The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain

National Defense Medical Center, Taiwan

Status and phase: Enrolling; Phase 4

Conditions: Ankle Sprain 2Nd Degree; Ankle Sprain 3Rd Degree

Treatments: Combination Product: PRP+Rehabilitation; Drug: PRP; Other: Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03808454

Tri-Service General Hospital

Details and patient eligibility

About

Ankle sprain is a fairly common sports medicine clinic. In Taiwan at least 150,000 to 200,000 people will suffer from ankle sprains every years. Clinicians have been looking for ways to shorten treatment time and reduce discomfort. Platelet Rich Plasma(PRP) is an endogenous therapeutic technology that involved in regenerative medicine due to its potential to stimulate and accelerate tissue healing. PRP can release lots of growth factors like platelet-derived growth factor (PDGF),transforming Growth Factor Beta(TGF-β), vascular endothelial growth factor(VEGF),Epidermal growth factor(EGF) and insulin-like growth factor (IGF). Its use had been based on the theory that increased autologous platelets, that then yield high concentrations of growth factors and other proteins, will lead to increased healing of tendon and soft tissue on a cellular level. In addition, there is no objective evaluation after treatment, so that patients can not provide effective and accurate quantitative feedback. In this study, the investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous PRP injection combined with general rehabilitation therapy.

Full description

The investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous PRP injection combined with general rehabilitation therapy randomly. The investigators also use the new ankle proprioception evaluation system and evaluation of clinical function after treatment. It is expected to establish another feasible and rapid treatment method for ankle sprain. Combined with high accuracy ankle body defect evaluation method, it is helpful to design proper treatment and rehabilitation strategy in the future so as to improve the rehabilitation of limbs Coordination and control capabilities.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ankle sprain within one months
• Gr II or Gr III ankle sprain (anterior talus fibular ligament)by sonogram proved
• MMSE≥23
• could cooperate the examination of the test

Exclusion criteria

• Hemianopsia or hemineglect any brain lesion such as cerebrum of cerebellum involved movement
• cancer victim
• pregnant If needed PRP treatment
• Liver cirrhosis
• Platelet < 150000/UL
• Sepsis, Leukemia
• use anti-coagulation agents
• under hemodialysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Platelet rich plasma (PRP)

Experimental group

Description:

PRP injection only

Treatment:

Drug: PRP

PRP+Rehabilitation

Experimental group

Description:

PRP injection combined with rehabilitation

Treatment:

Combination Product: PRP+Rehabilitation

Rehabilitation

Active Comparator group

Description:

Rehabilitation treatment only

Treatment:

Other: Rehabilitation