Pain education and pain management skills in virtual reality in the treatment of chronic low back pain: A multiple baseline single-case experimental design.

Chronic lower back pain is a major health problem and current treatments do not always lead to adequate pain control. Virtual reality (VR) is an upcoming technology that has shown to be effective in reducing acute pain. However, the value of VR in reducing chronic pain is still unknown. Therefore, the current study focuses on the effects of a recently developed VR application 'Reducept' using a multiple baseline single-case experimental design in 8 patients (N = 8). Reducept is a VR-training program aiming to improve pain management skills and providing pain education in patients with (chronic lower) back pain. Results based on visual and statistical analyses indicated that Reducept has the potential to reduce chronic lower back pain, although its clinical relevance was small. This study is one of the first that focuses on the possible effects of Reducept using sophisticated visual and statistical analyses. Our study shows a detailed overview of individual changes in pain intensity over time. Further research is necessary to investigate the working mechanism of Reducept and its impact on chronic pain conditions.

Changes in quantitative sensory testing and patient perspectives following spinal cord stimulation for persistent spinal pain syndrome: An observational study with long-term follow-up.

BACKGROUND: Spinal cord stimulation (SCS) can impact sensory, pain and tolerance thresholds in various ways, which can be accessed via quantitative sensory testing (QST). The objectives of this study were to (1) assess the subjective sensory responses using QST in patients following SCS therapy for PSPS and (2) to get a clinical impression of the results of SCS during an interview of these patients with PSPS and SCS during long term follow-up. METHODS: Forty patients with PSPS who received SCS treatment underwent QST via electrical and mechanical pressure stimuli. QST was performed at four different moments (1) pre-implantation SCS, (2) two weeks postoperatively, (3) three months after permanent SCS implantation and (4) six months after permanent SCS implantation. Patients' perspectives on pain, use of drugs and quality of life were assessed via semi-structured interviews during a follow-up between 5 and 11 years. RESULTS: We found statistical significant differences in the changes of sensory, pain and tolerance thresholds. A decrease in pain complaints and analgesics use were reported by the patients during follow-up. The quality of life in patients increased from three to eight (NRS 0 [worst QoL imaginable] -10 [best QoL imaginable]) after receiving SCS. CONCLUSIONS: The increased thresholds on areas without pain or being covered by the SCS induced paresthesias may indicate that there are central changes contributing to these deviations in thresholds. The overall QoL in patients improved greatly after receiving SCS. SIGNIFICANCE: This study provides an overview of the effect of SCS on sensory, pain and tolerance thresholds in patients with PSPS throughout the SCS treatment process. In addition, this study presents data from 40 patients with PSPS treated with SCS, analysing several long-term patient-reported outcome measures. The results serve to give more insight into the mechanism of SCS and document SCS as a possible treatment for PSPS.

Monitoring Opioids in Europe: The Need for Shared Definitions and Measuring Drivers of Opioid Use and Related Harms.

The past 20 years, the USA is facing a serious opioid crisis initiated by an increase in prescription opioid use. Europe has also seen an increase in prescription opioid use, but the extent of related harm is still largely unknown. Given the impact of the US opioid epidemic, it is important to closely monitor signs of emerging opioid-related problems to guarantee early warnings and timely actions. Shared and meaningful definitions for opioid use and related harms, and relevant information about specific drivers for opioid use and related problems are needed for an adequate policy response. In this commentary, we discuss these definitions, the need to know more about the specific drivers for increased opioid use, its related harm, and proposals for strategies to move forward. Policy recommendations include making a distinction between licit and illicit opioids when monitoring and reporting on opioid-related harm, and using oral morphine equivalents to quantify prescription opioid use in a clinically relevant and comparable manner. A major topic of further research is exploring unique and universal drivers of prescription opioid (mis)use across Europe, in particular the role of opioid diversion.

Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double-blind, multicentre, phase 3, electrical dose-controlled trial.

