Initial evaluation of efficacy of autologous platelet-rich plasma ultrasound - guided injection in supraspinatus tendonitis treatment

Nội dung text: Initial evaluation of efficacy of autologous platelet-rich plasma ultrasound - guided injection in supraspinatus tendonitis treatment

1. Journal of military pharmaco-medicine n 08-2017 INITIAL EVALUATION OF EFFICACY OF AUTOLOGOUS PLATELET-RICH PLASMA ULTRASOUND-GUIDED INJECTION IN SUPRASPINATUS TENDONITIS TREATMENT Nguyen Duc Phong*; Pham Hoai Thu*; Nguyen Van Hung* SUMMARY Objectives: To evaluate the efficacy and safety of ultrasound-guided injection of platelet-rich plasma (PRP) in the treatment of supraspinatus tendonitis after 12 weeks of follow-up. Subjects and methods: A prospetive controlled clinical trial was followed up to 12 weeks in 44 patients with supraspinatus tendonitis, who were divided into two groups: 22 patients (22 supraspinatus tendons) received a single ultrasound-guided injection of PRP into supraspinatus tendon sheath, 22 patients (22 supraspinatus tendons) were given a single ultrasound-guided injection of 0.5 ml methylprednisolone acetate 40 mg/mL (Depo-Medrol) into supraspinatus tendon sheath. Results: After 12 weeks of treatment, there were improvement in VAS, abduction angle of shoulder joint and SPADI scores in the studied group: The average VAS and SPADI scores were decreased from 6.5 to 2.5 points and from 57.6 to 27.4 points, respectively. The average abduction angle of shoulder joint was increased from 88.4 0 to 155.1 0, significantly higher than that in the control group (p < 0.05). Side effects observed the investigated group were: 18.2% of the patients increased pain at the injection site more than 24 hours (compared to 13.6% in the control group) (p > 0.05) and there was no serious complication in both groups. Conclusions: A single ultrasound-guided injection of PRP is more effective than a single ultrasound-guided injection of Depo-Medrol in treatment of supraspinatus tendonitis. The procedure is a safe theraputic intervention. * Keywords: Supraspinatus tendonitis; Autologous platelet-rich plasma; Ultrasound-guided injection. INTRODUCTION The most common disorder is shoulder pain, Peri-shoulder joint soft tissue inflammation in which supraspinatus and long head of is a group of the periarticular soft tissue biceps tendons are usually affected [1]. disorders of shoulder, including ligaments, Supraspinatus tendon lies in a narrow tendons, bursas... it often causes pain and space under the scapula. In the arm o reduces range of motion of the shoulder abducted and 90 elevated postion, the and affects patients’ quality of life. Peri- tendon is squezzed and rubbed between the shoulder joint soft tissue inflammation is femoral head and the coraco-acromial classified into four clinical types: shoulder ligaments, which reduces the blood flow pain, acute shoulder pain, shoulder to the tendon, causes the tendon vulnerable pseudo-paralysis and frozen shoulder [2]. to injury, resulting in inflammation, calcification, * Hanoi Medical University Corresponding author: Nguyen Van Hung (hungnnguyenvn@gmail.com) Date received: 20/08/2017 Date accepted: 28/09/2017 172
2. Journal of military pharmaco-medicine n 08-2017 partial thickness tear or full thickness tear with PRP injection under ultrasound of the tendon [3]. Although pain killer, guidance and control group of 22 patients nonsteroidal anti-inflammatory drugs may (22 supraspinatus tendinitis) treated with be effective in treatment of supraspinatus Depo-Medrol injection under ultrasound tendonitis, they can cause many complications guidance. Patients were treated at with long-term use, such as peptic ulcers, Rheumatology Department in Bachmai gastrointestinal bleeding, hypertension, Hospital from 10 - 2016 to 7 - 2017. renal and liver damage, ect. Injection of Patients agreed to participate in the study. corticosteroids has the rapid effect in The exclusion criteria were patients improving symptoms but repeated and with another types of peri-shoulder joint prolonged