Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial

Authors: Hyun-jong Lee, Jung-Chul Seo, Min-Ah Kwak, Sung-Hoon Park, Bo-Mi Min, Min-su Cho, ImHee Shin, Jin-yong Jung, Woon-seok Roh

Published in: Trials | Issue 1/2014

Login to get access

Abstract

Background

Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis.

Methods/Design

The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation).

Discussion

This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis.

Trial registration

This trial is registered with the US National Institutes of Health Clinical Trials registry:NCT01909284.
Appendix
Available only for authorised users
Literature
1.
Wiltse LL, Newman PH, Macnab I: Classification of spondylolisis and spondylolisthesis. Clin Orthop Relat Res. 1976, 117: 23-29.PubMed
2.
Saraste H: Long-term clinical and radiological follow-up of spondylolysis and spondylolisthesis. J Pediatr Orthop. 1987, 7: 631-638. 10.1097/01241398-198707060-00001.CrossRefPubMed
3.
Kalichman L, Hunter DJ: Diagnosis and conservative management of degenerative lumbar spondylolisthesis. Eur Spine J. 2008, 17: 327-335.CrossRefPubMed
4.
Vibert BT, Sliva CD, Herkowitz HN: Treatment of instability and spondylolisthesis: surgical versus nonsurgical treatment. Clin Orthop Relat Res. 2006, 443: 222-227. 10.1097/01.blo.0000200233.99436.ea.CrossRefPubMed
5.
Marchetti PG, Bartolozzi P: Classification of spondylolisthesis as a guideline for treatment. Textbook of Spinal Surgery. Edited by: Bridwell KH, Dewald RL, Hammerberg KW. 1997, Philadelphia: Lippincott-Raven, 1211-1254. 2
6.
Meyereding H: Spondylolisthesis. Surg Gynecol Obstet. 1932, 54: 371-379.
7.
Timon SJ, Gardner MJ, Wanich T, Poynton A, Pigeon R, Widmann RF, Rawlins BA, Burke SW: Not all spondylolisthesis grading instruments are reliable. Clin Orthop Relat Res. 2005, 434: 157-162.CrossRefPubMed
8.
Metz LN, Deviren V: Low-grade spondylolisthesis. Neurosurg Clin N Am. 2007, 18: 237-248. 10.1016/j.nec.2007.02.010.CrossRefPubMed
9.
Matsunaga S, Ijiri K, Hayashi K: Nonsurgically managed patients with degenerative spondylolisthesis: a 10 to 18 year follow-up study. J Neurosurg Spine. 2000, 93: 194-198.CrossRef
10.
Lee M, Scott-Young M: Highly selective epidural steroid injection for the treatment of radicular pain arising from spondylolisthesis. J Bone Joint Surg Br. 2004, 86: 456-
11.
Carlsson CP, Sjolund BH: Acupuncture for chronic low back pain: a randomized placebo-controlled study with long-term follow-up. Clin J Pain. 2001, 17: 296-305. 10.1097/00002508-200112000-00003.CrossRefPubMed
12.
Sawazaki K, Mukaino Y, Kinoshita F, Honda T, Mohara O, Sakuraba H, Togo T, Yokoyama K: Acupuncture can reduce perceived pain, mood disturbances and medical expenses related to low back pain among factory employees. Ind Health. 2008, 46: 336-340. 10.2486/indhealth.46.336.CrossRefPubMed
13.
Leibing E, Leonhardt U, Koster G, Goerlitz A, Rosenfeldt JA, Hilgers R, Ramadori G: Acupuncture treatment of chronic low-back pain – a randomized, blinded, placebo-controlled trial with 9-month follow-up. Pain. 2002, 96: 189-196. 10.1016/S0304-3959(01)00444-4.CrossRefPubMed
14.
Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer H, Maier C, Endres HG, Trampisch HJ, Molsberger A: German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007, 167: 1892-1898. 10.1001/Archinte.167.17.1892.CrossRefPubMed
15.
Brinkhaus B, Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S, Irnich D, Walther HU, Melchart D, Willich SN: Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med. 2006, 166: 450-457.PubMed
16.
