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

Myofascial Pain Syndrome Clinical Trial

Official title:

35kDa Hyaluronan Fragment Injection Treatment Myofascial Pain Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06444035
• Other study ID #: HSHN005
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Nakhia Impex LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Wound
• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Mongolia	Nahia Impex Llc	Ulaanbaatar

Sponsors (1)

Lead Sponsor	Collaborator
Nakhia Impex LLC

Country where clinical trial is conducted

Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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