Reduction of chronic non-specific low back pain: A randomised controlled clinical trial on acupuncture and baclofen
© Zaringhalam et al; licensee BioMed Central Ltd. 2010
Received: 1 November 2009
Accepted: 24 April 2010
Published: 24 April 2010
Chronic non-specific low back pain (LBP) is a prevalent (80%) and multi-dimensional illness. This study aims to test whether acupuncture, baclofen, or combined treatment with acupuncture and baclofen alleviates symptoms of non-specific chronic LBP in men.
Eight-four (84) men aged 50-60 years with non-specific chronic LBP were randomly assigned to four groups: the baclofen group received only baclofen (30 mg/day); the acupuncture group received only acupuncture at selected acupoints; the acupuncture + baclofen group received combined treatment with acupuncture and baclofen treatments; and the control group received no pain reduction treatment. After five weeks of treatment, visual analogue scale (VAS) and self-reported pain disability with the Roland-Morris Disability Questionnaire (RDQ) were conducted for outcome measures.
After treatment, the baclofen, acupuncture and acupuncture + baclofen groups all had lower VAS and RDQ scores. Significantly higher reduction and improvement in VAS and RDQ scores were found in the acupuncture and acupuncture + baclofen groups compared to the baclofen group.
The present study indicates that the combined treatment of acupuncture and baclofen is more effective than baclofen treatment alone to reduce pain in patients with non-specific chronic LBP.
Trial registration number
Low back pain (LBP) may be the most prevalent illness, with 80% of the population experiencing it at least once in their lifetime . Up to 90% of all patients with acute LBP recover quickly with or without treatment [2, 3]. Ten to forty percent of all LBP cases become chronic which is a burden on the society [4, 5]. Furthermore, LBP is a multi-dimensional problem  involving pathoanatomical, neurophysiological, physical and psychosocial factors . Most LBP cases are non-specific as definitive diagnosis cannot be established with current radiological methods . The results of research on the effectiveness of treatments for non-specific chronic LBP are inconsistent [8, 9]. Some studies suggest that the classification of chronic LBP disorders should be homogenous so that specific interventions tailored for these homogenous groups can be more effective . The most common medications for non-specific LBP are skeletal muscle relaxants and opioid analgesics [8, 10]. Muscle relaxants are used to reduce pain of patients with non-specific LBP and, in particular, non-benzodiazepine muscle relaxants such as baclofen are used for symptomatic treatment of chronic LBP [8, 11]. Some researchers found that muscle relaxants including baclofen are ineffective . Thus, the use of muscle relaxants for LBP remains controversial. When these drugs are not adequate, another kind of therapy, e.g. acupuncture, is often sought [12, 13]. Acupuncture stimulates specific points on the body surface with fine needles  and relieves pain in chronic LBP patients as accepted by the World Health Organization (WHO) . Acupuncture treatment may improve the disability of patients with LBP [13, 16]. While acupuncture is widely used by patients with chronic LBP, its effectiveness in pain reduction still lacks evidence [12, 17, 18]. A couple of randomised controlled trials found that combined treatment with acupuncture and baclofen were effective in pain reduction [11, 18]; however, the efficacy of this combination has not been demonstrated for non-specific chronic LBP. This study aims to test whether acupuncture, baclofen and combined treatment with acupuncture and baclofen can alleviate symptoms of non-specific chronic LBP in men.
