Novel Intradiscal Biacuplasty (IDB) for the Treatment of Lumbar Discogenic Pain

Abstract:   Reported here is the treatment of severe axial discogenic pain in a young man utilizing the new minimally invasive transdiscal radiofrequency technique called intradiscal biacuplasty (Baylis Medical Inc., Montreal, Canada). The new procedure is detailed and step-by-step fluoroscopic imaging presented. There were no intra- and postoperative complications, and significant improvements in patient functional capacity, and pain scores were noted. Visual analog scale pain score decreased from 5 to 1 cm at 6-month follow-up, Oswestry disability scores improved from 14 (28% or moderate disability) to 6 points (12% or minimal disability) and SF-36-PF (physical function) score changed from 67 to 82. Potential advantages of cooled, bipolar radiofrequency to heat the posterior annulus are discussed.     

Comparative Evaluation of Oxygen‐Ozone Therapy and Combined Use of Oxygen‐Ozone Therapy with Percutaneous Intradiscal Radiofrequency Thermocoagulation for the Treatment of Lumbar Disc Herniation

Aim: To compare the efficacy of oxygen‐ozone therapy and the combined use of oxygen‐ozone therapy with percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) for the treatment of contained lumbar disc herniation. Methods: Ninety‐one adult patients with low back pain secondary to contained lumbar disc herniation were randomly assigned into two groups. Ozone group received intradiscal oxygen‐ozone therapy (4 to 7 mL of oxygen ozone mixture); ozone‐PIRFT group received a combination of oxygen‐ozone therapy with PIRFT (radiofrequency lesioning at 80°C for 360 s). Outcome Measures: Primary outcome measures included a visual analog scale (VAS) for pain and the Oswestry disability index (ODI). Secondary outcome measures included pain relief, reduction of analgesic consumption, and patient's satisfaction. Clinical assessment of these outcome measures was performed at 2 weeks, 1 month, 3 months, 6 months, and 1 year after the procedure. Results: VAS scores and ODI were significantly decreased by both ozone and ozone‐PIRFT when compared with the baseline values at all points of follow‐up; however, ozone‐PIRFT produced a significant reduction in the VAS scores and ODI when compared to ozone at 2 weeks, 1 month, 3 months, 6 months, and 1 year follow‐up. Ozone‐PIRFT also resulted in a significant change in all secondary measures at all points of follow‐up, as compared with the ozone group. Conclusion: Ozone‐PIRFT is more efficacious than ozone alone in reducing pain scores, analgesic consumption, improving functional outcome, and satisfaction of patients with contained lumbar disc herniation.     

Acute back pain management in primary care: a qualitative pilot study of the feasibility of a nurse-led service in general practice

OBJECTIVES: (1) To determine the acceptability of the Royal College of General Practitioner Guidelines to small samples of nurses, General Practitioners and acute back pain patients, (2) to determine what additional roles for nurses in the management of acute back pain in primary care might be acceptable to these samples, (3) to evaluate the responses of General Practitioners, nurses and patients to a suggested service model based on the RCGP Guidelines, (4) to identify opportunities for and barriers to the further development of such models and to obtain the appraisal of the above by an external group of assessors. METHODOLOGY: Using a qualitative design the pilot study included Primary Care (General Practitioners, Practice Nurses and Patients) with the main outcome measures as: appraisal questionnaires (for RCGP Guideline), qualitative content analysis of focus group narratives, and appraisal of process and outcomes by an external panel. RESULTS: Attitudes towards the RCGP guidelines were positive, but professionals and patients alike did not think their recommendations could be implemented with the current service provision in primary care. There was criticism by professionals of the capacity for a nurse-led service within practices. Access to chiropractors, osteopaths and/or specialist physiotherapists in National Health Service primary care was raised as a need by both groups. All members of the Advisory Panel approved the processes for the recruitment of participants, focus group questions and analysis. DISCUSSION: Barriers to implementation of the RCGP Guideline and to a nurse-led acute back pain service in general practice, were illustrated. These mainly relate to grossly inadequate capacity to deal with multidimensional patient needs, allowing progression to chronic pain states and much higher health care costs. There was a strong desire to include a different group of professionals in primary care. We recommend a local needs assessment and consideration of a national strategy for the implementation of the RCGP Guideline in primary care.     

A national framework for supporting improvements in the physiotherapy assessment and management of low back pain: the Scottish experience

Background

Similar to other countries worldwide, Scotland lacked a national view of whether the quality of the physiotherapy management of low back pain was compliant with national guidelines. Anecdotal evidence suggested that standards of care varied considerably despite the wide availability of clinical guidelines to clinicians.

