臺灣博碩士論文加值系統

腕隧道症候群是最常見的壓迫性周邊神經病變，影響手部功能進而造成工作失能，重度以上腕隧道症候群大多以手術治療，輕度到中度者會選擇保守性治療，然而許多保守治療的效果不佳，傳統醫藥的輔助性、保守性療法成為研究目標，其中包括雷射針灸。雷射針灸(Laser acupuncture, LA)是將低能量雷射(low-level-laser therapy, LLLT)照射在穴位上，屬於非侵入性治療。利用雷射針灸治療腕隧道症候群僅有一篇2002年發表於國際期刊的小型、有對照組、交叉試驗研究，因此，為了明確雷射針灸對於腕隧道症候群的臨床療效，而設計本研究。
本研究屬於前瞻性、雙盲、隨機且有對照組的臨床試驗，目前已收案16位受試者共21隻手腕，隨機分成兩組，雷射針灸治療組和控制組，每週接受三次治療(real LA / sham LA)共兩週，受試者均在晚上戴腕部支架到最後一次追蹤日。本研究選用勞宮(PC8)、大陵(PC7)、內關(PC6)、郄門(PC4)、合谷(LI4) 、手三里(LI10) 、曲池(LI11)、魚際(LU10)、神門(HT7)、少海(HT3)共10個穴位，使用雷射針灸儀器之參數為波長808nm、功率300mW、功率密度300mW/mm2，每個穴位照射10秒，real LA治療有上述雷射能量輸出，sham LA治療則無雷射能量輸出。療效評估的時間點為治療前，以及治療兩週後第2、4、8、12週。療效評估的主要指標為波士頓腕隧道量表(Boston carpal tunnel syndrome questionnaire, BCTQ)，次要指標為視覺疼痛量表(visual analog scale, VAS)、捏力(finger pinch, FP)、自評效果、正中神經之超音波截面積(cross sectional area, CSA)，和正中神經之神經電生理檢查(nerve conduction velocity, NCV)。
截至2019年6月本研究目前已收案21隻手腕並完成3個月追蹤，無試驗不良反應。根據初步統計結果顯示，控制組和雷射針灸組兩組間的基本資料均無統計上顯著差異，治療兩週後在各項療效評估指標，控制組和雷射針灸組之間亦無統計上顯著差異。唯兩組的自評效果都有稍微改善，且組內比較發現，兩組在BCTQ的症狀嚴重度和功能狀態、VAS、捏力等症狀較治療前改善，伴隨著正中神經超音波截面積縮小，均具統計上顯著差異。關於正中神經電生理檢查，僅雷射針灸組之運動神經遠端潛期(distal motor latency, DML)較治療前具有統計上顯著差異改善，然而感覺神經傳導速度(sensory nerve conduction velocity, SNCV)在兩組內雖有增加趨勢，卻無統計上顯著意義地改善。分析療效評估的追蹤時間，本研究發現，可以治療後4週作為神經學改善的追蹤時間指標(end point)，並以治療後8週作為症狀追蹤的症狀學改善的追蹤時間指標。此外，本研究目前仍將持續收案至2019年12月以進行後續統計分析。
以雷射針灸治療腕隧道症候群臨床療效評估的初步結果看來，本研究雖組間比較無統計上顯著差異，但雷射針灸組之各項療效評估指標的改善幅度較控制組多，且大部分療效評估項目在組內治療前後比較，均有統計上顯著差異地改善，因此仍具有臨床研究價值。期待未來有更大型、隨機、雙盲、安慰劑對照的臨床試驗進行。

