Injection Therapy for Neuropathic Pain

Dove Medical Press

Status: Completed

Conditions: Neuropathic Pain

Treatments: Drug: Freshly manufactured 35 kDa hyaluronan fragment

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05809700

HSHN001

Details and patient eligibility

About

Shoulder, neck, back and temporal pain and herpes zoster pain are neuropathic pain. Preliminary clinical studies have confirmed that injection of freshly prepared HA35 can relieve neuropathic pain. This clinical study is a prospective repeated experiments. The purpose of this study was to verify the effectiveness of HA35 injection therapy.

Full description

In this study, the recombinant human hyaluronidase PH20 and neutral hyaluronidase (PH20) of bovine testicular sperm acrosomes were used to cleave macromolecular HA. Regardless of the cutting time, the HA fragment HA35, with an average molecular weight of 35 kDa, was produced (Registration number L20200708MP07707, Ministry of Health, Mongolia). Hyaluronidase is often used to improve the penetration and absorption of other injectable drugs. Hyaluronidase injection is also used off label to degrade excessive components used in cosmetic injections, such as cross-linked macromolecular HA fillers (https://www.realself.com/news/hyaluronidase-dissolve-fillers). In this study, HA35 was prepared by mixing hyaluronidase extracted from bovine testis (hyaluronidase for injection, H31022111) and HA (sodium hyaluronate for injection, H20174089) at room temperature for 20 minutes. The analgesic effect of HA35 on herpes zoster and shoulder, neck, back, and temporal pain was studied. This was a single-arm, open-label prospective clinical study in which patients were evaluated before and after treatment.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The course of neck, back and temporal pain ranged from 0 to 8 months.
• The course of herpes zoster of 0-2 months.
• Adults aged 18-60 years.
• Be willing and capable of giving informed consent.
• Have a clinical diagnosis of neuropathic pain as determined by a multidisciplinary study team.
• Subject must sign the informed consent in person prior to beginning any screening procedure.

Exclusion criteria

• Have a persistent pain resulted from other medical conditions or unknown causes.
• Pregnant females.
• Be concomitantly participating in another clinical study.
• Have been immunocompromised.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

HA35 local injection of pain location Group

Experimental group

Description:

According to the ratio of 100 mg high molecular weight HA (sodium hyaluronate for injection, H20174089)/2000 units of hyaluronidase extracted from bovine testis (hyaluronidase for injection H31022111), high molecular weight HA injection and hyaluronidase injection were mixed at room temperature for 20 minutes.

Treatment:

Drug: Freshly manufactured 35 kDa hyaluronan fragment