Efficacy of Perineural Injection Therapy in Primary Fibromyalgia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia, Primary
• Intervention / Treatment: Procedure: Perineural Injection

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 15561
    • Kasr Alainy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:.

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Perineural injection arm; 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; .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
No Intervention: Standard treatment; will be received standard of care treatment of fibromyalgia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia impact questionnaire	assessment of the quality of life and function	3 moths
visual analogue scale	visual analogue scale, numeric rating scale for measuring the pain	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Perineural Injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: PerineuralFMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No