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Platelet Rich Plasma in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Local platelet rich plasma (PRP) injection-T-Lab PRP kit
Local steroid injection-Diprospan ®, Schering Plough
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel syndrome, Injection, Platelet rich plasma

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Baskent University Faculty of Medicine, Ankara HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platelet rich plasma (PRP) -T lab PRP kit

Diprospan ®, Schering Plough

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

median nerve sensory conduction velocity
median nerve sensory conduction velocity in the palm wrist segment

Secondary Outcome Measures

Full Information

First Posted
April 25, 2018
Last Updated
June 27, 2019
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT04000932
Brief Title
Platelet Rich Plasma in Carpal Tunnel Syndrome
Official Title
Comparison of Local Steroid Injection With Platelet Rich Plasma in the Treatment of Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal tunnel syndrome, Injection, Platelet rich plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, controlled, double blind.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich plasma (PRP) -T lab PRP kit
Arm Type
Experimental
Arm Description
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.
Arm Title
Diprospan ®, Schering Plough
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Local platelet rich plasma (PRP) injection-T-Lab PRP kit
Other Intervention Name(s)
procedure
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Local steroid injection-Diprospan ®, Schering Plough
Other Intervention Name(s)
procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
median nerve sensory conduction velocity
Description
median nerve sensory conduction velocity in the palm wrist segment
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huma Boluk, MD
Phone
90 537 0630777
Email
humaboluk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huma Boluk, MD
Phone
90 312 7122340
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevgi Ikbali Afsar, Assoc Prof
Organizational Affiliation
Baskent University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baskent University Faculty of Medicine, Ankara Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huma Boluk Senlikci, MD
Phone
+905370630777
Email
humaboluk@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11805259
Citation
Mondelli M, Giannini F, Giacchi M. Carpal tunnel syndrome incidence in a general population. Neurology. 2002 Jan 22;58(2):289-94. doi: 10.1212/wnl.58.2.289.
Results Reference
background
PubMed Identifier
17082517
Citation
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. doi: 10.1093/occmed/kql125. Epub 2006 Nov 2.
Results Reference
background
PubMed Identifier
17613571
Citation
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. doi: 10.1177/0269215507077294.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
23558771
Citation
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.
Results Reference
background
PubMed Identifier
18452111
Citation
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.
Results Reference
background
PubMed Identifier
15509939
Citation
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. doi: 10.1097/01.prs.0000138251.07040.51.
Results Reference
background
PubMed Identifier
21813443
Citation
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.
Results Reference
background
PubMed Identifier
23519544
Citation
Sanchez 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.
Results Reference
background
PubMed Identifier
21029038
Citation
Emel E, Ergun SS, Kotan D, Gursoy 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.
Results Reference
background
PubMed Identifier
19802878
Citation
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.
Results Reference
background
PubMed Identifier
21244302
Citation
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.
Results Reference
background
PubMed Identifier
20058545
Citation
Jazayeri SM, Azizi S, Moghtaderi AR. Autologous blood injection in carpal tunnel syndrome (CTS). Electromyogr Clin Neurophysiol. 2009 Nov-Dec;49(8):369-72.
Results Reference
background
PubMed Identifier
9390659
Citation
Stevens JC. AAEM minimonograph #26: the electrodiagnosis of carpal tunnel syndrome. American Association of Electrodiagnostic Medicine. Muscle Nerve. 1997 Dec;20(12):1477-86. doi: 10.1002/(sici)1097-4598(199712)20:123.0.co;2-5.
Results Reference
background
PubMed Identifier
10865306
Citation
D'Arcy CA, McGee S. The rational clinical examination. Does this patient have carpal tunnel syndrome? JAMA. 2000 Jun 21;283(23):3110-7. doi: 10.1001/jama.283.23.3110. Erratum In: JAMA 2000 Sep 20;284(11):1384.
Results Reference
background

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Platelet Rich Plasma in Carpal Tunnel Syndrome

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