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

Not Applicable

• Conditions: Myofascial Pain Syndrome; Chronic Wound
• Interventions: Drug: HA35 injection

• Registration Number: NCT06444035
• Lead Sponsor: Nakhia Impex LLC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-30
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-06-04
• Study First Posted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2024-10-30
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of myofascial pain syndrome by local injection of pain points	HA35 injection	Subjects received subcutaneous injection of HA35 injection 100mg / 5mL / day near the back pain point for 15 days.

Primary Outcome Measures

Name	Time	Method
Chronic myofascial pain score	after treatment 1 day, 3 days, 5 days, 15 days, 30 days, 60 days, 90 days	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.

Secondary Outcome Measures

Name	Time	Method
Overall pain assessment during injection therapy and follow-up	after treatment 15 days, 30 days, 60 days, 90 days	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.
Satisfaction survey of injection treatment	after treatment 90 days	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.

Trial Locations

Locations (1)

Nahia Impex Llc; 🇲🇳 Ulaanbaatar, Mongolia