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CompletedNCT06444035Updated Sep 22, 2026

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

An interventional study of HA35 injection in Chronic Wound and Myofascial Pain Syndrome, sponsored by Nakhia Impex LLC. Completed at 1 site in Mongolia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Nakhia Impex LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Wound
  • Myofascial Pain Syndrome
03

In context

Myofascial Pain Syndromes

339 studies on the registry are indexed under Myofascial Pain Syndromes; 66 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 307 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

Nakhia Impex LLC is the lead sponsor of 15 studies on the registry; none are open to participants now.

Browse Nakhia Impex LLC studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

Interventions

  • DrugHA35 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.

    Also known as: B-HA injection

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: after treatment 1 day, 3 days, 5 days, 15 days, 30 days, 60 days, 90 days

Secondary outcomes

  1. 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.

    Time frame: after treatment 15 days, 30 days, 60 days, 90 days

  2. 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.

    Time frame: after treatment 90 days

07

Study locations

1 site
  • Nahia Impex Llc
    Ulaanbaatar, Mongolia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2024 to primary completion in Oct 2024, 5 months.

Of 204 interventional studies with no phase under Myofascial Pain Syndromes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 13. This study's 5 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2024
First posted
Jun 5, 2024
StartActual
May 30, 2024
Primary completionActual
Oct 30, 2024
CompletionActual
Dec 2, 2024
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06444035
Lead sponsor
Nakhia Impex LLC
Responsible party
Sponsor
First posted
Jun 5, 2024
Start date
May 30, 2024
Primary completion
Oct 30, 2024
Completion
Dec 2, 2024
Last update
Sep 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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