跳至主要内容
临床试验/NCT05688787
NCT05688787Unknown不适用

Efficacy of Perineural Injection Therapy in a Group of Egyptians Patients With Primary Fibromyalgia: Non-Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
visual analogue scale

研究概览

简要总结

The goal of fibromyalgia Treatment is to relieve the pain and improve quality of life and physical function which need a

Final Version: April 2019Research Template 3 multifaceted treatment approach involving non pharmacological pain management and medicine

Lyftgot perineural injection therapy "lyftgot PIT" previously known as neural prolotherapy , is a method of injection treatment designed and developed by DR Lyftgot from new Zealand to treat the neurogenic inflammation and the neuropathic pain caused by the sensocrine small nerve fiber .PIT is based on the injection of small amount of dextrose 5%in a neutral PH sterile water solution in the subcutaneous tissue around the sick nerve to correct the neuroglycopenia and to inhibit the neurogenic inflammation.

详细描述

Fibromyalgia is a chronic non inflammatory wide spread pain disorder associated with a complex of symptoms as fatigue, depression and cognitive impairment , it is the second most common disorder encountered in rheumatology practice (Berger et aL,2007) The pathophysiology is certainly unclear involves a number of factors , including abnormalities in the neuroendocrine and autonomic nervous system ,psychological variables, genetic factor, and environmental stressors (Hudson JI, 2006 ) Fibromyalgia is no longer a diagnosis of exculsion ,patient are diagnosed according to the American college of rheumatology diagnostic criteria which requires a three conditions to be met a wide spread pain index >7 and symptom severity scale score >5 or WPI from 3-6 and ss scale score >9, symptoms have been present at similar level for at least 3 month and patient doesn't have a disorderthat would otherwise explain the pain

The goal of fibromyalgia Treatment is to relieve the pain and improve quality of life and physical function which need a

Final Version: April 2019Research Template 3 multifaceted treatment approach involving non pharmacological pain management and medicine

Lyftgot perineural injection therapy "lyftgot PIT" previously known as neural prolotherapy , is a method of injection treatment designed and developed by DR Lyftgot from new Zealand to treat the neurogenic inflammation and the neuropathic pain caused by the sensocrine small nerve fiber .PIT is based on the injection of small amount of dextrose 5%in a neutral PH sterile water solution in the subcutaneous tissue around the sick nerve to correct the neuroglycopenia and to inhibit the neurogenic inflammation These small nerve fibers are responsible for delivering to the tissue the nerve growth factors necessary for the repair healing and reconstruction of the connective tissue system connecting the superficial skin system to the deep myo-fascial-skeletal system and for restoration of its original compostion with its normal osmotic and electro magnetic pressure (lyftogt,2007) Dextrose 5% block the TRPV1 receptor which inhibit the propagation of the neuropathic pain signal giving the patient the immediate analgesia , it also inhibit the neurogenic inflammation and stimulate the release of nerve growth factor that help in thr repair PIT is a novel , safe, effective and economical treatment for the pain felt in fibromyalgia In this study we aim to asses the efficacy of this treatment in alleviating the pains felt by these patients

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult fully conscious patients fulling the American college of rheumatology preliminary diagnostic criteria for fibromyalgia

排除标准

  • •Any other causes of secondary fibromyalgia or musculoskeletal pain as osteoarthritis , endocrinal disease (thyroid dysfunction)
  • •Rheumatic MSK diseases commonly associated with secondary fibromyalgia as rheumatoid arthritis, SLE
  • •less than 18 years old

研究组 & 干预措施

Perineural injection arm

Active Comparator

30 patients will be received 4 sessions of perineural injection

1 week a part with optional additional sessions per the physician recommadation and the patient preference .injections are done with a 27 gauge half 1/2 needle directed perpendicular to the skin and going

1/ to the skin surface delivering 1_2 cc of buffered 5% dextrose solution in the subcutaneous superficial perineural tissue we will be targeting the most triggering points for each patient emphasizing on pain located in thoraco-dorsal fascia, the fascia of the erectorspinae muscles along T10 to L2 dorsal rami, interspinoustenderness from medial branches of dorsal rami, superiorcluneal nerve at 7-8 cm from middle line cross the iliac crest & T10 cross over iliac crest at a distance 8-10cm

干预措施: Perineural Injection (Procedure)

Standard treatment

No Intervention

will be received standard of care treatment of fibromyalgia

结局指标

主要结局

visual analogue scale

时间窗: 3 months

visual analogue scale, numeric rating scale for measuring the pain

Fibromyalgia impact questionnaire

时间窗: 3 moths

assessment of the quality of life and function

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mervat Eissa

Associate Professor

Cairo University

研究点 (1)

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