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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03496389
Enrollment
30
Registered
2018-04-12
Start date
2018-07-01
Completion date
2019-08-01
Last updated
2018-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Rupture, Muscle Weakness

Brief summary

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.

Interventions

DRUGGabapentin

Gabapentin 300mg daily

DRUGTramadol

Tramadol 50mg QID

DRUGPanadol

Panadol 500mg QID

Sponsors

Hospital Authority, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18-50 2. Unilateral isolated ACL tear for primary ACLR confirmed clinically and radiologically 3. No concomitant ligamentous, meniscal or chondral injuries.

Exclusion criteria

1. Concomitant multiple ligament injuries including posterior cruciate ligament, medial collateral ligament ligament, or lateral collateral ligament 2. Concomitant meniscal injuries 3. Concomitant chondral injuries 4. preoperative radiographic signs of arthritis 5. Revision ACL surgery 6. Contralateral knee with 7. Medical co-morbidities including Diabetes Mellitus, chronic renal failure 8. Documented hypersensitivity to Gabapentin 9. History of epilepsy 10. History of depression 11. Non-compliance to rehabilitation protocol.

Design outcomes

Primary

MeasureTime frameDescription
Change in from baseline quadriceps muscle strengthat postoperative 4, 6, 9, 12 monthsWill be measured using Biodex isodex dynamometer to measure peak torque of knee extension

Secondary

MeasureTime frameDescription
Anterior-posterior knee stabilityat postoperative 4, 6, 9, 12 monthsMeasured by Lachman test
Rotational laxityat postoperative 4, 6, 9, 12 monthsMeasured using the pivot shift test according to the IKDC score
Functional outcomeat postoperative 4, 6, 9, 12 monthsMeasured using single leg hop test

Contacts

Primary ContactJonathan P Ng, MBBCh MRCS
ngjp2606@gmail.com(852)53329291

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026