Six-week high-intensity exercise program for middle-aged patients with knee osteoarthritis: a randomized controlled trial [ISRCTN20244858]

Background  

Studies on exercise in knee osteoarthritis (OA) have focused on elderly subjects. Subjects in this study were middle-aged with symptomatic and definite radiographic knee osteoarthritis. The aim was to test the effects of a short-term, high-intensity exercise program on self-reported pain, function and quality of life.     

Postsurgical pain outcome of vertical and transverse abdominal incision: Design of a randomized controlled equivalence trial [ISRCTN60734227]

Background

There are two ways to open the abdominal cavity in elective general surgery: vertically or transversely. Various clinical studies and a meta-analysis have postulated that the transverse approach is superior to other approaches as regards complications. However, in a recent survey it was shown that 90 % of all abdominal incisions in visceral surgery are still vertical incisions. This discrepancy between existing recommendations of clinical trials and clinical practice could be explained by the lack of acceptance of these results due to a number of deficits in the study design and analysis, subsequent low internal validity, and therefore limited external generalisability. The objective of this study is to address the issue from the patient's perspective.

Methods

This is an intraoperatively randomized controlled observer and patient-blinded two-group parallel equivalence trial. The study setting is the Department of General-, Visceral-, Trauma Surgery and Outpatient Clinic of the University of Heidelberg, Medical School. A total of 172 patients of both genders, aged over 18 years who are scheduled for an elective abdominal operation and are eligible for either a transverse or vertical incision. To show equivalence of the two approaches or the superiority of one of them from the perspective of the patient, a primary endpoint is defined: the pain experienced by the patient (VAS 0–100) on day two after surgery and the amount of analgesic required (piritramide [mg/h]). A confidence interval approach will be used for analysis. A global α-Level of 0.05 and a power of 0.8 is guaranteed, resulting in a size of 86 patients for each group. Secondary endpoints are: time interval to open and close the abdomen, early-onset complications (frequency of burst abdomen, postoperative pulmonary complications, and wound infection) and late complications (frequency of incisional hernias). Different outcome variables will be ranked by patients and surgeons to assess the relevance of possible endpoints from the patients' and surgeons' perspective.

Conclusion

This is a randomized controlled observer and patient-blinded two-group parallel trial to answer the question if the transverse abdominal incision is equivalent to the vertical one due to the described endpoints.

     

Active rehabilitation for chronic low back pain: Cognitive-behavioral, physical, or both? First direct post-treatment results from a randomized controlled trial [ISRCTN22714229]

Background  

The treatment of non-specific chronic low back pain is often based on three different models regarding the development and maintenance of pain and especially functional limitations: the deconditioning model, the cognitive behavioral model and the biopsychosocial model.     

A型肉毒毒素盆底痛点定位注射在女性盆底肌筋膜疼痛治疗中的意义

目的:探讨A型肉毒毒素(BTXA)盆底痛点定位注射治疗女性盆底肌筋膜疼痛(MFPP)的临床疗效。方法:回顾性分析2013年1月～2017年6月收治的女性MFPP患者107例,进行盆底痛点评估后行BTXA痛点定位注射治疗。按有无合并下尿路症状(LUTS)分为单纯MFPP组和MFPP并LUTS组,比较两组患者临床症状特点,盆底痛点定位注射治疗前及治疗3个月后患者盆底疼痛、生活质量及排尿症状的改善情况。结果:MFPP并LUTS组的患者年龄更大,盆底疼痛程度更严重,生活质量更差(P<0.05)。两组患者经BTXA盆底痛点注射后盆底疼痛NRS评分下降,生活质量评分(QOL)下降,MFPP并LUTS组的患者排尿次数减少,排尿量增多(P<0.05),两组患者在治疗后未见明显并发症。结论:女性MFPP易合并LUTS,BTXA盆底痛点定位注射不仅能缓解女性MFPP,同时能缓解LUTS,是一种安全、经济、有效的治疗方法。     

Comparison of different electrotherapy methods and exercise therapy in shoulder impingement syndrome: A prospective randomized controlled trial

Objective

The aim of this study was to assess and compare the effects of different electrotherapy methods and exercise therapy on pain, function and quality of life in shoulder impingement syndrome.

