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Completed

NCT Number: NCT06444035

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

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Key information

Conditions

Chronic Wound Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndrome Myofascial Pain Syndromes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nahia Impex Llc

Ulaanbaatar, Mongolia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: B-HA injection

Primary outcomes

  1. Chronic myofascial pain score

    Time frame: 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 outcomes

  1. Overall pain assessment during injection therapy and follow-up

    Time frame: 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.

  2. Satisfaction survey of injection treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nakhia Impex LLC

Industry

Registry information

Official study title

35kDa Hyaluronan Fragment Injection Treatment Myofascial Pain Syndrome

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2024
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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