Extended Therapeutic Effect of 35kDa Hyaluronan Fragment Injection in Patients With Chronic Pain Caused by Myofascial Pain Syndrome

NCT ID: NCT06444035

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2024-12-31

Brief Summary

To verify the efficacy and safety of HA35 in chronic pain management and to further supplement effective treatments for chronic pain, we designed a proof-of-concept clinical study. This study aims to evaluate the 15-day treatment of HA35 on patients with myofascial pain syndrome and to observe the effects for up to 3 months.

Conditions

Chronic Wound; Myofascial Pain Syndrome

Study Design

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

Study Groups

Treatment of myofascial pain syndrome by local injection of pain points

Subjects received subcutaneous injection of HA35 injection 100mg / 5mL / day near the back pain point for 15 days.

Group Type: EXPERIMENTAL

HA35 injection

Intervention Type: DRUG

HA35/B-HA injection (Registration number L20200708MP07707; Ministry of Health). The subjects can continue to take oral analgesics during the treatment period, and the comparison of the dose and interval days of the analgesics before and after the treatment can also be used as the effect judgment of the injection.

Interventions

HA35 injection

HA35/B-HA injection (Registration number L20200708MP07707; Ministry of Health). The subjects can continue to take oral analgesics during the treatment period, and the comparison of the dose and interval days of the analgesics before and after the treatment can also be used as the effect judgment of the injection.

Intervention Type: DRUG

Other Intervention Names

B-HA injection

Eligibility Criteria

Inclusion Criteria

• Male and female, aged 18-65 years old ;
• suffering from muscle strain, sprain, fall, wind and other diagnosed as myofascitis in patients with chronic back pain;
• the pain reported by the subject should reach level 3 or higher on the digital rating scale of 0-10 ( 0 means no pain, 10 represents the strongest pain imaginable );
• the mental state is good, and the pain level can be evaluated independently;
• be able to cooperate with the treatment independently and sign a written consent.

Exclusion Criteria

• Previous severe trauma with permanent musculoskeletal dysfunction;
• symptomatic lumbar disc herniation with neurological deficits;
• specific spinal diseases, including rheumatoid arthritis, ankylosing spondylitis, and osteoporosis;
• diagnosed with mental illness;
• agree not to sign the written consent;
• pregnant, lactating or fertile women;
• currently participating ( or participating in the past 30 days ) in research-based treatment or equipment trials.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nakhia Impex LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nahia Impex Llc

Ulaanbaatar, , Mongolia

Countries

Mongolia

Other Identifiers

HSHN005

Identifier Type: -

Identifier Source: org_study_id