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 < 0.01). A significant positive correlation between corrugator muscle activity and the affective components of pain VAS scores with pressure stimulation was found (ρ = 0.465, 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.

Effects of acupuncture and acupressure of the acupoint compared to the tendon on the blood circulation of human tendon in vivo.

PURPOSE: The purpose of this study was to compare the effects of acupuncture and acupressure of acupoints on tendon blood circulation with those of both types of stimulation of tendon itself. METHODS: Before, during (except for acupressure), and after acupuncture and acupressure of the tendon and acupoint, blood circulation of the Achilles tendon was measured using red laser lights. RESULTS: The blood volume of the treated and non-treated tendons increased after acupuncture of the tendon (effect of time p = 0.030), whereas that tended to increase after acupuncture of the acupoint (effect of time p = 0.063). In addition, no significant difference in the increases in blood volume was found among the four conditions, i.e., after acupuncture stimulation of the tendon and acupoint for the treated and non-treated tendons (p = 0.492). The blood volume of the treated tendon significantly increased after acupressure of the tendon (effect of time p < 0.001), but not of the acupoint (effect of time p = 0.260), whereas that of the non-treated tendon did not change after acupressure of both the tendon and acupoint. CONCLUSION: These results suggested that acupuncture of the tendon and acupoint acted centrally to enhance blood circulation of both the treated and non-treated tendons during the recovery period, whereas acupressure of the tendon locally increased blood circulation of the treated tendon only, but not the non-treated tendon and both the treated and non-treated tendons after acupressure of acupoint.

Acupuncture for Japanese Katakori (Chronic Neck Pain): A Randomized Placebo-Controlled Double-Blind Study.

Background and Objectives: Although acupuncture is listed as a beneficial treatment for neck/shoulder stiffness, which has increased with the spread of information technology, to date, evidence of its efficacy under double-blind conditions has not been shown. This study aimed to assess whether acupuncture treatment with superficial skin piercing is superior to placebo treatment. Materials and Methods: A randomized, double-blind (practitioner-patient) placebo-controlled trial was performed at a single center with four arms (ISRCTN76896018). Four hundred patients with essential neck/shoulder stiffness were randomly assigned to penetrating needle treatment (acupuncture ritual and skin penetration), skin-touch needle treatment (acupuncture ritual and skin touch), no-touch needle treatment (acupuncture ritual alone), and no-treatment control. Each of the six acupuncturists applied a needle to each of the four acupoints in the neck/shoulder of 50 patients. Results: Each of the three treatments significantly (p = 0.01) improved neck/shoulder stiffness compared with the no-treatment control immediately and 24 h after treatment. There was a significant improvement in penetrating needle treatment over no-touch needle treatment 24 h later. However, there was no significant difference between the penetrating and skin-touch and skin-touch vs. no-touch. Conclusions: All treatments that received the ritual of acupuncture were better than the no-treatment control. Only genuine acupuncture involves the specific effects of needle insertion into the body. The acupuncture ritual had a significant impact on the subjective improvement of neck/shoulder stiffness; however, improvement with ritual alone versions of placebo acupuncture was not maintained as with superficial skin piercing. Our study provides important evidence of acupuncture efficacy and information regarding inert no-touch placebo control in acupuncture research.

Evaluation and Treatment of Vulvodynia: State of the Science.

Vulvodynia affects 7% of American women, yet clinicians often lack awareness of its presentation. It is underdiagnosed and often misdiagnosed as vaginitis. The etiology of vulvodynia remains unknown, making it difficult to identify or develop effective treatment methods. The purpose of this article is to (1) review the presentation and evaluation of vulvodynia, (2) review the research on vulvodynia treatments, and (3) aid the clinician in the selection of vulvodynia treatment methods. The level of evidence to support vulvodynia treatment varies from case series to randomized controlled trials (RCTs). Oral desipramine with 5% lidocaine cream, intravaginal diazepam tablets with intravaginal transcutaneous electric nerve stimulation (TENS), botulinum toxin type A 50 units, enoxaparin sodium subcutaneous injections, intravaginal TENS (as a single therapy), multimodal physical therapy, overnight 5% lidocaine ointment, and acupuncture had the highest level of evidence with at least one RCT or comparative effectiveness trial. Pre to posttest reduction in vulvar pain and/or dyspareunia in non-RCT studies included studies of gabapentin cream, amitriptyline cream, amitriptyline with baclofen cream, up to 6 weeks' oral itraconazole therapy, multimodal physical therapy, vaginal dilators, electromyography biofeedback, hypnotherapy, cognitive behavioral therapy, cold knife vestibulectomy, and laser therapy. There is a lack of rigorous RCTs with large sample sizes for the treatment of vulvodynia, rendering it difficult to determine efficacy of most treatment methods. Clinicians will be guided in the selection of best treatments for vulvodynia that have the highest level of evidence and are least invasive.

