Injection Therapy for Neuropathic Pain

NCT ID: NCT05809700

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-07-28

Brief Summary

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.

Detailed 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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HA35 local injection of pain location Group

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.

Group Type: EXPERIMENTAL

Freshly manufactured 35 kDa hyaluronan fragment

Intervention Type: DRUG

This mixture of high molecular weight HA and hyaluronidase containing 100 mg of HA was locally injected at the pain point or where the nerve trunk innervates the pain point. Then, the pain scale (NPRS) was used to evaluate pain, and the pain relief of patients before and after treatment was recorded.

Each time, according to the amount of high molecular weight HA containing 100 mg HA and hyaluronidase mixture, the pain point area and pain point area of the nerve trunk innervation of the local multipoint injection. Then, the pain scale was used to evaluate pain, and the pain relief of patients before and after treatment was recorded.

Interventions

Freshly manufactured 35 kDa hyaluronan fragment

This mixture of high molecular weight HA and hyaluronidase containing 100 mg of HA was locally injected at the pain point or where the nerve trunk innervates the pain point. Then, the pain scale (NPRS) was used to evaluate pain, and the pain relief of patients before and after treatment was recorded.

Each time, according to the amount of high molecular weight HA containing 100 mg HA and hyaluronidase mixture, the pain point area and pain point area of the nerve trunk innervation of the local multipoint injection. Then, the pain scale was used to evaluate pain, and the pain relief of patients before and after treatment was recorded.

Intervention Type: DRUG

Other Intervention Names

HA35

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dove Medical Press Ltd

NETWORK

Sponsor Role: lead

Responsible Party

Mizhou Hui

Research fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huinuode Biotechnology Co., Ltd.

Qingdao, Shandong, China

Countries

China

Other Identifiers

HSHN001

Identifier Type: -

Identifier Source: org_study_id