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

35kDa Hyaluronan Fragment Injection Treatment Myofascial Pain Syndrome

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Myofascial Pain Syndrome; Chronic Wound
• Intervention / Treatment: Drug: HA35 injection

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mongolia
  • Ulaanbaatar, Mongolia
    • Nahia Impex Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: B-HA injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall pain assessment during injection therapy and follow-up	The global pain scale (GPS) was used to assess the global pain. The total consists of 20 items, each rated on a scale from 0 to 10. The sum of the scores for all items is divided by 2 to obtain the total score. The higher the score, the more significant the pain and its impact.	after treatment 15 days, 30 days, 60 days, 90 days
Satisfaction survey of injection treatment	A questionnaire survey was conducted on patients using the Satisfaction with Medication Questionnaire ( TSQM 1.4 ). There are 4 subscales and 14 questions: the Effectiveness Scale (questions 1-3), the Side Effects Scale (questions 4-8), the Convenience Scale (questions 9-11), and the Overall Satisfaction Scale (questions 12-14). Each subscale is scored from 0 to 100, with higher scores indicating greater satisfaction.	after treatment 90 days

Collaborators and Investigators

• Sponsor: Nakhia Impex LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: HSHN005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No