No influence of ibuprofen on bone healing after Colles’ fracture – A randomized controlled clinical trial

IntroductionNonsteroidal anti-inflammatory drugs (NSAIDs) may delay bone healing. This knowledge is mainly derived from retrospective uncontrolled clinical studies and from animal experiments. The purpose of this prospective controlled study was to investigate whether ibuprofen influences pain, function, and bone healing after a Colles’ fracture.Patients and methodsA single center, triple-blind, randomized clinical trial. 95 patients, 80 females and 15 males, with displaced Colles’ fracture aged median 65 (range 40–85) years old were included and operated by external fixation from June 2012 through June 2015. 89 participants received interventional medicine and 83 completed the one-year follow-up. The 7-day ibuprofen group received 600 mg of ibuprofen three times a day, the 3-day ibuprofen group received ibuprofen for three days and a placebo for the following four days, and finally, the placebo group received a placebo for seven days. All patients received paracetamol 1000 mg four times a day and 50 mg tramadol if needed. The primary outcome were radiological changes in radius tilt, length, and inclination observed during and 6 weeks after the surgery. The analgesic outcome were 14 days experience of pain, and registered use of tramadol. The functional outcomes were the percentage differences in the motion between the injured and non-injured wrist, and the DASH score at 3 and 12 months. All analyses were performed according to the intention to treat.ResultsNo clinically relevant difference was observed in the radiological migration between the treatment groups, 0.064≤P ≤ 0.81. There was no difference in the pain score between the treatment groups, P = 0.13. The use of tramadol was lower in the ibuprofen groups than in the placebo group, P = 0.035. Ibuprofen treatment did not affect the range of motion, 0.148 ≤P ≤ 0.963. Patients in all groups demonstrated DASH score, and wrist motion improvement, close to 90% of normal amplitude. The complication rate was higher in the 7-day ibuprofen group compared to the placebo group, P = 0.043.ConclusionsIbuprofen treatment demonstrated a tramadol-sparing effect during the postoperative period. Neither wrist function nor radiological migration were influenced. The complication rate was higher in the ibuprofen-treated group compared the placebo-treated group.     

Do hip protectors decrease the risk of hip fracture in institutional and community-dwelling elderly? A systematic review and meta-analysis of randomized controlled trials

Hip fractures are an important cause of morbidity and mortality in the elderly. Hip protectors are padded undergarments designed to decrease the impact of a fall on the hip. We systematically reviewed randomized controlled trials of hip protectors to determine if they reduce hip fractures in the elderly. Analyses were pooled according to participant residence—community or institutional (the latter, included nursing homes, residential group homes or seniors hostels). We included individually randomized and statistically adjusted cluster randomized trials. Seven trials of 12- to 28-month duration were included. The Safehip brand of hip protector was used in most studies. Compliance rates in the treatment groups varied from 31 to 68%. In four trials including a total of 5,696 community-dwelling seniors, the hip fracture rates in control groups ranged from 1.1 to 7.4%, and the pooled risk difference with hip protector allocation was 0% [95% confidence intervals (CI), –1%, +1%), with a relative risk of 1.07 (0.81, 1.42). In three trials including 1,188 institutionalized elderly participants, hip fracture rates in the control groups varied from 8 to 19.4%, and the pooled risk difference for sustaining one or more hip fractures with hip protector allocation was –3.7% (95% CI, –7.4%, 0.1%), with a relative risk of 0.56 (0.31, 1.01) (with statistically significant heterogeneity of treatment effect). In a post-hoc subgroup analysis of two trials comprised of exclusively nursing home residents, the risk difference with hip protector allocation was –4.4% (–8.09, –0.76) with a relative risk of 0.50 (0.28, 0.91) ( n =1,014). Thus, there is little evidence to support the use of hip protectors outside the nursing home setting. The potential benefit of hip protectors in reducing hip fractures in nursing home residents requires further confirmation.     