Men aged 50-60 years with non-specific chronic LBP were recruited through local newspapers except for a few patients (eight people) who had contacted the trial research centres of the Tehran University of Medical Sciences (TUMS). Screening of participants was carried out by a qualified musculoskeletal physiotherapist. Participants met all the following inclusion criteria: (1) lumbar or lumbosacral pain for six months or longer; (2) no radiation of low back pain to other regions; (3) normal neurological signs of lumbosacral nerves including deep tendon and plantar reflexes, voluntary motor function, straight leg raise and sensory function; (4) no acupuncture treatment in the past six months; (5) absence of significant pathology such as bone fracture or severe psychiatric conditions; (6) stable health; and (7) all participants experienced ongoing pain, the intensity of which did not change over the course of a day. Patients were excluded if they had any of the following: (1) major trauma or systemic disorders; (2) conflicting or ongoing co-interventions (drugs and/or alternative treatments); (3) prior use of acupuncture for LBP in the past six months; (4) refusal to be randomised; (5) protrusion or prolapse of one or more intervertebral discs with concurrent neurological symptoms; (6) prior vertebral column surgery; (7) infectious spondylopathy; (8) low back pain secondary to an inflammatory, malignant or autoimmune disease; (9) congenital deformation of the spine (except for slight lordosis or scoliosis); or (10) compression fracture caused by osteoporosis, spinal stenosis, spondylolysis or spondylolisthesis [13, 19]. At the first appointment, patient characteristics and baseline measurements were recorded. Part of the screening process relied on self-reported information concerning current medical conditions, medications and serious injuries. Before signing a written informed consent, each participant was given an information sheet explaining the nature of the study. This study was approved by the Ethics Committee of the TUMS.
Baseline participant characteristics
Number of participant
Pain duration (years)
Base RDQ score
Base VAS score
High school or less
Treatment course for all groups was five weeks, i.e. standard for chronic pain treatment [19, 20]. Control group did not receive any treatment for chronic pain. All participants were advised to maintain their normal lifestyle and not to start any new medications. Acupuncture reporting followed the STandards for Reporting Interventions in Clinical Trial of Acupuncture (STRICTA) . Participants in the AC and BA+AC groups received acupuncture treatment performed by a certified acupuncturist twice a week for five weeks. Acupuncture protocol used in this study was consistent with the neurohumoral mechanism theory of acupuncture . Each patient received needles bilaterally in the following acupoints: Shenshu (BL23), Dachangshu (BL25), Panguanshu (BL28), Ciliao (BL32), Kunlun (BL60), Huantiao (GB30) and Yanglingquan (GB34). An aseptic procedure was employed with disposable, stainless 30-gauge needles coupled with electrical stimulation at 4-6 Hz with pulse duration of 0.5 ms . Needles (0.2 mm × 40 mm, Seirin, USA) were inserted into the acupoints until the patient felt dull pain or deqi. At each session 10-12 needles were used bilaterally and needles were left in place for 20-25 minutes. Baclofen was orally administered 30 mg/day (15 mg bid) which is the recommended effective dose for chronic LBP  without causing motor impairment . Patients in the BA+AC group received both baclofen (30 mg/day) and acupuncture for five weeks.
Primary outcomes were pain intensity quantified with a 10 cm visual analogue scale (VAS, 0-100 mm)  and self-reported pain disability assessed with an Iranian version of the Roland Morris Questionnaire (RDQ, 0-24 points) which is a reliable and valid instrument for measuring functional status in Persian-speaking patients with LBP [25, 26]. VAS scores were measured immediately before the first treatment and subsequently at one, two, three, four, five and ten weeks after the first treatment. RDQ scores were measured immediately before the first treatment and subsequently at five and ten weeks after the first treatment. Each VAS or RDQ score was measured immediately before treatment at the specified week [19, 27]. The concept of the minimal clinically important difference (MCID) , helped interpret changes in VAS and RDQ scores at the individual level. If available, MCID in these outcome measures were defined as a 2-point reduction on VAS and 2.5 points reduction on RDQ.
Data are presented as mean (SD). Statistica software (version 6.0, StatSoft, USA) was used in all statistical analyses. One-way analysis of variance (ANOVA) was performed followed by post-hoc Tukey's multiple comparison test (Statistica version 6.0) to determine significant differences in VAS and RDQ scores between groups. Independent t-test was used for comparison of VAS or RDQ scores between two different groups. Statistical significance level was set at P < 0.05.
