Surgical Treatment of Lateral Epicondylitis: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2018 ◽  
Vol 46 (5) ◽  
pp. 1106-1113 ◽  
Author(s):  
Martin Kroslak ◽  
George A.C. Murrell
Keyword(s):  
Outcome Measures ◽  
Primary Outcome ◽  
Tennis Elbow ◽  
Surgical Techniques ◽  
Surgical Excision ◽  
Additional Benefit ◽  
Secondary Outcome ◽  
Elbow Pain ◽  
Duration Of Symptoms ◽  
Significant Difference

Background: A number of surgical techniques for managing tennis elbow have been described. One of the most frequently performed involves excising the affected portion of the extensor carpi radialis brevis (ECRB). The results of this technique, as well as most other described surgical techniques for this condition, have been reported as excellent, yet none have been compared with placebo surgery. Hypothesis: The surgical excision of the degenerative portion of the ECRB offers no additional benefit over and above placebo surgery for the management of chronic tennis elbow. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: This study investigated surgical excision of the macroscopically degenerated portion of the ECRB (surgery; n = 13) as compared with skin incision and exposure of the ECRB alone (sham; n = 13) to treat patients who had tennis elbow for >6 months and had failed at least 2 nonsurgical modalities. The primary outcome measure was defined as patient-rated frequency of elbow pain with activity at 6 months after surgery. Secondary outcome measures included patient-rated pain and functional outcomes, range of motion, epicondyle tenderness, and strength at 6 months and 2.5 years. All outcome measures up to and including the 6-month follow-up were measured in person; the longer-term questionnaire was conducted in person or over the phone. Results: The 2 groups, surgery and sham, were similar for age, sex, hand dominance, and duration of symptoms. Both procedures improved patient-rated pain frequency and severity, elbow stiffness, difficulty with picking up objects, difficulty with twisting motions, and overall elbow rating >6 months and at 2.5 years ( P < .01). Both procedures also improved epicondyle tenderness, pronation-supination range, grip strength, and modified Orthopaedic Research Institute–Tennis Elbow Testing System at 6 months ( P < .05). No significant difference was observed between the groups in any parameter at any stage. No side effects or complications were reported. The study was stopped before the calculated number of patients were enrolled (40 per group); yet, a post hoc futility analysis was conducted that showed, based on the magnitude of the differences between the groups, >6500 patients would need to be recruited per group to see a significant difference between the groups at 26 weeks in the primary outcome (patient-rated frequency of elbow pain with activity). Conclusion: With the number of available participants, this study failed to show additional benefit of the surgical excision of the degenerative portion of the ECRB over placebo surgery for the management of chronic tennis elbow.

scholarly journals Surgical Treatment of Lateral Epicondylitis

2017 ◽  
Vol 5 (3_suppl3) ◽  
pp. 2325967117S0012 ◽  
Author(s):  
Martin Kroslak ◽  
George A.C. Murrell
Keyword(s):  
Tennis Elbow ◽  
Surgical Techniques ◽  
Surgical Excision ◽  
Secondary Outcome ◽  
Sham Operation ◽  
Elbow Pain ◽  
Duration Of Symptoms ◽  
Post Surgery ◽  
Number Of Patients ◽  
Significant Difference

Objectives: A number of surgical techniques for managing tennis elbow have been described, one of the commonest (Nirschl & Pettrone. J Bone Joint Surg Am, 61(6A): 832-839) involves excising the affected portion of extensor carpi radialis brevis (ECRB) origin. The results of this technique, as well as most other described surgical techniques for this condition, have been reported as excellent, yet none have been compared with placebo surgery. Methods: This study was a prospective, randomised, double blinded, placebo controlled clinical trial investigating the surgical excision of the macroscopically degenerated portion of ECRB (Nirschl technique; n=13) compared with a sham operation (skin incision and exposure of ECRB alone; n=13) to manage tennis elbow, in patients with tennis elbow for more than 6 months who failed at least two non-surgical modalities. The primary outcome measure was defined as patient rated frequency of elbow pain with activity at 6 months post-surgery. Secondary outcome measures included patient rated frequency and severity of pain, functional outcomes, range of motion, epicondyle tenderness and strength at 6 months and >12 months post-surgery. Results: The two groups were matched for age, gender, hand dominance and duration of symptoms. Both the surgery and placebo procedures improved patient rated pain frequency and severity, elbow stiffness, difficulty with picking up objects, twisting motions and overall elbow rating over 6 months and at >12 months (p<0.01). Both procedures also improved epicondyle tenderness, pronation-supination range, grip strength and modified ORI-TETS at 6 months (p<0.05). No significant difference was observed between the groups in any parameter at any stage. No side effects or complications were reported. The study was stopped before the calculated number of patients were enrolled, as a post-hoc analysis showed over 6500 patients would need to be recruited in each group to see a significant difference between the groups at 26 weeks, when measuring patient rated frequency of elbow pain with activity. Conclusion: This study indicates that the surgical excision of the degenerative portion of ECRB offers no additional benefit over and above placebo surgery for the management of chronic tennis elbow. [Figure: see text]

scholarly journals Vibration therapy versus standard treatment for tennis elbow: A randomized controlled study

