scholarly journals Efficacy of acupuncture for sciatica: study protocol for a randomized controlled pilot trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Fang-Ting Yu ◽  
Guang-Xia Ni ◽  
Guo-Wei Cai ◽  
Wen-Jun Wan ◽  
Xiao-Qing Zhou ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Lumbar Disc ◽  
Pilot Trial ◽  
Sham Acupuncture ◽  
Leg Pain ◽  
Power Calculation ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strategies for sciatica induced by lumbar disc herniation. Methods This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. Ninety patients will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians (NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the visual analogue scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain intensity, and quality of life. Adverse events will also be recorded. Discussion The results will inspire the optimal acupuncture strategy for sciatica and help establish a better design as well as power calculation for a full-scale study. Trial registration ChiCTR2000030680 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 9 March 2020).

scholarly journals Efficacy of acupuncture for sciatica: study protocol for a randomized controlled pilot trial.

2020 ◽  
Author(s):  
Fang-Ting Yu ◽  
Guang-Xia Ni ◽  
Guo-Wei Cai ◽  
Wen-Jun Wan ◽  
Xiao-Qing Zhou ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Lumbar Disc ◽  
Pilot Trial ◽  
Sham Acupuncture ◽  
Leg Pain ◽  
Power Calculation ◽  
Clinical Trial Registry ◽  
Randomized Controlled

Abstract Background: Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. We aim to explore the feasibility and efficacy of acupuncture with different acupoint selecting strategies for sciatica induced by lumbar disc herniation.Methods: This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. 90 patients will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians (NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the Visual-Analogue Scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain intensity, and quality of life. Adverse events will also be recorded.Discussion: The results will inspire the optimal acupuncture strategy for sciatica and help establish a better design as well as power calculation for a full-scale study. Trial registration: ChiCTR2000030680 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 9th March 2020).

scholarly journals Efficacy of Acupuncture for Sciatica: Study Protocol for A Randomized Controlled Pilot Trial.

2020 ◽  
Author(s):  
Fang-Ting Yu ◽  
Guang-Xia Ni ◽  
Zhi-Shun Liu ◽  
Xiu-Li Meng ◽  
Jin-Ling Li ◽  
...  
Keyword(s):  
Pilot Study ◽  
Pain Intensity ◽  
Lumbar Disc ◽  
Pilot Trial ◽  
Sham Acupuncture ◽  
Leg Pain ◽  
Power Calculation ◽  
Clinical Trial Registry ◽  
Randomized Controlled

Abstract Background: Acupuncture is widely used for pain diseases while evidence of its efficacy for sciatica is insufficient. This pilot study aims to investigate the feasibility and efficacy of acupuncture for sciatica induced by lumbar disc herniation. Methods: This is a multicenter, three-arm, patient-assessor-blinded randomized controlled pilot trial. 90 patients will be assigned randomly into 3 groups including disease-affected meridians (DAM) group, non-affected meridians (NAM) group, and sham acupuncture (SA) group in a 1:1:1 ratio. The trial involves a 4-week treatment along with follow-up for 22 weeks. The primary outcome is the change of leg pain intensity measured by the Visual-Analogue Scale (VAS) from baseline to week 4 after randomization. Secondary outcomes include functional status, back pain intensity, and quality of life. Adverse events will also be recorded.Discussion: This pilot study will investigate the feasibility and efficacy of acupuncture for patients with sciatica. The results of the study will help improve a better design and establish a power calculation for a full-scale study.Trial registration: ChiCTR2000030680 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 9th March 2020).

scholarly journals Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Niels-Peter Brøchner Nygaard ◽  
Carsten Koch-Jensen ◽  
Henrik Bjarke Vægter ◽  
Niels Wedderkopp ◽  
Morten Blichfeldt-Eckhardt ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Relief ◽  
Knee Osteoarthritis ◽  
Pain Intensity ◽  
Functional Performance ◽  
Secondary Outcome ◽  
Pain Intensity Score ◽  
Randomized Controlled ◽  
Link Type

Abstract Objective Pain is the principal symptom in knee osteoarthritis (OA). Current non-operative treatment options have only moderate effects and often patients experience persistent pain or side-effects. Novel advances in the field of cryoneurolysis applies low temperatures to disrupt nerve signaling at the painful area, providing pain relief. The primary aim of this randomized controlled trial (RCT) is to investigate if cryoneurolysis is superior to sham at decreasing pain intensity 2 weeks after the intervention in patients with knee OA. Secondary aims are to explore effects on pain, quality of life and functional performance over 24 months. Methods This two-arm, parallel-group RCT, approved by the Regional Ethics Committee, will randomly allocate patients (n = 94) to a cryoneurolysis intervention group + standardized education and exercise (CRYO) or a sham group + standardized education and exercise (SHAM) (1:1 ratio). Both groups will be assessed at baseline, 2 weeks post intervention, post education and exercise and at 6, 12 and 24 months after cryoneurolysis. The primary outcome is the NRS knee pain intensity score assessed 2 weeks post the intervention. Secondary outcome measures include functional performance (chair-stand test, 40 m walk, stair test and maximum voluntary contraction of the knee), patient reported outcomes (quality of life (EQ5D), Knee and osteoarthritis outcome scores (KOOS), among others), use of analgesics, and adverse events over 24 months. Impact statement Cryoneurolysis could potentially provide an effective, safe and non-pharmacological therapeutic option to treat pain in OA patients. The potential benefits include increased functional capacity and quality of life as a result of significant pain relief and improved benefits of physical exercise. Trial registration Clinicaltrials.gov, NCT03774121, registered 3 March 2018, http://www.clinicaltrials.gov

scholarly journals Acupuncture of fascia points to relieve hand spasm after stroke: a study protocol for a multicenter randomized controlled trial

2019 ◽  
Author(s):  
zengqiao zhang ◽  
Wei Feng ◽  
Kun-Peng Li ◽  
Jing He ◽  
Li-Ming Jiang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Hand Function ◽  
Sham Acupuncture ◽  
Clinical Trial Registry ◽  
Rehabilitation Therapy ◽  
Evaluation Indexes ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Functional Exercise

Abstract Background: The loss of life ability of patients after stroke is mostly caused by the dysfunction of upper limbs, especially hands. Hand functional exercise is the premise of alleviating hand dysfunction, and the relief of hand spasm is the basis of timely and effective hand functional exercise. Previous clinical observation showed that fascial point needling could effectively alleviate hand spasm immediately after stroke, but further evidence from large sample studies is needed. The overall objective of this trial is to further evaluate the clinical efficacy of fascial point acupuncture on hand spasm after stroke. Methods/design: This multicenter randomized controlled trial will compare the efficacy of fascial point acupuncture versus sham acupuncture and routine rehabilitation therapy in stroke patients with hand spasm. Patients will be randomized to undergo either the fascial point acupuncture or the sham acupuncture or the control (routine rehabilitation therapy). We will recruit 210 stroke inpatients who meet the trial criteria and observe the remission of hand spasm and improvement of limb function after 4 weeks of intervention. The first evaluation indexes are the remission of hand spasm and the duration of spasm remission. The second evaluation indexes are the hand function of affected limbs and the ability of daily living. When the accumulative total number of cases included reaches 120, a mid-term analysis will be conducted to determine any evidence that experimental intervention does have an advantage. Discussion: Our aim is to evaluate the efficacy of fascial point acupuncture in relieving hand spasm after stroke. The results will provide more evidences for the clinical application of this therapy in the future. Trial registration: The trial has been registered at the Chinese Clinical Trial Registry（ChiCTR）on April 9, 2019. Registration number: ChiCTR1900022379 Keywords: Fascia points, Acupuncture, Spasm, Stroke

scholarly journals Internet-Based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial

10.2196/22326 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e22326
Author(s):  
Julia Lam ◽  
Peter Svensson ◽  
Per Alstergren
Keyword(s):  
Pain Intensity ◽  
Temporomandibular Disorder ◽  
Functional Limitation ◽  
Pilot Trial ◽  
The Internet ◽  
Occlusal Splint ◽  
Splint Therapy ◽  
Randomized Controlled ◽  
Temporomandibular Pain

Background Chronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities. Objective The aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial. Methods An unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting. Results Only 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up—characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: z=–2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: z=–2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 months: z=–3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001). Conclusions This study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible. Trial Registration ClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762

New treatment of lumbar disc herniation involving 5-hydroxytryptamine2A receptor inhibitor: a randomized controlled trial

2005 ◽  
Vol 2 (4) ◽  
pp. 441-446 ◽  
Author(s):  
Masahiro Kanayama ◽  
Tomoyuki Hashimoto ◽  
Keiichi Shigenobu ◽  
Fumihiro Oha ◽  
Shigeru Yamane
Keyword(s):  
Lumbar Disc Herniation ◽  
Disc Herniation ◽  
Lumbar Disc ◽  
Leg Pain ◽  
Low Back ◽  
Content Type ◽  
Medical Interventions ◽  
Randomized Controlled ◽  
Nsaid Group ◽  
Fine Print

Object. Serotonin or 5-hydroxytryptamine (5-HT) is a chemical mediator associated with nucleus pulposus—induced radiculopathy. Inhibition of 5-HT receptors may potentially alleviate symptoms in patients with lumbar disc herniation. This prospective randomized controlled study was performed to evaluate the efficacy of the 5-HT2A receptor inhibitor in the treatment of symptomatic lumbar disc herniation. Methods. Forty patients with sciatica due to L4–5 or L5—S1 disc herniation were randomly allocated to treatment with the 5-HT2A inhibitor (sarpogrelate 300 mg/day) or nonsteroidal antiinflammatory drugs (NSAIDs; diclofenac 75 mg/day). Low-back pain, leg pain, and numbness were evaluated using a visual analog scale (VAS) before and after a 2-week course of treatment. The patients received only allocated medicine during the 2-week regimen and were thereafter allowed to choose any treatment options depending on their residual symptoms. One-year clinical outcomes were assessed based on the rates of additional medical interventions. The mean VAS score improvements in the 5-HT2A and NSAID groups were 33 and 46% for low-back pain, 32 and 32% for leg pain, and 35 and 22% for leg numbness, respectively. After the 2-week regimen, no additional medical interventions were required in 50% of 5-HT2A—treated patients and 15% of those receiving NSAIDs. Epidural or nerve root block procedures were performed in 35% of the 5-HT2A group and 45% of the NSAID group. Surgery was required in 20% of the 5-HT2A group and 30% of the NSAID group patients. Conclusions. The current study provided evidence that the efficacy of the 5-HT2A inhibitor was comparable with that of NSAID therapy for lumbar disc herniation. The 5-HT2A inhibitor has the potential to alleviate symptoms in patients with lumbar disc herniation.

scholarly journals Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-21
Author(s):  
Meng-Qi Yang ◽  
Yong-Mei Song ◽  
Huan-Yu Gao ◽  
Yi-Tao Xue
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
High Quality ◽  
Randomized Controlled ◽  
Link Type

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.

scholarly journals Effect of acupuncture on lung cancer-related fatigue: study protocol for a multi-center randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Zhaoqin Wang ◽  
Shanshan Li ◽  
Luyi Wu ◽  
Qin Qi ◽  
Huirong Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Primary Outcome ◽  
Acupuncture Treatment ◽  
Acupuncture Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cancer Related Fatigue ◽  
Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0% in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited. Method/design This is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT. Discussion This trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment. Trial registration Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: http://www.chictr.org.cn/showproj.aspx?proj=37823

scholarly journals Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: a protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ruimin Jiao ◽  
Man Huang ◽  
Weina Zhang ◽  
Zhishun Liu
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Acne Vulgaris ◽  
Sham Acupuncture ◽  
Lesion Count ◽  
Randomized Controlled ◽  
Scale Total Score

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.

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