Changes in VAS scores for pain intensity
Pain intensity scores (VAS) in experimental groups
Changes in RDQ scores for pain disability
Ronald Morris Questionnaire (RDQ) scores in experimental groups
The AC and BA+AC treatments for non-specific chronic LBP were more effective in pain reduction than baclofen treatment alone. Moreover, the anti-nociceptive effects in the AC and BA+AC groups were also more persistent at follow-ups. Acupuncture has demonstrated its potential as a promising treatment for chronic LBP [29, 30]. While a number of theories of how acupuncture may treat LBP are available, no accepted mechanism has emerged [30, 31]. Similar to descending inhibitory and/or diffuse noxious inhibitory controls in the central nervous system, acupuncture may stimulate the small-diameter afferent fibres, which then reduce the transmission of pain signals thereby inhibiting pain discrimination and perception . Low back muscle spasm and muscle blood flow decrease are the main underlying causes of chronic LBP . Acupuncture alleviates tension and improves blood flow in the treated muscles . Thus, acupuncture treatment may improve lumbar function and reduce pain via increasing the blood flow to the affected region . Non-benzodiazepine muscle relaxants are often used to treat non-specific LBP , as a gamma-aminobutyric acid (GABA) derivative with central nervous system action and a substance P antagonist [37, 38]. In this study baclofen (30 mg/day per oral) reduced the pain intensity but only effective in the first two weeks. These results are in line with a previous study that did not find significant and consistent decrease in pain intensity with baclofen treatment for chronic spastic pain . Due to the controversies some practitioners are reluctant to prescribe baclofen to their patients . Baclofen is effective for immediate pain relief , whereas acupuncture is effective to treat long-term pain and alleviate pain-related disabilities [27, 40, 41]. As baclofen treatment alone does not produce major functional benefits , combination treatment maybe an alternative . This RCT does show that the BA+AC group had lower VAS and RDQ scores than other groups, i.e., the combined acupuncture and baclofen treatment is more effective to treat non- specific chronic LBP than either treatment alone .
The present study indicates that the combined treatment of acupuncture and baclofen is more effective than baclofen treatment alone to reduce pain in patients with non-specific chronic LBP.
Low back pain
Visual analogue scale
Roland-Morris Disability Questionnaire
Non-steroidal anti-inflammatory drugs
World Health Organization
Tehran University of Medical Sciences
Baclofen plus acupuncture
STandards for Reporting Interventions in Clinical Trial of Acupuncture
Minimal clinically important difference
One-way analysis of variance
Randomised controlled trial.
The authors are grateful to the Tehran University of Medical Sciences and the Neuroscience Research Centre of the Shahid Beheshti University of Medical Sciences for their assistance in study design.
- Kelsey JL, White AA: Epidemiology and impact of low back pain. Spine. 1980, 5 (2): 133-139. 10.1097/00007632-198003000-00007.View ArticlePubMedGoogle Scholar
- Deyo RA, Weinstein JN: Low back pain. N Engl J Med. 2001, 344: 363-370. 10.1056/NEJM200102013440508.View ArticlePubMedGoogle Scholar
- Waddell G: The Backpain Revolution. 2004, Edinburgh: Churchill LivingstoneGoogle Scholar
- Dillingham T: Evaluation and management of low back pain: and overview. State Art Rev. 1995, 9 (3): 559-74.Google Scholar
- Croft PR, Macfarlane GJ, Papageorgiou AC, Thomas E, Silman AJ: Outcome of low back pain in general practice: a prospective study. BMJ. 1998, 316: 1356-1359.PubMed CentralView ArticlePubMedGoogle Scholar
