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Prospective, multicenter, randomized, single-blinded, parallel group，placebo-controlled，three-group establishment of specific treatment regimen for subtypes of tendinopathy
This clinical trial uses machine learning to match molecular and clinical features，so as to establish a "rapid recognition system of tendinopathy subtypes" and compares the clinical effects of corticosteroid，platelet rich plasma or placebo on different subtypes of tendinopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma group | Experimental | patients rejected with platelet rich plasma |
|
| Corticosteroid group | Active Comparator | patients rejected with corticosteroid |
|
| Normal saline group | Placebo Comparator | patients rejected with normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platelet rich plasma | Drug | Platelet rich plasma group: after the surgery of rotator arthroscopic rotator cuff repair, 3ml PRP (LongTai Biological Company) was injected into the rotator cuff tear under the rotator arthroscope for a time. PRP production process: before anesthesia, 20ml arterial blood was drawn and injected into the PRP tube. The blood was fully oscillated in the tube, and then placed in a centrifuge with 1500g for 9min to remove excess plasma and make 5ml PRP. 3ml is used for injection and 2ml is used for quality control. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Shoulder Score (OSS) | The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly normal shoulder function and a score of 60 represents the most severe difficulty in shoulder function. | 6months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Shoulder Score (OSS) | The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly | 3 months, 1year, and 2years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310058 | China |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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|
| Corticosteroid | Drug | Corticosteroid group: after the surgery of rotator cuff repair under arthroscopy, 1mL prednisone (MSD) + 2mL sodium hyaluronate (biochemical Industry Co., Ltd.) was injected under arthroscopy. |
|
| Normal saline | Drug | Normal saline |
|
| Constant-Mulery score(CMS) |
The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks. The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total. |
| 3 months, 6months, 1year, and 2years after surgery |
| Fear-avoidance belief questionnaire(FABQ) | The FABQ is a self-assessment scale with 16 options. Each option has 0~6 points and 7 grades (from extremely disagreeable to extremely agreed). "0" means completely disagreed, "6" means completely agreed, and "1~5" means not sure. The higher the score, the more inclined to fully agree. | 3 months, 6months, 1year, and 2years after surgery |
| Insomnia Severity Index(ISI) | The scale is a simple tool for screening insomnia, including 7 items, which are used to evaluate the nature and symptoms of sleep disorders of subjects. | 3 months, 6months, 1year, and 2years after surgery |
| Hospital Anxiety and Depression Scale(HADS) | HADS is a self-assessment scale, including two subscales, HADS-A and HADS-D, with a total of 14 items, including 7 items for anxiety (A) and 7 items for depression (D). Each item is scored at four levels according to the frequency of symptoms in the past month. Each item is scored at 0-3 points in four levels. The higher the score, the more serious the anxiety or depression. | 3 months, 6months, 1year, and 2years after surgery |
| SF-36 | SF-36 is a concise health questionnaire developed by the Boston Institute of Health, which is widely used in the measurement of the quality of life of the general population, the evaluation of clinical trials and the evaluation of health policies. SF-36 is used to assess physiological function, physiological function, physical pain, general health, energy, social function, emotional function and mental health, which are classified into "physical health" and "mental health" | 3 months, 6months, 1year, and 2years after surgery |
| Visual analogue scale(VAS) | Draw a 10cm horizontal line on the paper. One end of the line is "0", indicating no pain; the other end is "10", indicating severe pain; The middle represents different degrees of pain; Let the patient draw a mark on the horizontal line according to their feelings to indicate the degree of pain. | 3 months, 6months, 1year, and 2years after surgery |
| range of motion | Measure the patient's flexion, abduction, internal rotation and external rotation angle | 3 months, 6months, 1year, and 2years after surgery |
| muscle strength | Use dynamometer to evaluate patient's forward bending, abduction, external rotation and internal rotation strength. | 3 months, 6months, 1year, and 2years after surgery |
| retear rate | Proportion of the total number of people with retearing after arthroscopic rotator cuff repair | 3 months, 6months, 1year, and 2years after surgery |
| Acromiohumeral distance | Measurement of acromiohumeral distance based on x-ray | 3 months, 6months, 1year, and 2years after surgery |
| Signal to noise ratio of tendon in MRI | Measurement of Signal to Noise Ratio of Tendon in MRI based on software | 3 months, 6months, 1year, and 2years after surgery |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |