Society for Acupuncture Research 2015 International Conference: Award-Winning Abstracts in Clinical and Basic Sciences

Acupuncture-enhanced Psychotherapy for Painful Endometriosis: A Randomized Controlled Pragmatic Trial with Brain Imaging

Florian Beissner, Somatosensory and Autonomic Therapy Research, Hannover Medical School, Hannover, Germany; Christine Preibisch, Department of Neuroradiology, Technical University Munich, Munich, Germany; Annemarie Schweizer-Arau, Practice for Psychotherapeutic Medicine, Diessen, Germany; Roxana M. Popovici, kïz) kinderwunsch im zentrum, Munich, Germany; Isabel Lange, Institute of Medical Psychology, Ludwig-Maximilians-University Munich, Germany; Barbara de Oriol, Department of Obstetrics and Gynecology, Technische Universität München, Munich, Germany; Karin Meissner, Institute of Medical Psychology, Ludwig-Maximilians-University, Munich, Germany

This randomized controlled pragmatic trial investigated whether patients with a history of endometriosis, who suffered from pelvic pain, may benefit from a treatment combining psychotherapeutic strategies with acupuncture point stimulation. In addition, patients underwent functional magnetic resonance imaging before and after a three months treatment period to identify brain processes underlying treatment success.

Sixty-seven adult females diagnosed with endometriosis were randomized to either three months of treatment or a waiting-list control group. After three months, the control group patients were eligible for treatment, too. We evaluated pain (global and pelvic, dyspareunia, dyschezia), quality of life (SF-12), anxiety and depression (HADS), as well as functional well-being (FW-7). Functional imaging analysis focused on intrinsic functional connectivity of the hippocampus, as the psychological intervention aimed at reducing the effects of traumatic memories.

Three months after randomization, the proportion of patients with reduction in global pain by at least 50% was markedly higher in the treatment group than in the control group (43.8 vs. 3.6%; p < 0.001). Mean improvements in global and pelvic pain, dyspareunia, restrictions in daily life activities, physical quality of life, anxiety and depression scores, and functional well-being were significantly larger in treated patients than in controls. The data after six months further corroborated the results.

Functional connectivity analysis revealed a significant interaction between time and group allocation in the right anterolateral hippocampus showing altered connectivity with the bilateral primary and secondary somatosensory cortices as well as the frontoinsular cortex.

We conclude that patients with a history of endometriosis, who suffer from pelvic pain, can obtain substantial benefit from acupuncture-enhanced psychotherapy by a mechanism involving brain regions of the emotional memory and somatosensory systems.

A Randomized Study Comparing the Effectiveness of Acupuncture or Morphine Versus the Combination for the Relief of Dyspnea in Patients with Advanced NSCLC and Mesothelioma

Jacqueline Filshie, Department of Anesthetics and Pain Management, The Royal Marsden Hospital; Anna Minchom, The Lung Unit, The Royal Marsden Hospital; Ravi Punwani, The Lung Unit, The Royal Marsden Hospital; Jaishree Bhosle, The Lung Unit, The Royal Marsden Hospital; Kofi Nimako, The Lung Unit, The Royal Marsden Hospital; Ranga Gunapala, The Lung Unit, The Royal Marsden Hospital; Sanjay Popat, The Lung Unit, The Royal Marsden Hospital; Mary O'Brien, The Lung Unit, The Royal Marsden Hospital

Background: Dyspnea is a common symptom of lung cancer. Morphine is widely used to control dyspnea.

Method: We randomized 173 patients with advanced NSCLC or mesothelioma with dyspnea score ≥4 on visual analogue scale (VAS) to one of three arms (acupuncture [A], morphine [M] or combination [AM]). A was delivered to upper sternal, paravertebral, hand and trapezius trigger points. Semi-permanent acupuncture studs were inserted in upper midline sternal points and patients instructed to massage them when dyspneic. Arm A were given rescue morphine if needed. We recorded VAS dyspnea and relaxation, lung function tests and EORTC QLQ-30/QLQ-LC13 questionnaires at baseline, 30 mins, 90 mins, 4 hours, day 2, 7 and 14. Primary endpoint was proportion of patients achieving ≥1.5 improvement in VAS dyspnea at 4 hours.

Results: Dyspnea improved by ≥1.5 points on VAS in 74% of patients in A, 60% in M and 66% in AM (A versus M p = 0.12, AM versus M p = 0.50). Mean VAS relaxation was improved in A (-1.06 ± 2.60) and AM (-1.48 ± 2.05) compared to M (0.19 ± 2.43; p < 0.001). Day 7 median LAR VAS anxiety score was improved in A (1.50) and AM (1.2) compared to M (0; p = 0.003). Day 7 median LAR VAS relaxation score was improved in A (-1) and AM (-0.94) arm compared to M (0; p = 0.006). 21% of patients in A, 87% in M and 87% in AM took one or more doses of morphine (p < 0.001). 8% of A, 35% of M and 39% of AM reported grade 1/2 toxicities in line with morphine's toxicity profile. Two cases of skin irritation were attributable to acupuncture site dressings.

