AzTrials
AzTrials

Carpal Tunnel Syndrome (CTS)Phase 4NCT07904650

PRP Versus Saline Hydrodissection for CTS RCT

A Phase 4 study testing Autologous platelet-rich plasma, Normal Saline (0.9% Sodium Chloride) and Ultrasound-guided median nerve hydrodissection in people with Carpal Tunnel Syndrome (CTS), run by Medical University of Lodz at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
What is being tested?
Autologous platelet-rich plasma, Normal Saline (0.9% Sodium Chloride) and Ultrasound-guided median nerve hydrodissection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 sitePoland
Study dates
23 Mar 2025to 28 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 65 years
  • Clinical diagnosis of carpal tunnel syndrome with symptoms for at least 3 months
  • Pain intensity of at least 4/10 on the Numeric Pain Rating Scale (NPRS)
  • Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) score of at least 2
  • Positive findings on at least 2 of 3 provocative tests (Tinel sign, Phalen test, reverse Phalen test)
  • Sensory disturbance in the distribution of the median nerve (digits I-III)
  • Diagnosis confirmed by electroneurography or by ultrasonographic enlargement of the median nerve at the carpal tunnel inlet

Who cannot join

  • Pregnancy
  • Known allergy to injectable substances
  • Needle phobia
  • Skin lesions, open wounds, hematoma or edema at the injection site
  • Severe hepatic or renal insufficiency
  • Severe atherosclerosis
Show all 24Show fewer
  • Aneurysms
  • Uncontrolled arterial hypertension
  • Uncontrolled diabetes mellitus
  • Advanced osteoporosis
  • Untreated epilepsy
  • Use of antiepileptic medications
  • Psychiatric illness precluding informed consent
  • Severe depression
  • Infectious disease, including active infection
  • History of immunosuppressive therapy (chemotherapy, radiotherapy, sepsis)
  • Ongoing immunosuppressive or anticoagulant therapy
  • Coagulation disorders
  • Fibromyalgia
  • Active malignancy
  • Severe general debilitation
  • Previous carpal tunnel release surgery on the affected wrist
  • Local or systemic glucocorticoid use within the preceding month
  • Use of a non-steroidal anti-inflammatory drug within 48 hours before the intervention

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Lodz

    Lodz, Łódź Voivodeship, 93-113

Other trials in Poland

About this study

Official title: Platelet-Rich Plasma Versus Saline Hydrodissection for Carpal Tunnel Syndrome: A Randomized Trial

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.

Being tested
Autologous platelet-rich plasma, Normal Saline (0.9% Sodium Chloride), Ultrasound-guided median nerve hydrodissection
Keywords
Carpal Tunnel Syndrome, median nerve, platelet-rich plasma, ultrasonography, Interventional, injections
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous platelet-rich plasmaBiological

    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.

  • Normal Saline (0.9% Sodium Chloride)Other

    5 mL of 0.9% sodium chloride injected circumferentially around the median nerve under ultrasound guidance from a masked syringe.

  • Ultrasound-guided median nerve hydrodissectionProcedure or surgery

    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.

Study groups in NCT07904650
Study groupRoleWhat they receive
PRP hydrodissectionExperimentalParticipants 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.
Receives: Biological: Autologous platelet-rich plasma; Procedure: Ultrasound-guided median nerve hydrodissection
Normal saline hydrodissectionActive comparatorParticipants 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.
Receives: Other: Normal Saline (0.9% Sodium Chloride); Procedure: Ultrasound-guided median nerve hydrodissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 months and 6 months after the intervention

  2. 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.

    Measured: Baseline, 3 months and 6 months after the intervention

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, 3 months and 6 months after the intervention

  2. 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.

    Measured: Baseline, 3 months and 6 months after the intervention

  3. 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.

    Measured: Baseline, 3 months and 6 months after the intervention

  4. 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.

    Measured: Baseline, 3 months and 6 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start23 Mar 2025
  3. Primary completion31 Jul 2025
  4. Study completion28 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07904650
Sponsor's protocol ID
RNN/72/25/KE
Other IDs
1/2024
Status last verified
Oct 2026
First submitted
23 Oct 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in the publication will be available from the corresponding author upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Autologous platelet-rich plasma, Normal Saline (0.9% Sodium Chloride) and Ultrasound-guided median nerve hydrodissection in people with Carpal Tunnel Syndrome (CTS), run by Medical University of Lodz at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) (time frame: Baseline, 3 months and 6 months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07904650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in