scholarly journals Traditional Acupuncture and Laser Acupuncture in Chronic Nonspecific Neck Pain: Study Protocol for a Randomized Controlled Trial

Author(s):  
RAFAELA PERON ◽  
Érika Patrícia Rampazo ◽  
Richard Eloin Liebano

Abstract Background: Nonspecific neck pain is a multifactorial and very common condition in adult individuals. No reports were found in the literature comparing the effectiveness of Traditional Acupuncture (TA) and Laser Acupuncture (LA) in cases of chronic nonspecific neck pain. Therefore, the aim of the present study is to investigate the effectiveness of TA and LA therapies in individuals with chronic nonspecific neck pain.Methods/design: This study will be a controlled and randomized clinical trial. A total of 60 individuals will be randomized into two groups (30 each). The TA group will receive the acupuncture treatment using needles, while the LA group will receive the laser acupuncture treatment. The acupuncture points (Tianzhu, Fengchi, Jianjing, and Jianzhongshu) will be stimulated bilaterally with needles or laser. The primary outcome will be pain intensity, determined using the numerical rating scale. The secondary outcomes will be pressure pain threshold, temporal summation of pain, conditioned pain modulation, use of analgesic drugs after treatment, and the global perceived effect scale. The assessments will be performed immediately before and after treatment. At the follow-up, 1 months after the end of the treatments, evaluation will be made of the pain intensity and the global perceived effect. Statistical analysis of the data obtained will consider a significance level of p < 0.05.Discussion: This study will provide evidence concerning the effects of LA treatment, in comparison to TA, leading to benefits for individuals suffering from chronic nonspecific neck pain.Trial registration: RBR-7vbw5gd (Brazilian Registry of Clinical Trials - ​ReBEC)

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015286 ◽  
Author(s):  
Seunghoon Lee ◽  
Dongwoo Nam ◽  
Minsoo Kwon ◽  
Won Seo Park ◽  
Sun Jin Park

BackgroundThe purpose of this study is to evaluate the efficacy and safety of electroacupuncture (EA) for postoperative pain after laparoscopic appendectomy compared with sham electroacupuncture (SEA) and no acupuncture treatment.Methods and analysisThis study is a protocol for a three-arm, randomised, patient-assessor-blinded (to the type of acupuncture treatment), controlled, parallel trial. 138 participants diagnosed with appendicitis and scheduled for laparoscopic appendectomy will be randomly assigned to the EA group (n=46), SEA group (n=46) or control group (n=46). The EA group will receive acupuncture treatment at both regional and distal acupuncture points with electrostimulation. The SEA group will receive sham acupuncture treatment with mock electrostimulation. Both EA and SEA groups will receive a total of four treatments 1 hour preoperative, 1 hour postoperative and during the morning and afternoon the day after surgery with the same routine postoperative pain control. The control group will receive only routine postoperative pain control. The primary outcome is the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at 24 hours after surgery. The secondary outcomes are the PI-NRS, analgesic consumption, opioid-related side effects, time to first passing flatus, quality of life and adverse events evaluated 6, 12, 24 and 36 hours and 7 days after surgery.Ethics and disseminationThe study was planned in accordance with the Helsinki Declaration and the Korean Good Clinical Practice Guidelines to protect the participants and was approved by the institutional review board (IRB) of Kyung Hee University Medical Center (KMC IRB-1427–02). The results will be disseminated in peer-reviewed journals and presented at international conferences.Trial registration numberClinical Research Information Service (KCT0001328).


2021 ◽  
Author(s):  
Zhen Gao ◽  
Tao Yin ◽  
Lei Lan ◽  
Dehua Li ◽  
Ruirui Sun ◽  
...  