2018 ◽  
Vol 26 (3) ◽  
pp. 230949901879274 ◽  
Author(s):  
Nicholas Duncan Furness ◽  
Alistair Phillips ◽  
Sian Gallacher ◽  
James Charles Sherard Beazley ◽  
Jonathan Peter Evans ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Primary Outcome ◽  
Standard Treatment ◽  
Outcome Measure ◽  
Tennis Elbow ◽  
Dropout Rate ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Vibration Therapy ◽  
Outcome Scores

Aim: To determine whether a mechanical, high-frequency vibration device (Tenease™) can improve pain and function for the treatment of tennis elbow (TE), compared with standard treatment. Methods: Adults presenting to an elbow clinic with a clinical diagnosis of TE were randomized to standard treatment with physiotherapy, activity modification and analgesia or standard treatment plus Tenease therapy. Tenease therapy consisted of a 6-week period of treatment using the Tenease device with three 10-min episodes each day. The primary outcome measure was the quick Disabilities of the Arm, Shoulder and Hand score at 6 months, with scores also taken at 6 weeks. Secondary outcome measures were the Patient Rated Tennis Elbow Evaluation Score and EuroQol 5-Dimension Visual Analogue Scale at the same time points. Results: Fifty-four patients were recruited into the study. Following randomization and initial dropout, 18 patients were included in the standard group and 27 in the Tenease group. Both groups reported improvements in primary outcome measure scores. The control group had a mean score of 44.3 (standard deviation (SD) = 18.8) at baseline, which dropped to 31.2 (SD = 17.2) at 6 months ( p = 0.002). The Tenease group had a mean score of 43.2 (SD = 22.7) at baseline, which dropped to 23.4 (SD = 15.0) at 6 months ( p = 0.064). Similar improvements were seen in secondary outcome measures with none reaching statistical significance. There were no statistically significant differences seen between the primary outcome scores at 6 weeks ( p = 0.9) or 6 months ( p = 0.5). No complications were noted in either group. Conclusions: Vibration therapy did not result in any statistically significant improvement in functional outcome scores compared to standard treatment for TE. It is important to note that this was a relatively small cohort and a high dropout rate was observed.

Laser Acupuncture for Chronic Non-Specific Low Back Pain: A Controlled Clinical Trial

2009 ◽  
Vol 27 (3) ◽  
pp. 94-100 ◽  
Author(s):  
Gregory Glazov ◽  
Peter Schattner ◽  
Derrick Lopez ◽  
Kerrie Shandley
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Specific Effect ◽  
Laser Acupuncture ◽  
Secondary Outcome ◽  
Control Group ◽  
Low Back ◽  
Significant Difference

Objective The primary aim was to determine if laser acupuncture (LA) is more effective than sham laser in reducing pain and disability in adults with chronic non-specific low back pain. Methods The design was a double blind, two-group parallel randomised controlled trial. The active intervention was an 830 nm (infrared), 10 mW, Ga-Al-As laser diode laser for acupuncture and a sham control. The primary outcome measures were changes in pain (visual analogue scale) and disability (Oswestry Disability Index) at the end of 5–10 treatment sessions. Secondary outcomes were patient global assessment, psychological distress (Depression Anxiety Stress Scale) and subjective wellbeing (Personal Wellbeing Index). Follow up was performed at 6 weeks and 6 months after completion of treatment. Results 100 participants were enrolled and treated in a general practice setting. Per protocol analysis of the primary outcome measures using ANOVA suggested that although there was a significant overall improvement in pain and disability after the course of treatments (p<0.01), there was no significant difference between the intervention and control group in both the primary and most secondary outcome measures. Conclusion This study did not show a specific effect for LA using infrared laser at 0.2 Joules per point for chronic low back pain. The overall intervention appeared effective because of placebo and other factors. As there was some concern about baseline inequality between the groups further research using tighter inclusion criteria should attempt to replicate the result and examine if a dose response may exist.