Should acute scaphoid fractures be fixed? A randomized controlled trial

BACKGROUND: With the proliferation of different fixation screws, there is an increasing trend to recommend early internal fixation of the broken scaphoid even if the fracture is not displaced. The benefits and risks of early fixation of scaphoid fractures have not been established. These were investigated in eighty-eight patients who were of working age with clearly defined minimally displaced or undisplaced bicortical fractures of the waist of the scaphoid. METHODS: Patients who provided informed consent were randomized to treatment with early internal fixation with use of a Herbert screw without a cast (forty-four patients) or to nonoperative treatment for eight weeks with immobilization in a below-the-elbow plaster cast with the thumb left free (forty-four patients). The patients were evaluated at two, eight, twelve, twenty-six, and fifty-two weeks with respect to the severity of pain; tenderness; swelling; wrist movement; grip strength; and symptoms and disability, which were assessed with the Patient Evaluation Measure. In addition, radiographs were made and assessed at each visit. RESULTS: No difference was detected between the groups with respect to age, sex, hand dominance, side of injury, mechanism of injury, or the occupation of the patients. The range of motion, score on the Patient Evaluation Measure, and grip strength were significantly better in the group managed operatively than in the group managed nonoperatively at the eight-week follow-up evaluation, which corresponded with the visit when the cast was removed in that group. Patients returned to work at five to six weeks after the injury in both groups. At twelve weeks, grip strength was better in patients who had had surgery. No significant difference was detected between the two groups with respect to any other outcome measure at any other time. Ten of the forty-four fractures treated nonoperatively had not healed radiographically at twelve weeks, and, as a consequence, the treatment was altered. Complications occurred in thirteen patients who had been managed operatively. All complications were minor, and ten were related to the scar. CONCLUSIONS: This study did not demonstrate a clear overall benefit of early fixation of acute scaphoid fractures beyond the decrease in the rate of a change in treatment because of a delayed union at twelve weeks. Early internal fixation of minimally displaced or nondisplaced fractures of the scaphoid waist, which would heal in a cast, could lead to overtreatment of a large proportion of such fractures, exposing such patients to avoidable surgical risk. Thus, we have adopted a program of so-called aggressive conservative treatment, whereby we carefully assess fracture-healing with plain radiographs, and computed tomography scans if necessary, after six to eight weeks of cast immobilization and recommend surgical fixation with or without bone-grafting at that time if a gap is identified at the fracture site. Such an approach should result in fracture union in over 95% of such patients. LEVEL OF EVIDENCE: Therapeutic Level I.     

Nortriptyline for treating enuresis in ADHD—a randomized double-blind controlled clinical trial

Background

Treating enuresis in children with attention deficit hyperactivity disorder (ADHD) has not been previously reported. This study aims to investigate the efficacy, tolerability, and adverse effects of nortriptyline for treating enuresis in children with ADHD.

Methods

Forty-three children aged from 5 to 14?years old were randomized into two groups. The treatment group received methylphenidate plus nortriptyline, while the placebo group received methylphenidate plus placebo. Nortriptyline and placebo were administered for 30?days and methylphenidate was administered for 45?days. The major outcome measure was parent-reported frequency of enuresis for 2?weeks prior to the intervention, during the intervention, and for 2?weeks after stopping the adjuvant therapy. Adverse effects were also checked.

Results

While nortriptyline statistically decreased the incidence of nocturnal enuresis during the intervention, the number of enuresis events did not significantly change in the placebo group. In addition, enuresis was not different from the baseline frequency of enuresis after stopping nortriptyline or placebo administration. Both nortriptyline and placebo were tolerated well.

Conclusions

Administration of nortriptyline for treating enuresis in ADHD has not been investigated before. Nortriptyline is statistically superior to placebo. However, enuresis will relapse after stopping nortriptyline in children with ADHD who continue taking methylphenidate.     

Can oral metronidazole substitute parenteral drug therapy in acute appendicitis? A new policy in the management of simple or complicated appendicitis with localized peritonitis: a randomized controlled clinical trial

To demonstrate the efficacy of oral metronidazole (OM) in simple or complicated appendicitis with localized peritonitis, a randomized prospective study was carried out in 1083 patients, ranging in age from 4 to 50 years (mean age, 21.38). The patients were randomly divided into two groups. The study group (SG) (524 patients) received OM (500 mg for adults, 7-10 mg/kg if less than 15 years) 2-3 hours before operation. The drug was continued 4 to 5 hours after operation, every 8 hours, for three doses if the appendix was mild to severely inflamed. In the case of complicated appendicitis (114 patients), the same dose was given for 3 to 6 days, depending on the absence or presence of pus. Ceftizoxime was administered to the control group (CG) (559 patients) 2 to 3 hours before operation and then postoperatively every 6 hours for three doses if the appendix was mild to severely inflamed. The complicated cases in the CG (120 patients) received a combination of penicillin, chloramphenicol, and gentamicin for 3 to 6 days, depending on the absence or presence of pus. The serum concentration of metronidazole measured in 43 patients was at bactericidal level in 40 (mean +/- SD standard deviation, 10.65 +/- 4.89 microg/mL). The rate of wound infection was not significantly different in the SG and the CG with the same degree of pathology (3.17% vs 2.96% if uncomplicated; 15.78% vs 14.16% if complicated, respectively). Pelvic collection occurred in four adults and one child in the CG with perforated appendicitis (4.16%). The same complication developed in two adults and two children in the SG with perforated appendicitis (3.5%). All six adults and one of the children in the SG had to be re-explored, whereas the remaining two children responded to conservative management (OM and gentamicin). In uncomplicated cases, hospital stay and hospital charge were both almost the same in both groups. However, length of hospitalization was nearly 1 day shorter and hospital cost per day was about 30 per cent less in complicated cases in the SG as compared with the CG. Conclusively, OM may not only substitute parenteral antibiotics in acute appendicitis as a prophylactic agent, but it may also be used as a cost-effective drug and is more convenient to the patient.     

Evaluation of the effectiveness of a semi-finished occlusal appliance – a randomized, controlled clinical trial

Introduction

Painful temporomandibular disorders (TMDs) are usually treated with physiotherapy, self-exercises, medication-based therapy and splint therapy. For splint therapy different types of splints are available. Therefore this randomized controlled study compared the effectiveness of a semi-finished occlusal appliance (SB) with a laboratory-made occlusal appliance (SS) in myofascial pain patients.

Method

The trial subjects allocated to the experimental groups with the (SB) occlusal appliance and those provided with a laboratory-made occlusal appliance (SS) did, in addition, receive conservative treatment (self-exercises, drug-based and manual therapy). The control group was given conservative therapy (CO) only. Overall, a total of 63 patients participated in the study with each group consisting of 21 subjects.

Results

When the first follow-up examination took place (14 days after splint insertion) mouth opening within the SB group was significantly enlarged. When the second examination was conducted (2.5 months after splint insertion) mouth opening was significantly enlarged in both splint groups when compared with the initial value. In the control group, no significant enlargement of mouth opening was detected. At no point there was a significant reduction in the number of pressure-sensitive areas of the TMJ. On palpation of the masticatory muscles however, a significant reduction in the number of pressure-sensitive areas could be observed within the CO group and the SS group after 2.5 months. When comparing pain reduction (muscle/joint pain) and mouth opening, no significant differences could be detected between the treatments.

Conclusion

The results suggest that TMD should be treated conservatively. In cases of restricted mouth opening, the additional use of occlusal appliances can eliminate the patient’s discomfort more quickly. In this context, the tested, semi-finished occlusal appliance appears to offer an immediately available, temporary alternative to laboratory-made splints.     

Photobiomodulation therapy (PBMT) on acute pain and inflammation in patients who underwent total hip arthroplasty—a randomized,triple-blind,placebo-controlled clinical trial

When conservative treatments fail, hip osteoarthritis (OA), a chronic degenerative disease characterized by cartilage wear, progressive joint deformity, and loss of function, can result in the need for a total hip arthroplasty (THA). Surgical procedures induced tissue trauma and incite an immune response. Photobiomodulation therapy (PBMt) using low-level laser therapy (LLLT) and/or light-emitting diode therapy (LEDT) has proven effective in tissue repair by modulating the inflammatory process and promoting pain relief. Therefore, the aim of this study was to analyze the immediate effect of PBMt on inflammation and pain of patients undergoing total hip arthroplasty. The study consisted of 18 post-surgical hip arthroplasty patients divided into two groups (n?=?9 each) placebo and active PBMt who received one of the treatments in a period from 8 to 12 h following THA surgery. PBMt (active or placebo) was applied using a device consisting of nine diodes (one super-pulsed laser of 905 nm, four infrared LEDs of 875 nm, and four red LEDs 640 nm, 40.3 J per point) applied to 5 points along the incision. Visual analog scale (VAS) and blood samples for analysis of the levels of the cytokines TNF-α, IL-6, and IL-8 were recorded before and after PBMt application. The values for the visual analog scale as well as those in the analysis of TNF-α and IL-8 serum levels decreased in the active PBMt group compared to placebo-control group (p?<?0.05). No decrease was observed for IL-6 levels. We conclude that PBMt is effective in decreasing pain intensity and post-surgery inflammation in patients receiving total hip arthroplasty.     