Women's Experience of Living with Vulvodynia Pain: Why They Participated in a Randomized Controlled Trial of Acupuncture.

Introduction: Vulvodynia is vulvar pain lasting at least 3-months without clear identifiable cause that may have other associated factors. The aim, to explore motivations of women participating in a double-blind randomized controlled trial of acupuncture for vulvodynia. Methods: Responses to the question: "Tell me about why you decided to participate in this study" were analyzed using conceptual content analysis to identify patterns in motivation for study participation. Results: Four patterns emerged: 1) desire to address uncontrolled pain, 2) desire for understanding, 3) wish to contribute to knowledge generation, and 4) need to remove cost barriers. Conclusion: Motivations indicate vulvodynia-specific aspects of acceptability of acupuncture. Clinical Trial Registration: NCT03364127.

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 < 0.05). In 6 of 21 phases, the ratios of the flexors to extensors in activity in the NSNP group were significantly larger than in the control group (p < 0.05). 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.

Protocol for double-blind RCT of acupuncture for vulvodynia.

Background: Vulvodynia, vulvar pain of unknown origin lasting at least 3 months, affects 7% of American women. Dyspareunia, its frequent companion, renders sexual intercourse virtually impossible. Although few therapies are efficacious and rapid pain relief is rarely possible, there have been no sham/placebo-controlled studies of acupuncture for vulvodynia. Aims are to: 1) determine efficacy of acupuncture for vulvodynia, 2) explore duration of the acupuncture effect. Methods: In a pretest/posttest randomized controlled, double-blind (practitioner-patient) efficacy trial of a standardized acupuncture protocol, we will randomize 80 participants 1:1 to either penetrating needle or skin-touch placebo needle groups. Both types of needles are designed to blind both the acupuncturist and participant. Participants with vulvodynia will insert and remove a tampon as a standardized stimulus and complete primary measures of vulvar pain (pain intensity) and secondary measures of dyspareunia (Female Sexual Function Index, FSFI dyspareunia subscale score) and sexual function (FSFI total score) pretreatment, after the 10th acupuncture session, and pain measures weekly until return to pretest levels. Upon study completion control group participants will be offered 10 free real acupuncture sessions. Discussion: This is the first multi-needle multi-session RCT using double-blind acupuncture needles as a reliable sham. We hypothesize that controlling for baseline, at posttest there will be statistically significant less vulvar pain and dyspareunia and more sexual function over five weeks in the penetrating needle group compared to the skin touch placebo group. Conclusion: This study is responsive to the need for efficacious pain management for women with vulvodynia.ClinicalTrials.gov Identifier: NCT03364127.

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.

Effects on Acupuncturist Blinding: Different Diameters of Double-blind Acupuncture Needles.

