Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol

BackgroundFunctional gastrointestinal disorders (FGIDs) are the commonest reason for gastroenterological consultation, with patients usually seen by a specialist working in isolation. There is a wealth of evidence testifying to the benefit provided by dieticians, behavioral therapists, hypnotherapists and psychotherapists in treating these conditions, yet they rarely form a part of the therapeutic team, and these treatment modalities are rarely offered as part of the therapeutic management. There has been little examination of different models of care for FGIDs. We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders.MethodsThe “MANTRA” (Multidisciplinary Treatment for Functional Gut Disorders) study compares comprehensive multi-disciplinary outpatient care with standard hospital outpatient care. Consecutive new referrals to the gastroenterology and colorectal outpatient clinics of a single secondary and tertiary care hospital of patients with an FGID, defined by the Rome IV criteria, will be included. Patients will be prospectively randomized 2:1 to multi-disciplinary (gastroenterologist, gut-hypnotherapist, psychiatrist, behavioral therapist (‘biofeedback’) and dietician) or standard care (gastroenterologist or colorectal surgeon). Patients are assessed up to 12 months after completing treatment. The primary outcome is an improvement on a global assessment scale at the end of treatment. Symptoms, quality of life, psychological well-being, and healthcare costs are secondary outcome measures.DiscussionThere have been few studies examining how best to deliver care for functional gut disorders. The MANTRA study will define the clinical and cost benefits of two different models of care for these highly prevalent disorders.TRIAL REGISTRATION Number: Clinicaltrials.gov NCT03078634Registered on Clinicaltrials.gov, completed recruitment, registered on March 13th 2017.Ethics and Dissemination:Ethical approval has been received by the St Vincent's Hospital Melbourne human research ethics committee (HREC-A 138/16). The results will be disseminated in peer-reviewed journals and presented at international conferences.Protocol version 1.2     

Digital versus Local Anesthesia for Finger Lacerations: A Randomized Controlled Trial

Objectives To compare the pain of needle insertion, anesthesia, and suturing in finger lacerations after local anesthesia with prior topical anesthesia with that experienced after digital anesthesia. Methods This was a randomized controlled trial in a university‐based emergency department (ED), with an annual census of 75,000 patient visits. ED patients aged ≥8 years with finger lacerations were enrolled. After standard wound preparation and 15‐minute topical application of lidocaine‐epinephrine‐tetracaine (LET) in all wounds, lacerations were randomized to anesthesia with either local or digital infiltration of 1% lidocaine. Pain of needle insertion, anesthetic infiltration, and suturing were recorded on a validated 100‐mm visual analog scale (VAS) from 0 (none) to 100 (worst); also recorded were percentage of wounds requiring rescue anesthesia; time until anesthesia; percentage of wounds with infection or numbness at day 7. Outcomes were compared by using Mann‐Whitney U and chi‐square tests. A sample of 52 patients had 80% power to detect a 15‐mm difference in pain scores. Results Fifty‐five patients were randomized to digital (n= 28) or local (n= 27) anesthesia. Mean age (±SD) was 38.1 (±16.8) years, 29% were female. Mean (±SD) laceration length and width were 1.7 (±0.7) cm and 2.0 (±1.0) mm, respectively. Groups were similar in baseline patient and wound characteristics. There were no between‐group differences in pain of needle insertion (mean difference, 1.3 mm; 95% confidence interval [CI] =?17.0 to 14.3 mm); anesthetic infiltration (mean difference, 2.3 mm; 95% CI =?19.7 to 4.4 mm), or suturing (mean difference, 7.6 mm; 95% CI =?3.3 to 21.1 mm). Only one patient in the digital anesthesia group required rescue anesthesia. There were no wound infections or persistent numbness in either group. Conclusions Digital and local anesthesia of finger lacerations with prior application of LET to all wounds results in similar pain of needle insertion, anesthetic infiltration, and pain of suturing.     

