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Platelet Rich Plasma in Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT04000932
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sevgi Ikbali Afsar, 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.

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.


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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


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




Primary Outcome Measures :
  1. median nerve sensory conduction velocity [ Time Frame: 3 months ]
    median nerve sensory conduction velocity in the palm wrist segment



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000932


Contacts
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Contact: Huma Boluk, MD 90 537 0630777 humaboluk@gmail.com
Contact: Huma Boluk, MD 90 312 7122340

Locations
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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
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Principal Investigator: Sevgi Ikbali Afsar, Assoc Prof Baskent University Faculty of Medicine

Publications:
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.

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Responsible Party: Sevgi Ikbali Afsar, Associate Professor, Baskent University
ClinicalTrials.gov Identifier: NCT04000932     History of Changes
Other Study ID Numbers: KA14/13
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sevgi Ikbali Afsar, Baskent University:
Carpal tunnel syndrome
Injection
Platelet rich plasma
Additional relevant MeSH terms:
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Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Betamethasone sodium phosphate
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Betamethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents