Injection Therapy for Neuropathic Pain

NCT05809700 | Completed

• 1 other identifier: HSHN001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

HA35 local injection of pain location Group

EXPERIMENTAL

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

Interventions

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.

Also known as: HA35

HA35 local injection of pain location Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dove Medical Press Ltd: lead

Study Sites (1)

Huinuode Biotechnology Co., Ltd.

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research fellow

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: June 1, 2023
• Primary Completion: July 12, 2023
• Study Completion: July 28, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)