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

Primary Purpose

Muscle Weakness, Anterior Cruciate Ligament Rupture

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gabapentin
Tramadol
Panadol
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Gabapentin + panadol

    Tramadol + panadol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in from baseline quadriceps muscle strength
    Will be measured using Biodex isodex dynamometer to measure peak torque of knee extension

    Secondary Outcome Measures

    Anterior-posterior knee stability
    Measured by Lachman test
    Anterior-posterior knee stability
    Measured by anterior drawer test
    Anterior-posterior knee stability
    Measured by KT- 1000 knee arthrometer
    Rotational laxity
    Measured using the pivot shift test according to the IKDC score
    Functional outcome
    Measured using single leg hop test
    Functional outcome
    Measured using Lysholm knee scoring system

    Full Information

    First Posted
    March 29, 2018
    Last Updated
    April 5, 2018
    Sponsor
    Hospital Authority, Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03496389
    Brief Title
    Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction?
    Official Title
    Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction? A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2018 (Anticipated)
    Primary Completion Date
    July 1, 2019 (Anticipated)
    Study Completion Date
    August 1, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Authority, Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscle Weakness, Anterior Cruciate Ligament Rupture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Gabapentin + panadol
    Arm Type
    Experimental
    Arm Title
    Tramadol + panadol
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Gabapentin
    Intervention Description
    Gabapentin 300mg daily
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol
    Intervention Description
    Tramadol 50mg QID
    Intervention Type
    Drug
    Intervention Name(s)
    Panadol
    Intervention Description
    Panadol 500mg QID
    Primary Outcome Measure Information:
    Title
    Change in from baseline quadriceps muscle strength
    Description
    Will be measured using Biodex isodex dynamometer to measure peak torque of knee extension
    Time Frame
    at postoperative 4, 6, 9, 12 months
    Secondary Outcome Measure Information:
    Title
    Anterior-posterior knee stability
    Description
    Measured by Lachman test
    Time Frame
    at postoperative 4, 6, 9, 12 months
    Title
    Anterior-posterior knee stability
    Description
    Measured by anterior drawer test
    Time Frame
    at postoperative 4, 6, 9, 12 months
    Title
    Anterior-posterior knee stability
    Description
    Measured by KT- 1000 knee arthrometer
    Time Frame
    at postoperative 4, 6, 9, 12 months
    Title
    Rotational laxity
    Description
    Measured using the pivot shift test according to the IKDC score
    Time Frame
    at postoperative 4, 6, 9, 12 months
    Title
    Functional outcome
    Description
    Measured using single leg hop test
    Time Frame
    at postoperative 4, 6, 9, 12 months
    Title
    Functional outcome
    Description
    Measured using Lysholm knee scoring system
    Time Frame
    at postoperative 4, 6, 9, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan P Ng, MBBCh MRCS
    Phone
    (852)53329291
    Email
    ngjp2606@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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