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Completed

NCT Number: NCT05809700

Injection Therapy for Neuropathic 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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huinuode Biotechnology Co., Ltd.

Qingdao, Shandong, 266000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Freshly manufactured 35 kDa hyaluronan fragment

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.

Other names: HA35

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dove Medical Press Ltd

Network

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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