Comparison of Connective Tissue Manipulation and Abdominal Massage Combined With Usual Care vs Usual Care Alone for Chronic Constipation: A Randomized Controlled Trial

ObjectiveThe aim of the present study was to determine and compare the effects of connective tissue manipulation (CTM) and abdominal massage when combined with usual care on the symptoms of constipation and quality of life (QoL) immediately following a 4-week treatment in patients suffering from chronic constipation.MethodsA total of 60 patients with chronic constipation were randomly assigned to CTM, abdominal massage, or control groups. Connective tissue manipulation and abdominal massage were conducted at 5 sessions a week for 4 weeks. Each session was approximately 15 to 20 minutes. The severity of constipation by the Constipation Severity Instrument, symptoms of constipation by a bowel diary and Bristol Stool Scale, and QoL by patient assessment of QoL questionnaire were evaluated at baseline and at the end of 4 weeks.ResultsThere were significant differences in the changes in constipation severity (P < .001), symptoms of constipation (P ≤ .001), and QoL (P < .001) among the 3 groups. However, based on pair-wise analysis, there were no significant differences in the changes of the severity and symptoms of constipation and QoL between the CTM and abdominal massage groups (P > .05).ConclusionThe findings of the present study revealed that compared to usual care alone, the combination of usual care and CTM or abdominal massage may be more beneficial for chronic constipation. However, the superiority of CTM or abdominal massage was not observed. Further high-quality studies with long-term follow-up are needed to investigate the optimal massage therapy program in patients with chronic constipation.     

PTD方案与TD方案治疗多发性骨髓瘤疗效的随机对照试验

目的比较PTD（帕米膦酸二钠十沙利度胺＋地塞米松）方案与TD（沙利度胺＋地塞米松）方案治疗多发性骨髓瘤的临床疗效。方法在2004年1月。2008年12月间,将符合纳入标准的患者按就诊顺序随机分配到PTD方案组和TD方案组,治疗8周后观察其疗效和不良反应。统计分析使用SPSS13．0软件。结果共纳入25例患者,其中PTD方案组13例,TD方案组12例。结果显示,PTD方案与TD方案的总有效率分别为84．6％和83．3％,差异无统计学意义（P〉0．05）;在骨痛改善方面,PTD组显效率（5／13vs1／12）及短期起效率（4／13vs1／12）优于TD组,差异有统计学意义（P〈0．05）。结论PTD方案较TD方案对骨痛的缓解程度更强、起效更快;在总有效率方面,尚需增大样本量进一步研究。     

Music Therapy Reduces Pain in Palliative Care Patients: A Randomized Controlled Trial

ContextTreatment of pain in palliative care patients is challenging. Adjunctive methods of pain management are desirable. Music therapy offers a nonpharmacologic and safe alternative.ObjectivesTo determine the efficacy of a single music therapy session to reduce pain in palliative care patients.MethodsTwo hundred inpatients at University Hospitals Case Medical Center were enrolled in the study from 2009 to 2011. Patients were randomly assigned to one of two groups: standard care alone (medical and nursing care that included scheduled analgesics) or standard care with music therapy. A clinical nurse specialist administered pre- and post-tests to assess the level of pain using a numeric rating scale as the primary outcome, and the Face, Legs, Activity, Cry, Consolability Scale and the Functional Pain Scale as secondary outcomes. The intervention incorporated music therapist-guided autogenic relaxation and live music.ResultsA significantly greater decrease in numeric rating scale pain scores was seen in the music therapy group (difference in means [95% CI] ?1.4 [?2.0, ?0.8]; P < 0.0001). Mean changes in Face, Legs, Activity, Cry, Consolability scores did not differ between study groups (mean difference ?0.3, [95% CI] ?0.8, 0.1; P > 0.05). Mean change in Functional Pain Scale scores was significantly greater in the music therapy group (difference in means ?0.5 ([95% CI] ?0.8, 0.3; P < 0.0001).ConclusionA single music therapy intervention incorporating therapist-guided autogenic relaxation and live music was effective in lowering pain in palliative care patients.     

