A Blinded Randomised Trial of Acupuncture (Manual and Electroacupuncture) Compared with a Non-Penetrating Sham for the Symptoms of Osteoarthritis of the Knee

Objectives To compare the effect of acupuncture (manual and electroacupuncture) with that of a non-penetrating sham (‘placebo’ needle) in patients with osteoarthritic knee pain and disability who are blind to the treatment allocation. Methods Acupuncture naive patients with symptomatic and radiological evidence of osteoarthritis of the knee were randomly allocated to a course of either acupuncture or non-penetrating sham acupuncture using a sheathed ‘placebo’ needle system. Acupuncture points for pain and stiffness were selected according to acupuncture theory for treating Bi syndrome. Both manual and electrical stimulation were used. Response was assessed using the WOMAC index for osteoarthritis of the knee, self reported pain scale, the EuroQol score and plasma β-endorphin. The effectiveness of blinding was assessed. Results There were 34 patients in each group. The primary end point was the change in WOMAC pain score after the course of treatment. Comparison between the two treatment groups found a significantly greater improvement with acupuncture (mean difference 60, 95% CI 5 to 116, P=0.035) than with sham. Within the acupuncture group there was a significant improvement in pain (baseline 294, mean change 95, 95% CI 60 to 130, P<0.001) which was not seen by those who had sham acupuncture (baseline 261, mean change 35, 95% CI-10 to 80, P=0.12). Similar effects within group, but not between groups, were seen with the secondary end points of WOMAC stiffness, WOMAC function, and self reported pain. One month after treatment the between group pain difference had been lost (mean difference 46; 95% CI −9 to 100, P=0.10) although the acupuncture group was still benefiting compared to baseline (mean difference 59; 95% CI 16 to 102, P=0.009). The EuroQol score, a generic measure of health related quality of life, was not altered by the treatments. A minority of patients correctly guessed their treatment group (41% in the acupuncture group and 44% in the control group). Plasma β-endorphin levels were not affected by either treatment. Conclusions Acupuncture gives symptomatic improvement for patients with osteoarthritis of the knee, and is significantly superior to non-penetrating sham acupuncture. The study did not confirm earlier reports of release of plasma β-endorphin during acupuncture.

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Acupuncture for Knee Osteoarthritis – a Randomised Trial Using a Novel Sham

Acupuncture in Medicine ◽

10.1136/aim.24.suppl.7 ◽

2006 ◽

Vol 24 (1_suppl) ◽

pp. 7-14 ◽

Cited By ~ 20

Author(s):

Eric Manheimer ◽

Byungmook Lim ◽

Lixing Lao ◽

Brian Berman

Keyword(s):

Pain Relief ◽

Global Assessment ◽

Sham Acupuncture ◽

Mean Difference ◽

Acupuncture Group ◽

Patient Global Assessment ◽

Osteoarthritis Of The Knee ◽

Womac Pain ◽

Womac Pain Score ◽

Womac Function

Background Evidence on the efficacy of acupuncture for reducing the pain and dysfunction of osteoarthritis is equivocal. Objective To determine whether acupuncture provides greater pain relief and improved function compared with sham acupuncture or education in patients with osteoarthritis of the knee. Design Randomised, controlled trial. Setting Two outpatient clinics (an integrative medicine facility and a rheumatology facility) located in academic teaching hospitals and one clinical trials facility. Patients 570 patients with osteoarthritis of the knee (mean age [±SD], 65.5 ± 8.4 years). Intervention 23 true acupuncture sessions over 26 weeks. Controls received 6 two-hour sessions over 12 weeks or 23 sham acupuncture sessions over 26 weeks. Measurements Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores at 8 and 26 weeks. Secondary outcomes were patient global assessment, 6-minute walk distance, and physical health scores of the 36-Item Short-Form Health Survey (SF-36). Results Participants in the true acupuncture group experienced greater improvement in WOMAC function scores than the sham acupuncture group at 8 weeks (mean difference, −2.9 [95% CI, −5.0 to −0.8]; P=0.01) but not in WOMAC pain score (mean difference, −0.5 [CI, −1.2 to 0.2]; P=0.18) or the patient global assessment (mean difference, 0.16 [CI, −0.02 to 0.34]; P> 0.2). At 26 weeks, the true acupuncture group experienced significantly greater improvement than the sham group in the WOMAC function score (mean difference, −2.5 [CI, −4.7 to −0.4]; P=0.01), WOMAC pain score (mean difference, −0.87 [CI, −1.58 to −0.16]; P=0.003), and patient global assessment (mean difference, 0.26 [CI, 0.07 to 0.45]; P=0.02). Limitations At 26 weeks, 43% of the participants in the education group and 25% in each of the true and sham acupuncture groups were not available for analysis. Conclusions Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups.

