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

H

Hospital Authority, Hong Kong

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Muscle Weakness
Anterior Cruciate Ligament Rupture

Treatments

Drug: Panadol
Drug: Tramadol
Drug: Gabapentin

Study type

Interventional

Funder types

Other

Identifiers

NCT03496389
Gabapentin ACLR

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups

Gabapentin + panadol
Experimental group
Treatment:
Drug: Gabapentin
Drug: Panadol
Tramadol + panadol
Active Comparator group
Treatment:
Drug: Tramadol
Drug: Panadol

Trial contacts and locations

0

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Central trial contact

Jonathan P Ng, MBBCh MRCS

Data sourced from clinicaltrials.gov

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