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临床试验/NCT03496389
NCT03496389Unknown2 期

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

Hospital Authority, Hong Kong0 个研究点目标入组 30 人开始时间: 2018年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
30
主要终点
Change in from baseline quadriceps muscle strength

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Gabapentin + panadol

Experimental

干预措施: Gabapentin (Drug)

Gabapentin + panadol

Experimental

干预措施: Panadol (Drug)

Tramadol + panadol

Active Comparator

干预措施: Tramadol (Drug)

Tramadol + panadol

Active Comparator

干预措施: Panadol (Drug)

结局指标

主要结局

Change in from baseline quadriceps muscle strength

时间窗: at postoperative 4, 6, 9, 12 months

Will be measured using Biodex isodex dynamometer to measure peak torque of knee extension

次要结局

  • Anterior-posterior knee stability(at postoperative 4, 6, 9, 12 months)
  • Functional outcome(at postoperative 4, 6, 9, 12 months)
  • Rotational laxity(at postoperative 4, 6, 9, 12 months)

研究者

发起方
Hospital Authority, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ng Jonathan Patrick

Principle investigator

Hospital Authority, Hong Kong

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