Carpal Tunnel Syndrome (CTS)
Conditions
Keywords
Carpal Tunnel Syndrome, median nerve, platelet-rich plasma, ultrasonography, Interventional, injections
Brief 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). 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.
Interventions
BIOLOGICALAutologous platelet-rich plasma
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.
Sponsors
Medical University of Lodz
European Society of Physical and Rehabilitation Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) | Baseline, 3 months and 6 months after the intervention | 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. |
| Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS) | Baseline, 3 months and 6 months after the intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic pain - Douleur Neuropathique 4 (DN4) questionnaire | Baseline, 3 months and 6 months after the intervention | 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. |
| Median nerve cross-sectional area (CSA) | Baseline, 3 months and 6 months after the intervention | 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. |
| Peak force of hand grip, pinch grip and thumb flexion | Baseline, 3 months and 6 months after the intervention | Peak force (N) for hand grip, pinch grip and thumb flexion measured with the VALD DynaMo dynamometer. |
| Time to peak force of hand grip, pinch grip and thumb flexion | Baseline, 3 months and 6 months after the intervention | Time to peak force (s) for hand grip, pinch grip and thumb flexion measured with the VALD DynaMo dynamometer. |
Countries
Poland
Outcome results
None listed