Shoulder PainNCT05756595
A Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Pain
A study testing HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) in people with Shoulder Pain and Neck Pain, run by Dove Medical Press Ltd at 1 site in China.
Trial summary
Local used high molecular weight Hyaluronan (HA) with high viscosity has a variety of receptors in the human body, including CD44, LYVE-1, RHAMM, HARE, Siglec-9, TLR2, CEMIP and TMEM2. Intra-articular local injection of HA has a certain degree of analgesic effect. Read more about this study
- Who is it for?
- Ages 39 to 63 years
- Conditions the study is for
- Shoulder Pain, Neck Pain, Back Pain
- What is being tested?
- HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2020to 8 Feb 2023
- 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 39 to 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Shoulder, neck, back and temporal pain. The course of the disease ranged from 0 to 8 months.
- Herpes zoster pain. The course of 0-2 months.
Who cannot join
- Individuals with severe spinal pathology (including fractures, inflammatory diseases and tumors)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Preliminary Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Herpes Zoster Pain and Shoulder, Neck, Back and Temporal Pain
Local used high molecular weight Hyaluronan (HA) with high viscosity has a variety of receptors in the human body, including CD44, LYVE-1, RHAMM, HARE, Siglec-9, TLR2, CEMIP and TMEM2. Intra-articular local injection of HA has a certain degree of analgesic effect. Local injection of HA into the nerve trunk directed by ultrasound was used for the treatment of neuropathic pain. It was reported that the analgesic effect of HA is regulated by TRPV1 ion channels. This study hypothesizes that hyaluronidase cleaves HA to generate low molecular weight HA fragments HA35 with good tissue permeability, which may bind to a variety of HA receptors on the cell surface within the tissues and produce a broad-spectrum analgesic effect. In this study, 35kDa Hyaluronan fragment HA35 was prepared by mixing hyaluronidase PH20 injection and high molecular weight Hyaluronan (HA) injection at room temperature for 20 minutes. In this study, hyaluronidase injection and Hyaluronan injection were off-label used to conduct an investigator-initiated study (IIT or IIS) for the treatment of herpes zoster and shoulder, neck, back and temporal pain.
Read the detailed description
Bioactive Hyaluronan fragment HA35 of 35kDa was isolated from human colostrum. Literature studies have shown that female breast hyaluronidase and male testicular sperm acrosomal hyaluronidase PH20 come from the same gene. The investigators, recombinant human hyaluronidase PH20 and neutral hyaluronidase (PH20 or SPAM1) of bovine testicular sperm acrosome were used to cleave macromolecular Hyaluronan. Regardless of the cutting time, the Hyaluronan fragment HA35 with an average molecular weight 35kDa was produced(Registration number L20200708MP07707, Ministry of Health, Mongolia). Hyaluronidase injection is often used to improve the penetration and absorption of other injectable drugs. Hyaluronidase injection is also used to degrade excessive use of cosmetic injection or improper use of cross-linked macromolecular Hyaluronan fillers, which is an off-label drug use of hyaluronidase（https://www.realself.com/news/ hyaluronidase-dissolve-fillers）. In this study, Hyaluronan fragment HA35 of 35kDa was prepared by mixing hyaluronidase injection extracted from bovine testis (hyaluronidase for injection, H31022111) and Hyaluronan injection (sodium hyaluronate injection, H20174089) at room temperature for 20 minutes. Its analgesic effect on herpes zoster, shoulder, neck, back, and temporal pain was studied.
In this study, off-label drug use of hyaluronidase injection and Hyaluronan injection （https://www.realself.com/news/ hyaluronidase-dissolve-fillers）were used in the clinical study of shoulder, neck, back and temporal pain and herpes zoster pain, namely investigator initiated trails. In this clinical trial, 26 patients with shoulder, neck, back and temporal pain were studied in the Department of pain diagnosis and treatment of the affiliated Hospital of Qingdao University. Ten patients with herpes zoster were treated in the pain Department of the affiliated Hospital of Qingdao University. According to the ratio of 100mg high molecular Hyaluronan / 2000 unit hyaluronidase, the high molecular Hyaluronan injection (sodium hyaluronate injection, H20174089) and the hyaluronidase injection extracted from bovine testis (hyaluronidase for injection) were mixed at room temperature for 20 minutes. Each time according to the amount of high molecular Hyaluronan containing 100 mg Hyaluronan and hyaluronidase mixture, pain point area and pain point area of the nerve trunk innervation of the local multi-point injection. Then, pain scale was used to evaluate and record the pain relief of patients before and after treatment.