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Impact of Acupuncture on Antihistamine Use in Patients Suffering Seasonal Allergic Rhinitis: Secondary Analysis of Results from a Randomised Controlled Trial

Acupuncture in Medicine ◽

10.1136/acupmed-2017-011382 ◽

2018 ◽

Vol 36 (3) ◽

pp. 139-145 ◽

Cited By ~ 8

Author(s):

Daniela Adam ◽

Linus Grabenhenrich ◽

Miriam Ortiz ◽

Sylvia Binting ◽

Thomas Reinhold ◽

...

Keyword(s):

Allergic Rhinitis ◽

Seasonal Allergic Rhinitis ◽

Secondary Analysis ◽

Sham Acupuncture ◽

Mean Difference ◽

Acupuncture Group ◽

The Other ◽

Common Disease ◽

The Impact ◽

Non Parametric

Background Seasonal allergic rhinitis (SAR) is a common disease that has detrimental effects on the quality of life (QoL) of affected individuals. Approximately 18% of patients try to alleviate their symptoms through acupuncture. The ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) study (ClinicalTrials.gov registration no. NCT00610584) assessed the impact of acupuncture on SAR, showing significant improvements in rhinitis-specific QoL (RQoL) and in rescue medication (RM) use. Objective A secondary analysis of SAR patients’ use of antihistamine. Methods Patients were randomised into three study groups: acupuncture plus RM, sham acupuncture plus RM, and RM alone. The patients documented their medication use before and during the intervention period (8 weeks). The main outcome was the number of days with antihistamine use. Statistical analyses were conducted using parametric and non-parametric tests. The robustness of the results was tested by sensitivity analyses using non-parametric bootstrapping. Results The data from 414 patients were analysed. The acupuncture group used antihistamines significantly less often compared with the other groups (acupuncture vs sham acupuncture: mean difference −4.49 days, p=0.01; acupuncture vs RM: mean difference −9.15 days, p<0.001). Approximately 38% of the acupuncture group did not use any antihistamine in contrast to only 16% in the RM group. The pre-post comparison suggested that the acupuncture patients did not need to increase the days of antihistamine use to alleviate their symptoms, unlike the other groups. Conclusions Acupuncture appeared to significantly reduce the number of days of antihistamine use while improving RQoL and SAR symptoms; it can therefore be considered a valuable, additional treatment option for patients with SAR. Trial Registration Number NCT00610584; Post-results.

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Granulocyte Colony-Stimulating Factor (G-CSF) Levels in a Randomized, Controlled Acupuncture Trial for Chemotherapy-Induced Neutropenia.

Blood ◽

10.1182/blood.v110.11.4088.4088 ◽

2007 ◽

Vol 110 (11) ◽

pp. 4088-4088

Author(s):

Weidong Lu ◽

Ursula A. Metulonis ◽

Anne Doherty-Gilman ◽

Hang Lee ◽

Elizabeth Dean-Clower ◽

...

Keyword(s):

