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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after treatment 1 day, 3 days, 5 days, 15 days, 30 days, 60 days, 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after treatment 15 days, 30 days, 60 days, 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nahia Impex Llc | Ulaanbaatar | Mongolia |
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| ID | Term |
|---|---|
| D009209 | Myofascial Pain Syndromes |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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. | after treatment 90 days |