Effectiveness of myofascial release in the management of plantar heel pain: A randomized controlled trial

BackgroundPrevious studies have reported that stretching of the calf musculature and the plantar fascia are effective management strategies for plantar heel pain (PHP). However, it is unclear whether myofascial release (MFR) can improve the outcomes in this population.ObjectiveTo investigate whether myofascial release (MFR) reduces the pain and functional disability associated with plantar heel pain (PHP) in comparison with a control group receiving sham ultrasound therapy (SUST).DesignRandomized, controlled, double blinded trial.SettingNonprofit research foundation clinic in India.MethodSixty-six patients, 17 men and 49 women with a clinical diagnosis of PHP were randomly assigned into MFR or a control group and given 12 sessions of treatment per client over 4 weeks. The Foot Function Index (FFI) scale was used to assess pain severity and functional disability. The primary outcome measure was the difference in FFI scale scores between week 1 (pretest score), week 4 (posttest score), and follow-up at week 12 after randomization. Additionally, pressure pain thresholds (PPT) were assessed over the affected gastrocnemii and soleus muscles, and over the calcaneus, by an assessor blinded to the treatment allocation.ResultsThe simple main effects analysis showed that the MFR group performed better than the control group in weeks 4 and 12 (P < 0.001). Patients in the MFR and control groups reported a 72.4% and 7.4% reduction, respectively, in their pain and functional disability in week 4 compared with that in week 1, which persisted as 60.6% in the follow-up at week 12 in the MFR group compared to the baseline. The mixed ANOVA also revealed significant group-by-time interactions for changes in PPT over the gastrocnemii and soleus muscles, and the calcaneus (P < 0.05).ConclusionsThis study provides evidence that MFR is more effective than a control intervention for PHP.     

Contributions of myofascial pain in diagnosis and treatment of shoulder pain. A randomized control trial

Background  

Rotator cuff tendinopathy and subacromial impingement syndrome present complex patomechanical situations, frequent difficulties in clinical diagnosis and lack of effectiveness in treatment. Based on clinical experience, we have therefore considered the existence of another pathological entity as the possible origin of pain and dysfunction. The hypothesis of this study is to relate subacromial impingement syndrome (SIS) with myofascial pain syndrome (MPS), since myofascial trigger points (MTrPs) cause pain, functional limitation, lack of coordination and alterations in quality of movement, even prior to a tendinopathy. MTrPs can coexist with any degenerative subacromial condition. If they are not taken into consideration, they could perpetuate and aggravate the problem, hindering diagnosis and making the applied treatments ineffective.     

Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]

Background  

Topical NSAIDs have been proven to relieve the symptoms of osteoarthritis (OA) in short-term studies (2 weeks). To justify its chronic use, efficacy of a topical NSAID over a longer term of study should be demonstrated. The efficacy and safety of a topical diclofenac solution over a 6-week treatment course in symptomatic primary OA of the knee was investigated.     

Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481]

Background  

Conservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options. There is an increasing interest in the usefulness of wrist magnetic resonance imaging could play in predicting who will benefit for various treatments.     

Rationale and design of a multicenter randomized controlled trial on a 'minimal intervention' in Dutch army personnel with nonspecific low back pain [ISRCTN19334317]

Background  

Researchers from the Royal Netherlands Army are studying the potential of isolated lumbar extensor training in low back pain in their working population. Currently, a randomized controlled trial is carried out in five military health centers in The Netherlands and Germany, in which a 10-week program of not more than 2 training sessions (10–15 minutes) per week is studied in soldiers with nonspecific low back pain for more than 4 weeks. The purpose of the study is to investigate the efficacy of this 'minimal intervention program', compared to usual care. Moreover, attempts are made to identify subgroups of different responders to the intervention.     

