| CTRI Number |
CTRI/2024/09/074070 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing Ultrasound-Guided PRP Injections and Conservative Treatment for Pain and Function in Athletes with Grade III AC Joint Injuries: A Randomized Trial |
|
Scientific Title of Study
|
Effectiveness of ultrasound-guided platelet-rich plasma injection in comparison with conservative management in improving pain and function in athletes with Rockwood grade III acromioclavicular joint injuries of shoulder: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Laimujam Sobhasini Devi |
| Designation |
Senior Resident |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No. 795004
Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No. 795004
Imphal West
MANIPUR
795004
India |
| Phone |
8732030087 |
| Fax |
|
| Email |
sobhasinil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AKOIJAM JOY SINGH |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal West District, Manipur |
| Address |
Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No. 795004
Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No. 795004
Imphal West
MANIPUR
795004
India |
| Phone |
8732030087 |
| Fax |
|
| Email |
joyakoijam2@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Laimujam Sobhasini Devi |
| Designation |
Senior Resident |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No. 795004
Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No. 795004
Imphal West
MANIPUR
795004
India |
| Phone |
8732030087 |
| Fax |
|
| Email |
sobhasinil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No. 795004 |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences Imphal Manipur |
| Address |
Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No 795004 |
| Type of Sponsor |
Government 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 |
| Laimujam Sobhasini Devi |
RIMS Hospital, Imphal, Manipur |
Department of Sports Medicine, Regional Institute of Medical Sciences, Imphal West District, Manipur
Pin No. 795004
Imphal West
MANIPUR |
08732030087
sobhasinil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conservative management |
The conservative management Rockwood grade 3 AC joint injuries consist of four phases, with progression based on individual symptoms and goals rather than strict timelines.40
Phase 1: Immobilization
Brief period of sling use (6 weeks) to alleviate pain and reduce stress on the AC joint
Used of analgesics and application of ice to relieve pain
Patients begin early range of motion exercises to prevent stiffness and atrophy
Phase 2: Range of Motion and Early Strengthening
Start with passive and active-assisted range of motion exercises, focusing on external rotation and forward elevation
Avoid provocative movements like internal rotation behind the back, cross-body adduction, and extreme forward elevation unless tolerated
Include closed-chain scapular exercises to reduce AC joint stress
Phase 3: Advanced Strengthening
Continue closed-chain exercises and introduce tubing or cable exercises for periscapular muscles and rotator cuff
Incorporate rowing and kinetic chain exercises for scapular stability, avoiding high-stress exercises early on
Phase 4: Sports-Specific Training
Advance to kinetic chain exercises, plyometrics, and sport-specific strengthening
For power athletes, start with pushups, bench press, and overhead press, avoiding lockout to limit AC joint stress
Implement graduated throwing programs and sport-specific drills based on tolerance
This approach ensures tailored rehabilitation for optimal recovery and return to activity.
|
| Intervention |
Ultrasound-guided platelet-rich plasma injection |
2ml Intra-articular and 2ml over the capsule under US-guidance using the needle (21 Gauge, 5ml syringe) by an in-plain technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Rockwood Type 3 Acromioclavicular Joint Dislocation in X-ray of bilateral acromioclavicular joint in Zanca view
2. Age group 18-35 years
3. Duration of injury within 4 weeks
|
|
| ExclusionCriteria |
| Details |
1. Any associated fracture and rotator cuff injury
2. Any previous shoulder surgery
3. Local infection around the shoulder
4. Uncontrolled systemic diseases
5. Local corticosteroid injection within 8 weeks
6. Thrombocytopenia
7. Haemodynamic instability
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Shoulder pain measured by Visual Analogue Scale (VAS)
2. Shoulder function measured by Constant Murley Score (CMS) |
1st, 3rd, 6th, and 12th months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder function measured by Quick Dash scores |
1st, 3rd, 6th, and 12th months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
**Title:** Effectiveness of ultrasound-guided platelet-rich plasma injection in comparison with conservative management in improving pain and function in athletes with Rockwood grade III acromioclavicular joint injuries of the shoulder: a randomized controlled trial.
**Investigator:** Dr. Laimujam Sobhasini Devi
**Supervisor/Guide:** Dr. Akoijam Joy Singh **Department:** Department of Sports Medicine, RIMS, Imphal
**Study Duration:** - **Initiation:** October 2024 - **Completion:** September 2025
**Novelty of the Study:** This study focuses on the effectiveness of PRP injections, administered under ultrasound guidance, specifically for Rockwood grade III acromioclavicular joint (ACJ) injuries. It employs the Double Spin Method for PRP preparation and is the first randomized controlled trial (RCT) of its kind conducted in India.
**Study Design:** Randomized Controlled Trial (RCT)
**Objective:** To assess the effectiveness of ultrasound-guided PRP injection compared to conservative management in improving pain and function in athletes with Rockwood grade III ACJ injuries of the shoulder.
**Participants:** - **Sample Size:** 60 participants, calculated based on a previous study by Windhamre HB et al. - **Recruitment:** Patients attending the Sports Medicine OPD at RIMS, Imphal, on specific weekdays, who meet the inclusion criteria, will be recruited through convenience sampling.
**Randomization:** Block randomization method will be used.
**Independent Variables:** - **Demographics:** Age, Gender, Sports Discipline, Duration of symptoms - **Interventions:** 1. Ultrasound-guided platelet-rich plasma injection 2. Conservative management
**Outcome Variables and Measurements:** - **Shoulder Pain:** Visual Analog Scale (VAS) - **Shoulder Function:** Constant Murley Score and Quick DASH scores
**Statistical Analysis Plan:** - **Descriptive Data:** Mean, frequency, percentage, and standard deviation - **Categorical Data:** Chi-square test - **Continuous Variables:** Student’s t-test - **Within-Group Comparison:** Repeated measures ANOVA - **Between-Group Comparison:** Student’s t-test - **Significance:** p-value < 0.05
**Contact Information:** - **Email:** sobhasinil@gmail.com - **Phone:** 8732030087
|