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出境医 / 临床实验 / Platelet Rich Plasma in Carpal Tunnel Syndrome

Platelet Rich Plasma in Carpal Tunnel Syndrome

Study Description
Brief Summary:
The aim of this study is to evaluate the effect of local platelet rich plasma injection therapy in patients with mild to moderate idiopathic carpal tunnel syndrome (CTS) with clinical and electrophysiological parameters. Also the effect of platelet rich plasma and local steroid injection will be compared.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Local platelet rich plasma (PRP) injection-T-Lab PRP kit Drug: Local steroid injection-Diprospan ®, Schering Plough Phase 3

Detailed Description:

Research sample; Voluntary female patients who are referred to the Physical Therapy and Rehabilitation Outpatient Clinic and who have a clinical and electrophysiological diagnosis of mild or moderate CTS. Patients aged between 25-70 years and who have complaints consistent with CTS for more than 3 months will be selected.

The size of the sample was determined by the preliminary statistical study conducted using the NCSS-PASS 12 program, and will consist of 84 patients.

Patients will be randomly allocated to one of two groups. Local platelet rich plasma (PRP) injection in the first group (n = 42) and local steroid injection in the second group (n = 42) will be performed once into the carpal tunnel. PRP will be obtained by centrifugation of autologous anticoagulated whole blood. 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate will be administered as local steroids. Both groups will be recommended a resting splint for use in the day time when possible and at night time. Clinical and electrophysiological evaluations of all patients will be performed by a researcher who is blinded to the treatment received by the patient. The electrophysiological and clinical evaluations of the patients will be done by the same investigator before and after the 1st and 3rd months of therapy. At one and three month follow up, Symptom severity and functional capacity will be assessed using the Boston Carpal Tunnel Syndrome Questionnaire. The hand grip strength of the patients will be assessed using a Jamar hand dynamometer ( (Baseline hydraulic hand dynomometer, Irvington, NY, USA) and the finger holding power by pinchmeter. Conventional motor and sensory nerve conduction studies will be applied as electrodiagnostic studies.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, controlled, double blind.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The patient will not be informed about which group will be taken. Randomization will be performed by a simple randomization method by a researcher who is blind to the clinical and electrophysiological findings. The injection will be performed by a second researcher who is blind to the contents of the injection. The evaluations of the patients will be performed by a researcher who is blinded to the treatment applied and the initial assessment.
Primary Purpose: Treatment
Official Title: Comparison of Local Steroid Injection With Platelet Rich Plasma in the Treatment of Carpal Tunnel Syndrome
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Platelet rich plasma (PRP) -T lab PRP kit
A single 1ml PRP extract injection will be will be injected into the carpal tunnel of the wrist in which a diagnosis of carpel tunnel syndrome has been established. A 23 gauge needle will used to perform the injection through the distal wrist creased into the carpal tunnel. performed once into the carpal tunnel in the wrist . PRP will be obtained by centrifugation of autologous anticoagulated whole blood.
 Drug: Local platelet rich plasma (PRP) injection-T-Lab PRP kit
Platelet rich plasma (PRP) will be obtained by centrifugation of autologous anticoagulated whole blood. 1 ml PRP extract will be injected into the carpel tunnel (of the side with a diagnosis of carpel tunnel syndrome) via the distal wrist line using 23 gauge needle.
Other Name: procedure
Active Comparator: Diprospan ®, Schering Plough
A single steroid injection (1 ml Diprospan ®, Schering Plough containing 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate) will be injected into the carpal tunnel of the wrist in which a diagnosis of carpel tunnel syndrome has been established. A 23 gauge needle will used to perform the injection through the distal wrist creased into the carpal tunnel.
 Drug: Local steroid injection-Diprospan ®, Schering Plough
The local steroid injection ((1 ml Diprospan ®, Schering Plough containing 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate) will be performed once into the carpal tunnel.1 ml Diprospan ®, Schering Plough extract will be injected by using 23 gauge needle from the distal wrist line through the carpal tunnel only once.
Other Name: procedure
Outcome Measures
Primary Outcome Measures :
  1. median nerve sensory conduction velocity [ Time Frame: 3 months ]
    median nerve sensory conduction velocity in the palm wrist segment


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patient 25-75 years old
  • Symptoms consistent with carpal tunnel syndrome for at least 3 months
  • Clinical and electrophysiological diagnosis of mild to moderate carpal tunnel syndrome
  • Written informed consent obtained

Exclusion Criteria:

  • Electrophysiological diagnosis of proximal median nerve neuropathy, cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome
  • Those with a past medical history of diabetes mellitus, hypothyroidism, pregnancy, chronic inflammatory rheumatic disease, renal insufficiency which may predispose to CTS
  • Patients with a history of wrist surgery or radius distal tip fracture
  • Patients who underwent carpal tunnel local steroid injection within the previous 3 months
  • Patients with a cardiac pacemaker
  • History of hematological disease (coagulopathy) or patients receiving anticoagulant or antiaggregant therapy
  • Severe cardiovascular disease
  • Infection, immunosuppression
  • Patients using non-steroidal anti-inflammatory drugs up to 5 days before PRP injection patients with hemoglobin levels below 11 and platelet levels below 150,000
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Huma Boluk, MD 90 537 0630777 humaboluk@gmail.com
Contact: Huma Boluk, MD 90 312 7122340

