scholarly journals Comparison of the Effectiveness of Three Different Acupuncture Methods for TMD-Related Pain: A Randomized Clinical Study

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Emanuela Serritella ◽  
Gabriella Galluccio ◽  
Alessandra Impellizzeri ◽  
Paola Di Giacomo ◽  
Carlo Di Paolo

Purpose. This study aimed to compare the effectiveness of three acupuncture methods for temporomandibular disorders- (TMDs-) related pain. Materials and Methods. Different locations of pain, according to DC/TMD clinical assessment, were considered: temporomandibular joint (TMJ), masticatory muscles, head, and neck. Sixty patients were assigned randomly to one of three treatment groups (20 patients in each): group BA received body acupuncture, group EA received electroacupuncture, and group CA received acupuncture + cupping. The groups were compared in terms of pain (verbal numeric scale), pain-related disability (Brief Inventory Pain, BPI), and impression of the treatment’s effectiveness (Patients' Global Impression of Improvement Scale, PGI-I). These were recorded before sessions of acupuncture treatment (T0), after 8 sessions of acupuncture treatment (T1), and after 4 weeks of follow-up after treatment (T2). The between-group and within-group differences in the data were analyzed statistically. The baseline characteristics were similar in all groups ( p > 0.05 ). Results. Significant improvements were noted in all types of pain compared to baseline values in all groups (all p < 0.05 ). No significant differences were noted in the improvement of TMDs-related pain according to the different acupuncture techniques (all p > 0.05 ). All acupuncture methods used resulted to be significantly effective in improving the pain-related interference in the patient’s common activities and quality of life. EA resulted to be significantly more effective than BA and CA in improving the interference of pain with patients’ mood ( p = 0.015 ) and quality of sleep ( p = 0.014 ). Conclusion. BA, EA, and CA are all effective acupuncture methods in reducing pain and pain interference with common activities and quality of life in patients affected by TMD.

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.


2010 ◽  
Vol 21 (2) ◽  
pp. 170-174 ◽  
Author(s):  
Emin Murat Canger ◽  
Peruze Çelenk ◽  
Murat Yenísey ◽  
Selcen Zeynep Odyakmaz

Amelogenesis imperfecta (AI) is a hereditary disorder expressing a group of conditions that cause developmental alterations in the structure of enamel. AI is a serious problem that reduces oral health-related quality of life and causes some physiological problems. The treatment of patients with AI may upgrade the quality of life and reinforce their self-esteem. Among the treatment options for AI, full-mouth metal reinforced porcelain restoration constitutes an important alternative because of its properties. This paper presents a case of AI of the hypoplastic rough type associated with a group of dental anomalies, and describes the prosthetic management of the patient. A 26-year-old female patient presented with a chief complaint of discolored teeth. Clinical and radiographic examination of the patient confirmed the diagnosis of rough pattern hypoplastic AI. The patient was treated with full-mouth metal reinforced porcelain fixed bridge. The adaptation of the temporomandibular joints and masticatory muscles was carefully observed periodically during 4 months and, after this period, the patient tolerated well her new vertical dimension. The patient received instructions on cleansing of the subpontic and interproximal areas. Follow-up visits were scheduled at 3 months and then at 6 months. No esthetic or functional problems were seen after the follow up period.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2190-2190 ◽  
Author(s):  
David Cella ◽  
Jan McKendrick ◽  
Harrison Davis ◽  
Ravi Vij ◽  
Clara Chen

