A Phase 4 interventional study of Autologous platelet-rich plasma and Normal Saline (0.9% Sodium Chloride) in Carpal Tunnel Syndrome (CTS), sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Medical University of Lodz · Phase 4, Interventional, and Treatment
This single-center, single-blind, randomized controlled trial compared two injectates used for ultrasound-guided hydrodissection of the median nerve in adults with carpal tunnel syndrome: autologous platelet-rich plasma (PRP) and 0.9% normal saline (NS). Participants received a single hydrodissection with 5 mL of the allocated injectate per treated wrist; in participants with bilateral carpal tunnel syndrome, both wrists were treated with the same injectate. Symptom severity and functional status (Boston Carpal Tunnel Questionnaire), neuropathic pain (DN4 questionnaire), median nerve cross-sectional area on ultrasound, and grip strength parameters were assessed at baseline and at 3 and 6 months after the intervention. The study aimed to determine whether PRP provides benefit beyond the mechanical effect of hydrodissection with saline.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Medical University of Lodz is the lead sponsor of 107 studies on the registry; 10 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Cancer (malignancy)
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Participants underwent a 15-mL venipuncture, and approximately 5 mL of autologous platelet-rich plasma (PRP) was prepared with the Arthrex ACP double-syringe system (centrifugation at 1500 rpm for 5 minutes). A single ultrasound-guided hydrodissection of the median nerve was performed at the carpal tunnel inlet with 5 mL of PRP per treated wrist, injected circumferentially around the nerve through a 22-gauge needle using an in-plane ulnar approach. No local anesthetic was used. In participants with bilateral carpal tunnel syndrome, both wrists were treated in the same session, each with a separate 5-mL injectate.
Biological: Autologous platelet-rich plasma · Procedure: Ultrasound-guided median nerve hydrodissection
Participants underwent an identical 15-mL venipuncture to maintain blinding; the blood was discarded. A single ultrasound-guided hydrodissection of the median nerve was performed at the carpal tunnel inlet with 5 mL of 0.9% sodium chloride per treated wrist, delivered from a masked syringe and injected circumferentially around the nerve through a 22-gauge needle using an in-plane ulnar approach. No local anesthetic was used. In participants with bilateral carpal tunnel syndrome, both wrists were treated in the same session, each with a separate 5-mL injectate.
Other: Normal Saline (0.9% Sodium Chloride) · Procedure: Ultrasound-guided median nerve hydrodissection
Approximately 5 mL of autologous platelet-rich plasma prepared from 15 mL of venous blood with the Arthrex ACP double-syringe system (centrifugation at 1500 rpm for 5 minutes), injected circumferentially around the median nerve under ultrasound guidance.
5 mL of 0.9% sodium chloride injected circumferentially around the median nerve under ultrasound guidance from a masked syringe.
Single ultrasound-guided hydrodissection of the median nerve at the carpal tunnel inlet (pisiform-scaphoid level) using a 22-gauge needle and an in-plane ulnar approach; the injectate is delivered circumferentially to separate the nerve from the flexor retinaculum, subsynovial connective tissue and flexor tendons. No local anesthetic is used.
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Self-administered 11-item scale assessing the severity of carpal tunnel syndrome symptoms. Each item is scored from 1 to 5, and the subscale score is calculated as the mean of the items (range 1.00-5.00), with higher scores indicating greater symptom severity. The validated Polish version was used.
Time frame: Baseline, 3 months and 6 months after the intervention
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
Self-administered 8-item scale assessing difficulty in performing daily activities. Each item is scored from 1 to 5, and the subscale score is calculated as the mean of the items (range 1.00-5.00), with higher scores indicating greater functional disability. The validated Polish version was used.
Time frame: Baseline, 3 months and 6 months after the intervention
Neuropathic pain - Douleur Neuropathique 4 (DN4) questionnaire
Clinician-administered questionnaire consisting of 7 interview items and 3 examination items. Total score ranges from 0 to 10; a score of 4 or more indicates probable neuropathic pain. Higher scores indicate more neuropathic pain features.
Time frame: Baseline, 3 months and 6 months after the intervention
Median nerve cross-sectional area (CSA)
Cross-sectional area of the median nerve (mm2) measured on ultrasound in the transverse plane at the carpal tunnel inlet (pisiform-scaphoid level) by continuous tracing inside the hyperechoic epineurium. The mean of three measurements was recorded.
Time frame: Baseline, 3 months and 6 months after the intervention
Peak force of hand grip, pinch grip and thumb flexion
Peak force (N) for hand grip, pinch grip and thumb flexion measured with the VALD DynaMo dynamometer.
Time frame: Baseline, 3 months and 6 months after the intervention
Time to peak force of hand grip, pinch grip and thumb flexion
Time to peak force (s) for hand grip, pinch grip and thumb flexion measured with the VALD DynaMo dynamometer.
Time frame: Baseline, 3 months and 6 months after the intervention
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication will be available from the corresponding author upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning after publication of the main results, with no planned end date.
Access criteria: Requests should be directed to the corresponding author (marcin.piwnik@umed.lodz.pl) and will be considered for scientifically sound proposals, subject to a data use agreement and applicable data protection regulations (GDPR).
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma