scholarly journals Cryoneurolysis’ outcome on pain experience (COPE) in patients with low-back pain: study protocol for a single-blinded randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
K. Truong ◽  
K. Meier ◽  
L. Nikolajsen ◽  
M. W. van Tulder ◽  
J. C.H Sørensen ◽  
...  

Abstract Background Low-back pain, including facet joint pain, accounts for up to 20 % of all sick leaves in DenmarkA proposed treatment option is cryoneurolysis. This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome. Methods A single-center randomized controlled trial (RCT) is performed including 120 participants with chronic facet joint pain syndrome, referred to the Department of Neurosurgery, Aarhus University Hospital. Eligible patients receive a diagnostic anesthetic block, where a reduction of pain intensity ≥ 50 % on a numerical rating scale (NRS) is required to be enrolled. Participants are randomized into three groups to undergo either one treatment of cryoneurolysis, radiofrequency ablation or placebo. Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments. All groups receive physiotherapy for 6 weeks, starting 4 weeks after treatment. The primary outcome is the patients’ impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are a reduction in low-back pain intensity (numeric rating scale) and quality of life (EQ-5D, SF-36) and level of function (Oswestry Disability Index), psychological perception of pain (Pain Catastrophizing Scale) and depression status (Major Depression Inventory). Data will be assessed at baseline (T0), randomization (T1), day one (T2), 4 weeks (T3), 3 (T4), 6 (T5) and 12 months (T6). Discussion This study will provide information on the effectiveness of cryoneurolysis vs. the effectiveness of radiofrequency ablation or placebo for patients with facet joint pain, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population. Trial registration The trial is approved by the ethical committee of Central Jutland Denmark with registration number 1-10-72-27-19 and the Danish Data Protection Agency with registration number 666,852. The study is registered at Clinicaltrial.gov with the ID number NCT04786145.

2016 ◽  
Author(s):  
Vikram B Patel

Lumbar or lower back pain is a very debilitating condition that affects  almost one fifth of the adult population during a given year. Almost everyone walking on two feet is bound to suffer from some back pain during their lifetime. The health care burden for treating low back pain is enormous, especially if the lost work hours are combined with the amount used in diagnosing and treating low back pain. Lumbar facet (zygapophysial) joints are one of the major components involved in causing lower back pain. Diagnosing the pain generator is more of an art than a science. Combining various parameters in the patient’s history, physical examination, and diagnostic studies is not much different from solving a murder mystery. Although facet joint pain may be accompanied by other pain generators, that is, lumbar intervertebral disks, nerve roots, and vertebral bodies, once treated, the relief in pain is more helpful in performing proper rehabilitation and improving further deterioration in low back pain. Muscles are almost always painful due to myofascial pain syndrome that accompanies the facet joint–related pain. Treating one without addressing the other leads to failure in management and optimization of patient’s pain and function. Several treatments are available for treatment of facet joint–mediated pain, including steroid injections using a miniscule amount and radiofrequency ablation of the nerves supplying the facet joints (medial branches of the dorsal primary ramus of the lumbar nerve root). With proper diagnosis and treatment, a patient’s pain and function can be optimized to a level where it may not impact the day-to-day activities or even resumption of the patient’s routine job function. The following review describes the anatomy, pathophysiology, diagnosis, and treatment of lumbar facet joint–mediated pain.   Key words: facet joint pain, facet joint syndrome, low back pain, medial branch radiofrequency, spondylolisthesis


2007 ◽  
Vol 88 (4) ◽  
pp. 449-455 ◽  
Author(s):  
Laxmaiah Manchikanti ◽  
Rajeev Manchukonda ◽  
Vidyasagar Pampati ◽  
Kim S. Damron ◽  
Carla D. McManus

2002 ◽  
Vol 13 (2) ◽  
pp. 1-5 ◽  
Author(s):  
Alan Bani ◽  
Uwe Spetzger ◽  
Joachim M. Gilsbach

Object The authors evaluated the effectiveness of using a facet joint block with local anesthetic agents and or steroid medication for the treatment of low-back pain in a medium-sized series of patients. Methods Over a period of 4 years, the authors performed 715 facet joint injections in 230 patients with variable-length histories of low-back pain. The main parameter for the success or failure of this treatment was the relief of the pain. For the first injection—mainly a diagnostic procedure—the authors used a local anesthetic (1 ml bupivacaine 1%). In cases of good response, betamethasone was injected in a second session to achieve a longer-lasting effect. Long-lasting relief of the low-back pain and/or leg pain was reported by 43 patients (18.7%) during a mean follow-up period of 10 months. Thirty-five patients (15.2%) noticed a general improvement in their pain. Twenty-seven patients (11.7%) reported relief of low-back pain but not leg pain. Nine patients (3.9%) suffered no back pain but still leg pain. One hundred sixteen patients (50.4%), however, experienced no improvement of pain at all. In two cases the procedure had to be interrupted because of severe pain. There were no cases of infection or hematoma. Conclusions Lumbar facet joint block is a minimally invasive procedure to differentiate between facet joint pain and other causes of lower-back pain. The procedure seems to be useful for distinguishing between facet joint pain from postoperative pain due to inappropriate neural decompression after lumbar surgery. It can be also recommended as a possible midterm intervention for chronic low-back pain.