Aim

To develop a framework that supports National Health Service (NHS) Scotland in providing consistently applied high-quality physiotherapy assessment and management of low back pain in line with guideline recommendations.

Design

Prospective, multicentred national study, data collection and improvement phase.

Setting

All NHS boards in Scotland (n = 14) plus two private provider sites.

Participants

One hundred and eighty-six individual NHS sites and two private providers of services to patients with low back pain.

Method

A national dataset was developed from evidence- and consensus-based guideline sources. All sites collected data (two 5-week periods) over 1 year (2008-2009) using a web-based database. This was interspersed by an improvement phase during which required improvements were considered and implemented. Issues were shared through a national network and national meeting.

Results

Data from 2147 patients showed improvements in the documented physiotherapy management of low back pain over the two cycles. All participants developed and implemented remedial action plans based on the results of the first cycle.

Conclusion

It is possible to implement a framework, which is led nationally but driven and owned locally, supporting physiotherapists in an active programme of locally determined improvement. However, although process and outcome are linked, the direct impact of this initiative on patient outcome is not known.     

Post‐operative pain relief following intrathecal injection of acetylcholine esterase inhibitor during lumbar disc surgery: a prospective double blind randomized study

Background: As spinal cholinergic receptors participate in the control of somatic pain, this effect could be potentiated by intrathecal injection of a cholinesterase inhibitor, neostigmine. Objective: This study was designed to evaluate the effectiveness of intrathecal administration of neostigmine on pain relief after single level lumbar disectomy. Methods: Sixty‐six patients with unilateral extruded lumbar disc were randomly allocated into two groups, neostigmine (‘N’), and control (‘C’); the former received 100 μg of neostigmine methylsulphate, whereas the latter received placebo intrathecally after termination of the surgery. Visual Analogue Scale was employed to measure post‐operative pain, which was a primary outcome of the study. Opiate dosage consumed was also recorded as a primary outcome during the first 24 h following surgery. Nausea and vomiting although important were considered as secondary outcomes. Results: Mean Visual Analogue Scale scores post‐operatively at 1, 4 and 8 h were 2·24, 1·82 and 1·88 in group ‘N’ and 5·36, 5·61 and 4·88 in group C. Mean morphine used intravenously in the first 24 h was 0·9 mg in group ‘N’ and 4·7 mg in group C. All results were found to be significantly different in the two groups. The frequency of nausea and vomiting was not significantly different in the two groups ‘C’ (24%) and ‘N’ (18%). Conclusion: Injection of 100 μg hyperbaric neostigmine intrathecally was effective for pain relief, and reduced post‐operative opiate demand.     

A randomized trial to determine the duration of analgesia following a 15- and a 30-minute application of acupuncture-like TENS on patients with chronic low back pain

Background: Acupuncture-like TENS (AL-TENS) has been shown to produce prolonged pain relief, but no study has yet investigated its duration on a population suffering from chronic low back pain (CLPB). Objective: Our objective was to quantify the duration and magnitude of analgesia induced by a 15- or 30-minute application of AL-TENS. Methodology: We recruited a sample of 11 participants presenting with CLBP and conducted a randomized, crossover study, where participants were given AL-TENS for 15 and 30 minutes on two separate occasions. The pain intensity of their CLBP was assessed with a visual analogue scale before, during, and after AL-TENS applications. Magnitude and duration of analgesia were determined for each subject and for both AL-TENS application times. Results: The AL-TENS applications induced a clinically and statistically significant (p = 0.003) analgesia in all participants. Median duration of analgesia was 9 hours and 10 hours 30 minutes following the 15- and 30-minute AL-TENS applications, respectively; this 1.5-hour difference was not statistically significant (p = 0.55). Furthermore, we observed no significant difference in the magnitude of analgesia between both applications of AL-TENS (p > 0.56), suggesting that the duration of application of AL-TENS does not influence the magnitude of analgesia. Conclusion: Our results suggest that clinicians could use a 15-minute AL-TENS application to provide significant analgesia in patients presenting with low back pain since if provides a comparable analgesia versus a 30-minute application.     

Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis

Pain neurophysiology education (PNE) is a form of education for patients with chronic low back pain (CLBP). The purpose of this systematic review was to investigate the evidence for PNE in the management of pateints with CLBP. A literature search of MEDLINE, CINAHL and AMED was performed from 1996(01)–2010(09). RCT appraisal and synthesis was assessed using the Cochrane Back Review Group (CBRG) guidelines. The main outcome measures were pain, physical-function, psychological-function, and social-function. Two moderate quality RCTs (n = 122) were included in the final review. According to the CBRG criteria there was very low quality evidence that PNE is beneficial for pain, physical-function, psychological-function, and social-function. Meta-analysis found PNE produced statistically significant but clinically small improvements in short-term pain of 5 mm (0, 10.0 mm) [mean difference (95%CI)] on the 100 mm VAS. This review was limited by the small number of studies (n = 2) that met the inclusion criteria and by the fact that both studies were produced by the same group that published the PNE manual. These factors contributed to the relatively low grading of the evidence. There is a need for more studies investigating PNE by different research groups to support early promising findings. Until then firm clinical recommendations cannot be made.     

Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study

The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P=.008, P=.004) and SF-36 Physical Function (P=.03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function.     

Effectiveness and safety of oral extended-release oxymorphone for the treatment of cancer pain: a pilot study

Goals of work Inadequate analgesia and/or unmanageable adverse events frequently result in the need to rotate patients with cancer pain to a different opioid. The availability of a novel oral extended-release (ER) formulation of oxymorphone provides clinicians with another treatment option. In this study, we assessed the analgesic effectiveness and safety of the new oral ER formulation of oxymorphone following treatment with controlled-release (CR) morphine sulfate or oxycodone.Patients and methods Adults with moderate to severe cancer pain were stabilized for 3 days on morphine CR or oxycodone CR, and then treated for 7 days at their stabilized dose. Drug selection was based upon patients previous use or investigator preference. Patients were then crossed over for 7 days of treatment at an estimated equianalgesic dosage of oxymorphone ER. Pain was assessed using a visual analog scale, and adverse events were recorded.Main results A total of 86 patients entered open-label treatment. Of 34 patients assigned to morphine CR and 52 assigned to oxycodone CR, 21 (61.8%) and 42 (80.8%) completed stabilization and began treatment with oxymorphone ER, respectively; 59 of 63 (93.7%) completed treatment with oxymorphone. There were no significant differences in daily pain intensity scores between oxymorphone ER and comparators (paired t -test). Rescue medication use, expressed as the percent of the daily dose of scheduled opioid, was greater during morphine CR treatment than after crossover to oxymorphone ER (25.2% vs 13.3%; P <0.05, Wilcoxons test). The tolerability/safety profiles (e.g., nausea, drowsiness, somnolence) were similar for all opioids.Conclusions Cancer patients stabilized on morphine CR or oxycodone CR were safely and rapidly converted to a lower milligram dose of oxymorphone ER that provided adequate pain relief with comparable tolerability. These results justify additional trials with oxymorphone ER.This work was supported by Endo Pharmaceuticals Inc., Chadds Ford, PA, and Penwest Pharmaceuticals Co., Danbury, CT.     

Practicality, safety and accuracy of computed tomography coronary angiography in the evaluation of low TIMI-risk score chest pain patients: a pilot study

Objectives: The present pilot study aimed to assess the practicality, safety and accuracy of performing CT coronary angiography (CT‐CA) in the evaluation of acute chest pain of patients with low thrombolysis in myocardial infarction (TIMI) risk scores. Methods: The present prospective observational study was undertaken in a university teaching hospital between November 2004 and December 2005. Participants were a convenience sample of patients admitted to hospital for investigation of chest pain with TIMI risk scores <3. Consenting patients underwent CT‐CA within 48 h of presentation. Outcomes of interest were practicality (proportion of diagnostic quality scans obtained and preparation time for CT‐CA), rate of serious adverse events, and accuracy at the patient level using selective coronary angiography as the reference standard. Results: Thirty‐four patients were recruited. Diagnostic quality scans were obtained in 26/34 or 76% of patients (four failed CT‐CA and four non‐diagnostic scans). The median CT preparation time was 1.9 h (range 0.17–4.0). No serious adverse events were found. Fourteen of those 26 patients with diagnostic CT‐CA subsequently had selective coronary angiography, of which nine were positive. The sensitivity and specificity of CT‐CA in identifying patients with significant coronary artery disease were 9/9 (100%; 95% confidence interval 72–100%) and 4/5 (80%; 95% confidence interval 28–100%), respectively. Conclusions: The majority of acute chest pain patients with low TIMI risk scores were successfully scanned with a 16‐slice CT to produce CT‐CA studies with good diagnostic quality and accuracy. No major adverse events were found. The place of CT‐CA in diagnostic workup for chest pain remains to be defined.