Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient–assessor blinded, controlled, parallel, clinical trial
Tóm tắt
A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain. Several studies have reported that thread-embedding acupuncture (TEA) is effective in the treatment of LHIVD. However, these studies were of low quality and there is therefore little clinical evidence for the effectiveness of TEA in this regard. The aim of the present study is to establish the clinical evidence regarding the efficacy and safety of TEA in the treatment of pain, function, and quality of life in patients with LHIVD. The study uses a rigorously designed, full-scale, randomized clinical trial (RCT) protocol. This is a multicenter, randomized, patient–assessor blinded, sham-controlled trial with two parallel arms. Seventy patients with LHIVD who have lower back pain more severe than 40 mm on the 100-mm visual analogue scale (VAS), and who are aged 19–70 years, will be recruited and randomly allocated to a TEA group and sham TEA (STEA) group. Both groups will receive treatment on 23 predefined acupoints once a week for eight weeks; needles with the thread removed will be used in the STEA group, while normal TEA will be employed in the TEA group. Changes in the 100-mm VAS for lower back pain after eight weeks will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry Disability Index, Roland–Morris disability questionnaire, EuroQol 5 Dimensions 5 Levels, and global perceived effect will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4, 8, 12, and 16 weeks after screening. The results of this trial will help to establish the clinical evidence regarding TEA in the treatment of patients with LHIVD. ClinicalTrials.gov,
NCT03236753
. Registered on August 2, 2017. Clinical Research Information Service of the Republic of Korea,
KCT0002439
. Registered on August 1, 2017.
Tài liệu tham khảo
Radcliff K, Hilibrand A, Lurie JD, Tosteson TD, Delasotta L, Rihn J, et al. The impact of epidural steroid injections on the outcomes of patients treated for lumbar disc herniation: a subgroup analysis of the SPORT trial. J Bone Joint Surg Am. 2012;94(15):1353–1358.
Ropper AH, Zafonte RD. Sciatica. N Engl J Med. 2015;372(13):1240–8.
Han L, Zhao P, Guo W, Wei J, Wang F, Fan Y, et al. Short-term study on risk-benefit outcomes of two spinal manipulative therapies in the treatment of acute radiculopathy caused by lumbar disc herniation: study protocol for a randomized controlled trial. Trials. 2015;16:122.
Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the Maine lumbar spine study. Spine. 2005;30(8):927–35.
Buttermann GR. Treatment of lumbar disc herniation: epidural steroid injection compared with discectomy. A prospective, randomized study. J Bone Joint Surg Am. 2004;86-a(4):670–9.
Deyo RA, Mirza SK. CLINICAL PRACTICE. Herniated lumbar intervertebral disk. N Engl J Med. 2016;374(18):1763–72.
Wang RR, Tronnier V. Effect of acupuncture on pain management in patients before and after lumbar disc protrusion surgery--a randomized control study. Am J Chin Med. 2000;28(1):25–33.
Furlan AD, Yazdi F, Tsertsvadze A, Gross A, Van Tulder M, Santaguida L, et al. Complementary and alternative therapies for back pain II. Evid Rep/Technol Assess. 2010;194:1–764.
Kim YJ, Kim MC, Lee CH, Kim JU, Yook TH. The effect of needle-embedding therapy and pharmacopuncture therapy on patients with urinary incontinence. J Acupunct Merid Stud. 2011;4(4):220–4.
Lee KH, Lee DH, Kwon KR, Park HS, Park YY. A literary study on embedding therapy. J Pharmacopunct. 2003;6(3):15–21.
Guo T, Ren Y, Kou J, Shi J, Tianxiao S, Liang F. Acupoint catgut embedding for obesity: systematic review and meta-analysis. Evid-Based Complement Altern Med. 2015;2015:401914.
Li XR, Zhang QX, Liu M, Chen Q, Liu Y, Zhang FB, et al. Catgut implantation at acupoints for allergic rhinitis: a systematic review. Chin J Integr Med. 2014;20(3):235–40.
