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Evaluation of the Effectiveness and Safety of Ultrasound-Guided Pharmacopuncture for Carpal Tunnel Syndrome : A Multicenter Randomized Clinical Study

Evaluation of the Effectiveness and Safety of Ultrasound-Guided Pharmacopuncture for Carpal Tunnel Syndrome : A Multicenter Randomized Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011180
Enrollment
64
Registered
2025-11-19
Start date
2026-01-20
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

None listed

Interventions

Procedure/Surgery : [Ultrasound-Guided Pharmacopuncture] - The type of pharmacopuncture solution and injection site are determined based on the practitioner’s evaluation, including the Four Diagnostic

Sponsors

Pusan National University Korean Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Patients experiencing hand numbness and pain for at least 3 months, with a VAS score = 50 mm on a 100-mm scale. ? Male or female adults aged 19 to 70 years. ? Patients who meet at least one of the following criteria (for bilateral cases, the side with more severe symptoms is evaluated): ? Presence of sensory abnormalities (e.g., hypoesthesia) in the median nerve distribution (palmar aspect of the thumb, index, middle, and radial half of the ring finger; dorsal aspect of the distal phalanges of the index, middle, and radial half of the ring finger). ? Thenar muscle atrophy compared with the contralateral side. ? Positive result on at least one of the following: Phalen test or Tinel sign. ? Able to communicate normally. ? Patients who voluntarily agree to clinical participation and follow-up, and who provide written informed consent approved by the Institutional Review Board (IRB).

Exclusion criteria

Exclusion criteria: ? Patients with neurological symptoms of the hand caused by conditions other than carpal tunnel syndrome, such as polyneuropathy, brachial plexopathy, thoracic outlet syndrome, or cervical disc herniation. ? Patients reporting hand sensory abnormalities due to systemic diseases such as rheumatoid arthritis, diabetes mellitus, thyroid disorders, or hormonal imbalance. ? Patients who have undergone surgery on the wrist or have received steroid injections or other medical injection treatments (e.g., local anesthetic injections) in the wrist within 1 month prior to screening. ? Patients who have received Korean medicine treatments (e.g., acupuncture, pharmacopuncture, moxibustion, cupping) on the wrist within 2 weeks prior to screening. However, if the treatment was administered at another institution for a reason unrelated to the condition targeted by this clinical trial, participation may be allowed at the investigator’s discretion. ? Patients who have taken systemic steroids, antipsychotics, antidepressants, anticonvulsants, or anxiolytics/sedatives within 1 month prior to screening, or other medications affecting pain (e.g., NSAIDs) that may influence the study results. Patients taking anxiolytics/sedatives at a stable dose for at least 4 weeks prior to screening are not excluded. ? Pregnant women or women who may be pregnant. ? Patients with serious systemic infections or other internal medical conditions considered inappropriate for study participation. ? Patients with wrist fractures, trauma, congenital deformities, or implanted devices in the wrist area. ? Patients for whom pharmacopuncture is considered inappropriate or unsafe (e.g., bleeding disorders, severe diabetes with high infection risk). ? Patients who have participated in another clinical study within the past month, or who plan to participate in another clinical study during this trial and its follow-up period. ? Patients unable to provide written informed consent. ? Any other individuals deemed unsuitable for participation at the investigator’s discretion.

Design outcomes

Primary

MeasureTime frame
hand numbness and pain Visual Analogue Scale, VAS

Secondary

MeasureTime frame
Boston carpal tunnel questionnaire, BCTQ;cross-sectional area, CSA;grip strength;Adverse events

Countries

Korea, Republic of

Contacts

Public ContactLEE JUNG-GYUNG

Pusan National University Korean Medicine Hospital

leejg9753@gmail.com+82-55-360-5725

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 4, 2026