CONTEXT: It's difficult to conduct experiments using a double-blind design in controlled clinical trials of acupuncture. To resolve this problem with blinding, we designed double-blind needles (DBNs) with stuffing to mimic the resistance felt during insertion of a regular acupuncture needle. Results of the past studies using 0.16 mm diameter DBNs found that the resistance felt by the acupuncturists during insertion successfully blinded them. OBJECTIVE: The study intended to compare the effects on an acupuncturist's blinding when the practitioner used penetrating DBNs with 0.14, 0.16, 0.18, and 0.20 mm diameters. DESIGN: We conducted a double-blind randomized trial. SETTING: The study took place at the Japan School of Acupuncture, Moxibustion. and Physiotherapy in Tokyo, Japan. PARTICIPANTS: The participant was one licensed acupuncturist who performed 320 needle insertions during acupuncture for 20 healthy students, who were familiar with acupuncture and who attended the Japan School of Acupuncture, Moxibustion, and Physiotherapy. METHODS: The acupuncturist was informed she would administer a penetrating or non-penetrating needle; however, only penetrating needles were used. She inserted the four sizes of needles in both of each student's dorsal forearms using an alternating twirling technique. This procedure was repeated once more on another day, with at least one day between sessions. PRIMARY OUTCOME MEASURES: After the acupuncturist removed each needle, we asked her to guess: (1) the type of needle inserted, (2) her level of confidence in the guess, and (3) the clues that contributed to her guess. A chi-squared test was used to determine whether the ratio of correctly or incorrectly identified needles met an expected probability of 0.5 for each needle diameter. RESULTS: Of the 320 needle insertions, the acupuncturist correctly identified 54% of 0.14 mm, 45% of 0.16 mm, 46% of 0.18 mm, and 50% of 0.20 mm needle insertions. The correct and incorrect ratios of identified needles were fitted with a probability of 0.5, with no significant differences in the acupuncturist's confidence (P = .16). In 99% of the tests, the cue that contributed to the acupuncturist's guess was the feeling of the needle insertion. CONCLUSION: These findings indicate that the differences in the diameters of DBNs from 0.14 to 0.20 mm didn't significantly affect the acupuncturist's blinding.

Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.

BACKGROUND: Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia. METHODS: Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding. RESULTS: At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments. DISCUSSION: Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.

Changes in Blood Circulation of the Tendons and Heart Rate Variability During and After Acupuncture.

Objective: The purpose of this study was to investigate the changes in blood circulation of tendons and heart rate variability (HRV) during and after acupuncture in order to elucidate the mechanisms of acupuncture-induced changes in tendon blood circulation. Materials and Methods: During 10 minutes of acupuncture treatment and a recovery period of 40 minutes, blood volume (THb) and oxygen saturation (StO2) of treated and nontreated tendons were measured using red laser lights. In addition, HRV was also measured during the experimental period. Results: THb and StO2 of the treated tendons significantly increased during acupuncture, and then remained high during the recovery period. THb and StO2 of the nontreated tendons did not change during acupuncture but gradually increased during the recovery period. In addition, the increase in THb of the nontreated tendons were significantly correlated with that of the treated tendons during the latter half of the recovery period. Heart rate (HR) continued to decrease during acupuncture and suddenly returned to the initial level after removal of the needle. The low-frequency (LF)/high-frequency (HF) ratio tended to increase during the recovery period. During the latter half of the recovery period, the changes in THb for both the treated and nontreated tendons were negatively correlated with the change in HR but not with changes in the LF/HF ratio. Conclusions: These results suggest that changes in blood circulation of tendons after acupuncture treatment were controlled by the autonomic nervous system, which could not be detected by HRV analysis.

Acupuncture- and Intermittent Compression-Induced Changes in Blood Circulation of Tendon.

Objective: The purpose of this study was to compare changes in blood circulation (blood volume and oxygen saturation [StO2]) of tendon by acupuncture (insertion depth of the needle was 4 mm) and intermittent compression. Subjects: Thirteen healthy volunteers (12 males and 1 female; age: 26.9 ± 9.8 years) participated in this study. Methods: Before the treatments (10 min for acupuncture, 3 min for intermittent compression, and 10 min for control condition) and the recovery period (40 min), the blood volume (total hemoglobin [THb]) and StO2 of treated and nontreated Achilles tendons were measured using red laser lights. Results: Regarding the acupuncture-induced changes in blood circulation of tendons, THb and StO2 of the treated tendon suddenly increased during acupuncture with up-and-down manipulation, and those of the treated and nontreated tendons gradually increased after removal of the needle. The authors were not able to present the measured variables during intermittent compression, since obvious noises were observed. After acupuncture and intermittent compression, THb and StO2 of the treated tendon remained high during the recovery period and those of the nontreated tendon gradually increased during the latter half of the recovery period. There were no differences in the mean changes of THb or StO2 of the treated and nontreated tendons during the recovery period between acupuncture and intermittent compression. Under the control condition, no significant changes were noted in the measured variables. Conclusion: These results suggest that intermittent compression to the tendon brought about increases in tendon blood circulation similar to those induced by acupuncture.

Acupuncture to Improve Symptoms for Stable Angina: Protocol for a Randomized Controlled Trial.

