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Pulsed radiofrequency treatment of the lumbar dorsal root ganglion in patients with chronic lumbar radicular pain: A randomized, placebo-controlled pilot study

Authors » Shanthanna H , Chan P , McChesney J , Thabane L , Paul J

Journal » Journal of pain research

Year » 2014

Links » Pubmed DOI PubMed Central

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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Background: No proof of efficacy, in the form of a randomized controlled trial (RCT), exists to support pulsed radiofrequency (PRF) treatment of the dorsal root ganglion (DRG) for chronic lumbar radicular (CLR) pain. We determined the feasibility of a larger trial (primary objective), and also explored the efficacy of PRF in decreasing pain on a visual analog scale (VAS) and improving the Oswestry Disability Index. Methods: This was a single-center, placebo-controlled, triple-blinded RCT. Patients were randomized to a placebo group (needle placement) or a treatment group (PRF at 42°C for 120 seconds to the DRG). Patients were followed up for 3 months post procedure. Outcomes with regard to pain, Oswestry Disability Index score, and side effects were analyzed on an intention-to-treat basis. Results: Over 15 months, 350 potential patients were identified and 56 were assessed for eligibility. Fifteen of them did not meet the selection criteria. Of the 41 eligible patients, 32 (78%) were recruited. One patient opted out before intervention. Three patients were lost to follow-up at 3 months. Mean VAS differences were not significantly different at 4 weeks (-0.36, 95% confidence interval [CI], -2.29, 1.57) or at 3 months (-0.76, 95% CI, -3.14, 1.61). The difference in mean Oswestry Disability Index score was also not significantly different at 4 weeks (-2%, 95% CI, -14%, 10%) or 3 months (-7%, 95% CI, -21%, 6%). There were no major side effects. Six of 16 patients in the PRF group and three of 15 in the placebo group showed a >50% decrease in VAS score. Conclusion: The recruitment rate was partially successful. At 3 months, the relative success of PRF-DRG was small. A large-scale trial to establish efficacy is not practically feasible considering the small effect size, which would necessitate recruitment of a challengingly large number of participants over a number of years. Until clear parameters for application of PRF are established, clinicians will need to use their individual judgment regarding its clinical applicability, given the present evidence. © 2014 Shanthanna et al.

The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain.

Authors » Ghahreman A , Ferch R , Bogduk N

Journal » Pain medicine (Malden, Mass.)

Year » 2010

Links » Pubmed DOI

This article is included in 6 Systematic reviews Systematic reviews (6 references)

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BACKGROUND: Transforaminal injection of steroids is used to treat lumbar radicular pain. Not known is whether the route of injection or the agent injected is significant. STUDY DESIGN: A prospective, randomized study compared the outcomes of transforaminal injection of steroid and local anesthetic, local anesthetic alone, or normal saline, and intramuscular injection of steroid or normal saline. Patients and outcome evaluators were blinded as to agent administered. METHODS: The primary outcome measure was the proportion of patients who achieved complete relief of pain, or at least 50% relief, at 1 month after treatment. Secondary outcome measures were function, disability, patient-specified functional outcomes, use of other health care, and duration of relief beyond 1 month. RESULTS: A significantly greater proportion of patients treated with transforaminal injection of steroid (54%) achieved relief of pain than did patients treated with transforaminal injection of local anesthetic (7%) or transforaminal injection of saline (19%), intramuscular steroids (21%), or intramuscular saline (13%). Relief of pain was corroborated by significant improvements in function and disability, and reductions in use of other health care. Outcomes were equivalent for patients with acute or chronic radicular pain. Over time, the number of patients who maintained relief diminished. Only some maintained relief beyond 12 months. The proportions of patients doing so were not significantly different statistically between groups. DISCUSSION: Transforaminal injection of steroids is effective only in a proportion of patients. Its superiority over other injections is obscured when group data are compared but emerges when categorical outcomes are calculated. Over time, the proportion of patients with maintained responses diminishes.

Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: Randomised trial

Authors » Kuijper B , Tans JT , Beelen A , Nollet F , de Visser M

Journal » BMJ (Clinical research ed.)

