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

Nakhia Impex

Status

Invitation-only

Conditions

Chronic Wound

Myofascial Pain Syndrome

Treatments

Drug: HA35 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06444035

HSHN005

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.