scholarly journals Efficacy of 12 Hourly Controlled-Release Condeine Compared with as Required Dosing of Acetaminophen Plus Codeine in Patients with Chronic Low Back Pain

1997 ◽  
Vol 2 (1) ◽  
pp. 33-38 ◽  
Author(s):  
Martin E Hale ◽  
Kevin L Speight ◽  
Zoltan Harsanyi ◽  
Tad Iwan ◽  
N Susan Slagle ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Controlled Release ◽  
Pain Relief ◽  
Pain Intensity ◽  
Chronic Low Back Pain ◽  
Fixed Combination ◽  
Combination Group ◽  
Low Back ◽  
Double Blind

OBJECTIVE: To compare pain relief and stability of pain control in patients with chronic low back pain treated with scheduled 12 hourly doses of controlled-release codeine or as required doses of a fixed combination of acetaminophen and codeine.PATIENTS AND METHODS: Patients were assigned to five days of treatment with controlled-release codeine (Codeine Contin; Purdue Frederick) 100 mg q12h or placebo q12h in a randomized, double-blind, parallel group study. Acetaminophen 325 mg q4h prn was available as rescue to the codeine group and acetaminophen 325 mg plus codeine 30 mg q4h prn was available to the placebo group. Pain intensity was assessed pretreatment and four times daily using a four-point categorical scale. Acceptability of therapy was assessed twice daily on a five-point scale.RESULTS: Of 104 patients enrolled, 82 were able to be evaluated for safety and efficacy. Sum of pain intensity differences scores were significantly lower on controlled-release codeine than on as required acetaminophen plus codeine at all assessments. The number of changes in pain intensity throughout the day was higher with acetaminophen plus codeine than with codeine alone (8.6±0.7 versus 6.1±0.6, respectively, P=0.011). Mean total daily codeine dose was 200 mg in the codeine group and 71.1±6.6 mg in the acetaminophen plus codeine group (P=0.0001). Mean total daily prn acetaminophen consumption was 542.2±86.5 mg in the codeine group and 770.8±71.5 mg in the fixed combination group (P=0.0452).CONCLUSION: Twelve hourly dosing of controlled-release codeine provides greater and more stable pain relief in patients with chronic low back pain than as required dosing of an acetaminophen plus codeine combination.

Extended-release tramadol (tramadol ER) in the treatment of chronic low back pain

2018 ◽  
Vol 4 (2) ◽  
pp. 87 ◽  
Author(s):  
Gary J. Vorsanger, PhD, MD ◽  
Jim Xiang, PhD ◽  
Theophilus J. Gana, MD, PhD ◽  
Maria Luz G. Pascual, MD, MPH ◽  
R. Rosanna B. Fleming, MS
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Adverse Events ◽  
Pain Intensity ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Open Label ◽  
Once Daily ◽  
To Receive

Background: This study evaluated the safety and efficacy of tramadol ER 300 mg and 200 mg versus placebo once daily in the treatment of chronic low back pain, using an open-label run-in followed by, without washout, a randomized controlled study design.Methods: Adults with scores ≥40 on a pain intensity visual analog scale (VAS; 0 = no pain; 100 = extreme pain) received open-label tramadol ER, initiated at 100 mg once daily and titrated to 300 mg once daily during a three-week open-label run-in. Patients completing run-in were randomized to receive tramadol ER 300 mg, 200 mg, or placebo once daily for 12 weeks.Results: Of 619 patients enrolled, 233 (38 percent) withdrew from the run-in, primarily because of adverse event (n = 128) or lack of efficacy (n = 41). A total of 386 patients were then randomized to receive either 300 mg (n = 128), 200 mg (n = 129), or placebo (n = 129). Following randomization, mean scores for pain intensity VAS since the previous visit, averaged over the 12-week study period, increased more in the placebo group (12.2 mm) than in the tramadol ER 300-mg (5.2 mm, p = 0.009) and 200-mg (7.8 mm, p = 0.052) groups. Secondary efficacy scores for current pain intensity VAS, patient global assessment, Roland Disability Index, and overall sleep quality improved significantly (p ≤ 0.029 each) in the tramadol ER groups compared with placebo. The most common adverse events during the double-blind period were nausea, constipation, headache, dizziness, insomnia, and diarrhea.Conclusions: In patients who tolerated and obtained pain relief from tramadol ER, continuation of tramadol ER treatment for 12 weeks maintained pain relief more effectively than placebo. Adverse events were similar to those previously reported for tramadol ER.

