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Efficacy of Perineural Injection Therapy in Primary Fibromyalgia

Primary Purpose

Fibromyalgia, Primary

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Perineural Injection
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia, Primary focused on measuring Perineural Injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kasr Alainy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Perineural injection arm

Standard treatment

Arm Description

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

will be received standard of care treatment of fibromyalgia

Outcomes

Primary Outcome Measures

Fibromyalgia impact questionnaire
assessment of the quality of life and function
visual analogue scale
visual analogue scale, numeric rating scale for measuring the pain

Secondary Outcome Measures

Full Information

First Posted
January 9, 2023
Last Updated
January 9, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05688787
Brief Title
Efficacy of Perineural Injection Therapy in Primary Fibromyalgia
Official Title
Efficacy of Perineural Injection Therapy in a Group of Egyptians Patients With Primary Fibromyalgia: Non-Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Primary
Keywords
Perineural Injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perineural injection arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
will be received standard of care treatment of fibromyalgia
Intervention Type
Procedure
Intervention Name(s)
Perineural Injection
Intervention Description
.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
Primary Outcome Measure Information:
Title
Fibromyalgia impact questionnaire
Description
assessment of the quality of life and function
Time Frame
3 moths
Title
visual analogue scale
Description
visual analogue scale, numeric rating scale for measuring the pain
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kasr Alainy Hospital
City
Cairo
ZIP/Postal Code
15561
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Perineural Injection Therapy in Primary Fibromyalgia

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