scholarly journals Donepezil for mild cognitive impairment in Parkinson’s disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kyoungwon Baik ◽  
Seon Myeong Kim ◽  
Jin Ho Jung ◽  
Yang Hyun Lee ◽  
Seok Jong Chung ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Treatment Group ◽  
Outcome Measures ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Control Group ◽  
Significant Difference

AbstractWe investigated the efficacy of donepezil for mild cognitive impairment in Parkinson’s disease (PD-MCI). This was a prospective, non-randomized, open-label, two-arm study. Eighty PD-MCI patients were assigned to either a treatment or control group. The treatment group received donepezil for 48 weeks. The primary outcome measures were the Korean version of Mini-Mental State Exam and Montreal Cognitive Assessment scores. Secondary outcome measures were the Clinical Dementia Rating, Unified Parkinson’s Disease Rating Scale part III, Clinical Global Impression scores. Progression of dementia was assessed at 48-week. Comprehensive neuropsychological tests and electroencephalography (EEG) were performed at baseline and after 48 weeks. The spectral power ratio of the theta to beta2 band (TB2R) in the electroencephalogram was analyzed. There was no significant difference in the primary and secondary outcome measures between the two groups. However, the treatment group showed a significant decrease in TB2R at bilateral frontotemporoparietal channels compared to the control group. Although we could not demonstrate improvements in the cognitive functions, donepezil treatment had a modulatory effect on the EEG in PD-MCI patients. EEG might be a sensitive biomarker for detecting changes in PD-MCI after donepezil treatment.

A randomised controlled trial of perivenous tumescent anaesthesia in addition to general anaesthesia for surgical ligation and stripping of the great saphenous vein

2019 ◽  
Vol 35 (5) ◽  
pp. 305-315 ◽  
Author(s):  
Sandip Nandhra ◽  
Tom Wallace ◽  
Joseph El-Sheikha ◽  
Daniel Carradice ◽  
Ian Chetter
Keyword(s):  
Quality Of Life ◽  
General Anaesthesia ◽  
Saphenous Vein ◽  
Primary Outcome ◽  
Great Saphenous Vein ◽  
Bodily Pain ◽  
Secondary Outcome ◽  
Surgical Ligation ◽  
Significant Difference

Introduction Open surgical ligation and stripping of the great saphenous vein is a highly cost-effective treatment when compared with conservative management and foam sclerotherapy but has limitations including post-operative morbidity and pain. This study aims to identify if the addition of tumescent anaesthesia could improve patient outcomes following treatment. Methods Patients with primary superficial venous incompetence undergoing open surgical ligation and stripping of the great saphenous vein were randomised to either General Anaesthesia (GA) alone (GA) procedure or the addition of tumescent (G + T). The primary outcome was bodily pain (within SF-36) at one week. Additional outcomes included post-procedural pain score (100 mm visual analogue scale), complications and quality of life. Results A total of 90 patients were randomised for inclusion. There was no significant difference in primary outcome; bodily pain at one week. Secondary outcome of 4-h post-procedural scores were significantly lower in the G + T group (32 (20–54) mm vs. (GA alone) 56 (24–70) mm (P = 0.016)). Complications were minor and equivalent. Both groups saw a significant increase (worsening) in Aberdeen Varicose Vein Questionnaire scores at week 1 with the G + T group faring worse at six weeks (10.0 (Interquartile Range [IQR] 5.6–17.9) vs. 4.3 (IQR 2.7–7.9) P = 0.004). Conclusion The G + T group did not demonstrate a significant difference in the one-week bodily pain domain. The addition of tumescent anaesthesia does improve immediate post-operative pain but appears to negatively impact on six-week quality of life. EudraCT Number: 2011-005574-39

scholarly journals Retrospective Assessment of the Efficacy of Modified Progressive Tinnitus Management Skills Education in a Military Medical Treatment Facility

2019 ◽  
Vol 184 (9-10) ◽  
pp. e468-e473 ◽  
Author(s):  
LaGuinn P Sherlock ◽  
Candice E Ortiz ◽  
Georgina P Blasco ◽  
Daniel I Brooks
Keyword(s):  
Medical Treatment ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Published Data ◽  
Treatment Facility ◽  
Coping Ability ◽  
Medical Treatment Facility ◽  
Treatment Facilities ◽  
Skills Education

