Muscle WeaknessPhase 2/3NCT03496389
Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction?
A Phase 2/3 study testing Gabapentin, Tramadol and Panadol in people with Muscle Weakness and Anterior Cruciate Ligament Rupture, run by Hospital Authority, Hong Kong.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Muscle Weakness, Anterior Cruciate Ligament Rupture
- What is being tested?
- Gabapentin, Tramadol and Panadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Aug 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50
- Unilateral isolated ACL tear for primary ACLR confirmed clinically and radiologically
- No concomitant ligamentous, meniscal or chondral injuries.
Who cannot join
- 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
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- Medical co-morbidities including Diabetes Mellitus, chronic renal failure
- Documented hypersensitivity to Gabapentin
- History of epilepsy
- History of depression
- Non-compliance to rehabilitation protocol.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction? A Randomised Controlled Trial
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.
- Being tested
- Gabapentin, Tramadol, Panadol
- Medical subject headings
- Muscle Weakness, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Gabapentin 300mg daily
TramadolDrug
Tramadol 50mg QID
PanadolDrug
Panadol 500mg QID
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin + panadol | Experimental | Not described Receives: Drug: Gabapentin; Drug: Panadol |
| Tramadol + panadol | Active comparator | Not described Receives: Drug: Tramadol; Drug: Panadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in from baseline quadriceps muscle strength
Will be measured using Biodex isodex dynamometer to measure peak torque of knee extension
Measured: at postoperative 4, 6, 9, 12 months
Secondary outcomes (6)
Anterior-posterior knee stability
Measured by Lachman test
Measured: at postoperative 4, 6, 9, 12 months
Anterior-posterior knee stability
Measured by anterior drawer test
Measured: at postoperative 4, 6, 9, 12 months
Anterior-posterior knee stability
Measured by KT- 1000 knee arthrometer
Measured: at postoperative 4, 6, 9, 12 months
Rotational laxity
Measured using the pivot shift test according to the IKDC score
Measured: at postoperative 4, 6, 9, 12 months
Functional outcome
Measured using single leg hop test
Measured: at postoperative 4, 6, 9, 12 months
Functional outcome
Measured using Lysholm knee scoring system
Measured: at postoperative 4, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ng Jonathan Patrick, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496389
- Sponsor's protocol ID
- Gabapentin ACLR
- Status last verified
- Apr 2018
- First submitted
- 29 Mar 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03496389
- Acronym / sponsor ID
- Gabapentin ACLR
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin + panadol | Experimental | Drug: Gabapentin, Drug: Panadol |
| Tramadol + panadol | Active comparator | Drug: Tramadol, Drug: Panadol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-50
- Unilateral isolated ACL tear for primary ACLR confirmed clinically and radiologically
- No concomitant ligamentous, meniscal or chondral injuries.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinGabapentin 300mg daily | Drug | Gabapentin + panadol |
| TramadolTramadol 50mg QID | Drug | Tramadol + panadol |
| PanadolPanadol 500mg QID | Drug | Gabapentin + panadol, Tramadol + panadol |
Primary outcome
Change in from baseline quadriceps muscle strength
Time frame: at postoperative 4, 6, 9, 12 months
Will be measured using Biodex isodex dynamometer to measure peak torque of knee extension
6 secondary outcomes
Anterior-posterior knee stability
Time frame: at postoperative 4, 6, 9, 12 months
Anterior-posterior knee stability
Time frame: at postoperative 4, 6, 9, 12 months
Anterior-posterior knee stability
Time frame: at postoperative 4, 6, 9, 12 months
Rotational laxity
Time frame: at postoperative 4, 6, 9, 12 months
Functional outcome
Time frame: at postoperative 4, 6, 9, 12 months
Functional outcome
Time frame: at postoperative 4, 6, 9, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gabapentin, Tramadol and Panadol in people with Muscle Weakness and Anterior Cruciate Ligament Rupture, run by Hospital Authority, Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan P Ng, MBBCh MRCS ((852)53329291, ngjp2606@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in from baseline quadriceps muscle strength (time frame: at postoperative 4, 6, 9, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.