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy that causes hand discomfort and work disability. Since no satisfactory conventional treatments for mild to moderate CTS exist, we apply complementary alternative medicine (CAM) to this problem. Laser acupuncture (LA), a new, non-invasive therapy which uses low-level-laser therapy (LLLT) in acupuncture could help to manage CTS. However, only one small randomized, double-blind and crossover trial had been conducted, which is not enough to provide an evidence-based assessment of the effects of LA on CTS.
The aim of this study is to investigate the efficacy of LA therapy on patients with mild to moderate CTS.
This study is a prospective double-blind randomized controlled trial. Sixteen subjects aged 20 to 80 years old with twenty-one wrists diagnosed as mild to moderate CTS had been randomizedly assigned to the intervention group (real LA, 3-sessions a week for two weeks) and control group (sham LA, 3-sessions a week for two weeks). All subjects were asked to wear night splints as the fundamental management approach. The laser parameters included a wavelength of 808nm, power output of 300mW and power density of 300mW/mm2, with ten seconds of treatment for each acupuncture point (PC4, PC6, PC7, PC8, LI4, LI10, LI11, HT3, HT7 and LU10). Sham LA treatment was applied without any laser power output. Primary outcome was based the Boston carpal tunnel syndrome questionnaire (BCTQ) and secondary outcomes included a visual analog scale (VAS), finger pinch (FP), self-evaluation, cross sectional area (CSA) of median nerve (MN) by sonography and electrophysiological test before interventions and after 2, 4, 8, 12 weeks post-intervention.
No significant differences in demographic data, including age, sex, body height, body weight, underlying disease, and characters of CTS, were found between the control group and intervention group. Sixteen participants with twenty-one wrists have finished the study course as of June 2019. All subjects felt mild improvement after treatment and no side effects observed. The symptom severity scale and hand function scale of BCTQ, VAS and FP were significantly better than pre-treatment with the CSA of MN decreasing in two groups. On the nerve conduction velocity (NCV) test, distal motor latency (DML) results of the LA group were significantly better than pre-treatment, but there were no significant changes in sensory nerve conduction velocity (SNCV) of MN in both groups. All measurement outcomes showed no significant difference between control group and intervention group. According to the results of follow-up, we found that four-week follow-up was the end point for improvement of neurology and eight-week follow-up was the end point for improvement of symptoms. This trial will continue until December 2019.
Although we found no significant differences between the two groups so far, most of the post-treatment evaluations were better than pre-treatment evaluations within the groups. We expect more trials with the larger sample size, double-blind, randomized and controlled will be conducted in the future to evaluate the efficacy of LA for CTS.

Abbreviations: CTS = Carpal tunnel syndrome; CAM = Complementary and alternative medicine; LLLT = Low-level-laser therapy; LA = Laser acupuncture; BCTQ = Boston carpal tunnel syndrome questionnaire; CSA = Cross sectional area of median nerve; MN = Median nerve; NCV = Nerve conduction velocity; SNCV = Sensory nerve conduction velocity; DML = Distal motor latency; VAS = Visual analog scale; FP = Finger pinch

