Effect of EMG biofeedback in the management of knee ligament injury

Not yet recruiting

Conditions: Sprain of cruciate ligament of knee,

Registration Number: CTRI/2025/06/088245

Lead Sponsor: Dr Bhaskar Mazumdar

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**I**nternational **K**nee **D**ocumentation **C**ommittee’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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 82

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1. Increase in mean Agonist/Antagonist ratio	2. Decrease in pain (by VAS)

Trial Locations

Locations (1): IPGMER and SSKM Hospital
🇮🇳
Kolkata, WEST BENGAL, India
IPGMER and SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
Dr Bhaskar Mazumdar
Principal investigator
9748300334
mazumdarbhaskar95@gmail.com