Abstract Introduction The number-one service-connected disability is tinnitus. Tinnitus currently has no cure, but the functional impact of tinnitus has been shown to be mitigated by Progressive Tinnitus Management (PTM), a multi-level management approach. The duration of PTM Level 3 skills education (PTM-SE) and the inclusion of mental health providers have been identified as barriers to implementation of PTM-SE in Department of Defense (DOD) medical treatment facilities. The goal of this study was to determine if a version of PTM-SE modified for use in DOD medical treatment facilities resulted in positive changes in tinnitus-related outcomes. Materials and Methods A retrospective study was conducted by examining the medical records of patients who attended modified PTM-SE appointments. The study was approved by the Walter Reed National Military Medical Center Institutional Review Board. The study sample included 130 patients who completed modified PTM-SE between January 2015 and June 2016. Primary outcome measures were tinnitus awareness and tinnitus annoyance; secondary outcome measures were effect on life and self-perceived coping ability. Outcome measures were analyzed with nonparametric statistics and logistic regression. Results Modified PTM-SE resulted in clinically significant improvements in the primary outcome measures (awareness, p &lt; 0.0001; annoyance, p &lt; 0.0001). The proportion of patients who indicated an improvement in coping with tinnitus was similar to other published data with similar modifications to PTM-SE. Conclusions The evidence supports the assumption that PTM is a flexible program of tinnitus management that even when modified to be suitable for use in a DOD medical treatment facility provides meaningful reductions in tinnitus awareness and annoyance and improves tinnitus coping ability among military beneficiaries. These findings should encourage audiologists to modify PTM to work within their military medical treatment facility.

ST03: A randomized trial of perioperative epirubicin, cisplatin plus capecitabine (ECX) with or without bevacizumab (B) in patients (pts) with operable gastric, oesophagogastric junction (OGJ) or lower oesophageal adenocarcinoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS4143-TPS4143 ◽  
Author(s):  
Elizabeth C Smyth ◽  
Ruth E Langley ◽  
Sally P Stenning ◽  
Laura Stevenson ◽  
William H. Allum ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Disease Free Survival ◽  
Stage I ◽  
Stage Ii ◽  
Oesophageal Adenocarcinoma ◽  
Secondary Outcome ◽  
Free Survival ◽  
Oesophagogastric Junction

TPS4143 Background: Perioperative ECX chemotherapy is a standard of care for localised gastric/OGJ/lower oesophageal adenocarcinoma (Cunningham NEJM 2006). B is a monoclonal antibody targeting VEGF-A, and in combination with chemotherapy results in improved response rates (RR) and progression free survival in advanced gastric cancer (Ohtsu JCO 2011). The aim of ST03 is to assess the safety and feasibility (stage I, first 200 pts) and efficacy (stage II) of the addition of B to perioperative ECX chemotherapy. Methods: ST03 is a multicentre, open-label, phase II/III randomised trial ongoing at 92 UK centres; sites in Germany will open in 2012. Eligibility criteria are histologically proven, untreated, resectable, lower oesophageal, OGJ or gastric adenocarcinoma; age ≥18 years; WHO PS 0-1; and adequate cardiac ejection fraction (EF). Exclusion criteria are TIA/CVA or MI ≤1 year; uncontrolled hypertension; ≥Grade II NYHA heart failure; recent gastrointestinal inflammatory conditions or major surgery/trauma/open biopsy <28d of study entry. Pts receive 3 pre- and 3 postoperative ECX (epirubicin 50 mg/m2 iv D1, cisplatin 60 mg/m2 iv D1 and capecitabine 1250mg/m2/D1-21) +/- B 7.5mg/kg D1 q3wk during chemotherapy, then 6 Bev q3wk (investigational arm). Surgery is pre-specified and laparoscopic procedures allowed only after quality assurance review. All specimens undergo central pathology review; blood and tissue collection for translational correlates is ongoing. The primary outcome measures for Stage I (safety results including cardiac EF) have been reported (Okines ASCO 2011). The stage II primary outcome measure is overall survival. Secondary outcome measures are RR, resection rate, disease free survival, toxicity, and QoL. An MRI substudy is open, a PET substudy is planned. 558 of ~950 pts required have been recruited, accrual expected to complete in 2013. An embedded pilot study within ST03 randomising HER2 positive patients to ECX ± lapatanib will open in 2012. Trial sponsored and co-ordinated by the MRC Clinical Trials Unit and funded by Cancer Research UK (CRUK06/025, NCT00450203).

scholarly journals Douching With Water Works Device for Perceived Vaginal Odor With or Without Complaints of Discharge in Women With No Infectious Cause of Vaginitis: A Pilot Study

2006 ◽  
Vol 2006 ◽  
pp. 1-4 ◽  
Author(s):  
Ashwin J. Chatwani ◽  
Sarmina Hassan ◽  
Salma Rahimi ◽  
Stacey Jeronis ◽  
Vani Dandolu
Keyword(s):  
Pilot Study ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Open Label ◽  
Significant Change

Objective. To determine if douching with Water Works device for 1 month can (1) lower or eliminate perceived vaginal odor by subject; (2) have any effects on vaginal ecosystem.Methods. Ten women with perceived vaginal odor with or without discharge, douched every day for 4 weeks in an open-label, nonrandomized pilot study. Primary outcome measures included perceived vaginal odor by subject, lactobacilli score from Nugent slide, and acceptance of the Water Works douching system. Secondary outcome included the safety of using this douching device.Results. At week 4, there was improvement in vaginal odor (P=.0006) and there was no significant change in lactobacilli score.Conclusion. Douching with Water Works device is associated with reduction or elimination of vaginal odor without adversely affecting the vaginal ecosystem.

