***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Study Design . A prospect i ve , r and omized , single ( investigator ) blind , comparative efficacy trial was conducted . Objective . To compare the efficacy of continuous low-level heat wrap therapy ( 40 C , 8 hours/day ) with that of ibuprofen ( 1200 mg/day ) and acetaminophen ( 4000 mg/day ) in subjects with acute nonspecific low back pain . Summary of Background Data . The efficacy of topical heat methods , as compared with oral analgesic treatment of low back pain , has not been established . Methods . Subjects ( n = 371 ) were r and omly assigned to heat wrap ( n = 113 ) , acetaminophen ( n = 113 ) , or ibuprofen ( n = 106 ) for efficacy evaluation , or to oral placebo ( n = 20 ) or unheated back wrap ( n = 19 ) for blinding . Outcome measures included pain relief , muscle stiffness , lateral trunk flexibility , and disability . Efficacy was measured over two treatment days and two follow-up days . Results . Day 1 pain relief for the heat wrap ( mean , 2 ) was higher than for ibuprofen ( mean , 1.51;P = 0.0007 ) or acetaminophen ( mean , 1.32;P = 0.0001 ) . Extended mean pain relief ( Days 3 to 4 ) for the heat wrap ( mean , 2.61 ) also was higher than for ibuprofen ( mean , 1.68;P = 0.0001 ) or acetaminophen ( mean , 1.95;P = 0.0009 ) . Lateral trunk flexibility was improved with the heat wrap ( mean change , 4.28 cm ) during treatment ( P ≤ 0.009 vs acetaminophen [ mean change , 2.93 cm ] , P ≤ 0.001 vs ibuprofen [ mean change , 2.51 cm ] ) . The results were similar on Day 4 . Day 1 reduction in muscle stiffness with the heat wrap ( mean , 16.3 ) was greater than with acetaminophen ( mean , 10.5;P = 0.001 ) . Disability was reduced with the heat wrap ( mean , 4.9 ) , as compared with ibuprofen ( mean , 2.7;P = 0.01 ) and acetaminophen ( mean , 2.9;P = 0.0007 ) , on Day 4 . None of the adverse events were serious . The highest rate ( 10.4 % ) was reported in the ibuprofen group . Conclusion . Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain A double-blind , 18-center , balanced trial of diflunisal vs. cyclobenzaprine HCl vs. these two drugs combined vs. placebo produced complete results from 175 patients . They had sought treatment at the cooperating centers for acute painful spasms of the back within a day or two of trauma or strain . Global results over the 7 to 10 days of observations revealed a clinical ly and statistically significant superiority of the combined therapy by Day 4 ( P=0.006 ) and almost all patients recovered within a week to 10 days . A combination therapy with an effective safe analgesic and a true muscle relaxant for less than a week appears to be an excellent relief measure for acute back problems UNLABELLED In order to assess the efficacy and safety of a new patch containing 14 mg of piroxicam ( CAS 36322 - 90 - 4 ) 1 % , applied once daily , in comparison with a reference marketed formulation , piroxicam 1 % cream applied three times a day , placebo patch applied once daily , a r and omized , placebo-controlled , parallel-group clinical trial was carried out by general practitioners in patients with lumbar osteoarthritis aged between 18 and 75 years .  Pain during daily activities scored on a 100 mm visual analogue scale was the primary outcome measure . Other secondary outcome measures were pain on isometric contraction , on full passive motion , and on pressure , and functional disability . Statistical analysis was performed on the differences between the three groups in the intention-to-treat population ( ITT ) . One hundred and eighty patients were enrolled . The available ITT population comprised 179 patients . The compliance was very good . Decrease in pain score during daily activities after the eight days of study treatment ( at the final visit , Vf ) was 42.2 % , 41.7 % and 25.8 % in the piroxicam patch , piroxicam cream and placebo groups , respectively . The difference between the pain scores in two active treatments arms was not statistically significant at the Vf whereas the differences between the pain scores of two active treatment arms vs the placebo arm were statistically significant validating the study design . All efficacy measures improved during the study , for both the active treatment groups , and the results for the secondary efficacy variables were generally consistent with those concerning the main efficacy criterion . The difference between the two active treatments in pain during daily activities were statistically significant at the final visit ; in fact the 95 % CI of the difference between the mean of responder rate of the piroxicam patch and piroxicam cream was -18.3 % , + 24.4 % indicating a trend of superiority of the piroxicam patch versus the cream ( per- protocol analysis ) . The data obtained during the intermediate visit ( V2 , day 4 ) allow us to assess that the piroxicam patch was on average better than the piroxicam cream in terms of fast pain reduction ( change from baseline : - 29.1 % for piroxicam patch in comparison to -24.6 % for piroxicam cream ) . Moreover the piroxicam patch proved to be on average more effective than the piroxicam cream in terms of secondary efficacy endpoints . Safety was considered satisfactory in all groups . CONCLUSIONS The piroxicam patch is effective in the treatment of lumbar osteoarthritis and has demonstrated to be well tolerated and it improves patients compliance . The piroxicam patch offers a comparable alternative to the marketed piroxicam cream for the treatment of  lumbar osteoarthritis  with the advantage of a better compliance with the once a day application of the patch compared to three daily applications for the piroxicam cream Study Design . Two replicate , 4-week , r and omized , double-blind , placebo-controlled , trials of rofecoxib 25 and 50 mg versus placebo for chronic low back pain . Objectives . To determine the efficacy and safety of two doses of rofecoxib compared to placebo in the treatment of chronic low back pain . Summary of Background Data . Although nonsteroidal anti-inflammatory drugs are commonly prescribed for chronic low back pain , their efficacy is unproven and toxicity can be serious . These studies evaluated the efficacy and tolerability of rofecoxib , a selective COX-2 inhibitor , in the treatment of chronic low back pain . Methods . Patients with chronic low back pain were r and omized 1:1:1 to rofecoxib 25 mg , 50 mg , or placebo once daily . Primary endpoint : Low Back Pain Intensity . Secondary endpoints : Pain Bothersomeness , Global Assessment s of Response to Therapy , Global Assessment of Disease Status , Rol and -Morris Disability Question naire , SF-12 Health Survey , Use of Rescue Acetaminophen , and Discontinuations Due to Lack of Efficacy . Results . Combining both studies , 690 patients were r and omized to placebo ( N = 228 ) ,  rofecoxib 25 mg ( N = 233 ) , or  rofecoxib 50 mg ( N = 229 ) . Mean ( ± SD ) age was 53.4 ( ± 12.9 ) years , pain duration 12.1 ( ± 11.8 ) years , 62.3 % female .  Both rofecoxib groups improved significantly . Mean differences from placebo in pain intensity were −13.50 mm , −13.81 mm ( 25 , 50 mg doses ) respectively ( P < 0.001 ) . Both regimens were superior to placebo in eight of nine secondary endpoints . Fifty mg provided no advantage over 25 mg . Both rofecoxib regimens were well tolerated , although 25 mg had a slightly better safety profile . Conclusions . Rofecoxib significantly  reduced chronic low back pain in adults and was well tolerated Locally administered nonsteroidal anti-inflammatory drugs have been widely used in acute soft-tissue damage and articular musculoskeletal pain . This double-blind , placebo-controlled , r and omized study was design ed to evaluate the efficacy and safety of a topical diclofenac sodium patch in the relief of pain and inflammation as a result of myofascial pain syndrome ( MPS ) in the upper trapezius . After sample size calculations indicated that 147 patients would be needed to detect a 25 % difference between drug and control , 153 patients with MPS were recruited and r and omized to receive either a diclofenac sodium patch or control ( menthol ) patch .  