Introduction: The development of numerous novel therapies for the treatment of relapsed or refractory multiple myeloma (MM) has resulted in improved response rates and durable responses that prolong survival. Assessment of health-related quality of life (HRQoL) has therefore become increasingly important as HRQoL decreases with increasing lines of therapy (LoTs) (Despiégel et al. Clin Lymphoma Myeloma Leuk 2019). In the phase 3 ELOQUENT-2 study (NCT01239797), elotuzumab (E) plus lenalidomide/dexamethasone (Ld) showed a 30% reduction in the risk of progression/death versus Ld in patients with relapsed or refractory MM and 1-3 prior LoTs (median follow-up: 24.5 months; Lonial et al. N Engl J Med 2015). The initial analysis of patient-reported outcomes (PROs) from ELOQUENT-2 at a 3-year extended follow-up showed that the improvement in efficacy observed with ELd was achieved without a detriment to HRQoL (Cella et al. Ann Hematol 2018). Here we present the final analysis of PRO data from ELOQUENT-2. Methods: In ELOQUENT-2, patients with relapsed or refractory MM and 1-3 prior LoTs were randomized 1:1 to receive ELd or Ld in 28-day cycles until disease progression, unacceptable toxicity, or withdrawal of consent. The Brief Pain Inventory-Short Form (BPI-SF; pain severity, pain interference, and worst pain), the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 questionnaire (QLQ-C30; prespecified key domains were physical function, fatigue, global health status/QoL, and pain), and the myeloma-specific module (QLQ-MY20; includes assessment of symptoms and treatment side effects) were administered at baseline (BL), on Day 1 of each treatment cycle, and at the end of treatment/study withdrawal. All randomized patients with ≥1 post-BL assessment were included in each PRO analysis. Overall mean change from BL was compared between treatment groups based on a mixed-effect model for repeated measures; statistical tests for the overall population only included treatment cycles with >30 patients in each treatment group. A paired t-test was used to compare scores at each cycle with BL; an unpaired t-test compared mean values between treatment groups. BPI-SF scores range from 0-10 with lower scores representing better pain outcomes. EORTC QLQ-C30 scores range from 0-100 with higher scores representing better physical functioning and global health status/QoL, and worse fatigue and pain; EORTC QLQ-MY20 scores range from 0-100 with higher scores representing worse symptoms and problems. Results: In total, 646 patients were treated with ELd (n=321) or Ld (n=325); 319 and 311 patients had ≥1 post-BL assessment and were included in the PRO analysis, respectively (minimum follow-up: 70.6 months). BL BPI-SF mean scores for ELd versus Ld were low across all domains: pain severity (2.6 vs 2.9), pain interference (2.5 vs 2.8), and worst pain (3.6 vs 3.8). Scores for all BPI-SF domains remained stable over the course of the study (eg, pain severity: Figure A). ELd-treated patients with BL moderate/severe pain severity (score of ≥5) had significantly lower mean pain severity scores versus Ld-treated patients in Cycles 1-5. A higher proportion of clinical responders (complete or partial response per European Group for Blood and Marrow Transplantation criteria) versus non-responders had a sustained reduction in pain score across all BPI-SF domains: pain severity (18% vs 6%), pain interference (15% vs 6%), and worst pain (30% vs 13%); the difference in time to sustained improvement was not statistically significant between the clinical responders and non-responders for any pain endpoint. For both treatment groups, there was no clinically meaningful change (≥10 points) from BL scores at any cycle (>30 patients) across all key domains for EORTC QLQ-C30 (eg, global health status/QoL: Figure B) and QLQ-MY20. Conclusions: This final analysis of PROs in ELOQUENT-2 confirms that the efficacy benefits observed with addition of elotuzumab to Ld in patients with relapsed or refractory MM treated with 1-3 prior LoTs were achieved without negatively affecting HRQoL compared with Ld. Study support: BMS. Medical writing: Kenny Tran, Caudex, funded by BMS. Disclosures Cella: FACIT.org: Equity Ownership. McKendrick:PRMA Consulting Ltd.: Employment, Other: I am employed by PRMA Consulting Ltd who provide consulting services to a number of pharmaceutical companies. Davis:PRMA Consulting Ltd.: Employment, Other: I am employed by PRMA Consulting Ltd who provide consulting services to a number of pharmaceutical companies.. Vij:Sanofi: Honoraria; Karyopharm: Honoraria; Janssen: Honoraria; Genentech: Honoraria; Celgene: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Takeda: Honoraria, Research Funding. Chen:Bristol-Myers Squibb: Employment.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 590-590
Author(s):  
Yvonne Brandberg ◽  
Theodoros Foukakis ◽  
Anne Andersson ◽  
Judith Bjohle ◽  
Ana Bosch ◽  
...  

