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Hydrodissection in Carpal Tunnel Syndrome

Comparison of Hydrodissection Techniques Using 5% Dextrose for the Treatment of Carpal Tunnel Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07207460
Acronym
KTS
Enrollment
74
Registered
2025-10-06
Start date
2024-01-01
Completion date
2025-08-01
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Median Nerve Entrapment

Keywords

Carpal Tunnel Syndrome, perineural injection, nerve hydrodissection, Conservative treatment, Entrapment neuropathy, 5% dextrose, ultrasound-guided hydrodissection

Brief summary

The aim of this study was to compare the effectiveness of perineural hydrodissection methods performed with 5 mL D5W solution and three different injection techniques \[ultrasound-guided in-plane, ultrasound-guided out-of-plane, and blind technique\] in cases diagnosed with mild to moderate CTS by EMG.

Detailed description

Carpal tunnel syndrome (CTS) is a highly prevalent condition in the general population, markedly impairing daily activities and sleep quality. Depending on disease severity and symptom burden, treatment approaches are broadly categorized as conservative or surgical. Beyond lifestyle modifications, numerous conservative interventions-including splinting, extracorporeal shock wave therapy, therapeutic ultrasound, phonophoresis, hydrodissection, kinesiotaping, corticosteroid (CS) injections, low-level laser therapy, platelet-rich plasma (PRP) injections, manual therapy, and acupuncture-have demonstrated clinical efficacy. More recently, 5% dextrose injections have emerged as a safe alternative to CS with minimal adverse effects. Injection therapies vary in both content and technique; however, no consensus exists regarding the optimal approach. Given the importance of minimizing side effects and ensuring long-term effectiveness, the refinement of injection agents and techniques remains a priority. Although ultrasound-guided injections improve safety and accuracy, they require expertise and incur additional costs, whereas blind techniques have long been applied reliably in clinical practice. Nevertheless, comparative studies evaluating these techniques remain limited. Therefore, the present study aimed to compare three different injection techniques for the management of CTS.

Interventions

PROCEDUREComparison of three different injection techniques using hydrodissection with 5% dextrose in the treatment of CTS

Comparison of three different injection techniques with D5W

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The study was conducted by four independent researchers. One investigator confirmed the CTS diagnosis using EMG and performed all follow-up EMG assessments. A second investigator measured the CSA using ultrasound. A third investigator performed all injections, while a fourth investigator was responsible for clinical evaluations and statistical analyses

Intervention model description

This study was designed as a randomized, controlled, single-blind trial. Patients diagnosed with mild or moderate CTS based on EMG findings were randomly assigned into three groups using a computerized randomization method. Perineural hydrodissection was performed with 5 mL of 5% dextrose solution in all groups: Group 1 with the in-plane US-guided ulnar approach, Group 2 with the out-of-plane US-guided proximal-to-distal ulnar approach, and Group 3 with the blind proximal-to-distal longitudinal approach. Assessments were conducted at baseline, 2 weeks, and 3 months after the injection. Outcome measures included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the DN4 questionnaire for CTS severity and functional status, as well as pain intensity assessed using a Visual Analog Scale (VAS). Median nerve cross-sectional area (CSA) was measured at baseline by a physician with over 10 years of US experience, and electromyography (EMG) evaluations were performed at baseline and 3 m

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients between the ages of 20-70 * Moderate and mild CTS patients diagnosed with CTS by EMG * Literate patients who agreed to participate in the study

Exclusion criteria

* Patients with RA, type 1 or type 2 diabetes mellitus * Patients with chronic renal failure * Polyneuropathy * Those with a history of cancer, those receiving chemotherapy * Those with a history of broken hand wrist fracture in the last 6 months * Patients with brachial plexopathy or thoracic outlet syndrome (TOS) * Patients who underwent surgery due to CTS * Pregnancy * Hypothyroidism in a mixed edema picture * Diagnosed with neuromuscular disease * Patients with bleeding disorders or those currently receiving anticoagulant therapy * patients with infection at the injection site

Design outcomes

Primary

MeasureTime frameDescription
Boston CTS0 , 2nd week 12th weekThe BCTQ is the most widely used measure for CTS. It includes 2 subscales with 11 questions assessing symptom severity and 8 questions assessing functional status.31 Scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.The BCTQ provides a standardized, patient-based outcome measure of symptom severity and functional status to assess the results of carpal tunnel syndrome treatments. The test has strong evidence of validity, reliability and responsiveness.
VAS0 2nd week 12th weekVAS was used to assess digital pain intensity and paresthesia/dysthesia before injection therapy administration. Scores ranged from 10 (extremely severe pain) to 0 (no pain).
DN-40 2nd week 12th weekIt is a clinical screening tool used to diagnose the presence of neuropathic pain.It was developed by the French Neuropathic Pain Group to address the difficulties and lack of consensus in diagnosing neuropathic pain.It is a questionnaire consisting of 10 items administered by the clinician.Seven pain-related items (i.e., sensory and pain descriptors) are administered in consultation with the patient. They express how pain is felt by the patient.The three items are based on clinical examination. The clinician assesses whether sensation to touch or pinprick is diminished (hyposthesia) and whether it increases with light brushing or causes pain (allodynia).

Secondary

MeasureTime frameDescription
Nerve CSA0 2nd 12th weekThe cross-sectional area (CSA) of the median nerve was measured at baseline, 2 weeks, and 3 months after injection by a physician with over 10 years of ultrasound experience. Patients were seated with the forearm supinated and the wrist in slight dorsiflexion, supported by a rolled towel or pillow. A high-frequency linear probe (5-12 MHz, Logic P5, GE Medical Systems) was placed on the palmar wrist in the transverse plane. The median nerve was identified at the level of the scaphoid (radial side) and pisiform (ulnar side), typically in the midline beneath the superficial flexor tendons. CSA was measured by tracing the inner border of the perineural echogenic rim. Each measurement was repeated three times, and the mean value was recorded.
EMG0 and 12th weekUsing electrophysiological studies, CTS degree (distal motor latency \[DML\]) greater than 3.6 was considered as moderate CTS, and those less than 3.6 as mild CTS. Only participants with mild-to-moderate CTS were included in the study.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026