usage can result in tendon rupture [7]. Autologous platelet-rich plasma soft tissue inflammation, such as acute (PRP) contains growth factors and anti- shoulder pain, shoulder pseudo-paralysis inflammatory cytokines, is a new therapeutic and frozen shoulder, neurological pain, procedure for treatment of tendinitis with local and systemic infections, haematological good efficacy and less side effects. There disease or anticoagultaion drug use, have been some studies on the treatment hemoglobin below 110 g/L, platelet below of tendinitis with PRP therapy in the wold, 150,000/mm 3, pregnancy, topical steroid however, there is no systematic study of injections within 6 weeks before the study, the application of PRP in treatment of patients do not agree to participate in the supraspinatus tendonitis in Vietnam. study. Patients who are taking nonsteroidal In addition, ultrasound-guided procedure is recommeded for the acuracy of the anti-inflammatory drugs (NSAIDs) must injection into the injured tissue. Therefore, quit the drug within 1 week prior to the we conducted this study with objectives: enrolment in the study. To evaluate the efficacy and safety of 2. Methods. ultrasound-guided injection of PRP in the Controlled clinical trial with intevention, treatment of supraspinatus tendonitis after longitudinal follow-up study. Patients in 12 weeks of follow-up. the research group were injected with SUBJECTS AND METHODS 2.5 mL of PRP produced using Adistem 1. Subjects. technology under ultrasound guidance, Our study included 44 patients who into the supraspinatus tendon sheath, in a were diagnosed with supraspinatus tendinitis single dose. The control group was injected based on clinical features and ultrasound with 0.5 mL methylprednisolone acetate examination (acrominal pain, restricted 40 mg/mL (Depo-Medrol), a corticosteroid movement, positive Jobe test) [7]. indicated for local treatment of tendosynovitis, Subjects were divided into 2 groups: in the supraspinatus tendon sheath under studied group included 22 patients ultrasound guidance. The procedure was (22 supraspinatus tendinitis) were treated performed by a rheumatologist with assistance 173
3. Journal of military pharmaco-medicine n 08-2017 of medison accuvix v 10.0 ultrasound Patients in the studied group did not machine, linear probe 5 - 13 Mhz at the use nonsteroidal anti-inflammatory drugs Department of Rheumatology, Bachmai (NSAIDs) within 7 days after injection, the Hospital. Assessment of outcomes was control group was treated in combination based on VAS score, SPADI score and with nonsteroidal anti-inflammatory drugs: shoulder abduction angle at baseline (T0), mobic 7.5 mg x 2 tablets/day, myonal 1 week after treatment (T1), 4 weeks after 50 mg x 3 tablets/day or equivalent doses. treatment (T4), 8 weeks after treatment (T8) and 12 weeks after treatment (T12). * Data analysis: Data in the study Side effects of therapy were observed were analyzed using SPSS statistics 20 and noted at any time of the study. software. RESULTS 1. Characteristics of patients. Table 1: Patients’ characteristics. Research group Control group p (n = 22 tendons) (n = 22 tendons) Age 61.4 ± 9.4 60.1 ± 8.2 > 0.05 Male 68.2% 63.7% > 0.05 Female 31.8% 36.3% > 0.05 BMI 22.1 ± 2.8 21.6 ± 1.3 > 0.05 Side of the affected Right 68.2% 63.7 % >0.05 tendon Left 31.8% 36.3% >0.05 Duration (month) 10.6 ± 8.4 10.1 ± 5.8 > 0.05 VAS (T0) 6.5 ± 1.1 6.5 ± 0.8 > 0.05 Abduction angle (T0) 88.4 ± 7.9 87.9 ± 8.7 > 0.05 SPADI (T0) (%) 57.6 ± 7.4 58.4 ± 4.3 > 0.05 There was no difference in age, gender, duration of illness, BMI, side of the inflammed tendon, pain intensity, abduction angle, shoulder joint function between the two study groups (p > 0.05). 174