Ovarian Cancer ◽

Cancer Patients ◽

Statistical Significance ◽

Gynecologic Cancer ◽

Acupuncture Group ◽

Control Group ◽

Acupuncture Points ◽

Hematologic Toxicity ◽

Csf Levels ◽

Time Point

Abstract Purpose Ovarian cancer is the most lethal gynecologic cancer. Chemotherapy, the standard of care, has hematologic toxicity, primarily neutropenia. G-CSF is currently used to support white blood cell (WBC) and absolute neutrophil counts (ANC). Prior clinical trials from China suggest that acupuncture could ameliorate chemotherapy-induced leukopenia; the proposed mechanism is an increase in G-CSF levels. In the current study, we investigated the effect of acupuncture, administered during myelosuppressive therapy, on WBC and ANC counts in ovarian cancer patients. Patients and methods Twenty-one newly diagnosed or recurrent ovarian cancer patients were randomized to receive active versus sham acupuncture while undergoing standard IV platinum and taxane-containing chemotherapy. A standardized protocol with 9 acupuncture points was employed with manual and electroacupuncture stimulation. The frequency of acupuncture treatment was 2–3 times per week for a total of 10 sessions, starting 1 week before the 2nd cycle of chemotherapy. WBC and ANC counts were checked weekly at five time points. Serum G-CSF was collected four times during the study. Results Of 587 patients screened, 21 patients were enrolled and received either acupuncture or sham treatment. Patients in both the active and control arms had similar patient characteristics and treatment. Both median WBC and ANC values at nadir in the acupuncture arm were higher than in the control arm, but the differences were not statistically significant, after adjusting for the baseline difference. However, the median WBC in the acupuncture arm at recovery was statistically significantly higher than the control arm, after adjustment (8,600 cell/μL, range: 4,800–12,000 vs. 4,400 cell/μL range: 2,300–10,000) (p=0.045). The recovering median ANC in the patients receiving acupuncture also was higher, but this difference was not statistically significant (p=0.094). The median serum G-CSF at baseline for patients in the active vs. control arm was similar (37.3 pg/mL, range 28.6–393.3 vs. 32.0, range 11.8–211.3, respectively) (p=0.291). At the second time point, the 1st day of the 2nd cycle, the acupuncture group had a higher G-CSF value than the control group (p=0.121). At nadir, the acupuncture group still had a slightly higher G-CSF value than in the control group (p=0.796). However, at the recovery day, the 1st day of 3rd cycle, the G-CSF value in the acupuncture group was lower than in the control arm (p=0.729). No statistical significance in G-CSF value was found at each time point between the two groups. Conclusion The acupuncture protocol used in this study was feasible and safe. We report trends of higher WBC and ANC values during one cycle of myelosuppressive chemotherapy in ovarian cancer patients, suggesting a potential myeloprotective effect of acupuncture. However, current data do not support an acupuncture effect on G-CSF production. These findings warrant a larger study to explore the observed clinical trends and other potential underlying mechanisms.

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Effect of Acupuncture on Perception Threshold: A Randomised Controlled Trial

Acupuncture in Medicine ◽

10.1136/acupmed-2011-010055 ◽

2012 ◽

Vol 30 (1) ◽

pp. 32-36

Author(s):

Shuang Wu ◽

Hidenori Yamaguchi ◽

Koh Shibutani

Keyword(s):

Controlled Trial ◽

Mental Foramen ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Control Group ◽

Perception Threshold ◽

Left Hand ◽

Before And After ◽

Sham Acupuncture Group ◽

Randomised Controlled

Objective To determine the current perception thresholds (CPTs) for arm and mental foramen areas to enable a quantitative evaluation of the effectiveness of acupuncture treatment. Methods Ninety-eight volunteers enrolled as participants and were randomly assigned to one of three groups: an acupuncture group (34 subjects); a sham acupuncture group (32 subjects) and a waiting group (32 subjects). CPTs for the arm and mental foramen areas were determined before and after acupuncture at LI4 Hegu of the left hand. A Neurometer CPT was used to evaluate the perception threshold at the homolateral mental foramen and arm. For further exploration, thresholds of homolateral and contralateral mental foramina were determined before and after acupuncture in a subgroup of 13 participants in the acupuncture group. Results Acupuncture at LI4 increased the perception thresholds of the left mental foramen in the acupuncture group significantly (p<0.01). The increases were significantly greater than in the control group for all frequencies, and significantly greater than sham acupuncture for 250 Hz and 5 Hz. In the subgroup, only the CPTs at 5 Hz increased significantly for the contralateral mental foramen. Conclusions Acupuncture at LI4 increases the perception threshold in the mandibular area, but not in the arm. This finding is probably related to the analgesic effect of acupuncture.

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Effects of Acupuncture on Cardiac Remodeling in Patients with Persistent Atrial Fibrillation: Results of a Randomized, Placebo-Controlled, Patient- and Assessor-Blinded Pilot Trial and Its Implications for Future Research

Medicina ◽

10.3390/medicina58010041 ◽

2021 ◽

Vol 58 (1) ◽

pp. 41

Author(s):

Jung Myung Lee ◽

Seung Min Kathy Lee ◽

Jungtae Leem ◽

Jin-Bae Kim ◽

Jimin Park ◽

...

Keyword(s):

Atrial Fibrillation ◽

Treatment Group ◽

Cardiac Remodeling ◽

Acupuncture Treatment ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Future Research ◽