腹部正中切口两层缝合法与传统四层缝合法的临床随机对照研究

目的探讨腹部正中切口两层缝合法的临床效果及与传统切口四层缝合法的区别。方法采用随机对照试验方法,将2008年1月～2008年4月期间符合纳入标准的124例患者分为两组,试验组61例,采用两层缝合法,对照组63例,采用四层缝合法。比较两组患者术前基本情况、手术切口相关指标及术后全身／切口恢复指标的差异。结果术前两组患者基线情况一致。术后两组患者在住院时间、下床活动时间、术后进食时间及术后经肛门排气时间上,其差异均无统计学意义（P〉0．05）;但在术后患者出现发热症状的构成比上,试验组明显低于对照组,其差异有统计学意义（P=0．014）。两组术后切口愈合级别以甲级愈合为主,其差异无统计学意义（P〉0．05）。从术后切口并发症角度看,两组均无切口感染、切口异物肉芽肿形成和窦道形成,但对照组分别有切口活动性出血3例和切口裂开2例,试验组均为0例;此外,试验组出现切口液化的构成比也明显少于对照组,其差异有统计学意义（P=0．003）。结论就腹部正中切口而言,两层缝合法较传统四层缝合法可能会为患者带来更小的切口创伤,更少的切口异物刺激以及合理的解剖结构复位,从而具有更佳的临床效果和安全性。但两层缝合法是否还适用于其它类型伤口尚需进一步研究。     

Integrative Acupuncture and Spinal Manipulative Therapy Versus Either Alone for Low Back Pain: A Randomized Controlled Trial Feasibility Study

Objectives

The objective of this study was to assess the feasibility of conducting a large-scale randomized controlled trial (RCT) examining whether an integrative care model combining spinal manipulative therapy (SMT) and acupuncture can lead to better outcomes for low back pain (LBP) than either therapy alone.

Manual Wheelchair-Handling Skills by Caregivers Using New and Conventional Rear Anti-Tip Devices: A Randomized Controlled Trial

Kirby RL, Walker R, Smith C, Best K, MacLeod DA, Thompson K. Manual wheelchair-handling skills by caregivers using new and conventional rear anti-tip devices: a randomized controlled trial.

Objective

To test the hypothesis that, in comparison with caregivers handling manual wheelchairs equipped with conventional rear anti-tip devices (C-RADs), those using a new design (Arc-RADs) perform relevant wheelchair skills better and as safely.

Design

Randomized controlled trial.

Setting

Rehabilitation center.

Participants

Caregivers (n=16) and the wheelchair users (n=16) for whom they cared.

Intervention

Participants were trained in wheelchair-handling skills for an average of 54 minutes each.

Main Outcome Measures

Total percentage score on a set of 20 rear anti-tip device- and caregiver-relevant skills from the Wheelchair Skills Test, version 3.2, administered a minimum of 3 days after training.

Results

For the C-RAD and Arc-RAD groups, the mean ± SD Wheelchair Skills Test scores were 40%±0% and 98.8%±3.5%, respectively (P<.001). Skills that required the wheelchair to be tipped back extensively (eg, for ascending a 15cm curb) accounted for the differences between the groups. There were no adverse effects in either group.

Conclusions

The Arc-RAD design allows significantly better caregiver wheelchair-handling skills than the conventional design, without compromising safety.     