- Borkan J, van Tulder M, Reis S, Schoene ML, Croft P, Hermoni D: Advances in the field of low back pain in primary care: a report from the fourth international forum. Spine. 2002, 27 (5): E128-132. 10.1097/00007632-200203010-00019.View ArticlePubMedGoogle Scholar
- McCarthy C, Arnall F, Strimpakos N, Freemont A, Oldham J: The biopsychosocial classification of non-specific low back pain: a systematic review. Phys Ther Rev. 2004, 9 (1): 17-30. 10.1179/108331904225003955.View ArticleGoogle Scholar
- Chou R, Huffman LH: Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann intern med. 2007, 147 (7): 505-514.View ArticlePubMedGoogle Scholar
- van Tulder MW, Koes BW, Bouter LM: Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine. 1997, 22 (18): 2128-2156. 10.1097/00007632-199709150-00012.View ArticlePubMedGoogle Scholar
- Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, van Rompay M, Kessler RC: Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA. 1998, 280 (18): 1569-1575. 10.1001/jama.280.18.1569.View ArticlePubMedGoogle Scholar
- van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM: Muscle relaxants for nonspecific low back pain: a systematic review within the framework of the cochrane collaboration. Spine. 2003, 28 (17): 1978-1992. 10.1097/01.BRS.0000090503.38830.AD.View ArticlePubMedGoogle Scholar
- Chou R, Huffman LH: Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007, 147 (7): 492-504.View ArticlePubMedGoogle Scholar
- Ernst E, White AR: Acupuncture for back pain: a meta-analysis of randomized controlled trials. Arch Intern Med. 1998, 158 (20): 2235-2241. 10.1001/archinte.158.20.2235.View ArticlePubMedGoogle Scholar
- MacPherson H, White A, Cummings M, Jobst KA, Rose K, Niemtzow R: Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med. 2001, 9 (4): 246-249. 10.1054/ctim.2001.0488.View ArticlePubMedGoogle Scholar
- WHO acupuncture research. [http://apps.who.int/medicinedocs/en/d/Js4926e/]
- Eshkavari L: Acupuncture and pain: a review of the literature. AANA J. 2003, 71 (5): 361-370.Google Scholar
- Manheimer E, White A, Berman B, Forys K, Ernst E: Meta-analysis: acupuncture for low back pain. Ann Intern Med. 2005, 142 (8): 651-663.View ArticlePubMedGoogle Scholar
- Itoh K, Itoh S, Katsumi Y, Kitakoji H: A pilot study on using acupuncture and transcutaneous electrical nerve stimulation to treat chronic non-specific low back pain. Complement Ther Clin Pract. 2009, 15 (1): 22-25. 10.1016/j.ctcp.2008.09.003.View ArticlePubMedGoogle Scholar
- Helms JM: An overview of medical acupuncture. Altern Ther. 1998, 4 (3): 35-45.Google Scholar
- Frymoyer JW: Back pain and sciatica. N Engl J Med. 1988, 318: 291-300.View ArticlePubMedGoogle Scholar
- Cheng X: Chinese Acupuncture and Moxibustion. 1999, Beijing: Foreign Language PressGoogle Scholar
- Stux G, Pomeranz B: Acupuncture: a textbook and atlas. 1987, Berlin: Springer-VerlagView ArticleGoogle Scholar
- Dapas F, Hartman SF, Martinez L, Northrup BE, Nussdorf RT, Silberman HM, Gross H: Baclofen for the treatment of acute low-back syndrome. A double-blind comparison with placebo. Spine. 1985, 10 (4): 345-349. 10.1097/00007632-198505000-00010.View ArticlePubMedGoogle Scholar
- Deyo R: Comparative validity of the sickness impact profile and shorter scales for functional assessment in low-back pain. Spine. 1986, 11 (9): 951-954. 10.1097/00007632-198611000-00017.View ArticlePubMedGoogle Scholar
- Mousavi SJ, Parnianpour M, Mehdian H, Montazeri A, Mobini B: The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions. Spine. 2006, 31 (14): E454-E459. 10.1097/01.brs.0000222141.61424.f7.View ArticlePubMedGoogle Scholar
- Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB: Assessing health-related quality of life in patients with sciatica. Spine. 1995, 20 (17): 1899-1908. 10.1097/00007632-199509000-00011.View ArticlePubMedGoogle Scholar
