Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction?

Study Overview
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Brief Summary
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Anterior cruciate ligament (ACL) injury is a common sport injury in both professional and recreational athletes. Furthermore, persistent quadriceps weakness and wasting are frequently observed after anterior cruciate ligament reconstruction (ACLR). Several studies have demonstrated that muscular rehabilitation to normal strength is difficult, protracted, and often not achieved due to the inability to fully activate the quadriceps voluntarily. Pain and disuse are often blamed for the inhibition of muscle activation following joint injury. However, arthrogenic muscle inhibition (AMI) is often overlooked and not addressed. Thus, the magnitude of strength restoration of the quadriceps is frequently restricted despite solid rehabilitation protocols. As AMI is a reflex inhibition of musculature involving the neurotransmitter γ-aminobutyrate (GABA), Gabapentin may have a potential role in modulating AMI, therefore limiting muscle weakness after ACLR.

Official Title
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Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction? A Randomised Controlled Trial

Conditions
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Muscle Weakness, Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Tramadol
* Drug: Panadol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-50 Unilateral isolated ACL tear for primary ACLR confirmed clinically and radiologically No concomitant ligamentous, meniscal or chondral injuries. Exclusion Criteria: Concomitant multiple ligament injuries including posterior cruciate ligament, medial collateral ligament ligament, or lateral collateral ligament Concomitant meniscal injuries Concomitant chondral injuries preoperative radiographic signs of arthritis Revision ACL surgery Contralateral knee with Medical co-morbidities including Diabetes Mellitus, chronic renal failure Documented hypersensitivity to Gabapentin History of epilepsy History of depression Non-compliance to rehabilitation protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin + panadol<br> | Drug: Gabapentin<br>* Gabapentin 300mg daily<br>Drug: Panadol<br>* Panadol 500mg QID<br>|
| Active Comparator: Tramadol + panadol<br> | Drug: Tramadol<br>* Tramadol 50mg QID<br>Drug: Panadol<br>* Panadol 500mg QID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in from baseline quadriceps muscle strength | Will be measured using Biodex isodex dynamometer to measure peak torque of knee extension | at postoperative 4, 6, 9, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior-posterior knee stability | Measured by Lachman test | at postoperative 4, 6, 9, 12 months | 
| Anterior-posterior knee stability | Measured by anterior drawer test | at postoperative 4, 6, 9, 12 months | 
| Anterior-posterior knee stability | Measured by KT- 1000 knee arthrometer | at postoperative 4, 6, 9, 12 months | 
| Rotational laxity | Measured using the pivot shift test according to the IKDC score | at postoperative 4, 6, 9, 12 months | 
| Functional outcome | Measured using single leg hop test | at postoperative 4, 6, 9, 12 months | 
| Functional outcome | Measured using Lysholm knee scoring system | at postoperative 4, 6, 9, 12 months |