590 Background: Neoadjuvant therapy combining docetaxel, trastuzumab and pertuzumab (DTP) was compared to trastuzumab emtansine (T-DM1) in the randomised phase II PREDIX HER2 trial. Patients, ≥18 years with HER2 positive breast cancer, ≥20mm or with verified lymph node metastases, were randomised to six courses of DTP (Standard group) or T-DM1 (Experimental group) before surgery. After operation patients in the Standard arm received two, and those in the Experimental arm four courses of EC. Since there were no differences in proportions of complete response at surgery and in the event-free survival between the groups, health-related quality of life (HRQoL) is of special interest. Methods: HRQoL was measured, using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 + EORTC QLQ-BR23, before randomisation, after six courses before surgery, at three months and one year after surgery. Results: Response rate for the questionnaires varied between 87% and 99% for the 198 included patients. There were no between-group differences at baseline. Results after six courses revealed statistically significant differences (p≤0.01), favouring the Experimental group on 12 out of 21 of the EORTC QLQ-C30 and BR23 variables (Physical-, Role-, and Social- functioning, Global quality of Life, Fatigue, Dyspnea, and Diarrhea, Body image, Sexual functioning, Sexual enjoyment, Systemic therapy side effects and Upset by hair loss). Three months after surgery, however, statistically significant differences in favour of the Standard group were found for six variables (Physical functioning, Nausea/vomiting, Dyspnea, Constipation, Systemic therapy side effects, Upset by hair loss). No other between group differences were found with one exception: lower levels of Breast symptoms in the Experimental group. One possible explanation is that patients in the Experimental group were still on chemotherapy at that assessment point, whereas the majority in the Standard group had terminated their treatment. No differences were found between the groups at the one-year after surgery follow-up, where the levels on most variables had returned to baseline values. Conclusions: HRQoL was better in the Experimental group during neoadjuvant treatment. Three months after surgery, however, HRQoL was in favour or the Standard arm. HRQoL returned to baseline levels for most variables at the one-year follow-up and no between-group differences were found. Clinical trial information: NCT02568839 .


Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
David J Maron ◽  
John A Spertus ◽  
Paul G Kolm ◽  
Steven P Sedlis ◽  
G.B. John Mancini ◽  
...  

Background: The COURAGE trial randomized 2,287 patients to percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) or OMT alone. We hypothesized that patients with diabetes would have lower quality of life (QOL) at baseline and benefit less from PCI than patients without diabetes. Methods: Angina frequency and QOL were assessed with the Seattle Angina Questionnaire (SAQ) at baseline, 1, 2, and 3 years. Diabetes and treatment group differences were assessed by analysis of variance and linear mixed effects models. Results: (See Table .) Diabetes status could be determined in 2,234 patients. Of these, 766 (34%) had diabetes. There were no significant baseline differences in SAQ scores for angina frequency and QOL for patients with and without diabetes. All patients experienced significant (p<0.001) improvement in these SAQ scores from baseline through 3 years post-randomization in both treatment arms, however patients without diabetes had significantly greater improvement (p<0.001 for both scores). The addition of PCI to OMT produced a small but statistically significant advantage for patients without diabetes that persisted for 2 years for angina frequency and 1 year for QOL; a similar advantage for PCI was observed for patients with diabetes, but this was not statistically significant, due in part to the smaller sample size. Comparison of SAQ Scores by Diabetes Status and Treatment Conclusions: COURAGE patients with and without diabetes had similar baseline angina frequency and QOL, and experienced marked improvement in these parameters in both treatment groups. Diabetic patients had less improvement in these health status scores than non-diabetic patients. The addition of PCI to OMT produced a small incremental benefit compared with OMT alone that lasted for 1–2 years, after which there were no between-group differences for patients with or without diabetes.


