Fibromyalgia, PrimaryNCT05688787
Efficacy of Perineural Injection Therapy in Primary Fibromyalgia
A study testing Perineural Injection in people with Fibromyalgia, Primary, run by Cairo University at 1 site in Egypt.
Trial 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\"… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Primary
- What is being tested?
- Perineural Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult fully conscious patients fulling the American college of rheumatology preliminary diagnostic criteria for fibromyalgia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Fibromyalgia, Primary
- Being tested
- Perineural Injection
- Keywords
- Perineural Injection
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineural InjectionProcedure or surgery
.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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Perineural Injection |
| Standard treatment | No intervention | will be received standard of care treatment of fibromyalgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia impact questionnaire
assessment of the quality of life and function
Measured: 3 moths
visual analogue scale
visual analogue scale, numeric rating scale for measuring the pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Apr 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, PrimaryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervat Eissa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688787
- Sponsor's protocol ID
- PerineuralFMS
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perineural Injection Therapy in a Group of Egyptians Patients With Primary Fibromyalgia: Non-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05688787
- Acronym / sponsor ID
- PerineuralFMS
- Conditions
- Fibromyalgia, Primary
- Keywords
- Perineural Injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Perineural injection arm | Active comparator | Procedure: Perineural Injection30 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 |
| Standard treatment | No intervention | –will be received standard of care treatment of fibromyalgia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult fully conscious patients fulling the American college of rheumatology preliminary diagnostic criteria for fibromyalgia
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Perineural injection arm |
Primary outcome
Fibromyalgia impact questionnaire
Time frame: 3 moths
assessment of the quality of life and function
visual analogue scale
Time frame: 3 months
visual analogue scale, numeric rating scale for measuring the pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineural Injection in people with Fibromyalgia, Primary, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia impact questionnaire (time frame: 3 moths). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.