Key lessons learned from short-term treatment trials of cholinesterase inhibitors for amnestic MCI

2008 ◽  
Vol 20 (1) ◽  
pp. 40-46 ◽  
Author(s):  
Stephen Salloway ◽  
Stephen Correia ◽  
Sharon Richardson
Keyword(s):  
Cognitive Impairment ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Rating Scales ◽  
Controlled Trial ◽  
Term Treatment ◽  
Lessons Learned ◽  
Secondary Outcome ◽  
Short Term ◽  
Short Term Treatment

ABSTRACTObjective: This paper reviews the key lessons learned from the first published short-term, placebo-controlled trial of a cholinesterase inhibitor for treatment of mild cognitive impairment (MCI).Methods: The study was a 24-week placebo-controlled trial designed to evaluate the efficacy and safety of donepezil HCl (donepezil) in the treatment of cognitive impairment in subjects with MCI. Primary outcome measures were the NYU Paragraphs Test and the ADCS Clinicians Global-Impression of Change in the intent-to-treat last-observation-carried-forward group.Results: There was no benefit of donepezil treatment on primary outcome measures (NYU Paragraphs and ADCS CGI-C) in the ITT-LOCF group but positive findings were seen on NYU Paragraphs in the fully evaluable group and in certain secondary outcome measures across both groups.Conclusions: The results highlight the need for the use of primary cognitive and functional measures that are reliable and sensitive to change in patients with MCI. Measures of episodic memory, psychomotor speed and complex attention were most sensitive in this study. Functional rating scales are needed that measure change in individual subjects' key areas of functional deficit, which typically involve executive aspects of instrumental ADLs. Tolerability can be increased by use of flexible dosing and efficacy is likely to be enhanced by increasing the length of the trial from six to 12 months and by enriching the sample with subjects more likely to decline during the trial.

scholarly journals Outcome Measures Used in Arthroplasty Trials: Systematic Review of the 2008 and 2013 Literature

2017 ◽  
Vol 44 (8) ◽  
pp. 1277-1287 ◽  
Author(s):  
Bethan L. Richards ◽  
Peter D.H. Wall ◽  
Andrew P. Sprowson ◽  
Jasvinder A. Singh ◽  
Rachelle Buchbinder
Keyword(s):  
Outcome Measures ◽  
Joint Replacement ◽  
Primary Outcome ◽  
Risk Of Bias ◽  
Significant Heterogeneity ◽  
Quality Of Reporting ◽  
Chi Square ◽  
Joint Replacement Surgery ◽  
Significant Difference ◽  
Overall Risk

Objective.Previously published literature assessing the reporting of outcome measures used in joint replacement randomized controlled trials (RCT) has revealed disappointing results. It remains unknown whether international initiatives have led to any improvement in the quality of reporting and/or a reduction in the heterogeneity of outcome measures used. Our objective was to systematically assess and compare primary outcome measures and the risk of bias in joint replacement RCT published in 2008 and 2013.Methods.We searched MEDLINE, EMBASE, and CENTRAL for RCT investigating adult patients undergoing joint replacement surgery. Two authors independently identified eligible trials, extracted data, and assessed risk of bias using the Cochrane tool.Results.Seventy RCT (30 in 2008, 40 in 2013) met the eligibility criteria. There was no significant difference in the number of trials judged to be at low overall risk of bias (n = 6, 20%) in 2008 compared with 2013 [6 (15%); chi-square = 0.302, p = 0.75]. Significantly more trials published in 2008 did not specify a primary outcome measure (n = 25, 83%) compared with 18 trials (45%) in 2013 (chi-square = 10.6316, p = 0.001). When specified, there was significant heterogeneity in the measures used to assess primary outcomes.Conclusion.While less than a quarter of trials published in both 2008 and 2013 were judged to be at low overall risk of bias, significantly more trials published in 2013 specified a primary outcome. Although this might represent a temporal trend toward improvement, the overall frequency of primary outcome reporting and the wide heterogeneity in primary outcomes reported remain suboptimal.

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