2004 ◽  
Vol 22 (4) ◽  
pp. 207-213 ◽  
Author(s):  
Robin Chakraverty ◽  
Richard Dias

The work of a chronic back pain service in secondary care in the West Midlands is reported. The service offers acupuncture, spinal injection procedures, osteopathy and a range of other interventions for patients whose back pain has not responded to conservative management. This section of the report focuses on injection procedures for lumbar facet joint and sacroiliac joint pain, which have been shown to be the cause of chronic low back pain in 16–40% and 13–19% of patients respectively. Diagnosis relies on the use of intra-articular or sensory nerve block injections with local anaesthetic. Possible treatments following diagnosis include intra-articular corticosteroid, radiofrequency denervation (for facet joint pain) or ligament prolotherapy injections (for sacroiliac joint pain). The results of several hospital audits are reported. At six month follow up, 50% of 38 patients undergoing radiofrequency denervation following diagnostic blocks for facet joint pain had improved by more than 50%, compared to 29% of 34 patients treated with intra-articular corticosteroid injection. Sixty three per cent of 19 patients undergoing prolotherapy following diagnostic block injection for sacroiliac joint pain had improved at six months, compared to 33% of 33 who had intra-articular corticosteroid. Both radiofrequency denervation and sacroiliac prolotherapy showed good long-term outcomes at one year.


2015 ◽  
Vol 5;18 (5;9) ◽  
pp. 473-493
Author(s):  
David R Ellard

Background: Since the publication of guidelines by the UK National Institute for Health and Care Excellence (NICE) and the American Pain Society guidelines for low back pain in 2009 there have been deep divisions in the pain treatment community about the use of therapeutic intraarticular facet joint injections. While evidence for the effectiveness or not of intraarticular facet joint injections remains sparse, uncertainty will remain. The Warwick feasibility study, along with a concurrent study with a different design led by another group, aims to provide a stable platform from which the effectiveness and cost effectiveness of intraarticular facet joint injections added to normal care could be evaluated in randomized controlled trials (RCTs). Objectives: To reach consensus on key design considerations for the Warwick facet feasibility study from which the study protocol and working manuals will be developed. Study Design: A consensus conference involving expert professionals and lay members. Methods: Preliminary work identified 5 key design considerations for deliberation at our consensus conference. Three concerned patient assessment and treatment: diagnosis of possible facet joint pain, interaarticular facet joint injection technique, and best usual care. Two concerned trial analysis: a priori sub-groups and minimally important difference and are reported elsewhere. We did systematic evidence reviews of the design considerations and summarized the evidence. Our design questions and evidence summaries were distributed to all delegates. This formed the basis for discussions on the day. Clinical experts in all aspects of facet joint injection from across the UK along with lay people were invited via relevant organizations. Nominal group technique was used in 15 facilitated initial small group discussions. Further discussion and ranking was undertaken in plenary. All small group and plenary results were recorded and checked and verified post conference. Where necessary participants were contacted via email to resolve outstanding issues. Results: Fifty-two delegates attended the conference with lay people and all relevant professions represented. Consensus was reached on the details of how to assess patients for facet joint pain, undertake the injections, and deliver usual care. Where post conference checking of results revealed errors in calculating ranking results on the day, consensus was reached by email consultation. All but 3 delegates agreed to be associated with the outcome. Limitations: Allocating one day for discussing a wide range of topics imposed time pressure on discussion and calculation of the numerous rankings. Conclusions: Through the use of an evidence-based, systematic, inclusive, and transparent process we have established consensus from expert health professionals in the UK, with lay input, on the clinical assessment of suspected facet joint pain, interaarticular injection for facet joint pain, and best usual care for use in a feasibility study for a proposed pragmatic clinical trial of interaarticular facet joint injections. This provides a strong basis for a clinical trial that will be acceptable to the pain treatment community. Key words: Low back pain, interaarticular facet joint injections, best usual care, consensus, nominal group technique


2018 ◽  
Vol 18 (4) ◽  
pp. 747-753
Author(s):  
Olav Rohof ◽  
Chee Kean Chen

AbstractBackground and aimsThe evidence for interventional treatment of thoracic facet joint pain remains limited. This is partly due to inconsistency of the path of thoracic medial branches and a lower incidence of thoracic facet pain among spine pain patients. The purpose of this study is to evaluate the efficacy of bipolar radiofrequency (RF) neurotomy of medial branches for treating chronic thoracic facet joint pain.MethodsThis is a retrospective record review of all patients diagnosed to have thoracic facet pain with diagnostic block and subsequently treated with bipolar RF neurotomy of medial branch between January 2012 and December 2015. The outcome measures were mean changes in Numeral Rating Scale (NRS) and Pain Disability Index (PDI).ResultsThere were 71 patients with complete data available for analysis. The mean age of the patients was 57.9±11.2 years. The mean duration of pain was 23±10.5 months. The majority of patients (82%) had pain reduction of more than 50% at 12 months after bipolar RF neurotomy. The NRS decreased significantly from baseline of 7.75±1.25 to 2.86±1.53 at 3 months and 2.82±1.29 at 12 months post-procedure (p<0.001.p<0.001, respectively). The PDI improved significantly from 40.92±12.22 to 24.15±9.79,p<0.05). There were no serious adverse effects or complications of the procedure reported in this study.ConclusionsBipolar RF neurotomy of thoracic medial branch is associated with a significant reduction in thoracic facet joint pain. The promising findings from this case series merit further assessment with prospective, randomized controlled trial which will produce a more reliable and accurate finding for its clinical applications.


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