Visual analog scale ( VAS ) , cervical active range of motion , pressure pain threshold of the myofascial trigger point ( MTrP ) , patient global assessment , Neck Disability Index , and the occurrence of adverse events were assessed on Day 0 ( baseline ) , Day 4 , and Day 8 . Use of the diclofenac sodium patch elicited favorable responses for the VAS , cervical active range of motion , and Neck Disability Index by the end of the treatment course ( P<0.05 ) , and was consistently superior to the control patch at all time intervals . No significant differences were observed for the pressure pain threshold of the MTrP for either patch . Tolerability assessment similarly showed the diclofenac patch to be comparatively superior . When assessed at the end of the study , 20 diclofenac  patch patients , but only four control patients , considered the tolerability of treatment to be " very good . " Significant differences in adverse reactions were observed between the diclofenac and control patches , with the control patch more likely to produce overall skin irritation . This study demonstrate that the diclofenac sodium patch was superior to the control patch in terms of reducing pain and improving functional outcomes , and did not result in significant adverse effects Background Acute low back pain is a common condition result ing in pain and disability . Current national and international guidelines advocate general practitioner care including advice and paracetamol ( 4 g daily in otherwise well adults ) as the first line of care for people with acute low back pain .  Non-steroidal anti-inflammatory drugs ( NSAIDs ) and spinal manipulative therapy ( SMT ) are advocated in many guidelines as second line management options for patients with acute low back pain who are not recovering . No studies have explored the role of NSAIDs and /or SMT in addition to first line management for acute low back pain . The primary aim of this study is to investigate if NSAIDs and /or SMT in addition to general practitioner advice and paracetamol results in shorter recovery times for patients with acute low back pain . The secondary aims of the study are to evaluate whether the addition of SMT and /or NSAIDs  influences pain , disability and global perceived effect at 1 , 2 , 4 and 12 weeks after onset of therapy for patients with significant acute low back pain . Methods / design This paper presents the rationale and design of a r and omised controlled trial examining the addition of NSAIDs and /or SMT in 240 people who present to their general practitioner with significant acute low back pain Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background Neck pain ( NP ) is a common musculoskeletal disorder in primary care that frequently causes discomfort . Non-steroidal anti-inflammatory drugs ( NSAIDs ) may be used to reduce neck pain and associated inflammation and facilitate earlier recovery . Topical diclofenac diethylamine ( DDEA ) 1.16 % gel is clinical ly proven to be effective and well tolerated in acute and chronic musculoskeletal conditions , but until now no clinical data existed for its use in acute NP . The aim of this study was to assess the efficacy and safety of DDEA 1.16 % gel compared with placebo gel in acute NP . Methods In a r and omized , double-blind , placebo-controlled study , patients with acute NP ( n = 72 ) were treated with DDEA 1.16 % gel ( 2 g , 4x/day , for 5 days ) or placebo . Efficacy assessment s included pain-on-movement ( POM ) , pain-at-rest ( PAR ) , functional neck disability index ( NDI ) and response to treatment ( decrease in POM by 50 % after 48 h ) . Adverse events ( AEs ) were recorded throughout the study . Results The primary outcome , POM at 48 h , was statistically significantly lower with DDEA gel ( 19.5 mm ) vs. placebo ( 56.9 mm ) ( p < 0.0001 ) , representing a clinical ly relevant decrease from baseline ( 75 % vs. 23 % , respectively ) . All POM scores were significantly lower with DDEA gel vs. placebo from 1 h , as were PAR and NDI scores from first assessment ( 24 h ) onwards ( all p < 0.0001 ) . Response to treatment was significantly higher with DDEA gel ( 94.4 % ) vs. placebo ( 8.3 % ) ( p < 0.0001 ) . There were no AEs with DDEA gel . Conclusions D 
    Output:
    
NSAIDs reduced pain and disability , but provided clinical ly unimportant effects over placebo .
Conclusions NSAIDs are effective for spinal pain , but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinical ly important .