Injection Therapy for Neuropathic Pain

September 22, 2023 updated by: Mizhou Hui, Dove Medical Press Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Huinuode Biotechnology Co., Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

Other Names:
  • HA35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Numerical Pain Rating Scale (NPRS) scores
Time Frame: 30 min to 3 hours
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
the General Comfort Questionnaire (GCQ) scores
Time Frame: 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dove Medical Press Ltd

Collaborators

The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

July 12, 2023

Study Completion (Actual)

July 28, 2023

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSHN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be sent to the accepting journal study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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