An interventional study of Perineural Injection in Fibromyalgia, Primary, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:.
Exclusion Criteria:
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
Procedure: Perineural Injection
will be received standard of care treatment of fibromyalgia
.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
Fibromyalgia impact questionnaire
assessment of the quality of life and function
Time frame: 3 moths
visual analogue scale
visual analogue scale, numeric rating scale for measuring the pain
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
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