目 錄

論文電子檔著作權授權………………………………………………………………………………………………………………i
論文審定同意書…………………………………………………………………………………………………………………………ii
誌謝……………………………………………………………………………………………………………………………………………iii
中文摘要………………………………………………………………………………………………………………………………………iv
英文摘要………………………………………………………………………………………………………………………………………vi
目錄…………………………………………………………………………………………………………………………………………viii
圖目錄……………………………………………………………………………………………………………………………………………xi
表目錄…………………………………………………………………………………………………………………………………………xii
第一章 前言………………………………………………………………………………………………………………………………1
1.1 腕隧道症候群簡介……………………………………………………………………………………………………………1
1.1.1 腕隧道症候群之流行病學…………………………………………………………………………………………1
1.1.2 腕隧道症候群之病因學………………………………………………………………………………………………1
1.1.3 腕隧道症候群之症狀……………………………………………………………………………………………………1
1.1.4 腕隧道症候群之診斷……………………………………………………………………………………………………2
1.1.5 腕隧道症候群之治療……………………………………………………………………………………………………3
1.1.6 腕隧道症候群之中醫觀點…………………………………………………………………………………………3
1.2 低能量雷射療法簡介…………………………………………………………………………………………………………4
1.2.1低能量雷射治療腕隧道症候群之文獻回顧………………………………………………………………5
1.3 雷射針灸療法簡介……………………………………………………………………………………………………………6
1.3.1針灸治療腕隧道症候群之文獻回顧……………………………………………………………………………6
1.3.2雷射針灸治療腕隧道症候群之文獻回顧…………………………………………………………………8
第二章 研究動機與目的…………………………………………………………………………………………………………9
第三章 研究材料與方法…………………………………………………………………………………………………………9
3.1 研究設計………………………………………………………………………………………………………………………………9
3.1.1 受試者選取…………………………………………………………………………………………………………………10
3.1.2 穴位選取………………………………………………………………………………………………………………………11
3.1.2 雷射針灸操作………………………………………………………………………………………………………………14
3.2 療效評估指標……………………………………………………………………………………………………………………15
3.3 研究步驟……………………………………………………………………………………………………………………………17
3.3.1 控制組……………………………………………………………………………………………………………………………18
3.3.2 治療組……………………………………………………………………………………………………………………………18
3.4 統計分析……………………………………………………………………………………………………………………………19
第四章 研究結果……………………………………………………………………………………………………………………19
4.1 基本資料分析……………………………………………………………………………………………………………………19
4.2 波士頓腕隧道症候群量表……………………………………………………………………………………………20
4.2.1 症狀嚴重程度………………………………………………………………………………………………………………20
4.2.2 功能狀態………………………………………………………………………………………………………………………20
4.3 疼痛量表……………………………………………………………………………………………………………………………21
4.4 捏力……………………………………………………………………………………………………………………………………21
4.5 自評效果……………………………………………………………………………………………………………………………22
4.6 正中神經之神經傳導檢查……………………………………………………………………………………………22
4.6.1 感覺神經傳導速度……………………………………………………………………………………………………22
4.6.2 運動神經遠端潛期……………………………………………………………………………………………………23
4.7 正中神經截面積之超音波檢查……………………………………………………………………………………24
4.7 試驗不良反應……………………………………………………………………………………………………………………24
第五章 討論……………………………………………………………………………………………………………………………24
第六章 結論……………………………………………………………………………………………………………………………28
參考文獻………………………………………………………………………………………………………………………………………49
附錄………………………………………………………………………………………………………………………………………………55
附錄一 三軍總醫院人體試驗委員會同意臨床試驗證明書……………………………………………55
附錄二 本研究計畫投稿並刊登於Medicine期刊…………………………………………………………56
附錄三 受試者同意書………………………………………………………………………………………………………………62
附錄四 雷射針灸儀器………………………………………………………………………………………………………………68
附錄五 中文版波士頓腕隧道症候群量表…………………………………………………………………………69
附錄六 視覺疼痛量表………………………………………………………………………………………………………………71


圖 目 錄

附圖………………………………………………………………………………………………………………………………………………30
Figure 1. Acupoints used for carpal tunnel syndrome: PC8, PC7, PC6, PC4, LI4, LI10, LI11, LU10, HT7, HT3………………………………30
Figure 2. Laser acupuncture performed using the device at the PC7 acupuncture point………………………………………………………………………………………31
Figure 3. The device and test of finger pinch…………………………………32
Figure 4. Study course………………………………………………………………………………………………33
Figure 5. Study flow chart……………………………………………………………………………………34
Figure 6. Mean change from baseline in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) in both groups……………………………………35
Figure 7. Mean change from baseline in visual analog scale (VAS) in both groups …………………………………………………………………………………………………36
Figure 8. Mean change from baseline in finger pinch (FP) in both groups……………………………………………………………………………………………………………………………37
Figure 9. 兩組的自評效果………………………………………………………………………………………………38
Figure 10. Mean change from baseline in sensory nerve conduction velocity (SNCV) and distal motor latency (DML) in both groups……………………………………………………………………………………………………………………………39
Figure 11. Mean change from baseline in cross-sectional area (CSA) of median nerve (MN) in both groups…………………………………………………………………………………………………………………………………………40

表 目 錄

附表………………………………………………………………………………………………………………………………………………41
Table 1. Summarization of inclusion and exclusion criteria……………………………………………………………………………………………………………………………………41
Table 2. Electrophysiological classification of diagnosis and grades of carpal tunnel syndrome……………………………………………………………………………………………………………………………………42
Table 3. The demographic data and characteristics of the patients……………………………………………………………………………………………………………………………………43
Table 4. Comparison of clinical parameters between pre- and post-treatment in control group………………………………………………………………………45
Table 5. Comparison of clinical parameters between pre- and post-treatment in laser acupuncture group……………………………………………………………………………………………………………………………………………46
Table 6. Comparison of clinical parameters between groups…………………………………………………………………………………………………………………………………………47

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