scholarly journals Effectiveness of Parasagittal Interlaminar Epidural Local Anesthetic with or without Steroid in Chronic Lumbosacral Pain: A Randomized, Double-Blind Clinical Trial

2015 ◽  
Vol 3;18 (3;5) ◽  
pp. 237-248 ◽  
Author(s):  
Dr. Babita Ghai
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Local Anesthetic ◽  
Chronic Low Back Pain ◽  
Low Back ◽  
Double Blind ◽  
Time Points ◽  
One Year

Background: Epidural injections (EI) are the most commonly performed minimally invasive intervention to manage chronic low back pain (CLBP) with lumbosacral radicular pain (LRP). Local anesthetic (LA) and/ or steroids are frequently used injectates for EI and are reported with variable effectiveness. The majority of earlier studies have used either caudal, transforaminal (TF), or undefined interlaminar approaches for EI. The parasaggital interlaminar (PIL) approach route is reported to have good ventral epidural spread and comparable effectiveness to the TF route. However, there is a lack of head-to-head comparative effectiveness research of LA with or without steroid for managing CLBP with LRP using a PIL approach. Objective: To compare the effectiveness of EI of LA alone and LA with steroid using a PIL approach for managing CLBP with LRP. Study Design: Randomized, double blind, active control one year follow-up study. Setting: Interventional pain management clinic in a tertiary care center in India. Methods: Sixty-nine patients were randomized to receive fluoroscopic guided EI of either 8 mL of 0.5% lidocaine (group L, n = 34) or 6 mL of 0.5% lidocaine mixed with 80 mg (2 mL) of methylprednisolone acetate (group LS, n = 35). Patients were evaluated for pain intensity using 0 – 10 numerical rating scale (NRS) and functional disability using Modified Oswestry Disability Questionnaire (MODQ) at baseline; and 2 weeks, one, 2, 3, 6, 9, and 12 months after injection. Patients with inefficacy with the initial injection or response deterioration received an additional injection of the same injectate and dose. Patients were evaluated for achieving effective pain relief (EPR, i.e., ≥ 50% from baseline), overall NRS and MODQ, number of injections, and presence of ventral and perineural spread over one year follow-up. Primary outcome was proportion of patients achieving EPR at 3 months. Results: A significantly higher proportion of patients achieved EPR at 3 months in group LS [30 (86%, 90% CI 73% – 93%)] as compared to group L [17 (50%, 90% CI 36% – 64%)] (P = 0.02). Similar results were obtained at 6, 9, and 12 months, respectively. The probability of achieving EPR was significantly higher in group LS at various time-points during the one year follow-up as compared to group L (P = 0.01) A significant reduction in NRS and improvement in MODQ were observed at all time-points post-intervention compared to baseline (P < 0.001) in both groups. NRS and MODQ scores were significantly lower in group LS as compared to group L at all time intervals post baseline. On average patients in group L received 2.0 (0.85) and group LS received 1.7 (0.71) injections annually (P = 0.07). Ventral epidural spread was comparable in both groups (97%). No major complications were encountered in either group; however, intravascular spread of contrast was noted during 2 injections (one in each group) requiring relocation. Limitations: A single center study, lack of documentation of adjuvant therapies like individual analgesic medication, and lack of placebo group. Conclusions: Using a PIL approach and the addition of steroid to LA for EI may provide superior effectiveness in terms of extent and duration of pain relief for managing CLBP with unilateral LRP, even though, local anesthetic alone also was effective. Trial registration: CTRI/2014/04/004572 Key words: Epidural injection, epidural steroid, chronic low back pain, chronic lumbosacral pain, parasagittal interlaminar

scholarly journals Dose Conversion Between Tapentadol Immediate and Extended Release for Low Back Pain

2010 ◽  
Vol 1;13 (1;1) ◽  
pp. 61-70
Author(s):  
Mila S. Etropolski
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Chronic Low Back Pain ◽  
Extended Release ◽  
Immediate Release ◽  
Low Back ◽  
Open Label ◽  
Double Blind ◽  
The Mean

