Efficacy of Perineural Injection Therapy in Primary Fibromyalgia

NCT05688787 | Unknown

• 1 other identifier: PerineuralFMS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia, Primary

Keywords

Perineural Injection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Procedure: Perineural Injection

Standard treatment

NO INTERVENTION

will be received standard of care treatment of fibromyalgia

Interventions

Perineural Injection PROCEDURE

.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

Perineural injection arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospital

Cairo, 15561, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The participants in intervention group will be received 4 sessions of perineural injection 1 week a part with optional additional sessions per the physician recommadation and the patient preference. other group, will be received standard of care treatment of fibromyalgia

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: April 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

EG (1)