2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi154-vi154
Author(s):  
Laura Donovan ◽  
Minhee Won ◽  
J Gregory Cairncross ◽  
Fabio Iwamoto ◽  
Jan Buckner ◽  
...  

Abstract BACKGROUND PCV+RT substantially prolongs survival in AO patients, but long-term CF and QOL implications are unclear. We compared CF and QOL by treatment arm in RTOG 9402 participants and evaluated the impact that baseline characteristics had on CF, QOL, and survival. METHODS CF and QOL were evaluated using the Mini Mental State Exam (MMSE) and Brain-Quality of Life (B-QOL) scale at baseline and annually. Scores were analyzed between treatment arms at each time point for patients with ≥ 10 years of follow-up data. Shared parameter models evaluated MMSE and B-QOL scores and survival for all patients. RESULTS 42/148 (28.4%) participants in PCV+RT and 20/143 (14%) in RT alone arms survived ≥ 10 years. 35/42 and 39/42 (PCV+RT) and 18/20 and 17/20 (RT) participants completed baseline B-QOL and MMSE assessments, respectively. B-QOL scores did not differ between treatment groups at any time-point. Among 16 patients (10 PCV+RT, 6 RT) who completed year 10 MMSE evaluations, mean MMSE score at 10 years was higher in the RT arm (29.83 [95% CI 22.1, 30.0] vs. 26.50 [95% CI 29.4, 30.0], P= 0.04). Change in MMSE and B-QOL scores from baseline did not differ significantly between treatment groups at any time. In shared parameter models including all patients with baseline assessments, MMSE and B-QOL scores decreased over time (MMSE P= 0.0189, B-QOL P= 0.0005), but this did not differ by treatment group (MMSE P= 0.5727, B-QOL P= 0.3592). Younger age and higher KPS predicted better scores (MMSE P &lt; 0.0001, P = 0.0002; B-QOL P = 0.0043, P = 0.0007). PCV+RT predicted better survival in both models. CONCLUSIONS PCV+RT improves survival in AO. Shared parameter models show decrease in MMSE and B-QOL over time. However, relative to RT alone, the addition of PCV did not impact change in CF and QOL over time.


2015 ◽  
Vol 129 (10) ◽  
pp. 980-985 ◽  
Author(s):  
C Hopkins ◽  
R Almeyda ◽  
H Alreefy ◽  
H Ismail-Koch ◽  
J Lim ◽  
...  

AbstractObjective:This study aimed to measure changes in disease-specific quality of life in children following tonsillectomy or adenotonsillectomy.Methods:A multicentre prospective cohort study was performed involving seven ENT departments in England. A total of 276 children entered the study over a 2-month period: 107 underwent tonsillectomy and 128 adenotonsillectomy. Forty-one children referred with throat problems initially managed by watchful waiting were also recruited. The follow-up period was 12 months. Outcome measures were the T14, parental impressions of their child's quality of life and the number of days absent from school.Results:One-year follow-up data were obtained from 150 patients (52 per cent). The mean baseline T14 score in the non-surgical group was significantly lower (T14 = 23) than in the tonsillectomy group (T14 = 31) or the adenotonsillectomy group (T14 = 35; p < 0.001). There was a significant improvement in the T14 scores of responders in all groups at follow up. The effect size was 1.3 standard deviations (SD) for the non-surgical group, 2.1 SD for the tonsillectomy group and 1.9 SD for the adenotonsillectomy group. Between-group differences did not reach statistical significance. A third of children in the non-surgical group underwent surgery during the follow-up period.Conclusion:Children who underwent surgical intervention achieved a significant improvement in disease-specific quality of life. Less severely affected children were managed conservatively and also improved over 12 months, but 1 in 3 crossed over to surgical intervention.


Author(s):  
J. L. Pedersen ◽  
P.U. Pedersen ◽  
E.M. Damsgaard

Objective: The purpose of the study is to investigate the effect of two nutritional follow-up intervention methods: home visit and telephone follow-up, on ADL, physical function, quality of life, readmission, and mortality, and compare the interventions with no followup. This article describes the considerations behind the study design. Design: The study is a randomized clinical study. The randomization allocated participants to one of three groups: ‘home visit’, ‘telephone consultation’, or ‘control’. Setting: Participants were recruited from two geriatric wards between May 2011 and October 2013. The follow-up period fell eight weeks after discharge from hospital. Participants: Inclusion: Malnourished or at risk of malnutrition, 75+ years and older, home-dwelling, and living alone. Exclusion: Terminal illness, cognitive impairment, and nursing home resident. Intervention: Nutritional counselling after hospital discharge, based on individual nutritional needs identified during admission, and tailored to the individual’s preferences and situation. The intervention was performed by a clinical dietician, and included the patient’s daily home carer. The intervention took place 1 week, 2 weeks, and 4 weeks after discharge, either as face-to-face counselling in the patients’ homes (home visit group), or via telephone (telephone consultation group). The control group received no followup after discharge. Measurements: Primary outcome is a change in ADL (Barthel-100), while secondary outcomes include other physical measurements (handgrip strength, 30-sec. chair stand test, CAS), quality of life and depression measurements (SF-36, Depression List, Geriatric Depression Score), and Avlund mobility-tiredness score. Other secondary outcome measures are readmission, and mortality rates at 30 and 90 days post-discharge. Conclusion: This randomized clinical trial will evaluate and compare two approaches to nutritional follow-up after discharge from hospital with no follow-up. It is expected that these interventions will prevent deterioration in physical function, which is significant in preventing further deterioration of physical, mental, and social functions, and reduce hospital readmissions and mortality.


2021 ◽  
Author(s):  
Jian’an Li ◽  
Wenguang Xia ◽  
Chao Zhan ◽  
Shouguo Liu ◽  
Zhifei Yin ◽  
...  

AbstractObjectivesTo investigate superiority of a telerehabilitation program for Covid-19 (TERECO) over no rehabilitation with regard to functional exercise capacity, lower-limb muscle strength (LMS), pulmonary function, health-related quality of life (HRQOL), and perceived dyspnoea.DesignParallel-group randomised controlled-trial with 1:1 block-randomisation.SettingThree major hospitals from Jiangsu and Hubei provinces, China.Participants120 Covid-19 survivors with modified Medical Research Council (mMRC) dyspnoea score of 2-3 who had been discharged from hospital were randomised. 61 were allocated to the control group and 59 to the TERECO group.InterventionThe control group received educational instructions. The TERECO group participated in a 6-week home-based, pulmonary rehabilitation program delivered via smartphone and monitored with chest-worn heart rate telemetry. Exercise types comprised breathing control and thoracic expansion, aerobic exercise, and LMS exercise.OutcomesPrimary outcome was 6-minute walking distance (6MWD) in metres. Secondary outcomes were LMS measured as squat time in seconds; pulmonary function assessed by spirometry with parameters being forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, maximum voluntary ventilation (MVV), and peak expiratory flow; HRQOL measured with SF-12 physical component score (PCS) and mental component score (MCS); and mMRC dyspnoea, favourable outcome (no dyspnoea). Outcomes were assessed at 6 weeks (post-treatment) and 28 weeks (follow-up).Results120 patients were randomised, 15 (12.5%) were lost to follow-up at study endpoint. No serious adverse events occurred. 38 participants in the TERECO group complied with the exercise protocol (64.41% of randomized). The adjusted between-group difference in change in 6MWD from baseline was 65.45 metres (95% CI 43.8-87.1, p<0.001) at post-treatment and 68.62 metres (95% CI 46.39-90.85, p<0.001) at follow-up. Treatment effects for LMS were 20.12 seconds (95% CI 12.34-27.9, p<0.001) post-treatment and 22.23 seconds (95% CI 14.24-30.21, p<0.001) at follow-up. No group differences were found for lung function apart from post-treatment MVV (10.57 litres/minute, 95% CI 0.26-17.88, p=0.005). Increase in SF-12 PCS was greater in the TERECO group with treatment effects estimated as 3.79 (95% CI 1.24-6.35, p=0.004) at post-treatment and 2.69 (95% CI 0.06-5.32, p=0.045) at follow-up. No significant between-group differences were found for improvements in SF-12 MCS. At post-treatment 90.4% endorsed a favourable outcome for mMRC dyspnoea in the TERECO group vs. 61.7% in control (adjusted RR 1.46, 1.17-1.82, p=0.001).ConclusionsThis trial demonstrated superiority of TERECO over no rehabilitation for 6MWD, LMS, and SF-12 PCS. We found no persistent effects on pulmonary function, SF-12 MCS, and perceived dyspnoea.Trial registrationChinese Clinical Trial Registry: ChiCTR2000031834, 11 Apr 2020, URL: http://www.chictr.org.cn/showproj.aspx?proj=52216KEY POINTSWhat is already knownMany Covid-19 survivors discharged from hospital have reduced exercise capacity, impaired pulmonary function, muscle weakness, and reduced quality of life, all of which might be addressed with pulmonary rehabilitation.However, evidence on effective pulmonary rehabilitation measures for this population is currently lacking. As delivery of conventional rehabilitation services is furthermore limited due to pandemic control measures, telerehabilitation programs represent a possible alternative.What the study addsWe developed a telerehabilitation program for Covid-19 survivors (TERECO program) that is delivered via smartphone and can be carried out at home.Our study suggests that TERECO was safe and participants of the TERECO program had improved exercise capacity, lower-limb muscle strength, and physical quality of life. No relevant group differences were found for lung function, self-reported breathlessness, and mental quality of life.The TERECO program is inexpensive and could be implemented on a large scale to improve physical health of Covid-19 survivors after discharge from hospital.