Does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial

The concept of minimally invasive lumbar disc surgery comprises reduced muscle injury. The aim of this study was to evaluate creatine phosphokinase (CPK) in serum and the cross-sectional area (CSA) of the multifidus muscle on magnetic resonance imaging as indicators of muscle injury. We present the results of a double-blind randomized trial on patients with lumbar disc herniation, in which tubular discectomy and conventional microdiscectomy were compared. In 216 patients, CPK was measured before surgery and at day 1 after surgery. In 140 patients, the CSA of the multifidus muscle was measured at the affected disc level before surgery and at 1 year after surgery. The ratios (i.e. post surgery/pre surgery) of CPK and CSA were used as outcome measures. The multifidus atrophy was classified into three grades ranging from 0 (normal) to 3 (severe atrophy), and the difference between post and pre surgery was used as an outcome. Patients’ low-back pain scores on the visual analogue scale (VAS) were documented before surgery and at various moments during follow-up. Tubular discectomy compared with conventional microdiscectomy resulted in a nonsignificant difference in CPK ratio, although the CSA ratio was significantly lower in tubular discectomy. At 1 year, there was no difference in atrophy grade between both groups nor in the percentage of patients showing an increased atrophy grade (14% tubular vs. 18% conventional). The postoperative low-back pain scores on the VAS improved in both groups, although the 1-year between-group mean difference of improvement was 3.5 mm (95% CI; 1.4–5.7 mm) in favour of conventional microdiscectomy. In conclusion, tubular discectomy compared with conventional microdiscectomy did not result in reduced muscle injury. Postoperative evaluation of CPK and the multifidus muscle showed similar results in both groups, although patients who underwent tubular discectomy reported more low-back pain during the first year after surgery.     

Is wound drainage necessary in hip arthroplasty? A meta-analysis of randomized controlled trials

Purpose

The use of closed suction drainage systems for hip arthroplasty (HA) is a common practice. However, the effectiveness and safety are still questionable. Thus, the aim of this meta-analysis was to review the advantages and adverse effects of closed suction drainage systems in hip arthroplasty.

Methods

All randomized or quasi-randomized trials comparing the use of closed suction drainage systems with no drainage systems for hip arthroplasty were searched in PubMed, Medicine, EMBASE and other internet databases. We assessed the methodological quality of the studies and abstracted the relevant data independently.

Results

Sixteen studies involving 1,663 participants with surgical wounds comparing HA with and without the use of drainage were included in our analysis. Our results demonstrated blood transfusion was required more frequently the same as the persistent discharge in those who received drains. No significant differences in the incidence of wound hematoma, dehiscence or deep vein thrombosis were found between those allocated to drains and the non-drained wounds. Wound infection and the range of movement of the joint after surgery were similar between the two groups.

Conclusions

Based on the current evidence, there is insufficient evidence to support the routine use of closed suction drainage in hip arthroplasty. At the same time, our meta-analysis study suggested that using of closed suction drainage in HA increased requirement for postoperative blood transfusion. However, there is a moderate possibility of selection bias and publication bias in this review. Because of the limited number of studies which may weaken the strength of the evidence of our results, more samples, high-quality randomized trials are needed to increase the reliability of evidences.

Level of evidence

II.     

Does mental practice or mirror therapy help prevent functional loss after distal radius fracture? A randomized controlled trial

Study DesignA randomized, single-blinded controlled trial.IntroductionTherapy results after distal radius fractures (DRF) especially with older patients are often suboptimal. One possible approach for counteracting the problems are motor-cognitive training interventions such as Mental Practice (MP) or Mirror Therapy (MT), which may be applied in early rehabilitation without stressing the injured wrist.Purpose of the StudyThe aim of the study is to investigate the effects of MP and MT on wrist function after DRF. The pilot study should furthermore provide information about the feasibility of these methods.MethodsThirty-one women were assigned either to one of the two experimental groups (MP, MT) or to a control group (relaxation intervention). The participants completed a training for six weeks, administered at their homes. Measurements were taken at four times (weeks 0, 3, 6 and 12) to document the progression in subjective function (PRWE, QuickDASH) and objective constraints of the wrist (ROM, grip strength) as well as in health-related quality of life (EQ-5D).ResultsThe results indicated that both experimental groups showed higher improvements across the intervention period compared to the control group; e.g. PRWE: MT 74.0%, MP 66.2%, CG 56.9%. While improvements in grip strength were higher for the MP group, the MT group performed better in all other measures. However, time by group interactions approached significance at best; e.g. ROM: P = .076; η_p² = .141.ConclusionThe superiority of MP as well as MT supports the simulation theory. Motor-cognitive intervention programs are feasible and promising therapy supplements, which may be applied in early rehabilitation to counteract the consequences of immobilization without stressing the injured wrist.     

