Jan Hildebrandt

Injection Therapy for Subacute and Chronic Low Back Pain : An Updated Cochrane Review

Study Design. A systematic review of randomized controlled trials (RCTs). Objective. To determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low back pain. Summary of Background Data. The effectiveness of injection therapy for low back pain is still debatable. Heterogeneity of target tissue, pharmacological agent, and dosage, generally found in RCTs, point to the need for clinically valid comparisons in a literature synthesis. Methods. We updated the search of the earlier systematic review and searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases up to March 2007 for relevant trials reported in English, French, German, Dutch, and Nordic languages. We also screened references from trials identified. RCTs on the effects of injection therapy involving epidural, facet, or local sites for subacute or chronic low back pain were included. Studies that compared the effects of intradiscal injections, prolotherapy, or ozone therapy with other treatments were excluded unless injection therapy with another pharmaceutical agent (no placebo treatment) was part of one of the treatment arms. Studies about injections in sacroiliac joints and studies evaluating the effects of epidural steroids for radicular pain were also excluded. Results. Eighteen trials (1179 participants) were included in this review. The injection sites varied from epidural sites and facet joints (i.e. intra-articular injections, peri-articular injections and nerve blocks) to local sites (i.e. tender-and trigger points). The drugs that were studied consisted of corticosteroids, local anesthetics, and a variety of other drugs. The methodologic quality of the trials was limited with 10 of 18 trials rated as having a high methodologic quality. Statistical pooling was not possible because of clinical heterogeneity in the trials. Overall, the results indicated that there is no strong evidence for or against the use of any type of injection therapy. Conclusion. There is insufficient evidence to support the use of injection therapy in subacute and chronic lowback pain. However, it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy.

Validation of the German version of the Fear‐Avoidance Beliefs Questionnaire (FABQ)

Fearful avoidance of physical activities is a major factor in low back pain (LBP) and disability. In 1993 Waddell et al. developed the Fear‐Avoidance Beliefs Questionnaire (FABQ) focusing on patients’ beliefs about how physical activity and work affect LBP. The focus of our study was to analyse and validate the German version of the FABQ. Three‐hundred and two consecutive LBP outpatients participating on a functional restoration programme filled in the FABQ. Factor analysis yielded three factors which accounted for nearly 65% of the total variance of the questionnaire. Whereas the factor ‘physical activity’ (8.9% of the variance) remained the same as in the English version, the second factor of the original version split into two: one related to, ‘work as cause of pain’ (43.4% of the variance) and the other to patients’ assumptions of their probable return to work (11.8% of the variance). Both work‐related subscales showed a good internal consistency (α =0.89, resp. α =0.94), whereas the consistency of the subscale 3 ‘physical activity’ was only modest (α =0.64). Test–re‐test reliability score was fair to good for the whole scale (r =0.87;n =30). Regression analysis demonstrated that fear‐avoidance beliefs account for the highest proportion of variance (35%) regarding disability in activities of daily living and work loss. Patients out of work demonstrated more fear‐avoidance beliefs in comparison to those who were still working. It can be concluded that the German version of the FAQB is a reliable and valid instrument, but it shows a different factor structure from the original English version. The FABQ has been proven to identify patients with maladaptive beliefs which have to be focused on in proper treatment.

Effectiveness of a multimodal treatment program for chronic low-back pain

&NA; In recent years, multidisciplinary pain programs were seen to successfully treat patients by basing treatment on a combination of physical exercise and psychological interventions. However, in spite of their effectiveness, it still remains to be clarified exactly which features of these programs were responsible for patient improvement. Cognitive‐behavioral models posit that improvement is due, in part, to changes in patient coping strategies. Nonetheless, as reflected by the conflicting opinions present in the literature, it is questionable whether a so‐called ‘cognitive shift’ is an accurate indicator for return to work of disabled patients. Ninety patients with chronic low back pain took part in a multidisciplinary treatment program. Therapeutic environment reinforces wellness behavior and enhances the patients’ sense of control over their pain and resulting disability. The main therapeutic target point was to facilitate return to work. Ways of coping were measured by a well studied coping inventory in the German language (FEKB). Factor analysis revealed three factors: ‘catastrophizing’, ‘search for information’ and ‘cognitive control’. In addition, assessment included measurements of pain intensity, depression, disability, flexibility of the lumbar spine, and different performance parameters. All of them were measured prior to and at the end of treatment, and following intervals of 6 and 12 months after discharge from program. Measurements showed significant changes over time, but more importantly, nearly all results were seen to stabilize at the 6‐ and 12‐month evaluation following treatment. The coping strategies demonstrated little or poor change. In addition, coping measures and change in coping behavior showed poor prognostic relevance. But other psycho‐social parameters like self‐evaluation of potential return‐to‐work, application for pension, the length of pre‐absence from work, and a decrease in subjective disability following treatment were effective indicators for ‘back‐to‐work’. Other objective parameters, such as medical history, physical impairment and general physical variables were seen to have little predictive value in determining a return to work. The results suggest that the primary target point for further investigation is the analysis of the patients’ beliefs about their pain. Our results indicate that future research must be attentive to the complex interactions between environmental factors and the coping demands posed by the specific nature of pain problems.