- Weiner DK, Perera S, Rudy TE, Glick RM, Shenoy S, Delitto A: Efficacy of percutaneous electrical nerve stimulation and therapeutic exercise for older adults with chronic low back pain: A randomized controlled trial. Pain. 2008, 140 (2): 344-357. 10.1016/j.pain.2008.09.005.PubMed CentralView ArticlePubMedGoogle Scholar
- Yuan J, Purepong N, Hunter RF, Kerr DP, Park J, Bradbury I, McDonough S: Different frequencies of acupuncture treatment for chronic low back pain: An assessor-blinded pilot randomised controlled trial. Complement Ther Med. 2009, 17 (3): 131-140. 10.1016/j.ctim.2008.10.003.View ArticlePubMedGoogle Scholar
- 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 (4): 450-457. 10.1001/.450.PubMedGoogle Scholar
- Molsberger AF, Zhou J, Arndt D, Teske W: Chinese Acupuncture for Chronic Low Back: An International Expert Survey. J Altern Complement Med. 2008, 14 (9): 1089-1095. 10.1089/acm.2008.0138.A.View ArticlePubMedGoogle Scholar
- Koes BW, Assendelft WJJ, Heijden van der GJMG, Bouter LM: Spinal manipulation for low back pain. An updated systematic review of randomized controlled clinical trials. Spine. 1996, 21 (24): 2860-2871. 10.1097/00007632-199612150-00013.View ArticlePubMedGoogle Scholar
- Kawakita K, Gotoh K: Role of polymodal receptors in the acupuncture-mediated endogenous pain inhibitory systems. Prog Brain Res. 1996, 113: 507-523. full_text.View ArticlePubMedGoogle Scholar
- Johnson EW: The myth of skeletal muscle spasm. Am J Phys Med Rehabil. 1989, 68 (1): 1-10.1097/00002060-198902000-00001.View ArticlePubMedGoogle Scholar
- Kawakita K: Polymodal receptor hypothesis on the peripheral mechanisms of acupuncture and moxibustion. Am J Acupunct. 1993, 21 (4): 331-338.Google Scholar
- Leibing E, Leonhardt U, Koster G, Goerlitz A, Rosenfeldt JA, Hilgers R, Ramadori G: Acupuncture treatment of chronic low-back pain - a randomised, blinded, placebo-controlled trial with nine-month follow-up. Pain. 2002, 96 (1-2): 189-96. 10.1016/S0304-3959(01)00444-4.View ArticlePubMedGoogle Scholar
- Cherkin DC, Wheeler KJ, Barlow W, Deyo RA: Medication use for low back pain in primary care. Spine. 1998, 23 (5): 607-14. 10.1097/00007632-199803010-00015.View ArticlePubMedGoogle Scholar
- Herman RM, D'Luzansky SC, Ippolito R: Intrathecal baclofen suppresses central pain in patients with spinal lesions. A pilot study. Clin J Pain. 1992, 8 (4): 338-345.View ArticlePubMedGoogle Scholar
- Abbruzzese G: The medical management of spasticity. Eur J Neurol. 2002, 9 (s1): 30-34. 10.1046/j.1468-1331.2002.0090s1030.x.View ArticlePubMedGoogle Scholar
- Loubser PG, Akman NM: Effects of intrathecal baclofen on chronic spinal cord injury pain. J Pain Symptom Manage. 1996, 12 (4): 241-247. 10.1016/0885-3924(96)00152-2.View ArticlePubMedGoogle Scholar
- Chan CWY, Tsang H: Inhibition of the human flexion reflex by low intensity, high frequency transcutaneous electrical stimulation (TENS) has a gradual onset and offset. Pain. 1987, 28 (2): 239-253. 10.1016/0304-3959(87)90119-9.View ArticlePubMedGoogle Scholar
- Kumazawa T: Nociceptors and autonomic nervous control. Asian Med J. 1981, 24: 632-656.Google Scholar
- Zheng Z, Guo RJ, Helme RD, Muir A, Costa CD, Xue CL: The effect of electroacupuncture on opioid-like medication consumption by chronic pain patients: A pilot randomized controlled clinical trial. EUR J Pain. 2008, 12 (5): 671-676. 10.1016/j.ejpain.2007.10.003.View ArticlePubMedGoogle Scholar
- Itoh K, Hirota S, Katsumi Y, Ochi H, Kitakoji H: A pilot study on using acupuncture and transcutaneous electrical nerve stimulation to treat knee osteoarthritis (OA). Chin Med. 2008, 3: 2-10.1186/1749-8546-3-2.PubMed CentralView ArticlePubMedGoogle Scholar
- Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001, 357 (9263): 1191-94. 10.1016/S0140-6736(00)04337-3.View ArticlePubMedGoogle Scholar
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.