Design of a randomised acupuncture trial on functional neck/shoulder stiffness with two placebo controls

Background: Functional neck/shoulder stiffness is one of the most well-known indications for acupuncture treatment in Japan. There is little evidence for the effectiveness of acupuncture treatment for functional neck/shoulder stiffness. Research using two different placebos may allow an efficient method to tease apart the components of real acupuncture from various kinds of ‘non-specific’ effects such as ritual with touch or ritual alone. Herein, we describe a protocol of an ongoing, single-centre, randomised, placebo-controlled trial which aims to assess whether, in functional neck/shoulder stiffness, acupuncture treatment with skin piercing has a specific effect over two types of placebo: skin-touching plus ritual or ritual alone. Methods: Six acupuncturists and 400 patients with functional neck/shoulder stiffness are randomly assigned to four treatment groups: genuine acupuncture penetrating the skin, skin-touch placebo or no-touch placebo needles in a double-blind manner (practitioner-patient blinding) or no-treatment control group. Each acupuncturist applies a needle to each of four acupoints (Bladder10, Small Intestine14, Gallbladder21 and Bladder42) in the neck/shoulder to 50 patients. Before, immediately after and 24 hours after the treatment, patients are asked about the intensity of their neck/shoulder stiffness. After the treatment, practitioners and patients are asked to guess whether the treatment is “penetrating”, “skin-touch” or “no-touch” or to record “cannot identify the treatment”. Discussion In addition to intention-to-treat analysis, we will conduct subgroup analysis based on practitioners’ or patients’ guesses to discuss the efficacy and effectiveness of treatments with skin piercing and various placebo controls. The results of practitioner and patient blinding will be discussed. We believe this study will further distinguish the role of different components of acupuncture. Trial registration Current Controlled Trial ISRCTN7689601

Characteristics of Surface Electromyograph Activity of Cervical Extensors and Flexors in Nonspecific Neck Pain Patients: A Cross-Sectional Study

Background and Objectives: We identified typical surface electromyogram (sEMG) activities of the cervical extensors and flexors during motions in the three anatomical planes in healthy adults. The aim of this study was to explore characteristics of sEMG activities of these cervical muscles in nonspecific neck pain (NSNP) patients based on healthy adults. Materials and Methods: Participants were 24 NSNP patients (NSNP group, mean ± SD of age, 47.5 ± 15.5) and 24 healthy adults (control group, 20.5 ± 1.4). For each participant, sEMG of the cervical extensors and flexors was recorded during neck flexion, extension, bilateral lateral flexion, bilateral rotation, and at the neutral position in Phase I (the neck from the neutral position to the maximum range of motion), Phase II (at the maximum range of motion), and Phase III (from the maximum range of motion to the neutral position), yielding a total of 42 phases. A percentage of maximum voluntary contraction to normalize muscle activity in each phase was calculated to obtain the ratio of muscle activities in the extensors and flexors in each of 36 phases of the motions to the neutral position and ratio of the flexors to extensors in activity for 21 phases. Results: In 28 of 36 phases of the motions, the ratios of muscle activities in the extensors and flexors to the neutral position in the NSNP group were significantly larger than the control group (p p Conclusions: In NSNP patients, the activity of the cervical extensors and flexors associated with neck motion increased with an imbalance in activity between these muscles compared to their activity in healthy adults. The results of this study will be useful in understanding the pathogenesis of NSNP and in constructing an objective evaluation of the treatment efficacy on NSNP patients

The Mode of Activity of Cervical Extensors and Flexors in Healthy Adults: A Cross-Sectional Study

Background and Objectives: The purpose of this study was to investigate the activity of bilateral cervical extensors and flexors on the sagittal, frontal, and horizontal planes of healthy adults during motions of the neck in a sitting position, which has not been satisfactorily investigated by surface electromyogram (sEMG). Materialand Methods: We recruited 35 healthy participants (mean ± standard deviation of age, 20.3 ± 2.4). sEMG recordings of the cervical extensors and flexors were performed for a total of nine seconds in three phases: Phase I involved the motion of the neck from the neutral position to the maximum range of motion; Phase II involved maintaining the neck at the maximum range of motion; and Phase III involved the motion of the neck from the maximum range of motion to the neutral position during neck flexion, extension, right and left lateral flexion, right and left rotation, and maintaining the neck in the neutral position. Muscle activities in each motion were normalized as a percentage of maximal voluntary contraction (%MVC) so that the muscles could be compared. Results: The %MVC of the extensors was significantly larger than that of the flexors in the neutral position (p < 0.001). In addition, the %MVCs of the following were significantly larger than the %MVC in the neutral position: the extensors in flexion (p = 0.014) and extension (p = 0.020), the ipsilateral extensors (p = 0.006) and flexors (p < 0.001) in lateral flexion in Phase I; the flexors in flexion (p < 0.001), the extensors in extension (p = 0.010), and the ipsilateral extensors and flexors in lateral flexion (p < 0.001) in Phase II; the extensors and flexors in flexion (p < 0.001), the flexors in extension (p < 0.001), the ipsilateral flexors (p < 0.001), the contralateral flexors (p = 0.004) and the contralateral extensors (p = 0.018) in lateral flexion in Phase III; and the bilateral extensors and contralateral flexors during rotation in all three phases (p < 0.001). Conclusion: The typical sEMG activities of the extensors and flexors during motion of the neck in healthy adults were identified in this study; this information can be used to understand the pathophysiology of non-specific neck pain and to provide an index for evaluating the effect of treatment

