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
About this trial
This is an interventional treatment trial for Muscle Weakness
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.
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
NCT ID
NCT03496389
First Posted
March 29, 2018
Last Updated
April 5, 2018
Sponsor
Hospital Authority, Hong Kong
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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