為了評估針刺療效以及減少安慰劑效應,試驗設計以隨機、單盲之 對照試驗,除了評估頸部活動度改善以及疼痛強度減少情況,也評估病 患生活品質,因為對於慢性疼痛病患而言,生活品質與生理健康狀態的 重要性並不亞於身體上的病痛。
在病患基本特性以及自認治療方式正確性兩組皆無差異的情況下,
針刺與假針刺對於頸部活動度及疼痛程度均有所改善,但未達到統計顯 著差異,然而針刺在完成治療後 12 週評估時,於身體心理功能以及情緒 角色受限的改善上,顯現明顯優於假針刺。而且試驗過程中,一位病患 左側風池穴瘀青、另一位有輕微暈眩,兩位病患症狀輕微且快速緩解,
顯示針刺是相當安全的一種治療方式。
對於慢性頸部 MPS,針刺治療對於頸部活動及疼痛有改善效果,針 刺治療更是有助於生活品質的改善。此外,針刺對於疼痛而言是一個安 全的治療工具。然而大規模的研究、設立第三組別藥物組以及加入客觀 具有疾病特異性的生化評估項目是未來進一步研究設計的方向。
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附錄一、署立南投醫院人體試驗委員會核准函
附錄二、署立南投醫院受試者同意書
續下頁
附錄二(續)
續下頁
附錄二(續)
續下頁
附錄二(續)
附錄三、SF-36 生活品質量表
續下頁
附錄三(續)
續下頁
附錄三(續)
續下頁
附錄三(續)
附錄四、ROM 記錄表
附錄五、SF-MPQ 問卷
The therapeutic effects of acupuncture on patients with chronic neck myofascial pain syndrome:
A single-blind randomized controlled trial
English Abstract
Purpose: Chronic neck myofascial pain syndrome (MPS) is a common
disorder in clinics which impacts patients on physiological and psychologic aspects. No gold standard method is suggested and acupuncture is often used to treat patients with pain. The aim of this study was to evaluate thetherapeutic efficacy of acupuncture on patients with chronic neck myofascial pain syndrome.
Method: We investigated the effects of acupuncture on patients with chronic
neck MPS by means of a single-blind randomized controlled trial.Thirty-five patients were randomly allocated to an acupuncture group or a sham acupuncture group. Each subject received acupuncture treatment two times per week for 3 consecutive weeks. The primary outcome measure was quality of life as assessed with the Medical Outcomes 36-Item Short Form Health Survey, and secondary outcome measures were neck range of motion, and results of the Short-Form McGill Pain Questionnaire, as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as at 4 weeks (F1) and 12 weeks (F2) after the end of treatment. Total 34 patients completed the trial.
Results: The results indicated that both groups had increased ROM scores
and decreased VAS and SF-MPQ scores (P < 0.05) at AT, and there were no significant differences in these measures between the two groups at F1 and F2; at F2, patients in the acupuncture group showed greater improvements on the physical functioning and role emotional subscales for quality of lifethan did patients in the sham acupuncture group (P = 0.013 and P = 0.049, respectively).
Conclusions: We conclude that acupuncture may be used for pain relief in
patients with chronic neck MPS, and acupuncture stimulation withachievement of qi is more effective in improving quality of life.
Keywords: Acupuncture; Chronic neck myofascial pain; Short Form-36
謝 辭
本試驗首先感謝謝慶良教授熱心且周延的督促指導整個試驗的計 劃、執行以及完成,中國醫藥大學生統中心李采娟教授不厭其煩地指導 及幸玉助理的熱心幫忙,中西所陳汶吉所長及技佐嫦萍的時時輔助,衛 生署南投醫院陳能謹院長、賴慧貞副院長、鄭勇彥主任、洪弘昌醫務秘 書、顏素美主任、黃依欣護理師、千佳助理、企劃室、檢查中心全體人 員和所有院內同仁的幫忙,以及所有參與試驗的受試病患配合,使得研 究得以順利進行圓滿結束,本人對於各位老師、同仁以及受試病患致上 由衷的感謝。
另外,對於默默付出的家人,父母的養育提攜以及家人們的支持與 鼓勵,還有牽手無怨無悔的陪伴以及工作及學業上的幫忙,促使我得以 無後顧之憂的在臨床及研究上學習精進,謝謝你們!
最後,感謝中國醫藥大學以及中西醫結合研究所提供如此豐富的學 術資源,相信可以帶領醫學領域之同仁,在中西醫學上有更精湛的成就。
我也會持續努力,謙卑的學習,希望將己所學貢獻於臨床及醫學研究領 域。
孫美緣 謹誌