4. Journal of military pharmaco-medicine n 08-2017 2. Evaluation of the efficacy of supraspinatus tendonitis treatment by autologous PRP therapy * According to VAS score: Figure 1: Evaluate the results of treatment by VAS score (n = 22 tendons). At the time of initial treatment, 1 week and 4 weeks after treatment, there was no difference of the two groups in terms of VAS score improvement (p > 0.05). After 8 and 12 weeks of treatment, the patients treated with PRP improved VAS score better than control group, statistically significant p < 0.05. * According to abduction angle: Table 2: Improvement of abduction angle. Research group Control group p (n = 22 tendons) X ± SD (n = 22 tendons) X ± SD T0 (1) 88.4 ± 7.9 87.9 ± 8.7 > 0.05 T1 (2) 108.2 ± 14.8 109.3 ± 10.3 >0.05 T4 (3) 127.7 ± 12.7 131.6 ± 10.4 > 0.05 T8 (4) 143.2 ± 11.1 135.5 ± 11.4 < 0.05 T12 (5) 155.1 ± 13.3 145.2 ± 14.5 < 0.05 ∆ T8 - 0 54.8 ± 11.0 47.5 ± 15.9 > 0.05 ∆ T12 - 0 66.8 ± 12.1 57.3 ± 18.2 < 0.05 p1,5 p < 0.001 p < 0.001 Both therapies improved the shoulder abduction angle (p < 0.05). At 12 weeks post-treatment, patients treated with PRP improved better than those treated with Depo-Medrol (p < 0.05). 175
5. Journal of military pharmaco-medicine n 08-2017 * According to improvement of shoulder function: Figure 2: Evaluate the results of treatment by SPADI score (n = 22 tendons). Both groups had improvement in shoulder function compared with pretreatment, p < 0.05. From the fourth week after treatment, the PRP injection group had a better improvement compared to the Depo-Medrol injection group, p < 0.05. 3. Side effects of the therapy. Table 3: Side effects of the therapy. Research group Control group Position Side effects (n = 22 tendons) (n = 22 tendons) Number Percentage (%) Number Percentage (%) Pain increase after 24 hours 4 18.2 3 13.6 Local Infection 0 0 0 0 Shock 0 0 0 0 Systemic Blush, headache dizziness 0 0 1 4.6 Others Hemorrhage 0 0 0 0 In the studied group, 4 patients (18.2%) developed pain after injection and in the control group, 3 patients (22.7%) developed pain after injection. The difference was not statistically significant. In the control group, there was one patient presenting with flushing after injection, but none of the patients had any other serious side effects. 176
6. Journal of military pharmaco-medicine n 08-2017 DISCUSSION guidance, decreased from 6.2 ± 0.6 to 1. Evaluation of the efficacy of 2.3 ± 1.2 and 0.7 ± 0.9, respectively [5]. supraspinatus tendinitis treatment by However, the reduction of VAS score in autologous PRP therapy. our study was lesser than in the author's study, probably because the patients in (PRP is the plasma volume of whole our study group had a longer duration of blood that has a platelet concentration disease (10.6 ± 8.4 vs. 6.4 ± 7.6 years). higher than the basal level in the original At 8 weeks and 12 weeks post-treatment, vein blood. PRP contains many growth PRP-treated group was associated with factors and some cytokines that have anti- better pain relief than Depo-Medrol- inflammatory and wound healing effects. treated group (p < 0.05) ( figure 1 ), similar Growth factors such as PDGF, VEGF, EGF, to the results of Sengodan et al (2017) in PDEGF, PDAF, ECGF are involved in wound patients with rotator cuffs syndrome, VAS healing process through angiogenesis, score at 8 weeks and 12 weeks after PRP cell division, cell differentiation and injection decreased from 5.4 ± 0.9 to 3.2 ± healing [8]. The cytokines produced 0.9, and 2.6 ± 0.8 [10]. during platelet activation, such as the interleukin I receptor antagonist (IL-IRA), In this study, both treatment groups are powerful anti-inflammatory agents showed improvement in shoulder range of which reduce the intensity and duration of motion. In the research group, the mean pain, release beta-endorphins which provide shoulder abduction angle after 12 weeks o analgesic, anti-inflammatory effects. IL-4, of treatment increased from 88.4 ± 7.9 to o IL-10, in addition to anti-inflammatory, 155.2 ± 13.3 , higher than that in the also play a role in tissue regeneration of control group. Shoulder abduction angle o tendons, ligaments [9]. Since Depo-Medrol also increased from 87.9 ± 8.7 to 145.2 ± o is a corticosteroid, it has anti-inflammatory 14.5 , statistically significant (p < 0.05) and analgesic effects, however, no studies (table 2 ). This