Locations
Layout table for location information
Turkey
Baskent University Faculty of Medicine, Ankara Hospital Recruiting
Ankara, Turkey, 06800
Contact: Huma Boluk Senlikci, MD    +905370630777    humaboluk@gmail.com   
Sponsors and Collaborators
Baskent University
Investigators
Layout table for investigator information
Principal Investigator: Sevgi Ikbali Afsar, Assoc Prof Baskent University Faculty of Medicine
Tracking Information
First Submitted Date  ICMJE April 25, 2018
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE July 15, 2018
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019) 		median nerve sensory conduction velocity [ Time Frame: 3 months ]
median nerve sensory conduction velocity in the palm wrist segment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Platelet Rich Plasma in Carpal Tunnel Syndrome
Official Title  ICMJE Comparison of Local Steroid Injection With Platelet Rich Plasma in the Treatment of Carpal Tunnel Syndrome
Brief Summary The aim of this study is to evaluate the effect of local platelet rich plasma injection therapy in patients with mild to moderate idiopathic carpal tunnel syndrome (CTS) with clinical and electrophysiological parameters. Also the effect of platelet rich plasma and local steroid injection will be compared.
Detailed Description

Research sample; Voluntary female patients who are referred to the Physical Therapy and Rehabilitation Outpatient Clinic and who have a clinical and electrophysiological diagnosis of mild or moderate CTS. Patients aged between 25-70 years and who have complaints consistent with CTS for more than 3 months will be selected.

The size of the sample was determined by the preliminary statistical study conducted using the NCSS-PASS 12 program, and will consist of 84 patients.