- Conditions
- Shoulder Pain, Neck Pain, Back Pain, Temporal Pain, Herpes Zoster Pain
- Being tested
- HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
- Keywords
- hyaluronidase, Hyaluronan, 35kDa Hyaluronan fragment, pain caused by herpes zoster, pain caused by shoulder neck back and temporal
- Medical subject headings
- Shoulder Pain, Neck Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)Drug
Also called HA35
This group will inject once a week. Evaluation of pain score after 30 seconds and 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| 35kDa hyaluronan fragment HA35 injection | Experimental | 100 mg Hyaluronan is locally injected at the pain point or where the nerve trunk is innervated by the pain point. Receives: Drug: HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores of all shoulder, neck, back, temporal and herpes zoster pain
The pain scale is a tool that doctors use to help assess patients' pain. Each patient rated their pain on a scale of 0 to 10. 0 means "no pain" and 10 means "the most painful". Statistical t-test was used to calculate and evaluate the pain intensity, which was expressed as mean ±standard deviation.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start6 Jul 2020
- Primary completion29 Dec 2022
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies 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
- Model description
- A self-controlled an open label clinical study(An investigator-initiated off-label use clinical study)
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dove Medical Press Ltd
- Sponsor type
- Research network
- Collaborators
- The Affiliated Hospital of Qingdao University, Nakhia Impex LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756595
- Sponsor's protocol ID
- hui19590204
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Jia X, Shi M, Wang Q, Hui J, Shofaro JH, Erkhembayar R, Hui M, Gao C, Gantumur MA. Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/HA35). J Inflamm Res. 2023 Jan 13;16:209-224. doi: 10.2147/JIR.S393495. eCollection 2023.
PubMed 36686276APPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Herpes Zoster Pain and Shoulder, Neck, Back and Temporal Pain
- ClinicalTrials.gov ID
- NCT05756595
- Acronym / sponsor ID
- hui19590204
- Conditions
- Shoulder Pain, Neck Pain, Back Pain, Temporal Pain, Herpes Zoster Pain
- Keywords
- hyaluronidase, Hyaluronan, 35kDa Hyaluronan fragment, pain caused by herpes zoster, pain caused by shoulder neck back and temporal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dove Medical Press LtdResearch network
- Collaborators
- The Affiliated Hospital of Qingdao University, Nakhia Impex LLC
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 6 Mar 2023 (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.
Local used high molecular weight Hyaluronan (HA) with high viscosity has a variety of receptors in the human body, including CD44, LYVE-1, RHAMM, HARE, Siglec-9, TLR2, CEMIP and TMEM2. Intra-articular local injection of HA has a certain degree of analgesic effect. Local injection of HA into the nerve trunk directed by ultrasound was used for the treatment of neuropathic pain. It was reported that the analgesic effect of HA is regulated by TRPV1 ion channels. This study hypothesizes that hyaluronidase cleaves HA to generate low molecular weight HA fragments HA35 with good tissue permeability, which may bind to a variety of HA receptors on the cell surface within the tissues and produce a broad-spectrum analgesic effect. In this study, 35kDa Hyaluronan fragment HA35 was prepared by mixing hyaluronidase PH20 injection and high molecular weight Hyaluronan (HA) injection at room temperature for 20 minutes. In this study, hyaluronidase injection and Hyaluronan injection were off-label used to conduct an investigator-initiated study (IIT or IIS) for the treatment of herpes zoster and shoulder, neck, back and temporal pain.
