Injection Therapy for Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

The Clinical Study of Injection of Freshly Prepared HA35 in the Treatment of Shoulder, Neck, Back, Temporal and Herpes Zoster Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05809700
• Other study ID #: HSHN001
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: July 28, 2023

Study information

• Verified date: September 2023
• Source: Dove Medical Press Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 28, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Huinuode Biotechnology Co., Ltd.	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Dove Medical Press Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Numerical Pain Rating Scale (NPRS) scores	The pain scale used is a tool that doctors use to help assess patients' pain. Each patient rated their pain on a scale of 0 to 10. A score of 0 means "no pain" and 10 means "the most painful". Statistical t-tests were used to calculate and evaluate the pain intensity, which were expressed as the mean ± standard deviation.	30 min to 3 hours
Primary	the General Comfort Questionnaire (GCQ) scores	Using 1-4 grade scoring method, that is, 1 means ' very disagree ', 2 means ' disagree ', 3 means ' agree ', 4 means ' very agree'. The total score is less than 60 points for low comfort, 60-90 points for moderate comfort, and more than 90 points for high comfort.	24 hours