BACKGROUND: Occipital nerve stimulation (ONS) has shown promising results in small uncontrolled trials in patients with medically intractable chronic cluster headache (MICCH). We aimed to establish whether ONS could serve as an effective treatment for patients with MICCH. METHODS: The ONS in MICCH (ICON) study is an investigator-initiated, international, multicentre, randomised, double-blind, phase 3, electrical dose-controlled clinical trial. The study took place at four hospitals in the Netherlands, one hospital in Belgium, one in Germany, and one in Hungary. After 12 weeks' baseline observation, patients with MICCH, at least four attacks per week, and history of being non-responsive to at least three standard preventive drugs, were randomly allocated (at a 1:1 ratio using a computer-generated permuted block) to 24 weeks of occipital nerve stimulation at either 100% or 30% of the individually determined range between paraesthesia threshold and near-discomfort (double-blind study phase). Because ONS causes paraesthesia, preventing masked comparison versus placebo, we compared high-intensity versus low-intensity ONS, which are hypothesised to cause similar paraesthesia, but with different efficacy. In weeks 25-48, participants received individually optimised open-label ONS. The primary outcome was the weekly mean attack frequency in weeks 21-24 compared with baseline across all patients and, if a decrease was shown, to show a group-wise difference. The trial is closed to recruitment (ClinicalTrials.gov NCT01151631). FINDINGS: Patients were enrolled between Oct 12, 2010, and Dec 3, 2017. We enrolled 150 patients and randomly assigned 131 (87%) to treatment; 65 (50%) patients to 100% ONS and 66 (50%) to 30% ONS. One of the 66 patients assigned to 30% ONS was not implanted and was therefore excluded from the intention-to-treat analysis. Because the weekly mean attack frequencies at baseline were skewed (median 15·75; IQR 9·44 to 24·75) we used log transformation to analyse the data and medians to present the results. Median weekly mean attack frequencies in the total population decreased from baseline to 7·38 (2·50 to 18·50; p<0·0001) in weeks 21-24, a median change of -5·21 (-11·18 to -0·19; p<0·0001) attacks per week. In the 100% ONS stimulation group, mean attack frequency decreased from 17·58 (9·83 to 29·33) at baseline to 9·50 (3·00 to 21·25) at 21-24 weeks (median change from baseline -4·08, -11·92 to -0·25), and for the 30% ONS stimulation group, mean attack frequency decreased from 15·00 (9·25 to 22·33) to 6·75 (1·50 to 16·50; -6·50, -10·83 to -0·08). The difference in median weekly mean attack frequency between groups at the end of the masked phase in weeks 21-24 was -2·42 (95% CI -5·17 to 3·33). In the masked study phase, 129 adverse events occurred with 100% ONS and 95 occurred with 30% ONS. None of the adverse events was unexpected but 17 with 100% ONS and eight with 30% ONS were labelled as serious, given they required brief hospital admission for minor hardware-related issues. The most common adverse events were local pain, impaired wound healing, neck stiffness, and hardware damage. INTERPRETATION: In patients with MICCH, both 100% ONS intensity and 30% ONS intensity substantially reduced attack frequency and were safe and well tolerated. Future research should focus on optimising stimulation protocols and disentangling the underlying mechanism of action. FUNDING: The Netherlands Organisation for Scientific Research, the Dutch Ministry of Health, the NutsOhra Foundation from the Dutch Health Insurance Companies, and Medtronic.

Qualitative and Quantitative Aspects of Pain in Patients With Myotonic Dystrophy Type 2.

Pain is a common but often ignored symptom in patients with myotonic dystrophy type 2 (DM2). In this explorative study, we assessed qualitative and quantitative aspects of pain in DM2 using 4 questionnaires and quantitative sensory testing. A disease control group (fibromyalgia [FMS]) as well as healthy controls were used to compare the results, because pain in DM2 shows many clinical similarities to pain in FMS. Thirty-four patients with genetically confirmed DM2 (71% female, mean age 54 years), 28 patients with FMS, and 33 healthy controls were included, age- as well as sex-matched. Pain prevalence was 65% in DM2, 100% in FMS (P < .001), and 15% in healthy controls (P < .001). The mean of the pressure pain thresholds was lower in DM2 than in healthy controls (P = .016), with the largest differences in the rectus femoris, trapezius, and thenar muscles. Mechanical and electric pain thresholds were significantly higher in DM2 than in FMS, and no differences were found in electric pain thresholds between DM2 and healthy controls. These results confirm that pain is a frequent and important symptom in patients with DM2, affecting quality of life. Peripheral mechanisms of pain seem to play a role in DM2. The widespreadness of the hyperalgesia suggests central sensitization, but this finding was not supported by the other results. This study opens new avenues for further research and eventually novel treatment strategies, in DM2 as well as in other muscular disorders. PERSPECTIVE: This article presents qualitative as well as quantitative aspects of pain in patients with DM2. Pain is a frequent and important symptom in patients with DM2, affecting quality of life. We found mechanical hyperalgesia, indicative of a peripheral mechanism of pain. The widespreadness of hyperalgesia may suggest central sensitization, but this finding was not supported by other results and needs further exploration.

Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial.

OBJECTIVE: To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. SETTING: The study was conducted at a level 1 trauma centre in the Netherlands. PARTICIPANTS: 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. INTERVENTIONS: Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. MEASUREMENTS: Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score--Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. RESULTS: The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI -1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. CONCLUSIONS: We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. TRIAL REGISTRATION NUMBERS: NCT00817128 and NTR 2090.

[Neuromodulation in severe neuropathic pain]. / Neuromodulatie bij ernstige neuropathische pijn.

Pain relief in patients with chronic neuropathic pain can be difficult to accomplish. If pharmacological treatment combined with a form of physical therapy and psychological support does not lead to improvement, nerve blocks and rehabilitation can be considered. Appropriately screened patients with persistent incapacitating pain may respond to neuromodulation. A specific form of this technique - spinal cord stimulation - delivers electric pulses via an implanted electrode connected to a battery in the epidural space around the spinal cord. We describe three patients, two of whom had persistent leg pain after disc surgery. The third patient suffered from diabetic neuropathy. Despite thorough pre-procedural screening by an anaesthetist-pain specialist, psychologist, physical therapist and specialised nurse, spinal cord stimulation failed in one patient. Psycho-social factors, inadequate coping skills and depression may lead to inadequate improvement and failure of this therapy.

Are pain-related fears mediators for reducing disability and pain in patients with complex regional pain syndrome type 1? An explorative analysis on pain exposure physical therapy.

OBJECTIVE: To investigate whether pain-related fears are mediators for reducing disability and pain in patients with Complex Regional Pain Syndrome type 1 when treating with Pain Exposure Physical Therapy. DESIGN: An explorative secondary analysis of a randomised controlled trial. PARTICIPANTS: Fifty-six patients with Complex Regional Pain Syndrome type 1. INTERVENTIONS: The experimental group received Pain Exposure Physical Therapy in a maximum of five treatment sessions; the control group received conventional treatment following the Dutch multidisciplinary guideline. OUTCOME MEASURES: Levels of disability, pain, and pain-related fears (fear-avoidance beliefs, pain catastrophizing, and kinesiophobia) were measured at baseline and after 3, 6, and 9 months follow-up. RESULTS: The experimental group had a significantly larger decrease in disability of 7.77 points (95% CI 1.09 to 14.45) and in pain of 1.83 points (95% CI 0.44 to 3.23) over nine months than the control group. The potential mediators pain-related fears decreased significantly in both groups, but there were no significant differences between groups, which indicated that there was no mediation. CONCLUSION: The reduction of pain-related fears was comparable in both groups. We found no indication that pain-related fears mediate the larger reduction of disability and pain in patients with Complex Regional Pain Syndrome type 1 treated with Pain Exposure Physical Therapy compared to conventional treatment. TRIAL REGISTRATION: International Clinical Trials Registry NCT00817128.

The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial.

BACKGROUND: Pain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1. METHODS/DESIGN: This study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version. DISCUSSION: This is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.

The use of laminectomy for the placement of a percutaneous spinal cord stimulation electrode.

OBJECTIVE: The placement of a percutaneous electrode for trial stimulation to evaluate the effectiveness of spinal cord stimulation can be impossible because of epidural adhesions from previous spinal surgeries. The authors would like to describe a combination of techniques in order to place a percutaneous lead for a test phase. MATERIALS AND METHODS: Technical report of an illustrative case where a partial laminectomy was used to assist a percutaneous lead placement. RESULTS: Adequate trial spinal cord stimulation with a single lead electrode at the right target area was possible. CONCLUSION: This case demonstrates the possibility to use a combination of an open and percutaneous technique for trial spinal cord stimulation in patients with prior operations in the target area of stimulation.

[Guideline 'Pain management for trauma patients in the chain of emergency care']. / Richtlijn 'Pijnbehandeling bij traumapatiënten in de spoedzorgketen'.