finding was similar to the have documented the role of corticosteroids results of Serdar et al (2013) in patients in wound healing process. Therefore, PRP with rotator cuffs disease. After 4 weeks, works better than Depo-Medrol due to its 8 weeks and 12 weeks of autologous PRP effects on lesion regenerative healing. treatment, shoulder abduction angle was increased from 90 o up to 110 o, 140 o and 160 o The results in our study showed significant (p < 0.05), respectively. improvement in VAS scores in both groups after 1 week and 4 weeks of Although there are many scores to treatment (p < 0.05). However, there was evaluate shoulder joint function, the SPADI no difference between the two groups score was used in this study since it was (p > 0.05). This result was similar to that previously used in most of the studies. of Nguyen Thi Xuan Huong (2015), VAS The results showed that both treatments score at 1 week and 6 weeks in Depo- improved shoulder function and this Merol injection patients under the ultrasound improvement was statistically significant 177
7. Journal of military pharmaco-medicine n 08-2017 starting from week 4 th (p < 0.05) ( figure 2 ). injection group, there was one patient who At this time, the studied group had a better was flushed after the injection. However, SPADI score than the control group. After the patient had a history of hypertension, 12 weeks of treatment, SPADI score of so the symptom disappears quickly after the studied group and control group 30 minutes of rest when blood pressure decreased from 57.6 to 27.4 and from returned to normal. In addition, both methods 58.4 to 41.8 points (p < 0.05), respectively. had no other serious complications. The This result was similar to the results of study by Nguyen Tran Trung [6] on the Serdar et al (2013). SPADI scores in treatment of lateral epicondylitis with autologous PRP group after 12 weeks of autologous PRP, there were 54.8% of treatment decreased from 77.5 to 27.6 patients suffering pain at the injection site, (p < 0.05). Similarly, the study by Dong- in which 38.7% lasted for 3 days and wook et al (2013) found that SPADI score 16.1% of patients had pain in 1 week. after 12 weeks of treatment for supraspinatus Research by Segodan et al (2017) also tendonitis by PRP decreased from 62.3 to showed that the most common side effect 21.1 points, more effective than acupuncture after PRP injection was pain, but usually (p < 0.05) [12]. mild and self-limited [10]. The rusults from our study suggested that patients with tendinitis treated with CONCLUSION PRP injection under the guidance of Autologous injection of PRP under the ultrasound had better results, longer giudance of ultrasound for the treatment lasting effects compared to Depo-Medrol of supraspinatus tendonitis has improved injection (p < 0.05). pain and shoulder joint function better 2. Side effects of the therapy. than Depo-Medrol injection. The procedure Previous studies had shown that PRP is a promissing and safe therapeutic therapy is a safe, less side effect treatment. intervention. In the investigated group, 22 patients (22 supraspinatus tendons) received PRP, REFERENCES there were 4 patients had shoulder pain 1. Tr ần Ng ọc Ân . Viêm quanh kh ớp vai. increased after the injection (18.2%). Bệnh th ấp kh ớp. Nhà xu ất b ản Y h ọc. 2002, However, it was only mild pain. There tr.364-374. were 2 cases with self-limited pain and 2. Đào Hùng H ạnh . S ử d ụng siêu âm đeer 2 cases needed treatment with low dose phát hi ện các t ổn th ươ ng trong viêm quanh kh ớp vai. Lu ận v ăn Th ạc s ỹ Y học. Tr ường acetaminophen. Similarly, in the Depo- Đại h ọc Y Hà N ội. 1995, tr.26-57. Medrol injection group, there were 3 patients 3. Tăng Hà Nam Anh, Nguy ễn Huy Toàn, with shoulder-joint pain (13.6%), among Cao Bá H ưởng và CS. K ết qu ả điều tr ị rách which 2 patients were treated with low chóp xoay qua n ội soi. T ạp chí Y D ược TP. dose acetaminophen. In the Depo-Medrol Hồ Chí Minh. 2013, tháng 2, tr.62-66. 178
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