Posterolateral MWM along with crossbody stretch and 1 session of Instrument assisted soft tissue mobilization along with crossbody stretch. Pre assessment and Post assessment of outcome measures will be done immediately post intervention and after 1 week of follow up. |