Abstract Background: Acupuncture is effective for reducing the symptoms of neck pain (NP). However, the underlying mechanisms are not fully elucidated. Based on evaluating the efficacy of two acupuncture prescriptions for treating NP. This study aims to investigate the potential central mechanism of acupuncture treatment for NP by functional magnetic resonance imaging (fMRI). Methods: This is a randomized controlled trial, 86 patients will be randomly assigned into two acupuncture treatment groups at a ratio of 1:1. The whole study period includes 2 weeks baseline, 2 weeks treatments and 12 weeks follow-up (4 and 12 weeks after treatment). The pain severity, the neck disability index, the cervical range of motion, the pressure pain threshold, etc. will be used to evaluate clinical efficacy of two acupuncture prescriptions for NP treatment. The MRI scans will be performed to detect cerebral activity changes of 20 patients in each group. The clinical data and MRI data will be analysed, respectively. Pearson correlation coefficient will be used to evaluate the association between changes of cerebral activity features and improvement of clinical symptoms.Discussion: The results might provide further evidence for the clinical application of acupuncture in the treatment of NP.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000040930. Registered on December 16, 2020.


2019 ◽  
Vol 33 (12) ◽  
pp. 1908-1918 ◽  
Author(s):  
Lucia Domingues ◽  
Fernando Manuel Pimentel-Santos ◽  
Eduardo Brazete Cruz ◽  
Ana Cristina Sousa ◽  
Ana Santos ◽  
...  

Objective: The aim of this study was to compare the effectiveness of a combined intervention of manual therapy and exercise (MET) versus usual care (UC), on disability, pain intensity and global perceived recovery, in patients with non-specific chronic neck pain (CNP). Design: Randomized controlled trial. Setting: Outpatient care units. Subjects: Sixty-four non-specific CNP patients were randomly allocated to MET ( n = 32) or UC ( n = 32) groups. Interventions: Participants in the MET group received 12 sessions of mobilization and exercise, whereas the UC group received 15 sessions of usual care in physiotherapy. Main measures: The primary outcome was disability (Neck Disability Index). The secondary outcomes were pain intensity (Numeric Pain Rating Scale) and global perceived recovery (Patient Global Impression Change). Patients were assessed at baseline, three weeks, six weeks (end of treatment) and at a three-month follow-up. Results: Fifty-eight participants completed the study. No significant between-group difference was observed on disability and pain intensity at baseline. A significant between-group difference was observed on disability at three-week, six-week and three-month follow-up (median (P25–P75): 6 (3.25–9.81) vs. 15.5 (11.28–20.75); P < 0.001), favouring the MET group. Regarding pain intensity, a significant between-group difference was observed at six-week and three-month follow-up (median (P25–P75): 2 (1–2.51) vs. 5 (3.33–6); P < 0.001), with superiority of effect in MET group. Concerning the global perceived recovery, a significant between-group difference was observed only at the three-month follow-up ( P = 0.001), favouring the MET group. Conclusion: This study’s findings suggest that a combination of manual therapy and exercise is more effective than usual care on disability, pain intensity and global perceived recovery.


2021 ◽  
Author(s):  
Kayoko Taguchi ◽  
Noriko Numata ◽  
Rieko Takanashi ◽  
Ryo Takemura ◽  
Tokiko Yoshida ◽  
...  