Control Group ◽

Sham Acupuncture Group ◽

Af Recurrence

Background and Objectives: In this study, we attempted to determine the effects of acupuncture on cardiac remodeling and atrial fibrillation (AF) recurrence rates in patients with AF after electrical cardioversion (EC). Materials and Methods: We randomly assigned 44 patients with persistent AF to an acupuncture group or a sham acupuncture group. An electroacupuncture treatment session was administered once weekly for 12 weeks at four acupuncture points (left PC5, PC6, ST36, and ST37). Results: Among the 44 recruited participants, 16 (treatment group) and 15 (control group) completed the trial. The three-month AF recurrence rate (primary outcome) was not significantly different between the two groups. Following the completion of treatment, patients who had been treated with acupuncture had a significant reduction in left atrial volume index (42.2 ± 13.9 to 36.1 ± 9.7 mL/m2; p = 0.028), whereas no change in atrial size was observed in the sham acupuncture group. No serious adverse events were observed. The AF recurrence rate and cardiac function did not differ significantly between the two groups. At three months, the acupuncture treatment group showed more favorable atrial structural remodeling compared to the sham acupuncture group. Conclusion: In future research on acupuncture in AF management, it is recommended that the inclusion criteria be amended to include only symptomatic AF, that an appropriate control group is designed, and that the acupuncture treatment frequency is increased to several times per week.

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Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-036773 ◽

2020 ◽

Vol 10 (9) ◽

pp. e036773

Author(s):

Weiming Wang ◽

Sixing Liu ◽

Yan Liu ◽

Zhiwei Zang ◽

Weina Zhang ◽

...

Keyword(s):

Plantar Fasciitis ◽

Controlled Trial ◽

Randomised Trial ◽

Sham Acupuncture ◽

Primary Objective ◽

Control Group ◽

P Value ◽

Waitlist Control ◽

Intention To Treat

IntroductionPlantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF.Methods and analysisThis will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of <0.05 considered significant following the intention-to-treat principle.Ethics and disseminationThe study has been approved by the Ethical Committee of the Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval no. 2019-210-KY). The results will be disseminated through presentation at a peer-reviewed medical journal, the relevant conferences and scientific meetings.Trial registrationNCT04185259.

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The Effect of Acupuncture on the Symptoms of Knee Osteoarthritis - An Open Randomised Controlled Study

Acupuncture in Medicine ◽

10.1136/aim.22.1.14 ◽

2004 ◽

Vol 22 (1) ◽

pp. 14-22 ◽

Cited By ~ 62

Author(s):

Emad Tukmachi ◽

Ronald Jubb ◽

Emma Dempsey ◽

Peter Jones

Keyword(s):

Symptom Relief ◽

Repeated Measure ◽

Controlled Study ◽

Acupuncture Points ◽

Osteoarthritis Of The Knee ◽

Womac Pain ◽

Visual Analogue Pain Scale ◽

Symptomatic Medication ◽

Randomised Controlled Study ◽

Randomised Controlled

Background Using an open randomised controlled study, we examined the effectiveness of manual and electroacupuncture on symptom relief for patients with osteoarthritis of the knee. Methods Patients with symptomatic osteoarthritis of the knee were randomised to one of three treatment groups. Group A had acupuncture alone, group B had acupuncture but continued on their symptomatic medication, and group C used their symptomatic medication for the first five weeks and then had a course of acupuncture added. Patients receiving acupuncture were treated twice weekly over five weeks. Needles were inserted (with manual and electrical stimulation) in acupuncture points for pain and stiffness, selected according to traditional acupuncture theory for treating Bi syndrome. Patients were assessed by a blinded observer before treatment, after five weeks’ treatment and at one month follow up, using a visual analogue pain scale (VAS) and the Western Ontario McMaster (WOMAC) questionnaire for osteoarthritis of the knee. Results The 30 patients in our study were well matched for age, body mass index, disease duration, baseline VAS pain score and baseline WOMAC scores. Repeated measure analyses gave a highly significant improvement in pain (VAS) after the courses of acupuncture in groups A (P=0.012) and B (P=0.001); there was no change in group C until after the course of acupuncture, when the improvement was significant (P=0.001). Similarly significant changes were seen with the WOMAC pain and stiffness scores. These benefits were maintained during the one month after the course of acupuncture. Patients’ rating of global assessment was higher than that of the acupuncturist. Conclusion We conclude that manual and electroacupuncture causes a significant improvement in the symptoms of osteoarthritis of the knee, either on its own or as an adjunct therapy, with no loss of benefit after one month.