Corrugator Muscle Activity Associated with Pressure Pain in Adults with Neck/Shoulder Pain

Background and Objectives: No studies have reported corrugator muscle activity associated with pain in people with pain. This study aimed to develop an objective pain assessment method using corrugator muscle activity with pressure pain stimulation to the skeletal muscle. Methods: Participants were 20 adults (a mean ± SD age of 22.0 ± 3.1 years) with chronic neck/shoulder pain. Surface electromyography (sEMG) of corrugator muscle activity at rest (baseline) and without and with pressure pain stimulation applied to the most painful tender point in the shoulder was recorded. Participants evaluated the intensity of the neck/shoulder pain and the sensory and affective components of pain with pressure stimulation using a visual analogue scale (VAS). The percentages of integrated sEMG (% corrugator activity) without and with pressure pain stimulation to the baseline integrated sEMG were compared, and the relationships between the % corrugator activity and the sensory and affective components of pain VAS scores were evaluated. Results: Without pressure stimulation, an increase in corrugator muscle activity due to chronic neck/shoulder pain was not observed. The % corrugator activity with pressure pain stimulation was significantly higher than that without stimulation (p p = 0.039) and a tendency of positive correlation was found for the sensory component of pain VAS scores (ρ = 0.423, p = 0.063). Conclusions: The increase in corrugator muscle activity with pressure pain stimulation to the tender point in adults with chronic neck/shoulder pain was observed, although increased corrugator muscle activity resulting from the chronic neck/shoulder pain was not. These findings suggest that corrugator muscle activity with pressure pain stimulation can be a useful objective indication for tender point sensitivity assessment in the skeletal muscle with pain

The Potential of Double Blinding with Two Placebo Acupuncture Needles: A Randomized Controlled Pilot-Trial

Background: Whether acupuncture treatment employing multiple penetrating, skin-touch placebo, or no-touch placebo needles designed for double blinding actually do blind practitioners and patients has not been investigated. We aimed to investigate this question. Subjects: 120 patients with functional neck/shoulder stiffness but in otherwise healthy condition were randomly assigned to a treatment using four penetrating, four skin-touch placebo, or four no-touch placebo needles. Each of six acupuncturists applied four needles to four acupoints in the neck/shoulder of 20 patients. Acupuncturists and patients were asked to guess the treatment mode and their confidence in their guesses on 100 mm visual analog scales. Results: The kappa coefficients between practitioner guesses and treatment type and between patient guesses and treatment type were 0.15 and 0.44, respectively. The median score of practitioner confidence was 46.8, and no significant difference in confidence between correct and incorrect guesses was revealed for any treatment. The median score of patient confidence for correct guesses was 77.6. The kappa coefficient between practitioner and patient guesses was 0.06. Conclusions: The practitioners were blinded to the nature of treatment using the same multiple needles, but patient blinding was insufficient. Further improvement is necessary to achieve satisfactory patient blinding with these acupuncture needles

Is Skin-Touch Sham Needle Not Placebo? A Double-Blind Crossover Study on Pain Alleviation

It remains an open question whether placebo/sham acupuncture, in which the needle tip presses the skin, can be used as a placebo device for research on pain. We compare the analgesic effect of the skin-touch placebo needle with that of the no-touch placebo needle, in which the needle tip does not touch the skin, in a double-blind crossover manner including no-treatment control in 23 healthy volunteers. The subjects received painful electrical stimulation in the forearm before and during needle retention to the LI 4 acupoint and after the removal of the needle and rated pain intensity using a visual analogue scale. We found no significant difference in analgesic effects among the skin-touch placebo needle, no-touch placebo needle, and no-treatment control at every point before, during, and after the treatments (p>0.05). The results indicate that the skin-touch placebo needle can be used as a placebo device in clinical studies on pain