Platelet Rich Plasma in Carpal Tunnel Syndrome

Phase 3

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Local platelet rich plasma (PRP) injection-T-Lab PRP kit; Drug: Local steroid injection-Diprospan ®, Schering Plough

• Registration Number: NCT04000932
• Lead Sponsor: Baskent University

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 Timeline

• Study First Submitted: 2018-04-25
• Study Start: 2018-07-15
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28
• Primary Completion: 2019-12-30
• Study Completion: 2020-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 84

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet rich plasma (PRP) -T lab PRP kit	Local platelet rich plasma (PRP) injection-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.
Diprospan ®, Schering Plough	Local steroid injection-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.

Primary Outcome Measures

Name	Time	Method
median nerve sensory conduction velocity	3 months	median nerve sensory conduction velocity in the palm wrist segment

Trial Locations

Locations (1)

Baskent University Faculty of Medicine, Ankara Hospital; 🇹🇷 Ankara, Turkey