BACKGROUND Cognitive behavioral therapy is known to improve the management of chronic pain. However, the components of this therapy are still being investigated and debated. OBJECTIVE This study aimed to examine the effectiveness of an integrated cognitive behavioral therapy program with new components (attention-shift, memory work, video feedback, and image training) delivered via videoconferencing. METHODS This study was unblinded and participants were recruited and assessed face-to-face in the outpatient department. We conducted a randomized controlled trial for chronic pain to compare 16 weekly videoconference-based cognitive behavioral therapy (vCBT) sessions provided by a therapist with treatment as usual (TAU). Thirty patients (age range, 22-75 years) with chronic pain were randomly assigned to either vCBT (n=15) or TAU (n=15). Patients were evaluated at week 1 (baseline), week 8 (midintervention), and week 16 (postintervention). The primary outcome was the change in pain intensity, which was recorded using the numerical rating scale at 16 weeks from the baseline. Secondary outcomes were pain severity and pain interference, which were assessed using the Brief Pain Inventory. Additionally, we evaluated disability, pain catastrophizing cognition, depression, anxiety, quality of life, and cost utility. RESULTS In the eligibility assessment, 30 patients were eventually randomized and enrolled; finally, 15 patients in the vCBT and 14 patients in the TAU group were analyzed. Although no significant difference was found between the 2 groups in terms of changes in pain intensity by the numerical rating scale scores at week 16 from baseline (<i>P</i>=.36), there was a significant improvement in the comprehensive evaluation of pain by total score of Brief Pain Inventory (–1.43, 95% CI –2.49 to –0.37, <i>df</i>=24; <i>P</i>=.01). Further, significant improvement was seen in pain interference by using the Brief Pain Inventory (–9.42, 95% CI –14.47 to –4.36, <i>df</i>=25; <i>P</i>=.001) and in disability by using the Pain Disability Assessment Scale (–1.95, 95% CI –3.33 to –0.56, <i>df</i>=24; <i>P</i>=.008) compared with TAU. As for the Medical Economic Evaluation, the incremental cost-effectiveness ratio for 1 year was estimated at 2.9 million yen (about US $25,000) per quality-adjusted life year gained. CONCLUSIONS The findings of our study suggest that integrated cognitive behavioral therapy delivered by videoconferencing in regular medical care may reduce pain interference but not pain intensity. Further, this treatment method may be cost-effective, although this needs to be further verified using a larger sample size. CLINICALTRIAL University Hospital Medical Information Network UMIN000031124; https://tinyurl.com/2pr3xszb


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhen Gao ◽  
Tao Yin ◽  
Lei Lan ◽  
Dehua Li ◽  
Ruirui Sun ◽  
...  

Abstract Background Acupuncture is effective for reducing the symptoms of neck pain (NP). However, the underlying mechanisms are not fully elucidated. Based on evaluating the efficacy of two acupuncture prescriptions for treating NP, this study aims to investigate the potential central mechanism of acupuncture treatment for NP by functional magnetic resonance imaging (fMRI). Methods This is a randomized controlled trial; 86 patients will be randomly assigned into two acupuncture treatment groups at a ratio of 1:1. The whole study period includes 2 weeks baseline, 2 weeks treatments, and 12 weeks follow-up (4 and 12 weeks after treatment). The pain severity, the neck disability index, the cervical range of motion, and the pressure pain threshold, etc., will be used to evaluate the clinical efficacy of two acupuncture prescriptions for NP treatment. The MRI scans will be performed to detect cerebral activity changes of 20 patients in each group. The clinical data and MRI data will be analyzed, respectively. Pearson correlation coefficient will be used to evaluate the association between changes of cerebral activity features and improvement of clinical symptoms. Discussion The results will provide further evidence for the clinical application of acupuncture in the treatment of NP. Trial registration Chinese Clinical Trial Registry ChiCTR2000040930. Registered on 16 December 2020.


2018 ◽  
Vol 2018 ◽  
pp. 1-10
Author(s):  
Huihao Wang ◽  
Enyu Jiang ◽  
Kuan Wang ◽  
Zhen Deng ◽  
Hongsheng Zhan ◽  
...  

Objective. To compare the immediate and short term effectiveness of Shi’s Daoyin therapy (DT) rather than the Melbourne Protocol (MP) in terms of pain, mobility, and isometric strength of cervical muscles in nonacute nonspecific neck pain patients. Material and Methods. A total of 114 nonacute nonspecific neck pain patients aged 20~50 years were recruited and randomly assigned to be treated by either Shi’s DT or the MP. 56 cases and 54 cases received treatment for 3 weeks and were evaluated before and after intervention and at 3-week follow-up in Shi’s DT group and MP group, respectively. The outcome measures were Chinese version of the Neck Disability Index (NDI), cervical range of motion (ROM), maximal voluntary isometric force (MVIF), and pain intensity (Numeric Pain Rating Scale, NPRS). Results. All outcomes of both groups showed statistically significant improvements after the intervention and at 3-week follow-up (P < 0.05), while no statistically significant difference was found in NDI between groups. When followed up after 3 weeks, the ROM in axial rotation was significantly greater in the Shi’s DT group (P < 0.05), and the NPRS in the Shi’s DT group was significantly lower than the MP group (P < 0.05). At the end of the treatment period, the MVIF in lateral bending in the Shi’s DT group had a lower value (P = 0.044) than in the MP group, but there was no significant difference in flexion and extension between the two groups. Conclusions. Both Shi’s DT and MP groups demonstrated an obvious reduction in pain intensity and improvements in neck mobility after a short term follow-up period. The improvement of Shi’s DT in disability and pain during functional activities is generally similar to that of the MP for the treatment of nonacute nonspecific neck pain.


