| CTRI Number |
CTRI/2025/06/088245 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EMG Biofeedback] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of EMG biofeedback in the management of knee ligament injury |
|
Scientific Title of Study
|
Efficacy of electromyography biofeedback in management of partial anterior cruciate ligament tear in comparison to conservative management alone: 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 |
Dr Bhaskar Mazumdar |
| Designation |
Junior Resident |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Physical Medicine and Rehabilitation, IPGMER and SSKM Hospital, 244 Acharya J.C. Bose road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9748300334 |
| Fax |
|
| Email |
mazumdarbhaskar95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Firdaus Kamal |
| Designation |
Professor and Guide |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Physical Medicine and Rehabilitation, IPGMER and SSKM Hospital, 244 Acharya J.C. Bose road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830219554 |
| Fax |
|
| Email |
kamal.firdaus.kamal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Firdaus Kamal |
| Designation |
Professor and Guide |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Physical Medicine and Rehabilitation, IPGMER and SSKM Hospital, 244 Acharya J.C. Bose road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830219554 |
| Fax |
|
| Email |
kamal.firdaus.kamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital, 244 Acharya J.C. Bose road, Kolkata, West Bengal, PIN-700020, Country- India |
|
|
Primary Sponsor
|
| Name |
Dr Bhaskar Mazumdar |
| Address |
Department of Physical Medicine and Rehabilitation, IPGMER and SSKM Hospital, 244 Acharya J.C. Bose road, Kolkata, 700020 |
| 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 |
| Dr Bhaskar Mazumdar |
IPGMER and SSKM Hospital |
OPD Room No:1, Department of Physical Medicine and Rehabilitation, IPGMER and SSKM Hospital, 244 Acharya J.C. Bose road, Kolkata 700020
Kolkata
WEST BENGAL |
9748300334
mazumdarbhaskar95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A- EMG biofeedback + Conservative management for patients with partial ACL tear |
Electromyography biofeedback (EMG-BFB) is a method that monitors muscular electrical activity, providing feedback to adjust muscle tension which leads to increased strength. In this study, selected patients (based on pre-defined inclusion and exclusion criteria) will be assessed for isokinetic parameters on the affected side. Peak torque/bodyweight and agonist/antagonist ratio will be assessed. After this, one group of patients will receive EMG-BFB along with conservative management (anti-inflammatory medications and routine exercise protocol set for ACL injury). This group will be followed up at 4 weeks, 8 weeks and 12 weeks respectively from baseline. Isokinetic assessments will be monitored accordingly at these time intervals.
|
| Comparator Agent |
Group B- only Conservative management for patients with partial ACL tear |
Selected patients (as per set inclusion and exclusion criteria) will be assessed first for isokinetic parameters on the affected side. This group of patients will receive conservative treatment (anti-inflammatory medications and routine exercise protocol set for ACL injury) alone on an outpatient basis and will follow up at 4, 8, and 12 weeks, respectively, for further isokinetic assessment.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. MRI confirmed post-traumatic partial ACL (Grade II) tear
2. Patients should be having clinical features suggestive of partial ACL tear, positive in Lachman test and Pivot shift test
3. Duration of injury less than 3 months
4. Pain with VAS score of more than or equals to 5
5. Patient willing to opt for non-surgical management for partial ACL tear
|
|
| ExclusionCriteria |
| Details |
1. MRI confirmed complete ACL tear
2. Multi-ligamentous knee injury
3. Presence of associated meniscal or chondral injury confirmed by MRI
4. Bilateral Knee involvement
5. Previous knee injuries and surgeries
6. Inflammatory causes of knee pain
7. Knee joint contracture
8. Local site infection
9. Coagulopathy
10. Any neuromuscular deficit in bilateral lower limbs
11. uncontrolled medical illness
12. Presence of red flag signs (Recent trauma, Fever, Fractures, Malignancy)
13. Patient refusal
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in Peak torque/Body weight(PT/BW) ratio of knee flexor and extensor muscles
|
Baseline, 4 weeks, 8 weeks and 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Increase in mean Agonist/Antagonist ratio
2. Decrease in pain (by VAS) |
Baseline, 4 weeks, 8 weeks and 12 weeks
|
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
13/06/2025 |
| 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="1"
Months="2"
Days="0" |
|
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 is a parallel-group, open-label, randomized controlled study, conducting on selected patients (based on pre-defined inclusion and exclusion criteria) attending the OPD of the Department of PM&R at IPGME&R, SSKMH. After informed consent, enlisted patients will undergo a baseline clinical examination and routine hematological and biochemical investigations. All patients will be assessed using the International Knee Documentation Committee’s (IKDC) knee ligament standard evaluation form. Isokinetic parameters (peak torque/body weight [PT/BW], mean Agonist/Antagonist ratio) will be assessed and Visual Analogue Scale (VAS- for pain)on the symptomatic side at baseline. The isokinetic assessment procedure used in this study is a concentric knee flexion and extension protocol. Isokinetic assessment will be performed at two speeds: 60°/s and 180°/s. Patients will be encouraged to exert maximum force during the test and all contractions. Peak torque/bodyweight and mean Agonist/Antagonist will be assessed.
Following this, one group of patients will receive electromyography biofeedback (EMG-BFB) combined with conservative treatment (anti-inflammatory medications and isometric quadriceps and hamstring exercises, Patellar mobilization, heel slides, quad sets, passive knee extension, Straight Leg Raising (SLR), wall squat with a ball, balance & reach exercises, knee stabilization) within the first week (four times weekly) and during each session for the first four weeks. This group will be followed-up at 4 weeks, then repeat the same process for the next four weeks, with follow-up visits scheduled at 8 and 12 weeks, respectively (from baseline). Isokinetic assessments will be monitored accordingly at these time intervals. The other group of patients will receive conservative treatment alone on an outpatient basis and will follow up at 4, 8, and 12 weeks, respectively, for further isokinetic assessment. The results will be analyzed using standard statistical methods to fulfil the study’s aims and objectives. |