A double-blind randomized controlled trial of toremifen therapy for mastalgia

HYPOTHESIS: Toremifen is effective in reducing breast pain and does not increase the incidence of adverse events as a therapy for moderate to severe mastalgia.Design and PATIENTS: In a double-blind randomized controlled trial, patients with moderate to severe mastalgia received toremifen citrate, 30 mg daily, or a placebo tablet for 3 menstrual cycles and were followed up for breast pain score and adverse events. The serum levels of estradiol, progesterone, and prolactin were examined before treatment and correlated with the response rate to toremifen treatment. RESULTS: Seventy-two (69.2%) of 104 patients receiving toremifen and 29 (31.9%) of 91 receiving placebo responded to the treatment, with reduction in breast pain score of more than 50% (P<.001). Among the patients with cyclical mastalgia, the response rate for toremifen was 76.7% (59/77), whereas the response rate for placebo was 34.8% (23/66; P<.001). In contrast, the response rate of patients with noncyclical mastalgia was 48.1% (13/27) for toremifen and 24.0% (6/25) for placebo (P = .09). Adverse events were observed in 44 (42.9%) of 104 patients receiving placebo and 46 (50.5%) of 91 patients receiving toremifen (P = .45). A positive correlation between baseline breast pain score and serum estradiol level was observed in patients with cyclical mastalgia (r = 0.35, P = .003). CONCLUSIONS: Toremifen effectively relieves moderate and severe cyclical mastalgia and tends to exert a positive therapeutic effect on noncyclical mastalgia. In addition, toremifen therapy does not increase the incidence of intolerable adverse event. Therefore, it is a feasible therapy for mastalgia, especially cyclical mastalgia.     

The PEX study – Exercise therapy for patellofemoral pain syndrome: design of a randomized clinical trial in general practice and sports medicine [ISRCTN83938749]

Background  

Patellofemoral complaints are frequently seen in younger and active patients. Clinical strategy is usually based on decreasing provoking activities as sports and demanding knee activities during work and leisure and reassuring the patient on the presumed good outcome.     

A prospective randomized controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger

PURPOSE: This study was designed to test the null hypothesis that there is no difference in resolution of triggering 3 months after injection with either a soluble (dexamethasone) or insoluble (triamcinolone) corticosteroid for idiopathic trigger finger. METHODS: Eighty-four patients were enrolled in a prospective randomized controlled trial comparing dexamethasone and triamcinolone injection for idiopathic trigger finger. Sixty-seven patients completed the 6-week follow-up (35 triamcinolone arm, 32 dexamethasone arm), and 72 patients completed the 3-month follow-up (41 triamcinolone arm, 31 dexamethasone arm). Outcome measures included the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, trigger finger grading according to Quinnell, and satisfaction on a visual analog scale. To preserve autonomy, patients were permitted additional injections and operative treatment at any time. Twenty-five patients requested a second injection (10 triamcinolone arm, 15 dexamethasone arm), and 21 elected operative treatment (10 triamcinolone arm, 11 dexamethasone arm) during the study period. The analysis was according to intention to treat principles. RESULTS: Six weeks after injection, absence of triggering was documented in 22 of 35 patients in the triamcinolone cohort and in 12 of 32 patients in the dexamethasone cohort. The rates 3 months after injection were 27 of 41 in the triamcinolone cohort and 22 of 31 in the dexamethasone cohort. The triamcinolone cohort had significantly better satisfaction and Quinnell grades than did the dexamethasone cohort at the 6-week follow-up but not at the 3-month follow-up. There were no significant differences between Disabilities of the Arm, Shoulder, and Hand scores at the 6-week follow-up and the 3-month follow-up. After the close of the study, there were 8 recurrences among patients with documented absence of triggering in the triamcinolone cohort and 1 in the dexamethasone cohort. CONCLUSIONS: Although there were no differences 3 months after injection, our data suggest that triamcinolone may have a more rapid but ultimately less durable effect on idiopathic trigger finger than does dexamethasone.