Background: Tapentadol, a novel, centrally acting analgesic with 2 mechanisms of action (µopioid receptor agonism and norepinephrine reuptake inhibition), has been developed in an immediate-release (IR) and an extended-release (ER) formulation. Determination of the safety and equianalgesic ratios for conversion between formulations is important for physicians with patients taking tapentadol IR who may want to switch to tapentadol ER, or vice versa, for any reason. Objectives: To test whether the total daily dose (TDD) of tapentadol IR may be directly converted into a comparable TDD of tapentadol ER, and vice versa, with equivalent efficacy and comparable safety. Study Design: Randomized, double-blind, 2-period (2 weeks each) crossover study. Setting: Study centers (N = 13) in the United States. Methods: Patients with moderate to severe chronic low back pain received tapentadol IR 50, 75, or 100 mg every 4 or 6 hours (maximum TDD, 500 mg) during the 3-week open-label period to identify an optimal, stable dose of tapentadol IR for each patient. Patients were then randomized in a 1:1 ratio to receive, during the first 2-week double-blind period, either the optimal dose of tapentadol IR identified during the open-label period or a TDD of tapentadol ER (100, 150, 200, or 250 mg bid) that was as close as possible to the TDD of tapentadol IR from the open-label period. During a subsequent, 2-week double-blind period, patients received whichever formulation was not received during the first double-blind period. The primary endpoint was the mean average daily pain intensity (on an 11-point numerical rating scale) during the last 3 days of each double-blind treatment period. If the 95% confidence intervals (CIs) of the least squares mean difference between formulations were within the range of −2 to 2, the formulations were considered equivalent. Results: Of the 88 patients who were randomized, 72 completed both double-blind treatments, and 60 were included in the per-protocol analysis. The mean (standard deviation [SD]) pain intensity score decreased from 7.3 (1.19) pre-treatment to 4.2 (2.13) after 3 weeks of open-label treatment with tapentadol IR and remained constant throughout double-blind treatment (3.9 or 4.0 each week) for both formulations. The mean (SD) of the average pain intensity scores over the last 3 days of double-blind treatment was 3.9 (2.17) with tapentadol IR and 4.0 (2.29) with tapentadol ER, for an estimated difference of 0.1 (95% CI, −0.09 to 0.28). For both tapentadol IR and tapentadol ER, the median TDD administered was 300.0 mg, and acetaminophen was used by 39.5% and 45.2% of patients, respectively. The incidence of treatment-emergent adverse events during double-blind treatment was similar between the tapentadol IR and tapentadol ER groups. Limitations: Use of rescue medication theoretically could have influenced pain measurements, but in practice, pain measurements did not differ between treatments. Conclusions: Approximately equivalent TDDs of tapentadol IR and tapentadol ER provided equivalent analgesic efficacy for the relief of moderate to severe chronic low back pain and were similarly well tolerated, allowing for direct conversion between the 2 formulations. Key words: Chronic low back pain, conversion, efficacy, equivalence, extended release, immediate release, opioid, safety, tapentadol

scholarly journals Lumbar Facet Joint Nerve Blocks in Managing Chronic Facet Joint Pain: One-Year Follow-up of a Randomized, Double-Blind Controlled Trial: Clinical Trial NCT00355914

2008 ◽  
Vol 2;11 (3;2) ◽  
pp. 121-132
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Local Anesthetic ◽  
Chronic Low Back Pain ◽  
Facet Joint ◽  
Low Back ◽  
Lumbar Facet Joint ◽  
Nerve Blocks ◽  
Lumbar Facet

