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

NCT03496389 | Unknown Phase 2 FDA Drug

• 1 other identifier: Gabapentin ACLR
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Muscle Weakness; Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Anterior-posterior knee stability

  at postoperative 4, 6, 9, 12 months

• Anterior-posterior knee stability

  at postoperative 4, 6, 9, 12 months

• Anterior-posterior knee stability

  at postoperative 4, 6, 9, 12 months

• Rotational laxity

  at postoperative 4, 6, 9, 12 months

• Functional outcome

  at postoperative 4, 6, 9, 12 months

Study Arms (2)

Gabapentin + panadol

EXPERIMENTAL

Drug: Gabapentin; Drug: Panadol

Tramadol + panadol

ACTIVE COMPARATOR

Drug: Tramadol; Drug: Panadol

Interventions

Gabapentin DRUG

Gabapentin 300mg daily

Gabapentin + panadol

Tramadol DRUG

Tramadol 50mg QID

Tramadol + panadol

Panadol DRUG

Panadol 500mg QID

Gabapentin + panadol; Tramadol + panadol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

MeSH Terms

Conditions

Muscle Weakness; Anterior Cruciate Ligament Injuries

Interventions

Gabapentin; Tramadol; Acetaminophen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Central Study Contacts

Jonathan P Ng, MBBCh MRCS

CONTACT

(852)53329291; ngjp2606@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 12, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 12, 2018

Record last verified: 2018-04