Patients will be randomly allocated to one of two groups. Local platelet rich plasma (PRP) injection in the first group (n = 42) and local steroid injection in the second group (n = 42) will be performed once into the carpal tunnel. PRP will be obtained by centrifugation of autologous anticoagulated whole blood. 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate will be administered as local steroids. Both groups will be recommended a resting splint for use in the day time when possible and at night time. Clinical and electrophysiological evaluations of all patients will be performed by a researcher who is blinded to the treatment received by the patient. The electrophysiological and clinical evaluations of the patients will be done by the same investigator before and after the 1st and 3rd months of therapy. At one and three month follow up, Symptom severity and functional capacity will be assessed using the Boston Carpal Tunnel Syndrome Questionnaire. The hand grip strength of the patients will be assessed using a Jamar hand dynamometer ( (Baseline hydraulic hand dynomometer, Irvington, NY, USA) and the finger holding power by pinchmeter. Conventional motor and sensory nerve conduction studies will be applied as electrodiagnostic studies.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
prospective, randomized, controlled, double blind.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The patient will not be informed about which group will be taken. Randomization will be performed by a simple randomization method by a researcher who is blind to the clinical and electrophysiological findings. The injection will be performed by a second researcher who is blind to the contents of the injection. The evaluations of the patients will be performed by a researcher who is blinded to the treatment applied and the initial assessment.
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE
  • Drug: Local platelet rich plasma (PRP) injection-T-Lab PRP kit
    Platelet rich plasma (PRP) will be obtained by centrifugation of autologous anticoagulated whole blood. 1 ml PRP extract will be injected into the carpel tunnel (of the side with a diagnosis of carpel tunnel syndrome) via the distal wrist line using 23 gauge needle.
    Other Name: procedure
  • Drug: Local steroid injection-Diprospan ®, Schering Plough
    The local steroid injection ((1 ml Diprospan ®, Schering Plough containing 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate) will be performed once into the carpal tunnel.1 ml Diprospan ®, Schering Plough extract will be injected by using 23 gauge needle from the distal wrist line through the carpal tunnel only once.
    Other Name: procedure
Study Arms  ICMJE
  • Experimental: Platelet rich plasma (PRP) -T lab PRP kit
    A single 1ml PRP extract injection will be will be injected into the carpal tunnel of the wrist in which a diagnosis of carpel tunnel syndrome has been established. A 23 gauge needle will used to perform the injection through the distal wrist creased into the carpal tunnel. performed once into the carpal tunnel in the wrist . PRP will be obtained by centrifugation of autologous anticoagulated whole blood.
    Intervention: Drug: Local platelet rich plasma (PRP) injection-T-Lab PRP kit
  • Active Comparator: Diprospan ®, Schering Plough
    A single steroid injection (1 ml Diprospan ®, Schering Plough containing 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate) will be injected into the carpal tunnel of the wrist in which a diagnosis of carpel tunnel syndrome has been established. A 23 gauge needle will used to perform the injection through the distal wrist creased into the carpal tunnel.
    Intervention: Drug: Local steroid injection-Diprospan ®, Schering Plough
Publications *
  • Mondelli M, Giannini F, Giacchi M. Carpal tunnel syndrome incidence in a general population. Neurology. 2002 Jan 22;58(2):289-94.
  • Palmer KT, Harris EC, Coggon D. Carpal tunnel syndrome and its relation to occupation: a systematic literature review. Occup Med (Lond). 2007 Jan;57(1):57-66. Epub 2006 Nov 2. Review.
  • Piazzini DB, Aprile I, Ferrara PE, Bertolini C, Tonali P, Maggi L, Rabini A, Piantelli S, Padua L. A systematic review of conservative treatment of carpal tunnel syndrome. Clin Rehabil. 2007 Apr;21(4):299-314. Review.
  • Özçete ZA, Öztürk C, Yağız OA, Hepgüler S, Atamaz FÇ. Kısa dalga tedavisinin idiopatik karpal tünel sendromundaki etkinliği: Randomize çift kör kontrollü çalışma. Türk Fiz Tıp Rehab Derg.2013;59:103-7.
  • Park GY, Kwon DR. Platelet-rich plasma limits the nerve injury caused by 10% dextrose in the rabbit median nerve. Muscle Nerve. 2014 Jan;49(1):56-60. doi: 10.1002/mus.23863. Epub 2013 Sep 20.
  • Sariguney Y, Yavuzer R, Elmas C, Yenicesu I, Bolay H, Atabay K. Effect of platelet-rich plasma on peripheral nerve regeneration. J Reconstr Microsurg. 2008 Apr;24(3):159-67. doi: 10.1055/s-2008-1076752. Epub 2008 Apr 30.
  • Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. 2004 Nov;114(6):1502-8.
  • Thanasas C, Papadimitriou G, Charalambidis C, Paraskevopoulos I, Papanikolaou A. Platelet-rich plasma versus autologous whole blood for the treatment of chronic lateral elbow epicondylitis: a randomized controlled clinical trial. Am J Sports Med. 2011 Oct;39(10):2130-4. doi: 10.1177/0363546511417113. Epub 2011 Aug 2.
  • Sánchez M, Yoshioka T, Ortega M, Delgado D, Anitua E. Ultrasound-guided platelet-rich plasma injections for the treatment of common peroneal nerve palsy associated with multiple ligament injuries of the knee. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1084-9. doi: 10.1007/s00167-013-2479-y. Epub 2013 Mar 22.
  • Emel E, Ergün SS, Kotan D, Gürsoy EB, Parman Y, Zengin A, Nurten A. Effects of insulin-like growth factor-I and platelet-rich plasma on sciatic nerve crush injury in a rat model. J Neurosurg. 2011 Feb;114(2):522-8. doi: 10.3171/2010.9.JNS091928. Epub 2010 Oct 29.
  • Apel PJ, Ma J, Callahan M, Northam CN, Alton TB, Sonntag WE, Li Z. Effect of locally delivered IGF-1 on nerve regeneration during aging: an experimental study in rats. Muscle Nerve. 2010 Mar;41(3):335-41. doi: 10.1002/mus.21485.
  • Yu W, Wang J, Yin J. Platelet-rich plasma: a promising product for treatment of peripheral nerve regeneration after nerve injury. Int J Neurosci. 2011 Apr;121(4):176-80. doi: 10.3109/00207454.2010.544432. Epub 2011 Jan 19.
  • Jazayeri SM, Azizi S, Moghtaderi AR. Autologous blood injection in carpal tunnel syndrome (CTS). Electromyogr Clin Neurophysiol. 2009 Nov-Dec;49(8):369-72.
  • Stevens JC. AAEM minimonograph #26: the electrodiagnosis of carpal tunnel syndrome. American Association of Electrodiagnostic Medicine. Muscle Nerve. 1997 Dec;20(12):1477-86. Review.
  • D'Arcy CA, McGee S. The rational clinical examination. Does this patient have carpal tunnel syndrome? JAMA. 2000 Jun 21;283(23):3110-7. Review. Erratum in: JAMA 2000 Sep 20;284(11):1384.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019) 		84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • female patient 25-75 years old
  • Symptoms consistent with carpal tunnel syndrome for at least 3 months
  • Clinical and electrophysiological diagnosis of mild to moderate carpal tunnel syndrome
  • Written informed consent obtained

Exclusion Criteria:

  • Electrophysiological diagnosis of proximal median nerve neuropathy, cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome
  • Those with a past medical history of diabetes mellitus, hypothyroidism, pregnancy, chronic inflammatory rheumatic disease, renal insufficiency which may predispose to CTS
  • Patients with a history of wrist surgery or radius distal tip fracture
  • Patients who underwent carpal tunnel local steroid injection within the previous 3 months
  • Patients with a cardiac pacemaker
  • History of hematological disease (coagulopathy) or patients receiving anticoagulant or antiaggregant therapy
  • Severe cardiovascular disease
  • Infection, immunosuppression
  • Patients using non-steroidal anti-inflammatory drugs up to 5 days before PRP injection patients with hemoglobin levels below 11 and platelet levels below 150,000
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000932
Other Study ID Numbers  ICMJE KA14/13
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sevgi Ikbali Afsar, Baskent University
Study Sponsor  ICMJE Baskent University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sevgi Ikbali Afsar, Assoc Prof Baskent University Faculty of Medicine
PRS Account Baskent University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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