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

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03496389
• Other study ID #: Gabapentin ACLR
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: March 29, 2018
• Last updated: April 5, 2018
• Start date: July 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: April 2018
• Source: Hospital Authority, Hong Kong
• Contact: Jonathan P Ng, MBBCh MRCS
• Phone: (852)53329291
• Email: ngjp2606[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Muscle Weakness
• Paresis
• Rupture

Intervention

Drug:
• Gabapentin
Gabapentin 300mg daily
• Tramadol
Tramadol 50mg QID
• Panadol
Panadol 500mg QID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anterior-posterior knee stability	Measured by Lachman test	at postoperative 4, 6, 9, 12 months
Secondary	Anterior-posterior knee stability	Measured by anterior drawer test	at postoperative 4, 6, 9, 12 months
Secondary	Anterior-posterior knee stability	Measured by KT- 1000 knee arthrometer	at postoperative 4, 6, 9, 12 months
Secondary	Rotational laxity	Measured using the pivot shift test according to the IKDC score	at postoperative 4, 6, 9, 12 months
Secondary	Functional outcome	Measured using single leg hop test	at postoperative 4, 6, 9, 12 months
Secondary	Functional outcome	Measured using Lysholm knee scoring system	at postoperative 4, 6, 9, 12 months