Year » 2009

Links » Pubmed DOI PubMed Central

This article is included in 1 Structured summary of primary studies Structured summaries of primary studies (1 reference) 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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Objective: To evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy. Design: Randomised controlled trial. Setting: Neurology outpatient clinics in three Dutch hospitals. Participants: 205 patients with symptoms and signs of cervical radiculopathy of less than one month's duration Interventions Treatment with a semi-hard collar and taking rest for three to six weeks; 12 twice weekly sessions of physiotherapy and home exercises for six weeks; or continuation of daily activities as much as possible without specific treatment (control group). Main outcome measures: Time course of changes in pain scores for arm and neck pain on a 100 mm visual analogue scale and in the neck disability index during the first six weeks. Results: In the wait and see group, arm pain diminished by 3 mm/week on the visual analogue scale (β=-3.1 mm, 95% confidence interval -4.0 to -2.2 mm) and by 19 mm in total over six weeks. Patients who were treated with cervical collar or physiotherapy achieved additional pain reduction (collar: β=-1.9 mm, -3.3 to -0.5 mm; physiotherapy: β=-1.9, -3.3 to -0.8), resulting in an extra pain reduction compared with the control group of 12 mm after six weeks. In the wait and see group, neck pain did not decrease significantly in the first six weeks (β=-0.9 mm, -2.0 to 0.3). Treatment with the collar resulted in a weekly reduction on the visual analogue scale of 2.8 mm (-4.2 to -1.3), amounting to 17 mm in six weeks, whereas physiotherapy gave a weekly reduction of 2.4 mm (-3.9 to -0.8) resulting in a decrease of 14 mm after six weeks. Compared with a wait and see policy, the neck disability index showed a significant change with the use of the collar and rest (β=-0.9 mm, -1.6 to -0.1) and a non-significant effect with physiotherapy and home exercises. Conclusion: A semi-hard cervical collar and rest for three to six weeks or physiotherapy accompanied by home exercises for six weeks reduced neck and arm pain substantially compared with a wait and see policy in the early phase of cervical radiculopathy. Trial registration: Clinical trials NCT00129714.

Effectiveness of microdiscectomy for lumbar disc herniation: a randomized controlled trial with 2 years of follow-up.

Authors » Osterman H , Seitsalo S , Karppinen J , Malmivaara A

Journal » Spine

Year » 2006

Links » Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: To assess effectiveness of microdiscectomy in lumbar disc herniation patients with 6 to 12 weeks of symptoms but no absolute indication for surgery. SUMMARY OF BACKGROUND DATA: There is limited evidence in favor of discectomy for prolonged symptoms of lumbar disc herniation. However, only one randomized trial has directly compared discectomy with conservative treatment. METHODS: Fifty-six patients (age range, 20-50 years) with a lumbar disc herniation, clinical findings of nerve root compression, and radicular pain lasting 6 to 12 weeks were randomized to microdiscectomy or conservative management. Fifty patients (89%) were available at the 2-year follow-up. Leg pain intensity was the primary outcome measure. RESULTS: There were no clinically significant differences between the groups in leg or back pain intensity, subjective disability, or health-related quality of life over the 2-year follow-up, although discectomy seemed to be associated with a more rapid initial recovery. In a subgroup analysis, discectomy was superior to conservative treatment when the herniation was at L4-L5. CONCLUSIONS: Lumbar microdiscectomy offered only modest short-term benefits in patients with sciatica due to disc extrusion or sequester. Spinal level of the herniation may be an important factor modifying effectiveness of surgery, but this hypothesis needs verification.

Effect of continuous lumbar traction on the size of herniated disc material in lumbar disc herniation.

Authors » Ozturk B , Gunduz OH , Ozoran K , Bostanoglu S

Journal » Rheumatology international

Year » 2006

Links » Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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We investigated the effects of continuous lumbar traction in patients with lumbar disc herniation on clinical findings, and size of the herniated disc measured by computed tomography (CT). In this prospective, randomized, controlled study, 46 patients with lumbar disc herniation were included, and randomized into two groups as the traction group (24 patients), and the control group (22 patients). The traction group was given a physical therapy program and continuous lumbar traction. The control group was given the same physical therapy program without traction, for the same duration of time. Data for the clinical symptoms and signs were collected before and after the treatment together with calculation of a herniation index, from the CT images that showed the size of the herniated disc material. In the traction group, most of the clinical findings significantly improved with treatment. Size of the herniated disc material in CT decreased significantly only in the traction group. In the traction group the herniation index decreased from 276.6+/-129.6 to 212.5+/-84.3 with treatment (p<0.01). In the control group, pretreatment value was 293.4+/-112.1, and it decreased to 285.4+/-115.4 after the treatment (p>0.05). Patients with greater herniations tended to respond better to traction. In conclusion, lumbar traction is both effective in improving symptoms and clinical findings in patients with lumbar disc herniation and also in decreasing the size of the herniated disc material as measured by CT.

New treatment of lumbar disc herniation involving 5-hydroxytryptamine2A receptor inhibitor: a randomized controlled trial.

Authors » Kanayama M , Hashimoto T , Shigenobu K , Oha F , Yamane S

Journal » Journal of neurosurgery. Spine

Year » 2005

Links » Pubmed DOI

This article is included in 1 Systematic review Systematic reviews (1 reference)

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OBJECT: Serotonin or 5-hydroxytryptamine (5-HT) is a chemical mediator associated with nucleus pulposus-induced radiculopathy. Inhibition of 5-HT receptors may potentially alleviate symptoms in patients with lumbar disc herniation. This prospective randomized controlled study was performed to evaluate the efficacy of the 5-HT2A receptor inhibitor in the treatment of symptomatic lumbar disc herniation. METHODS: Forty patients with sciatica due to L4-5 or L5-S1 disc herniation were randomly allocated to treatment with the 5-HT2A inhibitor (sarpogrelate 300 mg/day) or nonsteroidal antiinflammatory drugs (NSAIDs; diclofenac 75 mg/day). Low-back pain, leg pain, and numbness were evaluated using a visual analog scale (VAS) before and after a 2-week course of treatment. The patients received only allocated medicine during the 2-week regimen and were thereafter allowed to choose any treatment options depending on their residual symptoms. One-year clinical outcomes were assessed based on the rates of additional medical interventions. The mean VAS score improvements in the 5-HT2A and NSAID groups were 33 and 46% for low-back pain, 32 and 32% for leg pain, and 35 and 22% for leg numbness, respectively. After the 2-week regimen, no additional medical interventions were required in 50% of 5-HT2A-treated patients and 15% of those receiving NSAIDs. Epidural or nerve root block procedures were performed in 35% of the 5-HT2A group and 45% of the NSAID group. Surgery was required in 20% of the 5-HT2A group and 30% of the NSAID group patients. CONCLUSIONS: The current study provided evidence that the efficacy of the 5-HT2A inhibitor was comparable with that of NSAID therapy for lumbar disc herniation. The 5-HT2A inhibitor has the potential to alleviate symptoms in patients with lumbar disc herniation.

Effects of cervical traction and exercise therapy in cervical spondylosis.

Authors » Shakoor MA , Ahmed MS , Kibria G , Khan AA , Mian MA , Hasan SA , Nahar S , Hossain MA

Journal » Bangladesh Medical Research Council bulletin

Year » 2002

Links » Pubmed

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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A randomised clinical trial was conducted in the Department of Physical Medicine, Chittagong Medical College Hospital from July, 2001 to June, 2002. The objectives of the study were to find out the effects of cervical traction (CT) and exercise on the patients with chronic cervical spondylosis. A total of 199 patients with cervical spondylosis were included in the clinical trial. One hundred patients were treated with cervical traction plus exercise and 99 patients were treated with non-steroidal anti-inflammatory drug (NSAID). Posture correction advice was given to all patients. The patients were treated for 6 weeks. There was a marked improvement in both the groups after treatment (P<0.001). But there was nearly significant difference regarding improvement in treatment with CT plus exercise than with NSAID (P = 0.06). The results indicate that the improvement of the patients with chronic cervical spondylosis was more in CT plus exercise than analgesics. So, CT & neck muscle strengthening exercise may have some more beneficial effects than NSAIDs on chronic cervical spondylosis.

Westeinde sciatica trial: randomized controlled study of bed rest and physiotherapy for acute sciatica.

Authors » Hofstee DJ , Gijtenbeek JM , Hoogland PH , van Houwelingen HC , Kloet A , Lötters F , Tans JT

Journal » Journal of neurosurgery

Year » 2002

Links » Pubmed DOI

This article is included in 3 Systematic reviews Systematic reviews (3 references) 1 Structured summary of primary studies Structured summaries of primary studies (1 reference) 1 Broad synthesis Broad syntheses (1 reference)

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OBJECT: The authors conducted a study to compare the efficacies of three nonsurgical treatment strategies in patients with sciatica. Their hypothesis was that bed rest, physiotherapy, and continuation of activities of daily living (ADLs) (control treatment) are each of equivalent efficacy. METHODS: This randomized controlled trial was designed for comparison of bed rest, physiotherapy, and continuation of ADLs. The setting was an outpatient clinic. General practitioners were asked to refer patients for treatment as soon as possible. The authors enrolled 250 patients (< 60 years of age) with sciatica of less than 1-month's duration and who had not yet been treated with bed rest or physiotherapy. Primary outcome measures were radicular pain (based on a visual analog pain scale [VAPS]) and hampered ADLs (Quebec Disability Scale [QDS]). Secondary outcome measures were the rates of treatment-related failure and surgical treatment. Measures were assessed at baseline and during follow up at 1, 2, and 6 months. Mean differences in VAPS and QDS scores between bed rest and control treatment were 2.5 (95% confidence interval [CI] -6.4 to 11.4) and -4.8 (95% CI -10.6 to 0.9) at 1 month and 0.9 (95% CI -8.7 to 10.4) and -2.7 (95% CI -9.9 to 4.4) at 2 months, respectively. The respective differences between physiotherapy and control treatment were 0.8 (95% CI -8.2 to 9.8) and -0.5 (95% CI -6.3 to 5.3) at 1 month and -0.3 (95% CI -9.4 to 10) and 0.0 (95% CI -7.2 to 7.3) at 2 months. The respective odds ratios for treatment failure and surgical treatment of bed rest compared with control treatment were 1.6 (95% CI 0.8-3.5) and 1.5 (95% CI 0.7-3.6) at 6 months. When physiotherapy was compared with control treatment, these ratios were 1.5 (95% CI 0.7-3.2) and 1.2 (95% CI 0.5-2.9) at 6 months, respectively. CONCLUSIONS: Bed rest and physiotherapy are not more effective in acute sciatica than continuation of ADLs.