Ding M, Feng H, Jin C, Xu L, Lin T. Intractable facial paralysis treated with different acupuncture and acupoint embedding therapies: a randomized controlled trial. Zhongguo Zhen Jiu. 2015;35(10):997–1000.
Park SH, Jeon YT, Han KI, Kim MJ, Lee HI, Lee JH, et al. Literature review of catgut-embedding therapy for lumbar disk herniation. J Korean Med Rehabil. 2015;25(4):29–40.
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18.
MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, et al. Revised STandards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.
Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the spine patient outcomes research trial (SPORT): a randomized trial. JAMA. 2006;296(20):2441–50.
Carragee EJ, Spinnickie AO, Alamin TF, Paragioudakis S. A prospective controlled study of limited versus subtotal posterior discectomy: short-term outcomes in patients with herniated lumbar intervertebral discs and large posterior anular defect. Spine. 2006;31(6):653–7.
Food and Drug Administration. Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Labeling for Products That Contain Acetaminophen; Guidance for Industry; Availability. https://www.federalregister.gov/documents/2015/11/17/2015-29281/organ-specific-warnings-internal-analgesic-antipyretic-and-antirheumatic-drug-products-for. Accessed 17 Nov 2015.
Li YQ, Lu L, Chen XL, Xu JL. Small needle knife therapy with catgut-embedding treatment of lumbar disc herniation. Chin Acupunct Moxibust. 2010;S1:30–2.
Xie HY, Zhang JW. Clinical observation of lumbar disc herniation catgut embedding therapy. J New Chin Med. 2012;8:122–3.
Zhang HF, Hao YS, Shi SX, Li ZC, Li ZA, Dai JR, et al. Ozone melts nuclear technique and herbal medicine, catgut-embedding on lumbar disc herniation. Chin J Tradit Med Traumatol Orthop. 2008;1:59–60.
Zhang ZQ, He XJ, Bai WJ, He YF. Clinical study of catgut embedding therapy for lumbar disc herniation. Chin Med Eng. 2013;8:95–6.
Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976;31(9):1191–8.
Jeon CH, Kim DJ, Kim SK, Kim DJ, Lee HM, Park HJ. Validation in the cross-cultural adaptation of the Korean version of the Oswestry Disability Index. J Korean Med Sci. 2006;21(6):1092–7.
Lee JS, Lee DH, Suh KT, Kim JI, Lim JM, Goh TS. Validation of the Korean version of the Roland-Morris disability questionnaire. Eur Spine J. 2011;20(12):2115–9.
Kim SH, Ahn J, Ock M, Shin S, Park J, Luo N, et al. The EQ-5D-5L valuation study in Korea. Qual Life Res. 2016;25(7):1845–52.
Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global perceived effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010;63(7):760–6.
James KE, Bloch DA, Lee KK, Kraemer HC, Fuller RK. An index for assessing blindness in a multi-Centre clinical trial: disulfiram for alcohol cessation--a VA cooperative study. Stat Med. 1996;15(13):1421–34.
Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004;25(2):143–56.
HN G. Clinical Observation of Acupoint Catgut Embedding Therapy for Lumbar Disc Herniation. Guangzhou: Guangzhou University of Chinese Medicine; 2012.
Tian YS, Wang LS, Wang XY, Sun WQ. Clinical observation on ankylosing spondylitis treated with acupoint catgut embedding combined vessel pricking therapy. Zhongguo Zhen Jiu. 2011;31(7):601–4.
Ma Y, Li X, Li F, Yu W, Wang Z. Clinical research of chronic pelvic cavity pain syndrome treated with acupoint catgut embedding therapy. Zhongguo Zhen Jiu. 2015;35(6):561–6.
Sun W, Chu N, Ma Y, Wang Y, Wang H, Jiang G. Effective anatomic structures of ultrasound-guide acupoint embedding therapy for cervical spondylosis. Zhongguo Zhen Jiu. 2015;35(10):1001–4.
Yoo DJ, Jung JY, Chung SH. Effects of the embedding acupuncture treatments for chronic low back pain patients. J Korean Med Rehabil. 2015;25(4):105–12.