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

NCT06444035 | Enrolling By Invitation

• 1 other identifier: HSHN005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Chronic myofascial pain score

  Subjective measurements of pain were submitted using the Numerical Pain Rating Scale (NPRS). Scored at 0-10, the higher the score, the more obvious the pain.

  after treatment 1 day, 3 days, 5 days, 15 days, 30 days, 60 days, 90 days

Secondary Outcomes (2)

• Overall pain assessment during injection therapy and follow-up

  after treatment 15 days, 30 days, 60 days, 90 days

• Satisfaction survey of injection treatment

  after treatment 90 days

Study Arms (1)

Treatment of myofascial pain syndrome by local injection of pain points

EXPERIMENTAL

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

Drug: HA35 injection

Interventions

HA35 injection 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.

Also known as: B-HA injection

Treatment of myofascial pain syndrome by local injection of pain points

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nakhia Impex LLC: lead

Study Sites (1)

Nahia Impex Llc

Ulaanbaatar, Mongolia

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: May 30, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 1, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-05

Locations

MO (1)