BACKGROUND: Acupuncture has demonstrated physiologic analgesic effects in Chinese patients with stable angina. One proposed mechanism of action for these analgesic effects is the downregulation of M1 macrophages, interleukin 1 beta, interleukin-6, interleukin-18, and tumor necrosis factor alpha. OBJECTIVE: This study aims to test a 10-session, 5-week acupuncture treatment protocol as a complementary therapy for symptoms of stable angina for American patients, who vary from Chinese patients in health care systems and other salient variables. METHODS: We are conducting a randomized controlled trial (RCT) of 69 adults (35 assigned to initial acupuncture and 34 to an attention control condition) with a medically confirmed diagnosis of stable angina, whose pain and associated symptoms have not been controlled to their satisfaction with guideline-directed medical management. Participants in the experimental group will receive a standardized traditional Chinese medicine point prescription. The attention control group will view non-pain-related health education videos over 5 weeks equal to the 10 hours of treatment for the acupuncture group. Participants will complete the McGill Pain Questionnaire and the Seattle Angina Questionnaire-7, as well as have inflammatory cytokines measured at baseline and study completion. The primary outcomes are anginal pain and quality of life. RESULTS: This study has been funded over 2 years by the National Institutes of Health, National Institute for Nursing Research. We are currently recruiting and expect to have initial results by December 2020. CONCLUSIONS: We will generate data on feasibility, acceptability, effect sizes, and protocol revisions for a future fully powered RCT of the protocol. Findings will help determine if patients with persistent ischemic symptoms experience a proinflammatory state and hyperalgesia caused by multiple neural and immune processes not always relieved with medication. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14705.

A Double-Blind Study on Acupuncture Sensations with Japanese Style of Acupuncture: Comparison between Penetrating and Placebo Needles.

To investigate the acupuncture sensations elicited by the Japanese style of acupuncture, penetrating acupuncture and skin-touch placebo needles were randomly administered at various insertion depths (5 and 10 mm for the penetrating needles and 1 and 2 mm for the placebo needles) at LI4 to 50 healthy subjects. Among the 12 acupuncture sensations in the Massachusetts General Hospital Acupuncture Sensation Scale (MASS), "heaviness" was the strongest and most frequently reported sensation with the 10 mm needles, but not with the 5 mm needles. There were no significant differences in number of sensations elicited, MASS index, range of spreading, and intensity of needle pain for 5 mm penetration versus 1 mm skin press and 10 mm penetration versus 2 mm skin press. The MASS index with 2 mm skin-touch needles was significantly larger than that with 1 mm skin-touch and 5 mm penetrating needles. The factor structures in the 12 acupuncture sensations between penetrating and skin-touch needles were different. The acupuncture sensations obtained in this study under satisfactorily performed double-blind (practitioner-patient) conditions suggest that a slight difference in insertion depth and skin press causes significant differences in quantity and quality of acupuncture sensations.

Patient blinding with blunt tip placebo acupuncture needles: comparison between 1 mm and 2 mm skin press.

OBJECTIVE: To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter. METHODS: Forty healthy volunteers were enrolled as subjects for patient blinding. Four acupuncturists applied the following needles randomly at three points in each forearm: 0.18 mm and 0.25 mm diameter penetrating needles inserted to a depth of 5 mm, and 0.18 mm and 0.25 mm diameter skin-touch needles depressing the skin at the acupoint to a depth of 1 mm and 2 mm from the skin surface. The subjects reported their guesses at the nature of needles they received, and rated needle pain and de qi. A blinding index was calculated to define the success of blinding for subjects. RESULTS: The blinding status of subjects for 1 mm press needles of 0.18 mm diameter was "random guess", but "unblinded" for 1 mm press needles of 0.25 mm diameter. For 2 mm press needles of both diameters, the blinding status was "opposite guess" and the blinding status for penetrating needles of both diameters was "unblinded." The percentages of "felt pain" with 2 mm press needles of both diameters were similar to that with penetrating needles, but those were not similar for 1 mm press needles. The frequency of de qi occurrence with 2 mm press needles of 0.18 mm diameter was similar to that of penetrating needles of both diameters. CONCLUSION: Placebo needles of 2 mm press made more subjects guess that the needles penetrated the skin than 1 mm press needles. The use of small diameter needles increased patient blinding.