Conclusion: Acupuncture was found to be as effective as morphine in treatment of dyspnea and has additive value for anxiety and relaxation. Acupuncture is morphine sparing. Acupuncture should be a treatment available to lung cancer patients with dyspnea.

Therapeutic Alliance between Patient and Practitioner Is Associated with Acupuncture Analgesia in Chronic Low Back Pain

Ishtiaq Mawla, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Jessica Gerber, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Stefanie DeLibero, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Ana Ortiz, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Ekaterina Protsenko, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Jaclyn Leiser, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Domenic Minicucci, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Jeungchan Lee, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Jieun Kim, Korea Institute of Oriental Medicine; MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Hyungjun Kim, Korea Institute of Oriental Medicine; MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Suk-Tak Chan, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Marco Loggia, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Brigham and Women's Hospital; Robert Edwards, Brigham and Women's Hospital; Ajay Wasan, University of Pittsburgh School of Medicine; Brigham and Women's Hospital; Chantal Berna, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Jian Kong, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Randy Gollub, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Bruce Rosen, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Ted Kaptchuk, Beth Israel Deaconess Medical Center; Vitaly Napadow, MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital; Logan College of Chiropractic; Kyunghee University

Introduction: Previous research provides compelling evidence that non-specific factors, such as patient/practitioner interaction, play an important role in acupuncture efficacy. One important factor may be therapeutic alliance, as perceived by the patient. We hypothesized that enhanced empathy and alliance influences the degree of analgesia experienced by chronic pain patients.

Methods: In a between-subjects design, chronic Low Back Pain (cLBP) subjects (N = 22, 12F, age: 46.1 ± 12.1, m±SD, back pain duration: 9.5 ± 8.2 years) were randomly assigned to one of three different forms of acupuncture treatment sessions, including 1)verum needle, 2)placebo needle, and 3)inactive laser acupuncture. Acupuncturists were trained to be neutral in their interaction with subjects throughout the treatment session. Low back pain intensity ratings were reported pre- and post-treatment (0–100 scale, anchors: no pain, worst pain imaginable). Upon conclusion of treatment, subjects completed the validated 10-item Consultation And Relational Empathy (CARE) questionnaire, designed to assess therapeutic alliance in treatment contexts (sample item: “How was the doctor at being interested in you as a whole person?”, 1–5 scale, anchors: Poor, Excellent). It was explicitly stated to subjects that acupuncturists would remain blinded to responses and a sealed envelope was provided for confidentiality.

Results: A Pearson's correlational analysis demonstrated that change in low back pain intensity (post-tx–pre-tx) was negatively correlated with CARE scores (r = −0.39, p < .001) i.e., greater therapeutic alliance was associated with greater analgesia across acupuncture treatments, regardless of treatment group.

Conclusions: Our results demonstrate that across treatment type and despite intended patient-practitioner interaction neutrality, subjects' experience of analgesia was linked with their perception of being cared for with empathic understanding. This result suggests that enhanced therapeutic alliance is important for beneficial clinical outcomes and could complement standard acupuncture protocols.

Brain White Matter Microstructure Changes Following Acupuncture Is Associated with Improved Clinical Outcomes for Carpal Tunnel Syndrome: A DTI Study

Hyungjun Kim, Korea Institute of Oriental Medicine; Yumi Maeda; Norman Kettner; Jeungchan Lee; Jieun Kim; Stephen Cina; Cristina Malatesta; Jessica Gerber; Claire McManus; Pia Mezzacappa; Rebecca Ong-Sutherland; Alexandra Libby; Leslie Morse; Kyungmo Park; Joseph Audette; Vitaly Napadow, Martinos Center for Biomedical Imaging

Purpose: We have previously demonstrated structural and functional brain neuroplasticity in primary sensorimotor (S1/M1) cortices for carpal tunnel syndrome (CTS), a common entrapment neuropathy associated with pain and paresthesia in the hand and wrist. We evaluated neuroplasticity following acupuncture in brain white matter related to primary somatosensory and motor areas.

Methods: We enrolled 60 CTS patients (49F, age = 49.7 ± 8.8) and 34 age and sex-matched healthy controls (25F, age = 48.6 ± 9.8). After baseline clinical and MRI evaluation, CTS patients were randomized to either local (n = 21), distal (n = 18), or sham (n = 21) acupuncture (2 months). Diffusion-weighted MRI images were used to quantify WM microstructure related to ROIs defined by somatotopic contra-and ipsi-lesional S1/M1 fMRI response to vibrotactile stimulation for median nerve innervated digits. Number of WM fibers and diffusivity measures were estimated for tracts leaving these ROIs using probabilistic tractography (FSL). Clinical measures were evaluated at baseline, following therapy, and at 3-month follow-up, and included median nerve latencies and Boston CTS Questionnaire (BCTSQ) symptom/functional scales.