Risk of hip fracture following a wrist fracture—A meta-analysis

AimsThis purpose of this meta analysis was to investigate and quantify the relative risk of hip fracture in patients who have sustained a wrist fracture.MethodStudies were identified by searching Medline, Embase, Cochrane CENTRAL database and CINAHL from their inception to August 2015. Studies reporting confirmed hip fracture following wrist fracture were included.Data extraction was carried out using a modified Cochrane data collection form by two reviewers independently. Quality assessment was carried out using a modified Coleman score and the Newcastle Ottawa scale for cohort studies. An assessment of bias was performed for each study using a modified Cochrane Risk of Bias tool.A pooled relative risk(RR) was estimated with 95% CI from the RR/HRs and CIs reported in the studies.Results12 studies were included in the final meta-analysis (4 male, 8 female only). Relative risk of hip fracture following wrist fracture for women was 1.43 (CI 1.27 to 1.60). In men it was not significantly increased (RR 2.11, 95% CI: 0.93–4.85). Heterogeneity was low (I squared 0%) for both groups so a fixed effects model was used.ConclusionRisk of a subsequent hip fracture is increased for women who suffer a wrist fracture (RR 1.43).Resources and preventative measures should be targeted towards these high risk patients to prevent the catastrophic event of a hip fracture.This meta analysis confirms and quantifies the increased relative risk of hip fracture after wrist fracture in women.     

Laterally closed tunnel technique with and without adjunctive photobiomodulation therapy for the management of isolated gingival recession—a randomized controlled assessor-blinded clinical trial

Lasers in Medical Science - The objective of this prospective randomized controlled single-center clinical trial was to prove the efficacy of adjunctive photobiomodulation in improving selected...     

Vascular clips versus ligatures in thyroid surgery—results of a multicenter randomized controlled trial (CLIVIT Trial)

Background

New techniques using vascular clips or ultrasonically activated shears have been suggested to shorten operation time without compromising safety. The objective of the CLIVIT Trial was to compare ligatures with vascular clips for hemostasis in elective benign thyroid surgery.

Methods

This multicenter, randomized, controlled, parallel group superiority trial was conducted in 13 German surgical centers. Patients scheduled for at least subtotal resection bilaterally were intraoperatively randomized. The primary endpoint was resection time. Secondary endpoints were the amount of postoperative bleeding, reoperation due to bleeding, wound infection, temporary (reversal within 12?months) and permanent (over 1?year) recurrent laryngeal nerve (RLN) paralysis, length of hospital stay, and safety. Registration: ISRCTN 96901396.

Results

Two hundred fifty patients were treated with ligatures and 241 with vascular clips. No differences in patients' baseline and surgical characteristics were observed. No difference was detected for mean resection time (clip 63.5?min?±?29.6, ligature 66.1?min?±?29.3, P?=?0.258). Postoperative bleeding (mean 86?ml?±?93), reoperation due to bleeding (clips 4, ligature 2), wound infections (clips 4, ligature 4), postoperative hospital stay (mean 3.0?±?1.9), and safety data also did not vary significantly. The rates of temporary and permanent RLN paralysis were 6.9?% (34/491) and 2.9?% (14/491), respectively. Not using a surgical drain (123 patients) was not associated with a higher rate of complications.

Conclusion

Vascular clips did not reduce the resection time. However, a 2.9?% rate of permanent RLN paralysis is of concern. Drains in elective surgery may be of no benefit.     

An occupation-based intervention in patients with hand-related disorders grouped using the sense of coherence scale—A randomized controlled trial

Study DesignA nonblinded randomized controlled trial.IntroductionOccupation-based interventions are superior to physical exercise–based interventions in patients with activity limitations. However, only a few studies have examined the effect in patients with hand-related disorders. Patients recover heterogeneously, which could be due to personal factors, such as sense of coherence (SOC).Purpose of the studyTo investigate the effectiveness of an occupation-based intervention for patients with hand-related disorders and whether SOC can give an indication of the expected effects.MethodsA total of 504 patients were stratified into three SOC groups and then randomized to either an occupation-based intervention, including physical exercises (OBI) or a physical exercise–based occupation-focused intervention. The primary outcome, functioning, was measured using the Disability of the Arm, Shoulder and Hand questionnaire. Primary endpoint was at three months. Patients were followed up for a year.ResultsNo significant difference was found in primary outcome analysis. Nevertheless, patients receiving OBI had a statistically significant and greater change in satisfaction with their occupational performance at one, two, and three months follow-up. Patients with a weak SOC had worse functioning and lower health-related quality of life than those in the other groups, at all times.ConclusionsOBI as delivered in this study was not superior to physical exercise–based occupation-focused intervention in this patient group. However, in taking a client-centered approach, we recommend that OBI be based on individual needs, given that patients had a statistically greater change in score regarding satisfaction with their occupational performance. It is evident that patients with a weaker SOC have a lower level of functioning. This knowledge should inform clinical practice.