2021 ◽  
Author(s):  
Xueyan Liu ◽  
Zhijie Wang ◽  
Hao Yao ◽  
Yanrong Yang ◽  
Huijuan Cao ◽  
...  

Abstract Background: Postoperative Gastrointestinal Dysfunction (PGID) is a common complication arising from colorectal cancer surgery. Attributing factors such as anesthesia, surgical retraction, early intake of water, etc. can inhibit gastrointestinal motility, causing constipation, reduction or absence of bowels sounds, nausea, vomiting and other symptoms. Delayed recovery in gastrointestinal function can lead to intestinal obstructions or paralysis, anastomotic leaks and other complications, affecting the patient’s recovery and quality of life negatively. Due to its complex pathophysiology, treatment for PGID in colorectal patients has remained a challenge. Acupuncture is an alternative therapy commonly used for post-operative recovery. This study aims to evaluate the therapeutic efficacy and safety of Acupuncture on PGID. Through the complementation of Acupuncture and Enhanced Recovery After Surgery (ERAS) protocols, the advantages of acupuncture treatments could be demonstrated to promote its application in future clinical practice.Methods/design: The study design is a prospective randomized controlled trial (RCT). 160 postoperative colorectal cancer patients will be recruited from Cancer Hospital Chinese Academy of Medical Sciences (CICAMS). Subjects who fulfill inclusion criteria will be randomly assigned into Acupuncture group (AG)(n=80) or control group (CG)(n=80). AG will receive Acupuncture treatment and ERAS care protocols, CG will only receive ERAS care protocols. Intervention will begin on the first day post-surgery, continuing for 4 days, with a follow-up assessment in a month. Time of first postoperative flatus would be the primary outcome measure. Secondary outcome measures include time of first postoperative defecation, time of first fluid intake, time of first ambulation, postoperative hospital stay, gastrointestinal reaction score, postoperative quality of life, acupuncture sensation evaluation scale. All results are evaluated from baseline, post-treatment and upon follow-up. Discussion: The results of the study would help elucidate evidence of the therapeutic effects of acupuncture on recovery of postoperative gastrointestinal function. The objective of the study aims for the eventual inclusion of acupuncture in the ERAS protocol, allowing for wider application in clinical practice.Trial Registration: Clinicaltrials.gov: ChiCTR2000036351. Register August 22,2020.


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