Results: No differences were noted between local and distal acupuncture, which were then combined into a “verum” group. Verum, but not sham, acupuncture improved nerve latencies (P = 0.04), while BCTSQ outcomes were improved for all groups following therapy, but only verum acupuncture at 3-month follow-up. Verum acupuncture increased ipsilesional M1 tract fiber number to a greater degree than sham (P = 0.04). Moreover, after verum and not sham acupuncture, changes in this tract's mean diffusivity and fiber number were correlated with changes in BCTSQ symptom severity at 3 month follow-up (r = −0.43, P = 0.02; r = 0.38, P = 0.04, respectively).

Conclusion: Verum acupuncture improved both symptoms and peripheral nerve conduction in CTS. Acupuncture also induced changes in M1-associated white matter microstructure, and this change was closely associated with long-term improvements in symptom severity. Our study demonstrates that brain white matter neuroplasticity is sensitive to acupuncture therapy.

Acupuncture with Manual and Electrical Stimulation for Labor Pain

Linda Vixner, Karolinska Institutet, Stockholm, Sweden. Dalarna University, Falun Sweden; Erica Schytt, Karolinska Institutet, Stockholm, Sweden; Elisabet Stener-Victorin, Karolinska Institutet, Stockholm, Sweden; Ulla Waldenström, Karolinska Institutet, Stockholm, Sweden; Lena Mårtensson, University of Skövde, Skövde, Sweden

Background: Previous studies are inconclusive regarding the effect of acupuncture on labor pain. The appropriate dose of acupuncture treatment required to elicit a potential effect on labor pain has not been fully explored. The overall aim of this thesis was to evaluate the effectiveness of acupuncture with manual stimulation (MA) of the needles as well as acupuncture with a combination of manual and electrical stimulation (EA) in reducing labor pain, compared with standard care without any form of acupuncture (SC).

Methods: The study was designed as a three-armed randomized controlled trial in which 303 nulliparous women with normal pregnancies were randomized to MA, EA, or SC. The primary outcome was labor pain, assessed using the Visual Analogue Scale (VAS). Secondary outcomes were relaxation, obstetric pain relief, labor and infant outcomes, recollection of pain and birth experience. The sample size calculation was based on the potential to discover a difference of 15 mm on the VAS.

Results: The mean VAS scores were 66.4 in the MA group, 68.5 in the EA group, and 69.0 in the SC group (mean differences: MA vs. SC 2.6 95% CI −1.7 to 6.9, and EA vs. SC 0.6 95% CI −3.6 to 4.8). Other methods of pain relief were used less frequently in the EA group, including epidural analgesia, MA 61.4%, EA 46%, and SC 69.9%. (EA vs. SC OR 0.4 95% CI 0.2 to 0.7)

Conclusion: Acupuncture, regardless of type of stimulation, did not differ from standard care without acupuncture in terms of reducing women's experience of pain during labor, or their memory of pain and childbirth overall two months after the birth. However, other forms of obstetric pain relief were less frequent in women receiving a combination of manual and electrical stimulation, suggesting that this method could facilitate coping with labor pain.

“Evidence-Informed Manualization”: Development and Feasibility Assessment of a Manual for Acupuncture during Acute Post-stroke Care

Claudia Citkovitz, Lutheran Medical Center, Brooklyn, NY; Belinda Anderson, Pacific College of Oriental Medicine, New York, NY; Patricia Cassidy, Lutheran Medical Center, Brooklyn, NY; Sally Rappeport, Lutheran Medical Center, Brooklyn, NY; Paul Ryan, Lutheran Medical Center, Brooklyn, NY; Volker Scheid, University of Westminster, London, UK

Purpose: In acupuncture research, treatment manualization serves to balance competing imperatives of individualization and repeatability. Manuals for previous clinical trials have been developed a priori by consensus processes; these provide insufficient individualization for acute post-stroke care, given the heterogeneity of patient presentation and plurality of acupuncture treatment approaches available. This study's approach drew on existing frameworks for complex interventions research, as well as manualization in nursing, rehabilitation medicine and other disciplines. Acupuncturist researchers developed the manual iteratively through cycles of information-gathering, planning, implementation and evaluation over 25 months.

Methods: At an inpatient neurology/rehabilitation unit, work proceeded in three phases: literature review and clinical self-observation by acupuncturists; development and use/evaluation of the manual's logical structures; and finally piloting the manual in a concurrent cohort study (N = 48). In this pragmatic approach, departures from the manual were permitted to optimize patient care. These departures then drove ongoing revisions of the manual, as an end product of the study. The resulting manual had two parts. First, flowsheets guided initial patient assessment and treatment, as well as ongoing treatment for the majority of patients. Second, for unusual or refractory cases, an index summarized best available evidence for consultation by the acupuncturist.

Results: Acupuncturists reported rationales for all departures. Within 205 treatments, manualized treatments were seldom seen as inappropriate (2 departures, or 1%) or suboptimal (4, or 2%). Results of the cohort study suggest feasibility of future trials for outcomes of functional independence, bowel function and sleep. A survey of stakeholders in the rehabilitation process (patients, family members, nurses, physicians and rehabilitation therapists) found that manualized treatments were widely perceived as beneficial.

Conclusions: “Evidence-informed manualization” of acupuncture treatment is accepted by acupuncturists and patients. It provides both individualization and repeatability, also allowing for revision on the basis of patient encounters during the study.