- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05053477
Radiofrequency, Perineural Injection, Idiopathic Carpal Tunnel Syndrome
Ultrasound-Guided Pulsed Radiofrequency Versus Perineural Platelet Rich Plasma Injection for Treatment of Idiopathic Carpal Tunnel Syndrome, A Prospective Randomized Controlled Study
Aim of the study The aim of the study is to evaluate the role of pulsed radiofrequency versus platelet rich plasma injection in treatment of idiopathic mild to moderate carpal tunnel syndrome Patients will be classified into three equal groups using randomized closed envelop method into three groups.
Control Group ( n=25):Patients will receive median nerve perineural injection of bupivacaine with mehylprednisolone under ultrasound guidance.
PRF Group ( n=25):Patients will receive median nerve pulsed radiofrequency (PRF) and median nerve perineural injection of bupivacaine under ultrasound guidance PRP Group (n=25): Patients will receive median nerve perineural injection of platelet-rich plasma (PRP) under ultrasound guidance
Measurements (will be done before the procedure, one week ,two month and four months after procedure except SNCV and serum CRP and TNF α (tumor necrosis factor alpha)will be done before the procedure and after four months only):
- VAS (visual analogue pain scale)
- BCTQ (Boston carpal tunnel Questionnaire)
- Degree of paresthesia tested by Reverse Phalen's test.
- CSA (cross sectional area)0 of the median nerve will be measured by the same pain therapist involved in the study.
- SNCV (nerve conduction velocity study): performed by same physiotherapist not involved in the study before and after intervention.
- Serum Tumor necrosis factor alpha (TNF α).
- C-reactive protein (CRP)
- Complications will be recorded and managed. Items 1,2 and 3 will be measured by a pain therapist not involved in this study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction Carpal Tunnel Syndrome (CTS) is the most common form of entrapment neuropathy. CTS is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist, characterized physiologically by evidence of increased pressure within the carpal tunnel and decreased function of the nerve at this level.
Diagnosis of CTS is mainly a clinical one based on the history and physical examination by Tinnel's test Phanel's test and Reverse Phalen's test.The Reverse Phalen's test is more appropriate clinical test for truly compressing the carpal tunnel and provoking symptoms of CTS The gold standard of diagnosis is nerve conduction velocity study (SNCV) and ultrasonography. SNCV is highly specific and it rules out neuropathies and demyelinating disease but it has a considerable false negative rate of 10-20% . Ultrasonography has high sensitivity (89%) and specificity (83%) for the diagnosis of CTS.
Median nerve cross-sectional area (CSA) is used for the assessment and the grading of median nerve pathology. While patients hold their wrists in a neutral position with the palm up and fingers semi-extended, the CSA of the median nerve will be measured in ellipse adjusted to maximum transverse and anteroposterior diameter at the proximal inlet of the carpal tunnel at the level of the pisiform bone. The normal CSA is 9 mm2. The cross-section area cutoff points that discriminate between different grades of CTS severity are 10-15 mm2 for mild to moderate symptoms, and >15 mm2 for severe symptoms PRF treatment is well established intervention technique for treatment of CT.Although the mechanism of action of PRF is not yet known but it has been postulated that PRF has a neuromodulatory effect as it modifies the neuronal membranes and selectively targets the small diameter C and A -ᶑ fibers PRP is autologous fraction of human blood that encompasses a bigger concentration of platelets than baseline levels of blood. PRP contains platelet degradation production the form of multiple growth factors such as are transforming growth factor beta (TGF beta),vascular endothelial growth factor (VEGF) platelet-derived growth factor (PDGF), and epithelial growth factor (EGF). PRP therapies aim to enhance the self-healing ability of human body, by exposing the injured tissue to a high concentration of autologous growth factors. Increased Schwann cell proliferation, myelinization, axonal regeneration, and better nerve healing after injury have been reported.
The immune system has increasingly been implicated in numerous neurological disorders. Patients with CTS have adaptive changes in the homeostasis of memory T cells and an increase in systemic inflammatory response modulating cytokines/chemokines. Which is a prominent feature of neuroinflammation and elevated levels of certain cytokines such as TNFα, IL-6 (interlukin 6), and IL-1β, have been demonstrated in patients with painful peripheral neuropathies.
Aim of the study The aim of the study is to evaluate the role of pulsed radiofrequency versus platelet rich plasma injection in treatment of idiopathic mild to moderate carpal tunnel syndrome
Plan of the study Inclusion criteria
- Patients aged (30-50) years of both gender.
- Patients with mild to moderate idiopathic CTS.
- Patient who are failed to respond to conservative treatment (such as splint, medications, physical therapy) for at least three months.
Exclusion criteria Severe CTS and secondary CTS.
