The goal of this clinical trial is to learn if a single session of ultrasound-guided nerve hydrodissection can relieve symptoms of diabetic lower limb entrapment neuropathy, a condition caused by compressed nerves in the leg that leads to numbness, pain, or muscle weakness in people with diabetes. The main questions it aims to answer are whether nerve hydrodissection improves nerve function (measured by the Toronto Clinical Scoring System) one month after treatment, and whether it relieves pain and improves quality of life. Researchers will compare two groups: one will receive the actual nerve hydrodissection (injection of medicine around the compressed nerve), and the other will receive a sham procedure that involves injecting a small amount of fluid under the skin (not around the nerve). Participants will not know which group they are in, and the researchers who measure the results will also not know. Participants will have four in-person visits over about one month, complete questionnaires about their nerve symptoms, pain, and quality of life, undergo nerve ultrasound at the beginning and at follow-up visits (at 1 month after treatment), and receive either the nerve hydrodissection or the sham procedure at the second visit. All participants will continue their regular diabetes and nerve medication during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
266
The patient is placed in a standard position, followed by routine disinfection and draping. A high-frequency ultrasound probe is used and covered with a sterile sheath to clearly visualize the target nerve. Using an in-plane puncture technique, the needle tip is advanced to the perineural fascial plane under real-time guidance. After confirming placement and negative aspiration, a pre-prepared solution of mecobalamin and normal saline is slowly injected. The main sites are the common peroneal nerve (fibular head) and tibial nerve (medial malleolus). Based on preliminary data, a volume of 20 mL is injected, which separates the nerve from surrounding tissues without causing significant discomfort. The fixed volume ensures a standardized procedure. During injection, fluid spread is monitored to ensure it surrounds the nerve and achieves hydrodissection. After injection, the needle is withdrawn, local compression is applied, and the site is covered with a sterile dressing.
The patient is placed in the same standard position, followed by identical disinfection and ultrasound positioning. Under ultrasound guidance, a needle identical in appearance is inserted into the superficial subcutaneous fascia above the target nerve, clearly avoiding the nerve structure. A syringe containing mecobalamin and normal saline is then connected, and a full set of simulated injection maneuvers including aspiration and slow "injection" is performed, while ensuring that the actual volume of fluid delivered is small (less than 5 mL). To simulate a real sensory experience, the operator provides standardized verbal cues during the procedure. After needle withdrawal, local compression and dressing application are performed identically to the treatment group.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGRemission rate of TCSS score
The Toronto Clinical Scoring System (TCSS) assesses neuropathy symptoms, sensory deficits, and reflexes, with a total score ranging from 0 to 19. Higher scores indicate worse outcomes (more severe neuropathy). Remission is defined as a decrease of 1 point or more from baseline. This outcome is compared between the ultrasound-guided nerve hydrodissection group and the sham treatment group.
Time frame: At 1 month after the treatment
Change in TCSS from baseline
Changes in TCSS from baseline
Time frame: Within 5 days and 1 month after the treatment
Changes in each component of TCSS compared to baseline
Changes in each component of the Toronto Clinical Scoring System (TCSS) from baseline. The TCSS assesses three components: symptoms, sensory deficits, and reflexes. Total score range: 0 to 19 Each component has its own sub-score range (symptoms: 0-6, sensory: 0-5, reflexes: 0-8) Higher scores indicate worse outcomes (more severe neuropathy) This outcome measures the within-group change from baseline at each follow-up time point.
Time frame: Within 5 days and 1 month after the treatment
Change in VAS pain score from baseline
Visual Analogue scale(VAS)Score range: 0-10 Higher scores indicate worse outcomes (more severe pain) This outcome measures the within-group change from baseline at each follow-up time point.
Time frame: Within 5 days and 1 month after the treatment
Change in EQ-5D quality of life score from baseline
Changes in the EuroQol Five-Dimensional Five-Level Questionnaire (EQ-5D-5L) from baseline. The EQ-5D-5L consists of two components: 1. Utility index score: Derived from the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) Score range typically from ≤ 0 (worst health state) to 1 (full health) Higher scores indicate better outcomes 2. EQ-VAS (Visual Analogue Scale): Self-rated overall health on a vertical scale Score range: 0 (worst imaginable health) to 100 (best imaginable health) Higher scores indicate better outcomes This outcome measures the within-group change from baseline at each follow-up time point.
Time frame: Within 5 days and 1 month after the treatment
Change in ultrasound-measured nerve cross-sectional area (CSA) from baseline
Changes in nerve cross-sectional area measured by ultrasound compared to baseline
Time frame: At 1 month after the treatment
Patient Global Impression of Change (PGIC)
Patients' self-assessment of overall change in their condition since the start of treatment, measured by the Patient Global Impression of Change (PGIC) scale. The PGIC is a 7-point rating scale: Score range: 1 to 7 Scoring: 1. = Very much better 2. = Much better 3. = A little better 4. = No change 5. = A little worse 6. = Much worse 7. = Very much worse Lower scores indicate better outcomes (greater improvement)
Time frame: Within 5 days and 1 month after the treatment
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