Platelet Rich Plasma in Carpal Tunnel Syndrome

NCT04000932 | Unknown Phase 3

• 1 other identifier: KA14/13
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndrome; Injection; Platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• median nerve sensory conduction velocity

  median nerve sensory conduction velocity in the palm wrist segment

  3 months

Study Arms (2)

Platelet rich plasma (PRP) -T lab PRP kit

EXPERIMENTAL

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

Diprospan ®, Schering Plough

ACTIVE COMPARATOR

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

Interventions

Local platelet rich plasma (PRP) injection-T-Lab PRP kit DRUG

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.

Also known as: procedure

Platelet rich plasma (PRP) -T lab PRP kit

Local steroid injection-Diprospan ®, Schering Plough DRUG

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.

Also known as: procedure

Diprospan ®, Schering Plough

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Faculty of Medicine, Ankara Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (16)

• 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.

  PMID: 11805259 BACKGROUND

• 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.

  PMID: 17082517 BACKGROUND

• 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.

  PMID: 17613571 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23558771 BACKGROUND

• 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.

  PMID: 18452111 BACKGROUND

• 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.

  PMID: 15509939 BACKGROUND

• 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.

  PMID: 21813443 BACKGROUND

• 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.

  PMID: 23519544 BACKGROUND

• 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.

  PMID: 21029038 BACKGROUND

• 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.

  PMID: 19802878 BACKGROUND

• 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.

  PMID: 21244302 BACKGROUND

• Jazayeri SM, Azizi S, Moghtaderi AR. Autologous blood injection in carpal tunnel syndrome (CTS). Electromyogr Clin Neurophysiol. 2009 Nov-Dec;49(8):369-72.

  PMID: 20058545 BACKGROUND

• 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.

  PMID: 9390659 BACKGROUND

• 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.

  PMID: 10865306 BACKGROUND

• Senlikci HB, Afsar SI, Cosar SN, Kurtcebe AN, Ozen S, Yemisci OU. The effectiveness of single-dose blinded platelet-rich plasma (PRP) vs. corticosteroid injection in mild-to-moderate carpal tunnel syndrome: A prospective, randomized, double blind study. J Bodyw Mov Ther. 2025 Jun;42:995-1001. doi: 10.1016/j.jbmt.2025.01.057. Epub 2025 Jan 31.

  PMID: 40325784 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Methods

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sevgi Ikbali Afsar, Assoc Prof

  Baskent University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huma Boluk, MD

CONTACT

90 537 0630777; humaboluk@gmail.com

Huma Boluk, MD

CONTACT

90 312 7122340

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: prospective, randomized, controlled, double blind.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: June 27, 2019
• Study Start: July 15, 2018
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: June 28, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)