Patients will be classified into three equal groups using randomized closed envelop method into three groups.
Control Group ( n=25):Patients will receive median nerve perineural injection of bupivacaine with mehylprednisolone under ultrasound guidance.
PRF Group ( n=25):Patients will receive median nerve pulsed radiofrequency (PRF) and median nerve perineural injection of bupivacaine under ultrasound guidance PRP Group (n=25): Patients will receive median nerve perineural injection of platelet-rich plasma (PRP) under ultrasound guidance
METHODS
Assessment and Preparation:
Patients will be then assessed by:
Detailed medical and surgical history taking. Clinical examination for median nerve by Reverse Phalen's test, Tinel's tests and Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Cross-sectional area (CSA): The median nerve will be identified using a 38 mm,L25x ,13-6 MHz, linear array transducer with a portable, bedside Ultrasound unit (Sonosite S-Nerve ,Sonosite Inc.,USA). The probe will be inserted in transversve direction at proximal crease of hand.
Nerve conduction velocity study (SNCV)
Laboratory investigations via venous blood sample:
- Platelet count.
- Random blood sugar.
- Coagulation profile (PT,PTT, INR).
- C-reactive protein (CRP)
- Immune test :Serum Tumor necrosis factor alpha (TNF α). All the procedures and the tests including VAS and BCTQ questionnaire will be explained to all the patients.
All patient will be admitted to day case unit then they will be transferred to block room , On arrival to the block room, patients will be connected to the standard monitoring (Drager Infiniti Gamma Patient Monitor) to display the following:
- Three lead Electrocardiogram
- Peripheral arterial oxygen saturation
- Non-invasive arterial blood pressure All patient will receive intravenouse sedation via peripheral line as midazolam with dosage range: 0.5 to 2 mg over ≥2 minutes; will repeat every 2 to 5 minutes as needed; titrate to clinical effect; maximum total dose: 5 mg.
In patient randomized to PRP group, 10 ml of whole blood will be freshly collected from each patient on citrated tube.The tubes will be initially centrifuged using (Electric centrifuge, model 800,China ) at 3000 rpm for 3 minutes. The supernatant plasma will be collected in another sterile plain tube and will be centrifuged again at 4000rpm for 15 minutes. The supernatant platelet poor plasma (PPP) will be removed leaving 2 ml of PRP on sediment (platelet pellet) which will be suspended by gently shaking the tube.
Intervention: With the palm facing upwards and the wrist joint in slight extension, the median nerve will be identified at the inlet of the carpal tunnel at the level of the pisiform bone using linear array transducer of bedside ultrasound unit. The skin will be prepared with povidone and draped in a sterile fashion, then local anesthetic infiltration using 1ml xylocaine 2% (Debocaine vial, sigma tec pharmaceutical) will be given using a 25-gauge needle.
Control Group : A 22-gauge needle of venous cannula will be gently advanced in transverse direction under ultrasound guidance using the in-plane technique via ulnar side of wrist towards the median nerve and 1ml bupivacaine 0.25% (Sunny bupivacaine vial, sunny medical group) plus 1ml (40 mg) mehylprednisolone (Solu Medrol 500mg vial, Pfizer) in total volume 2ml will be injected in perineural plane in the carpal canal.
PRF Group : After US identification of the median nerve , a 5-cm radiofrequency curved cannula with a 10-mm active tip will be inserted under ultrasound guidance using the in-plane technique in transverse direction. Using (Neurotherm NT1000, Neurotherm Inc., USA) sensory and motor stimulation will be tested after the needle tip placement near the median nerve. Responses to sensory and motor stimulation will be checked at 50 Hz, 0.5 V and at 2 Hz, 1 V respectively. PRF lesion will be carried out for 120 seconds at a 2 Hz frequency and pulse width of 20 ms at 42°C. Then 2ml of bupivacaine 0.25% will be injected perineurally.
PRP Group : A 22-gauge needle of venous cannula will be gently advanced in transverse direction under ultrasound guidance using the in-plane technique under ultrasound guidance using the in-plane technique towards the median nerve and 2 ml of PRP will be injected perineural in the carpal canal.
Post Procedure Care For Three Groups:
- Patients will be advised to apply ice on the injection site at day of intervention and modify activity as tolerated to alleviate any post injection discomfort or pain .
- Pain medication in the form of paracetamol (500mg) only will be allowed for the next 3 months if needed. The patients will be instructed to stop analgesics 48hr before visit of follow up to allow proper symptoms assessment.
- Physical therapy, splinting, or exercise will not allowed.
Measurements (will be done before the procedure, one week ,two month and four months after procedure except SNCV and serum CRP and TNF α will be done before the procedure and after four months only):
- VAS
- BCTQ
- Degree of paresthesia tested by Reverse Phalen's test.
