Platelet Rich Plasma in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Comparison of Local Steroid Injection With Platelet Rich Plasma in the Treatment of Carpal Tunnel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04000932
• Other study ID #: KA14/13
• Status: Recruiting
• Phase: Phase 3
• Start date: July 15, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: June 2019
• Source: Baskent University
• Contact: Huma Boluk, MD
• Phone: 90 537 0630777
• Email: humaboluk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: January 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Baskent University Faculty of Medicine, Ankara Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

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. — View 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. Review. Erratum in: JAMA 2000 Sep 20;284(11):1384. — View Citation

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. — View 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. — View 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. — View Citation

Mondelli M, Giannini F, Giacchi M. Carpal tunnel syndrome incidence in a general population. Neurology. 2002 Jan 22;58(2):289-94. — View Citation

Özçete ZA, Öztürk C, Yagiz OA, Hepgüler S, Atamaz FÇ. Kisa dalga tedavisinin idiopatik karpal tünel sendromundaki etkinligi: Randomize çift kör kontrollü çalisma. Türk Fiz Tip Rehab Derg.2013;59:103-7.

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. — View 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. — View 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. Review. — View Citation

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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median nerve sensory conduction velocity	median nerve sensory conduction velocity in the palm wrist segment	3 months