Internet-Based Cognitive-Behavioral Therapy for Complicated Grief: A Randomized Controlled Trial

The present study investigates the efficacy of an Internet-based cognitive-behavioral therapy program for bereaved people suffering complicated grief. The program combines established methods of psychotherapy with new technology– therapists and patients communicated exclusively by e-mail. Bereaved individuals diagnosed with complicated grief (n = 55) were randomly assigned to either the treatment group or a waiting list control condition. The 5-week intervention consisted of three modules: (1) exposure to bereavement cues; (2) cognitive reappraisal; and (3) integration and restoration. The Impact of Event Scale (IES), a failure to adapt scale, and the depression and anxiety subscales of the Brief Symptom Inventory (BSI) were used to assess treatment outcomes. Participants in the treatment group (n = 26) improved significantly relative to participants in the waiting condition on symptoms of intrusion, avoidance, maladaptive behavior, and general psychopathology, and showed a large treatment effect. Follow-up results show that this improvement was maintained after 3 months.     

LET versus EMLA for Pretreating Lacerations: A Randomized Trial

OBJECTIVE: To compare the anesthetic efficacy of EMLA cream (eutectic mixture of local anesthetics) with that of LET solution (lidocaine, epinephrine, tetracaine) for pretreating lacerations prior to lidocaine injection. METHODS: This was a randomized, double-blind clinical trial in a convenience sample of 60 patients aged 1 to 59 years with traumatic lacerations. Eligible wounds were uncomplicated, clean lacerations < or = 6 hours old. Finger and toe lacerations were excluded. At the time of initial presentation to triage, patients were randomized to LET or EMLA. A nurse applied the topical anesthetic into the laceration with a 5-mL syringe. A physician assessed the laceration edges for the presence of blanching and adequacy of anesthesia to a 27-gauge needlestick. Supplemental lidocaine was then infiltrated through the wound edges and the pain of infiltration was recorded by the patient (or guardian) on a 100-mm visual analog scale marked "most pain" at the high end. A sample of 44 patients had 90% power to detect a 20-mm difference in injection pain (two-tailed alpha = 0.05). RESULTS: Sixty patients were randomized to LET (29) or EMLA (31). Median age was 8.5 years; 23% were female. Most lacerations were facial and closed with sutures. There was no difference in baseline characteristics between groups. More wounds treated with LET were anesthetic to a needlestick than wounds treated with EMLA (73% vs 40%, p = 0.01); however, there was no between-group difference in the median pain of lidocaine infiltration (LET-12 mm vs EMLA-13 mm, p = 0.89). CONCLUSIONS: Pretreatment of simple lacerations with LET or EMLA at the time of patient presentation results in similar amounts of pain of subsequent local infiltration of lidocaine     

Effects of 4-Week Diacutaneous Fibrolysis on Myalgia,Mouth Opening,and Level of Functional Severity in Women With Temporomandibular Disorders: A Randomized Controlled Trial

ObjectiveThe purpose of this study was to assess the effects of 4-week protocol of diacutaneous fibrolysis (DF) compared with simulated DF (sham-DF) on myalgia and mouth opening.MethodsIn a sham randomized controlled trial, 34 women with temporomandibular disorders and myofascial pain were randomly divided as intervention group (IG) and sham-DF group (SG). The IG received 4 weeks of real DF, and the SG received sham. Pain was assessed through the visual analog scale and pressure pain thresholds (PPTs) on the temporomandibular joint (TMJ), and over the temporal and masseter muscles. The Mandibular Function Impairment Questionnaire was used to classify the participants regarding to the severity of the functional limitation related to TMD.ResultsPain scores decreased for both groups, but the IG showed lower values at week 4, with between-group differences. Bilateral temporal PPT showed higher values at week 4, with between-group differences. The SG had lower PPTs but the IG had higher PPTs, both compared to baseline results. The time-by-group interaction and the frequency of participants above 40 mm of mouth opening showed a significant difference for the IG over time with higher results at the 4-week assessment compared to its own baseline. Both groups showed lower MFIQ scores from baseline to 4-week assessment. There was a lower frequency of a moderate level of severity for the IG. No differences were observed for TMJ or for the masseter muscles PPT.ConclusionImprovements were observed for visual analog scale scores and PPTs on temporal muscles. There was a group-by-time interaction in the IG, suggesting a possible potential use of DF for mouth opening.