Pain management for trauma patients is a neglected aspect in the chain of emergency care in general practices, ambulance services, mobile trauma teams and in hospital emergency departments. The aim of the guideline 'Pain management for trauma patients in the chain of emergency care' is to provide pain management recommendations for trauma patients in the chain of emergency care and thereby improve the assistance that patients receive. Paracetamol is the treatment of choice, if necessary with additional use of NSAIDs or opioids; NSAIDs can be administered in the absence of contra-indications, but should be avoided in cases where the patient history is unknown; fentanyl and morphine can be given for severe pain during emergency care, esketamine can be considered in patients with severe pain and hypovolemia. The guideline contains 3 algorithms for measuring pain and for its pharmacological treatment in the chain of emergency care. Implementation of the algorithms requires an alternative working procedure; pain scores must be documented, and general practitioners and nursing staff may administer opioids intravenously.

Classifying post-stroke shoulder pain: can the DN4 be helpful?

The etiology of post-stroke shoulder pain (PSSP) is largely unclear and may involve both nociceptive and neuropathic mechanisms. No gold standard is present for PSSP diagnosis. The neuropathic pain diagnostic questionnaire (DN4), was originally developed to identify neuropathic pain in the clinical context. In this study we used the DN4 to categorize PSSP patients and compared symptoms and signs suggestive of either nociceptive or neuropathic pain. Pain complaints and sensory functions were compared between patients with chronic PSSP scoring at least four (DN4+, n=9) or less than four (DN4-, n=10) on the DN4. Pain was assessed using a numeric rating scale and the McGill pain questionnaire. Sensory functions were assessed using clinical examination and quantitative sensory testing combined with a cold pressor test. Patients classified as DN4+ reported constant pain, higher pain intensity, a higher impact of pain on daily living, more frequent loss of cold sensation, reduced QST thresholds at the unaffected side and increased QST thresholds at the affected side. Notably, several symptoms and signs suggestive of either neuropathic or nociceptive pain corresponded to the subgroups DN4+ and DN4- respectively. However, since the pathophysiological mechanisms remain unclear and none of the sensory signs could be exclusively related to either DN4+ or DN4-, PSSP prognosis and treatment should not be solely based on the DN4. Nonetheless, a thorough assessment of neuropathic and nociceptive pain complaints and somatosensory functions should be included in the diagnostic work-up of PSSP.

Somatosensory symptoms and signs and conditioned pain modulation in chronic post-stroke shoulder pain.

UNLABELLED: Persistent shoulder pain is a common complication after stroke. Its etiology and underlying mechanisms are not well understood and treatment is generally unsatisfactory. The objective of this study was to assess the role of central sensitization and disinhibition in chronic stroke patients with chronic PSSP (n = 19), pain-free stroke patients (n = 29), and healthy controls (n = 23). Positive and negative somatosensory symptoms and signs were assessed using clinical examination and electrical and mechanical quantitative sensory testing (QST). Conditioned pain modulation (CPM) was assessed by comparing QST thresholds before and after applying a cold pressor test. Sensory abnormalities were more frequently observed and more severe in patients with PSSP, including positive signs such as allodynia at the affected side and generalized hyperalgesia at the unaffected side. CPM was similar in stroke patients and healthy controls. This study showed that chronic PSSP was associated with several positive and negative somatosensory signs, implicating a role for central sensitization and possibly for disinhibition. Since the causal relationship remains unclear, and may be related to either neuroplasticity induced by ongoing nociception as well as to the neuropathic brain lesion, prospective studies are warranted. PERSPECTIVE: The assessment of somatosensory symptoms and signs and endogenous pain modulation demonstrated a role for central sensitization and possibly for disinhibition in chronic PSSP. Prevention and treatment of PSSP could benefit from a more detailed analysis of both peripheral and central pain mechanisms.

Pain exposure physical therapy may be a safe and effective treatment for longstanding complex regional pain syndrome type 1: a case series.

OBJECTIVE: To determine if treatment of longstanding complex regional pain syndrome type 1, focusing on functional improvement only while neglecting pain, results in clinical improvement of this syndrome. DESIGN: Prospective description of a case series of 106 patients. SETTING: Outpatient clinic for rehabilitation. INTERVENTIONS: Physical therapy of the affected limb directed at a functional improvement only while neglecting the pain, was performed following an extensive explanation. Normal use of the limb between the treatments was encouraged despite pain. A maximum of five of these sessions were performed in three months. MEASURES: Radboud Skills Test was used to monitor functional improvement of the arms. Speed and walking distance was used as the measure of outcome for the legs. RESULTS: The function of the affected arm or leg improved in 95 patients. Full functional recovery was experienced in 49 (46%) of them. A reduction in pain presented in 75 patients. In 23 patients functional recovery was reached despite an increase in pain. Four patients stopped early due to pain increase. CONCLUSIONS: Our results suggest that 'pain exposure physical therapy' is effective and safe for patients who are unresponsive to accepted standard therapies. Avoiding the use of a limb due to pain will result in loss of function. Forced usage of limbs restores the function, reverses these adaptive processes and leads to regain of control by practice with a reduction of pain in most cases.