Witt CM, Jena S, Selim D, Brinkhaus B, Reinhold T, Wruck K, Liecker B, Linde K, Wegscheider K, Willich SN: Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain. Am J Epidemiol. 2006, 164: 487-496. 10.1093/aje/kwj224.CrossRefPubMed
17.
Lauber S, Schulte TL, Liljenqvist U, Halm H, Hackenberg L: Clinical and radiologic 2-4-year results of transforaminal lumbar interbody fusion in degenerative and isthmic spondylolisthesis grades 1 and 2. Spine. 2006, 31: 1693-1698. 10.1097/01.brs.0000224530.08481.4e.CrossRefPubMed
18.
Revill SI, Robinson JO, Rosen M, Hogg MI: The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976, 31: 1191-1198. 10.1111/j.1365-2044.1976.tb11971.x.CrossRefPubMed
19.
Carlsson AM: Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983, 16: 87-101. 10.1016/0304-3959(83)90088-X.CrossRefPubMed
20.
21.
Maekawa N, Morimoto M, Morimoto M, Uchida T, Umeda T, Koga Y: Can we revaluate pain with PainVision, a device for quantitative analysis of perception and pain? A feasibility study of pain in herpes zoster patients. J Jpn Soc Clin Anesth. 2009, 29: 824-828. 10.2199/jjsca.29.824.CrossRef
22.
Matsumura H, Imai R, Gondo M, Watanabe K: Evaluation of pain intensity measurement during the removal of wound dressing material using ‘the PainVision™ system’ for quantitative analysis of perception and pain sensation in healthy subjects. Int Wound J. 2012, 9: 451-455. 10.1111/j.1742-481X.2011.00911.x.CrossRefPubMed
23.
Burckhardt CS: The use of the McGill Pain Questionnaire in assessing arthritis pain. Pain. 1984, 19: 305-314. 10.1016/0304-3959(84)90007-1.CrossRefPubMed
24.
Melzack R: The short-form McGill Pain Questionnaire. Pain. 1987, 30: 191-197. 10.1016/0304-3959(87)91074-8.CrossRefPubMed
25.
Melzack R: The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975, 1: 277-299. 10.1016/0304-3959(75)90044-5.CrossRefPubMed
26.
Roland M, Morris R: A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983, 8: 141-144. 10.1097/00007632-198303000-00004.CrossRefPubMed
27.
Jeon CH, Kim DJ, Kim SK, 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: 1092-1097. 10.3346/jkms.2006.21.6.1092.CrossRefPubMedPubMedCentral
28.
Frass M, Strassl RP, Friehs H, Mullner M, Kundi M, Kaye AD: Use and acceptance of complementary and alternative medicine among the general population and medical personnel: a systematic review. Ochsner J. 2012, 12: 45-56.PubMedPubMedCentral
29.
Hutchinson AJ, Ball S, Andrews JC, Jones GG: The effectiveness of acupuncture in treating chronic non-specific low back pain: a systematic review of the literature. J Orthop Surg Res. 2012, 30: 7-36.
Metadata
Title
Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial
Authors
Hyun-jong Lee
Jung-Chul Seo
Min-Ah Kwak
Sung-Hoon Park
Bo-Mi Min
Min-su Cho
ImHee Shin
Jin-yong Jung
Woon-seok Roh
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-105

Other articles of this Issue 1/2014

Trials 1/2014 Go to the issue

Study protocol

Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial

Study protocol

Perioperative use of crystalloids in patients undergoing open radical cystectomy: balanced Ringer’s maleate versus a glucose 5%/potassium-based balanced solution: study protocol for a randomized controlled trial

Study protocol

Effectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): study protocol for a randomized controlled trial

Study protocol

Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a study protocol for a randomized controlled pilot trial

Study protocol

Efficacy of two different self-expanding nitinol stents for atherosclerotic femoropopliteal arterial disease (SENS-FP trial): study protocol for a randomized controlled trial

Research

Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences