Chronic WoundNCT06444035
Extended Therapeutic Effect of 35kDa Hyaluronan Fragment Injection in Patients With Chronic Pain Caused by Myofascial Pain Syndrome
A study testing HA35 injection in people with Chronic Wound and Myofascial Pain Syndrome, run by Nakhia Impex LLC at 1 site in Mongolia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Wound, Myofascial Pain Syndrome
- What is being tested?
- HA35 injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMongolia
- Study dates
- 30 May 2024to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 35kDa Hyaluronan Fragment Injection Treatment 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.
- Conditions
- Chronic Wound, Myofascial Pain Syndrome
- Being tested
- HA35 injection
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA35 injectionDrug
Also called B-HA 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of myofascial pain syndrome by local injection of pain points | Experimental | Subjects received subcutaneous injection of HA35 injection 100mg / 5mL / day near the back pain point for 15 days. Receives: Drug: HA35 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after treatment 1 day, 3 days, 5 days, 15 days, 30 days, 60 days, 90 days
Secondary outcomes (2)
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.
Measured: after treatment 15 days, 30 days, 60 days, 90 days
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.
Measured: after treatment 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start30 May 2024
- Primary completion30 Oct 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakhia Impex LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444035
- Sponsor's protocol ID
- HSHN005
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 35kDa Hyaluronan Fragment Injection Treatment Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06444035
- Acronym / sponsor ID
- HSHN005
- Conditions
- Chronic Wound, Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nakhia Impex LLCIndustry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of myofascial pain syndrome by local injection of pain points | Experimental | Drug: HA35 injectionSubjects received subcutaneous injection of HA35 injection 100mg / 5mL / day near the back pain point for 15 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA35 injectionAlso: B-HA injectionHA35/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. | Drug | Treatment of myofascial pain syndrome by local injection of pain points |
Primary outcome
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.
2 secondary outcomes
Overall pain assessment during injection therapy and follow-up
Time frame: after treatment 15 days, 30 days, 60 days, 90 days
Satisfaction survey of injection treatment
Time frame: after treatment 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Related trials for Chronic Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA35 injection in people with Chronic Wound and Myofascial Pain Syndrome, run by Nakhia Impex LLC at 1 site in Mongolia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mongolia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic myofascial pain score (time frame: after treatment 1 day, 3 days, 5 days, 15 days, 30 days, 60 days, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.