- CSA of the median nerve will be measured by the same pain therapist involved in the study.
- SNCV: performed by same physiotherapist not involved in the study before and after intervention.
- Serum Tumor necrosis factor alpha (TNF α).
- C-reactive protein (CRP)
- Complications will be recorded and managed. Items 1,2 and 3 will be measured by a pain therapist not involved in this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: shamandy
- Phone Number: 01224612361
- Email: fot1987@hotmail.com
Study Locations
-
-
-
Alexandria, Egypt, 123456
- Recruiting
- Medical Research Institute
-
Contact:
- engi yousry, MD
- Phone Number: 01223372319
- Email: engi_yousry@yahoo.com
-
Contact:
- faten shamandy, phd
- Phone Number: 01224612691
- Email: fot1987@hotmail.com
-
-
Alex
-
Alexandria, Alex, Egypt, 123456
- Recruiting
- Medical Research Institute
-
Contact:
- engi yousry, MD
- Phone Number: 01223372319
- Email: engi_yousry@yahoo.com
-
Contact:
- faten shamandy, phd
- Phone Number: 01224612691
- Email: fot1987@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged (30-50) years of both gender.
- Patients with mild to moderate idiopathic CTS.
- Patient who are failed to respond to conservative treatment (such as splint, medications, physical therapy) for at least three months
Exclusion Criteria:
- Severe CTS and secondary CTS
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
Patients will receive median nerve perineural injection of bupivacaine with mehylprednisolone under ultrasound guidance
|
(40 mg)
Other Names:
|
Active Comparator: PRF Group
Patients will receive median nerve pulsed radiofrequency (PRF) and median nerve perineural injection of bupivacaine under ultrasound guidance
|
. PRF lesion will be carried out for 120 seconds at a 2 Hz frequency and pulse width of 20 ms at 42°C
Other Names:
|
Active Comparator: PRP Group
Patients will receive median nerve perineural injection of platelet-rich plasma (PRP) under ultrasound guidance
|
2 ml of PRP
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the role of pulsed radiofrequency versus platelet rich plasma injection in treatment of idiopathic mild to moderate carpal tunnel syndrome
Time Frame: four month
|
We will evaluate the median nerve by NCV to all participant
|
four month
|
Evaluate effect of pulsed radiofrequency versus platelet rich plasma injection on pain mediators
Time Frame: four month
|
We will measure the level of TNF to all participant
|
four month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain relief assessment
Time Frame: four month
|
We will evaluate pain relieve by visual analogue pain scale (0_10 where 0 is no pain and 10 is maximum pain)to all participant
|
four month
|
Numbness relief assessment
Time Frame: four month
|
assess the numbness by Boston Carpal Tunnel Questionnaire to all participant
|
four month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: engy yousry, MD, Staff
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1216-4-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel Syndrome
-
Stanford UniversityMayo Clinic; Brown University; Duke University; Harvard University; University of...CompletedCarpal Tunnel Syndrome | Carpal Tunnel | Carpal Tunnel Syndrome Bilateral | Carpal Tunnel Syndrome Left | Carpal Tunnel Syndrome RightUnited States
-
Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
-
Ohio State UniversityCompletedBilateral Carpal Tunnel Syndrome (Diagnosis)United States
-
University of Split, School of MedicineCompletedCarpal Tunnel Syndrome BilateralCroatia
-
CMC Ambroise ParéCompletedCarpal Tunnel ReleaseFrance
-
Vanderbilt UniversityOrthopedic Research and Education FoundationCompleted
-
University of PittsburghWithdrawnPain After Carpal Tunnel ReleaseUnited States
-
Centre Hospitalier Saint Joseph Saint Luc de LyonRecruitingCarpal Tunnel Syndrome BilateralFrance
-
Istituto Ortopedico RizzoliCompletedEntrapment Neuropathy, Carpal Tunnel | Compression Neuropathy, Carpal Tunnel | Median Neuropathy, Carpal TunnelItaly
-
David TangRecruitingCarpal Tunnel Syndrome | Splints | Carpal Tunnel | Nerve Compression | Carpal Tunnel Release | Hand Injuries and DisordersCanada
Clinical Trials on mehylprednisolone injection
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
National Taiwan University HospitalRecruitingOsteoarthritis (OA) of the KneeTaiwan
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Enrolling by invitationAdvanced Malignant TumorsChina
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruiting
-
Shengjing HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruitingER Positive/HER2 Low Breast CancerChina
-
Dalia Salah SaifUnknownRA - Rheumatoid ArthritisEgypt
-
United States Naval Medical Center, San DiegoCEL-SCI CorporationTerminated
-
National Taiwan University HospitalCompleted
-
Royan InstituteCompletedMyocardial InfarctionIran, Islamic Republic of