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Study of oral glucosamine, methylsulfonylmethane and their combination in osteoarthritis of the knee

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20215059 ◽

2021 ◽

Vol 10 (1) ◽

pp. 225

Author(s):

Shashikala Eda

Keyword(s):

Clinical History ◽

Study Groups ◽

Control Group ◽

Osteoarthritis Of The Knee ◽

Womac Pain ◽

X Rays ◽

Joint Disorder ◽

Physical Functions ◽

Male Patients ◽

Anti Inflammatory

Background: Osteoarthritis (OA) of the knee is the most common degenerative joint disorder that results in disability and increased morbidity. Conventional treatment of OA with non-steroidal anti-inﬂammatory drugs (NSAIDs) often leads to serious adverse side effects that may increase morbidity and mortality. Glucosamine and Methylsulfonylmethane (MSM) have anti-inflammatory and analgesic properties which may supplement NSAIDs. Hence this study was aimed to determine the effectiveness and safety of these drugs in the management of knee OAMethods: 76 (63.33%) female and 44 (36.67%) male patients of OA of the knees were divided equally into four groups depending upon the therapy with Glucosamine or MSM or their combination (study groups) or none of them (control group) for 12 weeks. After the written consent, a detail Clinical History& Examination, Biochemical investigations, X-rays of chest and knees and ECG were done. The outcome of the treatment was assessed by Western Ontario and McMaster University Osteoarthritis (WOMAC) Index and for any adverse drug effects.Results: After 12 weeks of study there was significant decrease in mean WOMAC pain scores (27.29-39.13) and total aggregate scores (23.53-37.14%) in study groups (p<0.01-p<0.001) as compared to control group (14.28 % and 8.82% respectively). Besides the relief of pain and improvement in physical functions were superior in patients treated with combination therapy. Conclusions: This study showed Glucosamine & MSM are effective in the management of OA of knee and are safe health supplement to NSAIDs while their combination was more superior and effective.

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Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/7498763 ◽

2017 ◽

Vol 2017 ◽

pp. 1-10 ◽

Cited By ~ 1

Author(s):

Hsien-Yin Liao ◽

Wen-Chao Ho ◽

Chun-Chung Chen ◽

Jaung-Geng Lin ◽

Chia-chi Chang ◽

...

Keyword(s):

Rating Scale ◽

Primary Outcome Measure ◽

Sham Acupuncture ◽

Acupuncture Group ◽

Secondary Outcome ◽

Control Group ◽

Double Blind Study ◽

Double Blind ◽

Psychological Improvement ◽

To Receive

Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it.Methods. Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS) score. Secondary outcome measures included changes in Barthel Index (BI), Instrumental Activities of Daily Living (IADL), Hamilton Depression Rating Scale (HAM-D), and Visual Analogue Scale (VAS) for pain scores.Results. Of the 52 patients who were randomized to receive acupuncture (n=28) or placebo (n=24), 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group (pvalue = 0.04). There were no significant differences in the other measures between the two groups.Conclusions. Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

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A community-centric multi-disciplinary education program with the 8-section brocade Tai Chi therapy for patients with osteoarthritis of the knee – a pilot study

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03480-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Kevin Ki-Wai Ho ◽

Gerald Pong ◽

Queena Wai-Chin Poon ◽

Jojo Yan-Yan Kwok ◽

Wai-Wang Chau ◽

...

Keyword(s):

Education Program ◽

Tai Chi ◽

Program Effectiveness ◽

Dropout Rate ◽

Activity Level ◽

Control Group ◽

Osteoarthritis Of The Knee ◽

Womac Pain ◽

Knee Oa ◽

Tai Chi Exercise

Abstract Background Osteoarthritis (OA) of the knee is one of the most common chronic degenerative joint diseases, and a multi-disciplinary approach to educating patients with OA knee are effective in symptoms management. Tai Chi exercise is a novel approach to relieving knee OA symptoms. Combining both educational program and Tai Chi has not yet been explored. Methods Multi-disciplinary education program included a total of 4-week 2-h weekly talks delivered by different health professionals with live demonstrations. This was then followed by a 1-h Tai Chi class (Baduanjin). Results from IPAQ (Physical activity level), WOMAC (evaluate knee OA conditions), and SF-36v2 (quality of life) were collected at the first class of education program, 3 and 6 months after the end of Tai Chi class. CSQ-8 (program effectiveness) was administered on the last day of Tai Chi class. Results One hundred and twelve patients joined the program. The overall attendance was over 90% with close-to-zero dropout rate. Satisfaction scored high in 85% of patients. WOMAC pain scores (p = 0.04) and SF-36v2 emotional role (p = 0.02) were statistically decreasing (improving) at 6 months after the program. SF-36v2 physical role and mental health tended to improve with time. Conclusions Combining both multidisciplinary education program program and Tai Chi exercise for knee OA patients was proven feasible. This program received high satisfaction, high attendance and very low dropout rates without any adverse event. Patients’ pain and emotion were significantly improved. A large-scale randomized trial introducing a control group is recommended. Trial registration Registry: ClinicalTrials.gov Registration number: NCT04204213 Date of registration: 18/12/2019 (Retrospectively registered)

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