Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. Paraspinal Stimulation Combined With Trigger Point Needling and Needle Rotation for the Treatment of Myofascial Pain: A Randomized Sham-controlled Clinical Trial Cla ´udio Couto, MD, MS,* Izabel Cristina C. de Souza, PhD,*w Iraci L.S. Torres, PharmD, PhD,*z Felipe Fregni, MD, PhD,y8 and Wolnei Caumo, MD, PhD*wzz# Background: There are different types and parameters of dry nee- dling (DN) that can affect its efficacy in the treatment of pain that have not been assessed properly. Objective: To test the hypothesis that either multiple deep intra- muscular stimulation therapy multiple deep intramuscular stim- ulation therapy (MDIMST) or TrP lidocaine injection (LTrP-I) is more effective than a placebo-sham for the treatment of myofascial pain syndrome (MPS) and that MDIMST is more effective than LTrP-I for improving pain relief, sleep quality, and the physical and mental state of the patient. Methods: Seventy-eight females aged 20 to 40 who were limited in their ability to perform active and routine activities due to MPS in the previous 3 months were recruited. The participants were randomized into 1 of the 3 groups as follows: placebo-sham, LTrP- I, or MDIMST. The treatments were provided twice weekly over 4 weeks using standardized MDIMST and LTrP-I protocols. Results: There was a significant interaction (time vs. group) for the main outcomes. Compared with the sham-treated group, MDIMST and LTrP-I administration improved pain scores based on a visual analog scale, the pain pressure threshold (P < 0.001 for all analyses), and analgesic use (P < 0.01 for all analyses). In addition, when comparing the active groups for these outcomes, MDIMST resulted in better improvement than LTrP-I (P < 0.01 for all analyses). In addition, both active treatments had a clinical effect, as assessed by a sleep diary and by the SF-12 physical and mental health scores. Conclusions: This study highlighted the greater efficacy of MDIMST over the placebo-sham and LTrP-I and indicated that both active treatments are more effective than placebo-sham for MPS associated with limitations in active and routine activities. Key Words: myofascial pain syndrome, intramuscular stimulation, acupuncture, sleep quality, pain threshold (Clin J Pain 2013;00:000–000) M yofascial pain syndrome (MPS) is characterized by the presence of myofascial trigger points (TrPs). 1 TrPs are defined as localized, hyperirritable nodules nested within a palpable taut band of skeletal muscle or fascia. 2 TrPs were the source of pain for 30% to 85% of patients with MPS presenting in the primary care setting and pain clinics according to some epidemiologic studies. 3–5 TrP injections (TrP-I) with local anesthetics have been performed to alleviate musculoskeletal pain since the early 1930s. According to the results of several studies, injection continues to be the most common choice for treatment. 6–8 However, the superiority of local injection or dry needling (DN) for the inactivation of TrP is controversial; both techniques have shown similar therapeutic efficacies. 7,9 Given the evidence presented above, we sought to compare the effects of TrP injection and DN in the same context. In this way, we would be able to examine whether one treat- ment is beneficial compared to the other, and we could compare both treatments against a placebo because this information is relevant to future clinical decisions. The intramuscular stimulation (IMS) technique is a type of DN that is applied in the spinal segment of the nerve roots associated with the dermatome, myotome, or scle- rotome, where the trigger points were found. 10,11 Previous studies revealed that IMS may be superior to DN at TrP 12,13 and classic methods 7,12,14 for the alleviation of pain in MPS. However, these findings are counterbalanced by inconsistent results from meta-analyses 15–17 regarding the effectiveness of acupuncture and DN for myofascial TrP, 17 back and neck pain. 15–17 These gaps are corroborated by the lack of studies examining the efficacy of acupuncture and/or DN treatment for pain conditions in the same context. Parameters such as the site 18 and depth of needle penetration, 19 the combined application of TrP injection and paraspinal DN, 20 and needle rotation (NR) 21 should be taken into consideration. Thus, we designed this study to Received for publication November 3, 2012; accepted March 19, 2013. From the zPain and Palliative Care Service at the Hospital de Clı´nicas de Porto Alegre (HCPA), Universidade Federal do Rio Grande do Sul (UFRGS); zPharmacology Department, Instituto de Cieˆncias Ba´sicas da Sau´de, UFRGS, Brazil; *Post Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS); wLaboratory of Pain & Neuro- modulation at HCPA/UFRGS; yLaboratory of Neuromodulation, Department of Physical Medicine & Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital; 8Physical Medicine and Rehabilitation; and #Neurology Harvard Medical School. Supported by grants from the following Brazilian agencies: The Com- mittee for the Development of Higher Education Personnel— CAPES—PNPD/CAPES (for W.C. and I.C.C.S), the National Council for Scientific and Technological Development—CNPq (I.L.S.T. and W.C.); and the Foundation of Support of Research at Rio Grande do Sul (FAPERGS). F.F. is supported by an NIH grant (5R21DK081773-03). The authors declare no conflict of interest. Reprints: Wolnei Caumo, MD, PhD, Rua Ramiro Barcelos, 2350, zip code 90035-003 Bairro Rio Branco, Porto Alegre, RS, Brazil (e-mail: caumo@cpovo.net). Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Website, www.clinicalpain.com. Copyright r 2013 by Lippincott Williams & Wilkins ORIGINAL ARTICLE Clin J Pain  Volume 00, Number 00, ’’ 2013 www.clinicalpain.com | 1