2015 ◽  
Vol 95 (2) ◽  
pp. 267-273 ◽  
Author(s):  
Alessandra Narciso Garcia ◽  
Lucíola da Cunha Menezes Costa ◽  
Mark J. Hancock ◽  
Matheus Oliveira de Almeida ◽  
Fabrício Soares de Souza ◽  
...  

Background The McKenzie method is widely used as an active intervention in the treatment of patients with nonspecific low back pain. Although the McKenzie method has been compared with several other interventions, it is not yet known whether this method is superior to placebo in patients with chronic low back pain. Objective The purpose of this trial is to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain. Design An assessor-blinded, 2-arm, randomized placebo-controlled trial will be conducted. Setting This study will be conducted in physical therapy clinics in São Paulo, Brazil. Participants The participants will be 148 patients seeking care for chronic nonspecific low back pain. Intervention Participants will be randomly allocated to 1 of 2 treatment groups: (1) McKenzie method or (2) placebo therapy (detuned ultrasound and shortwave therapy). Each group will receive 10 sessions of 30 minutes each (2 sessions per week over 5 weeks). Measurements The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The primary outcomes will be pain intensity (measured with the Pain Numerical Rating Scale) and disability (measured with the Roland-Morris Disability Questionnaire) at the completion of treatment. The secondary outcomes will be pain intensity; disability and function; kinesiophobia and global perceived effect at 3, 6, and 12 months after randomization; and kinesiophobia and global perceived effect at completion of treatment. The data will be collected by a blinded assessor. Limitations Therapists will not be blinded. Conclusions This will be the first trial to compare the McKenzie method with placebo therapy in patients with chronic nonspecific low back pain. The results of this study will contribute to better management of this population.


10.2196/30690 ◽  
2021 ◽  
Vol 23 (11) ◽  
pp. e30690
Author(s):  
Kayoko Taguchi ◽  
Noriko Numata ◽  
Rieko Takanashi ◽  
Ryo Takemura ◽  
Tokiko Yoshida ◽  
...  

Background Cognitive behavioral therapy is known to improve the management of chronic pain. However, the components of this therapy are still being investigated and debated. Objective This study aimed to examine the effectiveness of an integrated cognitive behavioral therapy program with new components (attention-shift, memory work, video feedback, and image training) delivered via videoconferencing. Methods This study was unblinded and participants were recruited and assessed face-to-face in the outpatient department. We conducted a randomized controlled trial for chronic pain to compare 16 weekly videoconference-based cognitive behavioral therapy (vCBT) sessions provided by a therapist with treatment as usual (TAU). Thirty patients (age range, 22-75 years) with chronic pain were randomly assigned to either vCBT (n=15) or TAU (n=15). Patients were evaluated at week 1 (baseline), week 8 (midintervention), and week 16 (postintervention). The primary outcome was the change in pain intensity, which was recorded using the numerical rating scale at 16 weeks from the baseline. Secondary outcomes were pain severity and pain interference, which were assessed using the Brief Pain Inventory. Additionally, we evaluated disability, pain catastrophizing cognition, depression, anxiety, quality of life, and cost utility. Results In the eligibility assessment, 30 patients were eventually randomized and enrolled; finally, 15 patients in the vCBT and 14 patients in the TAU group were analyzed. Although no significant difference was found between the 2 groups in terms of changes in pain intensity by the numerical rating scale scores at week 16 from baseline (P=.36), there was a significant improvement in the comprehensive evaluation of pain by total score of Brief Pain Inventory (–1.43, 95% CI –2.49 to –0.37, df=24; P=.01). Further, significant improvement was seen in pain interference by using the Brief Pain Inventory (–9.42, 95% CI –14.47 to –4.36, df=25; P=.001) and in disability by using the Pain Disability Assessment Scale (–1.95, 95% CI –3.33 to –0.56, df=24; P=.008) compared with TAU. As for the Medical Economic Evaluation, the incremental cost-effectiveness ratio for 1 year was estimated at 2.9 million yen (about US $25,000) per quality-adjusted life year gained. Conclusions The findings of our study suggest that integrated cognitive behavioral therapy delivered by videoconferencing in regular medical care may reduce pain interference but not pain intensity. Further, this treatment method may be cost-effective, although this needs to be further verified using a larger sample size. Trial Registration University Hospital Medical Information Network UMIN000031124; https://tinyurl.com/2pr3xszb


BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034003
Author(s):  
Kun Peng ◽  
Min Zeng ◽  
Jia Dong ◽  
Xiang Yan ◽  
Dexiang Wang ◽  
...  

IntroductionScalp nerve block has been proven to be an alternative choice to opioids in multimodal analgesia. However, for the infratentorial space-occupying craniotomy, especially the suboccipital retrosigmoid craniotomy, scalp nerve block is insufficient.Methods and analysisThe study is a prospective, single-centre, randomised, paralleled-group controlled trial. Patients scheduled to receive elective suboccipital retrosigmoid craniotomy will be randomly assigned to the superficial cervical plexus block group or the control group. After anaesthesia induction, superficial cervical plexus nerve block will be performed under the guidance of ultrasound. The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery. Secondary outcomes include the cumulative consumption of sufentanil at other four time points and numerical rating scale pain severity score.Ethics and disseminationThe protocol (version number: 2.0, 10 April 2019) has been approved by the Ethics Review Committee of China Registered Clinical Trials (Ethics Review No. ChiECRCT-20190047). The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberNCT04036812


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Wei Deng ◽  
Xiao-min Hou ◽  
Xu-yan Zhou ◽  
Qing-he Zhou

Abstract Background Rhomboid intercostal block (RIB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after video-assisted thoracoscopic surgery (VATS). This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of ultrasound-guided RIB block and RISS block after video-assisted thoracoscopic surgery. Methods Ninety patients aged between 18 and 80 years, with American Society of Anesthesiologists physical status Classes I–II and scheduled for elective unilateral VATS were randomly allocated into three groups. In group C, no block intervention was performed. Patients in group RIB received ultrasound-guided RIB with 20-mL 0.375% ropivacaine and those in group RISS received ultrasound-guided RIB and serratus plane block using a total of 40-mL 0.375% ropivacaine. All patients received intravenous sufentanil patient-controlled analgesia upon arrival in the recovery room. Postoperative sufentanil consumption and pain scores were compared among the groups. Results The dosages of sufentanil consumption at 24 h after the surgery in the RIB and RISS groups were significantly lower than that in group C (p < 0.001 and p < 0.001 for all comparisons, respectively), the postoperative Numerical Rating Scale (NRS) scores in the RIB and RISS groups at 0.5, 1, 3, 6, 12, 18, and 24 h after surgery when patients were at rest or active were significantly lower than that in group C (p < 0.05 for all comparisons). The required dosage of sufentanil and time to first postoperative analgesic request in groupRISS were less than those in the group RIB at 24 h after the surgery (p < 0.001 and p < 0.001 for all comparisons, respectively). Similarly, the Numerical Rating Scale scores for group RISS at 12, 18, and 24 h after the surgery when the patients were active were significantly lower than those for group RIB (p < 0.05 for all comparisons). Conclusion Both ultrasound-guided RIB block and RISS block can effectively reduce the demand for sufentanil within 24 h after VATS, and less sufentanil dosage is needed in patient with RISS block. Ultrasound-guided RIB block and RISS block can effectively relieve pain within 24 h after VATS, and RISS block is more effective.


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