Acute Low Back Pain with Radiculopathy: A Double-Blind, Randomized, Placebo-Controlled Study

Patients (112) with acute low-back pain of recent onset were recruited to this double-blind, randomized, placebo-controlled parallel group study in general practice to evaluate the efficacy and tolerability of the muscle relaxant, tizanidine. They were treated for 7 days with tizanidine (4 mg three times daily) or matching placebo. Aspirin tablets (300 mg) were taken as required as ‘rescue’ medication. Symptoms were assessed by the patient and doctor before treatment, and after 3 and 7 days. Patients recorded pain and aspirin consumption in a daily diary. Both treatments were effective. In patients who had taken no medication prior to entry, aspirin consumption was almost halved in the first 3 days of taking tizanidine compared with placebo ( P = 0.037). Results for pain at rest, pain at night, restriction of movement and pain on movement suggest that tizanidine may give greater improvement, earlier. No serious drug-related adverse events or abnormal biochemistry or haematology were observed in either group. Drowsiness occurred in 22% of patients taking tizanidine although, in patients with severe acute low-back pain, sedation, analgesia and bed rest might be beneficial and desired. Considerably more patients given aspirin/placebo had gastro-intestinal side-effects ( P = 0.018). In conclusion, tizanidine may reduce the need for analgesics and be useful in the treatment of acute low-back pain.

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11:2287. A double blind placebo controlled study evaluating the effect of a metalloproteinase inhibitor in chronic low back pain secondary to degenerative disc disease

The Spine Journal ◽

10.1016/j.spinee.2005.05.089 ◽

2005 ◽

Vol 5 (4) ◽

pp. S46

Author(s):

Anthony Guarino ◽

Martha Cornell

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Chronic Low Back Pain ◽

Degenerative Disc Disease ◽

Controlled Study ◽

Low Back ◽

Disc Disease ◽

Double Blind ◽

Double Blind Placebo ◽

Metalloproteinase Inhibitor

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Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised clinical trial

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-217259 ◽

2020 ◽

pp. annrheumdis-2020-217259

Author(s):

Paula Dakin ◽

Alan J Kivitz ◽

Joseph S Gimbel ◽

Nebojsa Skrepnik ◽

Stephen J DiMartino ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Phase Ii ◽

Chronic Low Back Pain ◽

Randomised Clinical Trial ◽

Controlled Study ◽

Low Back ◽

Efficacy And Safety ◽

Double Blind ◽

And Function

ObjectivesTo study the efficacy and safety of fasinumab in moderate-to-severe, chronic low back pain (CLBP).MethodsIn this phase II/III, double-blind, placebo-controlled study, patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were randomised to fasinumab 6 or 9 mg subcutaneous every 4 weeks (Q4W), 9 mg intravenous every 8 weeks (Q8W) or placebo. Primary endpoint was change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score. Key secondary efficacy variables included Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA). The results are based on a modified intent-to-treat analysis of 563/800 planned patients when enrolment was stopped early given emerging signals of joint risk in other osteoarthritis (OA) studies at doses being tested here.ResultsSignificant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) −0.7 (0.3); both nominal p<0.05), but not 6 mg (–0.3 (0.3); p=0.39). RMDQ and PGA improvements to week 16 were greatest for fasinumab 9 mg intravenous. Numerically greater efficacy occurred in patients with, versus those without, peripheral OA (pOA) over 16 weeks. Treatment-emergent adverse events (AEs) occurred in 274/418 (65.6%) patients in the combined fasinumab groups and 94/140 (67.1%) placebo patients. Joint AEs, mostly rapid progressive OA type 1, were more frequent in the combined fasinumab groups (19 events in 16 patients (3.8%) vs 1 event in 1 patient (0.7%) for placebo); all except one occurred in pOA patients.ConclusionsFasinumab highest doses, but not lower dose, improved both CLBP pain and function. Most joint AEs occurred in pOA patients, consistent with earlier findings in symptomatic OA. Further study is needed of patients with CLBP with and without pOA to determine optimal benefit–risk.

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The efficacy and safety of a homeopathic gel in the treatment of acute low back pain: a multi-centre, randomised, double-blind comparative clinical trial

British Homeopathic Journal ◽

10.1054/homp.1999.0460 ◽

2001 ◽

Vol 90 (01) ◽

pp. 21-28 ◽

Cited By ~ 23

Author(s):

C Stam ◽

MS Bonnet ◽

RA van Haselen

Keyword(s):

Clinical Trial ◽

Low Back Pain ◽

Back Pain ◽

Controlled Clinical Trial ◽

Low Back ◽

Double Blind ◽

Acute Low Back Pain ◽

Efficacy Parameter ◽

Industrialised Countries ◽

Topical Medications

AbstractAcute low back pain is a very common condition in Western industrialised countries. In most cases analgesics or topical medications are prescribed at first encounter with the general practitioner (GP).The aim of this study was to investigate whether the homeopathic gel Spiroflor SRL® gel (SRL) is equally effective and better tolerated than Cremor Capsici Compositus FNA (CCC) in patients with acute low back pain.A multi-centre, randomised, double-blind, controlled clinical trial was conducted in the practices of 19 GPs in the districts of Bristol and Manchester, UK. One hundred and sixty-one subjects suffering from acute low back pain were treated for one week either with SRL or with CCC. Pain was scored on a 100 mm visual analogue scale (VAS). Main efficacy parameter VAS reduction was compared between treatments. Evaluation of safety was primarily based on the number of subjects with adverse events (AEs), withdrawals due to an AE and adverse drug reactions (ADRs).The mean difference between the VAS reduction in the SRL group and the CCC group adjusted for VAS at baseline and age was −0.6 mm (90%CI=−6.5–5.3 mm). Fewer subjects in the SRL group (11%) experienced an AE than in the CCC group (26%). The same applies to the number of subjects with an ADR (3/81=4% vs 18/74=24%) and the number of subjects withdrawn due to an ADR (0/81=0% vs 8/74=11%).In conclusion, SRL and CCC are equally effective in the treatment of acute low back pain, however, SRL has a better safety profile. Spiroflor SRL® gel is preferable to Capsicum-based products for the topical treatment of low back pain, because of the lower risk of adverse effects.

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