Hyaluronidase for Trigger Point Injection in Myofascial Pain Syndrome
キーワード
概要
説明
Study approval was obtained from Institutional Review Board (IRB) of Samsung medical center, and written informed consent was obtained from all participants.
The required sample size was determined by power analysis on the basis of a previous study. The primary outcome was pain intensity in the posterior neck and upper back after TPI using verbal numerical rating scale (VNRS). The standard deviation of VNRS was assumed to be 20. Power calculations indicated that detecting 20 points difference in VNRS between the two groups (with α = 0.05 and β = 0.1) would require a sample of 29 subjects for each group. To account for dropouts, 33 subjects were recruited for each group.
Group L received TPI with a 3.2 ml of a 1:1 mixture of 1% lidocaine and 0.9% normal saline. Group H received TPI with the same volume of solution supplemented with hyaluronidase (H-LASE®, 1500 iu, L&H Pharm., Seoul, Korea) 600 iu/ml. The investigators monitored vital sign and any signs of complications such as bleeding, hematoma, allergic reactions for 30 minutes. Treatment efficacy was evaluated by one of the authors (J.W.C.) using VNRS. To reduce bias, this evaluator and the participants were not informed of the assigned group.
Patients' characteristics such as age, height, weight, BMI and pretreatment neck disability index (NDI) and brief pain inventory (BPI) were analyzed by independent t-test. The sex distribution was analyzed by the chi-square test. P values were corrected by Bonferroni's method. Pretreatment VNRS and the duration of pain were evaluated by the Wilcoxon two-sample test. Repeated measures ANOVA was used to compare changes in the VNRS over time between the two groups. Pre- and post-TPI changes in NDI and BPI were compared between the two groups with the Wilcoxon signed rank test and the independent t-test, respectively. All analyses were performed with SPSS 18.0 (SPSS Inc., Chicago, IL, USA) statistical software. Significance was assumed for P values of less than 0.05.
日付
| 最終確認済み: | 10/31/2014 |
| 最初に提出された: | 11/10/2014 |
| 提出された推定登録数: | 11/12/2014 |
| 最初の投稿: | 11/17/2014 |
| 最終更新が送信されました: | 11/12/2014 |
| 最終更新日: | 11/17/2014 |
| 実際の研究開始日: | 03/31/2010 |
| 一次完了予定日: | 03/31/2011 |
| 研究完了予定日: | 04/30/2011 |
状態または病気
介入/治療
Drug: trigger point injection
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Lidocaine Group L received trigger point injection with a 3.2 ml of a 1:1 mixture of 1% lidocaine and 0.9% normal saline | |
| Experimental: Hyaluronidase Group H received trigger point injection with the same volume of solution supplemented with hyaluronidase (H-LASE®, 1500 iu, L&H Pharm., Seoul, Korea) 600 iu/ml |
適格基準
| 研究の対象となる年齢 | 25 Years に 25 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Adults - Aged 25-75 years - Diagnosed with myofascial pain syndrome affecting both trapezius muscles Exclusion Criteria: - History of allergy to lidocaine or hyaluronidase - Anticoagulant medication or antiplatelet agent within 5 days before the study - Analgesic medication, including non-steroidal anti-inflammatory drugs, tramadol, acetaminophen, or opioids within 5 days of the study - Pain related to trauma within 6 months before the study - History of cervical or shoulder surgery - TPI within 3 months in the same region - Fibromyalgia - Cervical radiculopathy or myelopathy - Obesity, defined as body mass index of 27.5 or higher - Other medical or psychological conditions (cancer, rheumatoid arthritis, endocrine disease, major depression, schizophrenia) |
結果
主な結果の測定
1. Degree of pain as measured by the verbal numerical rating scale [within 2 weeks after intervention]