Background: Lumbar facet joints have been implicated as the source of chronic pain in 15% to 45% of patients with chronic low back pain. Various therapeutic techniques including intraarticular injections, medial branch blocks, and radiofrequency neurotomy of lumbar facet joint nerves have been described in the alleviation of chronic low back pain of facet joint origin. Objective: The study was conducted to determine the clinical effectiveness of therapeutic local anesthetic lumbar facet joint nerve blocks with or without steroid in managing chronic function-limiting low back pain of facet joint origin. Design: A randomized, double-blind, controlled trial. Setting: An interventional pain management setting in the United States. Methods: This study included 60 patients in Group I with local anesthetic and 60 patients in Group II with local anesthetic and steroid. The inclusion criteria was based on the positive response to the diagnostic controlled comparative local anesthetic lumbar facet joint blocks. Outcome measures: Numeric pain scores, Oswestry Disability Index, opioid intake, and work status. All outcome assessments were performed at baseline, 3 months, 6 months, and 12 months. Results: Significant improvement with significant pain relief (> 50%) and functional improvement (> 40%) were observed in 82% and 85% in Group I, with significant pain relief in over 82% of the patients and improvement in functional status in 78% of the patients. Based on the results of the present study, it appears that patients may experience significant pain relief 44 to 45 weeks of 1 year, requiring approximately 3 to 4 treatments with an average relief of 15 weeks per episode of treatment. Conclusion: Therapeutic lumbar facet joint nerve blocks, with or without steroid, may provide a management option for chronic function-limiting low back pain of facet joint origin. Key words: Chronic low back pain, lumbar facet or zygapophysial joint pain, facet joint nerve or medial branch blocks, comparative controlled local anesthetic blocks, therapeutic lumbar facet joint nerve blocks

scholarly journals An Update of the Systematic Assessment of the Diagnostic Accuracy of Lumbar Facet Joint Nerve Blocks

2012 ◽  
Vol 6;15 (6;12) ◽  
pp. E869-E907
Author(s):  
Frank J.E. Falco
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Relief ◽  
Diagnostic Accuracy ◽  
Chronic Low Back Pain ◽  
Facet Joint ◽  
Low Back ◽  
Lumbar Facet Joint ◽  
Nerve Blocks ◽  
Lumbar Facet

Background: Lumbar facet joints are a well recognized source of low back pain and referred pain in the lower extremity in patients with chronic low back pain. Conventional clinical features and other non-invasive diagnostic modalities are unreliable in diagnosing lumbar zygapophysial joint pain. Controlled diagnostic studies with at least 80% pain relief as the criterion standard have shown the prevalence of lumbar facet joint pain to be 16% to 41% of patients with chronic low back pain without disc displacement or radiculitis, with a false-positive rate of 17% to 49% with a single diagnostic block. Study Design: A systematic review of the diagnostic accuracy of lumbar facet joint nerve blocks. Objective: To determine and update the diagnostic accuracy of lumbar facet joint nerve blocks in the assessment of chronic low back pain. Methods: A methodological quality assessment of included studies was performed using Quality Appraisal of Reliability Studies (QAREL). Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were utilized for analysis. Studies scoring less than 50% are presented descriptively and analyzed critically. The level of evidence was classified as good, fair, and limited or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF). Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2012, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: Studies must have been performed utilizing controlled local anesthetic blocks. Pain relief was categorized as at least 50% pain relief from baseline pain and the ability to perform previously painful movements. Results: A total of 25 diagnostic accuracy studies were included. Of these, one study evaluated 50% to 74% relief as criterion standard with a single block with prevalence of 48%, 4 studies evaluated 75% to 100% relief as the criterion standard with a single block with a prevalence of 31% to 61%, 5 studies evaluated 50% to 74% relief as the criterion standard with controlled blocks with a prevalence of 15% to 61%, and 13 studies evaluated 75% to 100% relief as the criterion standard with controlled blocks with a prevalence of 25% to 45% in heterogenous populations. False-positive rates ranged from 17% to 66% in the 50% to 74% pain relief group and 27% to 49% with at least 75% relief as the criterion standard. Based on this evaluation, the evidence showed that there is good evidence for diagnostic facet joint nerve blocks with 75% to 100% pain relief as the criterion standard with dual blocks and fair evidence with 50% to 74% pain relief as the criterion standard with controlled diagnostic blocks; however, the evidence is poor with single diagnostic blocks of 50% to 74%, and limited for 75% or more pain relief as the criterion standard. Limitations: The shortcomings of this systematic review of the accuracy of diagnostic lumbar facet joint nerve blocks include a paucity of literature and continued debate on an appropriate gold standard. Conclusion: There is good evidence for diagnostic facet joint nerve blocks with 75% to 100% pain relief as the criterion standard with dual blocks, with fair evidence with 50% to 74% pain relief. Key words: Chronic low back pain, lumbar facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks

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