Pain prevalence and pain relief in trauma patients in the Accident & Emergency department.

BACKGROUND: Acute pain in the A&E department (ED) has been described as a problem, however insight into the problem for trauma patients is lacking. OBJECTIVE: This study describes the prevalence of pain, the pain intensity and the effect of conventional pain treatment in trauma patients in the ED. METHODS: In a prospective cohort study of 450 trauma patients, pain was measured on admission and at discharge, using standardized and validated pain instruments. RESULTS: The prevalence of pain was high, both on admission (91%) and at discharge (86%). Two thirds of the trauma patients reported moderate or severe pain at discharge. Few patients received pharmacological or non-pharmacological pain relieving treatment during their stay in the ED. Pain decreased in 37% of the patients, did not change at all in 46%, or had increased in 17% of the patients at discharge from the ED. The most effective pain treatment given was a combination of injury treatment and supplementary pharmacological interventions, however this treatment was given to a small group of patients. CONCLUSIONS: Acute pain in trauma patients is a significant problem in the ED's. Pain itself does not seem to be treated systematically and sufficiently, anywhere in the cycle of injury treatment in the ED.

Use of a tubular retractor system as a minimally invasive technique for epidural plate electrode placement under local anesthesia for spinal cord stimulation: technical note.

OBJECTIVE: To improve the technique of placement of large plate electrodes for spinal cord stimulation with a minimally invasive approach using the METRx tubular retractor system (Medtronic Sofamor Danek, Minneapolis, MN). This dilating system splits the paravertebral musculature, avoiding the need to strip these muscles from the spine. The technique described makes it possible to perform the procedure (currently, it is most frequently performed using general anesthesia) with local anesthesia and sedation, allowing test stimulation, and with little intraoperative or postoperative discomfort for the patient. METHODS: The tubular retractor system was used to approach the spine at the desired level using local anesthesia. A small laminectomy was performed through the working tube, and the plate electrodes were introduced by the same approach. Test stimulation could be performed to determine the correct electrode position because only local anesthesia was used. RESULTS: Seven patients were scheduled for placement of large plate electrodes for spinal cord stimulation. In six patients, with different indications for the placement of spinal cord stimulation, the electrode could be placed using the minimally invasive tubular retractor system approach with local anesthesia and slight sedation. A good test stimulation was obtained in all of the patients, resulting in good pain relief after definitive implantation. We were not able to perform the procedure in one patient because we could not reach the spinal canal at the level operated on previously. All patients experienced only acceptable postoperative back pain. CONCLUSION: Using a tubular retractor system, implantation of plate electrodes for spinal cord stimulation can be performed under local anesthesia with acceptable discomfort for the patient, making the approach of the spinal canal minimally invasive. This method allows test stimulation to assess the correct electrode position and results in less local postoperative discomfort because of the small-muscle splitting approach.

The present role of percutaneous cervical cordotomy for the treatment of cancer pain.

The results obtained by percutaneous cervical cordotomy (PCC) were analysed in 43 terminally ill cancer patients treated in our institution from 1998 to 2001. We wished to determine whether there is still a place for PCC in the actual clinical situation with its wide choice of pain therapies. All patients had severe unilateral pain due to cancer, resistant to opioids and co-analgesics. Following PCC, mean pain intensity was reduced from Numeric Rating Scale (NRS) 7.2 to 1.1. At the end of life, pain had increased to NRS 2.9. Initially following PCC a good result (NRS<3) was obtained in 95% of patients. At the end of life, a good result was still present in 69% of patients. Mean duration of survival after the intervention was 118 days (2-1460). In general, complications were mild and mostly subsided within 3-4 days. There was one case of partial paresis of the ipsilateral leg. PCC remains a valuable treatment in patients with treatment-resistant cancer pain and still deserves a place in the treatment of terminal cancer patients with severe unilateral neuropathic or incidence pain.