Detailed description
Bioactive Hyaluronan fragment HA35 of 35kDa was isolated from human colostrum. Literature studies have shown that female breast hyaluronidase and male testicular sperm acrosomal hyaluronidase PH20 come from the same gene. The investigators, recombinant human hyaluronidase PH20 and neutral hyaluronidase (PH20 or SPAM1) of bovine testicular sperm acrosome were used to cleave macromolecular Hyaluronan. Regardless of the cutting time, the Hyaluronan fragment HA35 with an average molecular weight 35kDa was produced(Registration number L20200708MP07707, Ministry of Health, Mongolia). Hyaluronidase injection is often used to improve the penetration and absorption of other injectable drugs. Hyaluronidase injection is also used to degrade excessive use of cosmetic injection or improper use of cross-linked macromolecular Hyaluronan fillers, which is an off-label drug use of hyaluronidase（https://www.realself.com/news/ hyaluronidase-dissolve-fillers）. In this study, Hyaluronan fragment HA35 of 35kDa was prepared by mixing hyaluronidase injection extracted from bovine testis (hyaluronidase for injection, H31022111) and Hyaluronan injection (sodium hyaluronate injection, H20174089) at room temperature for 20 minutes. Its analgesic effect on herpes zoster, shoulder, neck, back, and temporal pain was studied.
In this study, off-label drug use of hyaluronidase injection and Hyaluronan injection （https://www.realself.com/news/ hyaluronidase-dissolve-fillers）were used in the clinical study of shoulder, neck, back and temporal pain and herpes zoster pain, namely investigator initiated trails. In this clinical trial, 26 patients with shoulder, neck, back and temporal pain were studied in the Department of pain diagnosis and treatment of the affiliated Hospital of Qingdao University. Ten patients with herpes zoster were treated in the pain Department of the affiliated Hospital of Qingdao University. According to the ratio of 100mg high molecular Hyaluronan / 2000 unit hyaluronidase, the high molecular Hyaluronan injection (sodium hyaluronate injection, H20174089) and the hyaluronidase injection extracted from bovine testis (hyaluronidase for injection) were mixed at room temperature for 20 minutes. Each time according to the amount of high molecular Hyaluronan containing 100 mg Hyaluronan and hyaluronidase mixture, pain point area and pain point area of the nerve trunk innervation of the local multi-point injection. Then, pain scale was used to evaluate and record the pain relief of patients before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A self-controlled an open label clinical study(An investigator-initiated off-label use clinical study)
| Arm | Type | Receives |
|---|---|---|
| 35kDa hyaluronan fragment HA35 injection | Experimental | Drug: HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)100 mg Hyaluronan is locally injected at the pain point or where the nerve trunk is innervated by the pain point. |
Who may qualify
- Ages
- 39 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Shoulder, neck, back and temporal pain. The course of the disease ranged from 0 to 8 months.
- Herpes zoster pain. The course of 0-2 months.
Key exclusion criteria (1 listed)
- Individuals with severe spinal pathology (including fractures, inflammatory diseases and tumors)
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(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)Also: HA35This group will inject once a week. Evaluation of pain score after 30 seconds and 3 hours. | Drug | 35kDa hyaluronan fragment HA35 injection |
Primary outcome
Pain scores of all shoulder, neck, back, temporal and herpes zoster pain
Time frame: 3 hours
The pain scale is a tool that doctors use to help assess patients' pain. Each patient rated their pain on a scale of 0 to 10. 0 means "no pain" and 10 means "the most painful". Statistical t-test was used to calculate and evaluate the pain intensity, which was expressed as mean ±standard deviation.
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 6 Mar 2023.
- Results publication: PubMed 36686276Jia X, Shi M, Wang Q, Hui J, Shofaro JH, Erkhembayar R, Hui M, Gao C, Gantumur MA. Anti-Inflammatory Effects of the 35kDa Hyaluronic Acid Fragment (B-HA/HA35). J Inflamm Res. 2023 Jan 13;16:209-224. doi: 10.2147/JIR.S393495. eCollection 2023.
- Results publicationAPPLICATION OF LOW-MOLECULAR-WEIGHT HYALURONIC ACID(LMW-HA) FRAGMENTS(INJECTION) WO/2017/186088 US20200254005 EP3479830 AU2017255833 CA3049286
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089) in people with Shoulder Pain and Neck Pain, run by Dove Medical Press Ltd at 1 site in China.
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 2 inclusion and 1 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 6 Mar 2023. 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 China. 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?
Pain scores of all shoulder, neck, back, temporal and herpes zoster pain (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756595, which also lists 2 linked publications.
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 6 Mar 2023.