Lumbar Range of Motion: Reliability and Validity of the Inclinometer Technique in the Clinical Measurement of Trunk Flexibility

Study Design. This study examines the reliability and validity of measuring lumbar range of motion with an inclinometer. Objectives. To find out whether a manual determination of the reference points for measuring lumbar range of motion is as reliable as radiologic determination for positioning the inclinometers, lumbar range of motion was determined in degrees by evaluating radiographs and by using the inclinometer technique of Loebl. Summary of Background Data. Reliability and validity of the inclinometer technique as a clinical measurement of trunk flexibility were investigated. Fifty‐four patients participated in the study. Methods. Lumbar range of motion measurements were taken with and without radiologic control of the T12 and S1 vertebrae as reference points for positioning of the inclinometers. An interrater correlation was done of the inclinometer techniques of a physician and a physiotherapist. Functional radiographs were investigated in a standing position. Lumbar range of motion measurements based on radiographs and those taken using the inclinometer alone were correlated to validate the inclinometer technique. Results. Lumbar range of motion measurements taken with and without radiologic determination showed a very close correlation (r = 0.93; P < 0.001). Flexion alone also demonstrated a close correlation (r = 0.95; P < 0.001), whereas extension showed a somewhat smaller correlation (r = 0.82; P < 0.001). Total lumbar range of motion (r = 0.94; P < 0.001) and flexion (r = 0.88; P < 0.001) were closely related, as indicated by the interrater correlation, whereas extension (r = 0.42; P < 0.05) showed a lesser correlation. Correlation of the measurements taken radiographically and by inclinometer demonstrated an almost linear correlation for measurements of the total lumbar range of motion (r = 0.97; P < 0.001) and flexion (r = 0.98; P < 0.001), whereas extension (r = 0.75; P < 0.001) did not correlate as well. Conclusions. The noninvasive inclinometer technique proved to be highly reliable and valid, but the measurement technique for extension needs further refinement.

Morphine responsiveness, efficacy and tolerability in patients with chronic non-tumor associated pain – results of a double-blind placebo-controlled trial (MONTAS)

&NA; Efficacy, long‐term effectiveness and safety of opioids in chronic non‐tumor associated pain syndromes (NTAS) are still under debate. The study (MONTAS) was performed by physicians and psychologists as a multicenter prospective, randomized, double‐blind placebo‐controlled crossover trial, followed by an open long‐term study. Patients were enrolled only when pain relief from specific defined pretreatment was insufficient. Patients were randomly assigned to group I receiving sustained‐release morphine (doses: 20 mg/d titrated appropriately to a maximum of 180 mg/d) in the first week, placebo in the second week or group II receiving study medication in reverse order. The primary endpoint was defined as: (i) adequate pain relief (pain intensity of less than 50% of pretreatment intensity or less than 5 on a 11 point Numerical Rating Scale) and (ii) pain rated as tolerable and (iii) adverse effects rated as tolerable. Full responders (all criteria fulfilled under morphine) and partial responders (less pain relief, but tolerable side effects) were offered continuation of treatment with oral morphine in an open long‐term study (LAMONTAS), to be published later. Forty‐nine patients of 997 patients screened fulfilled the inclusion criteria for MONTAS and were enrolled. Mean pain intensity in all patients was reduced by morphine from 7.8 to 5.2 (NNT: 2.2); in 17 (35.4%) responders from 7.4 to 2.9, in 17 (35.4%) partial responders from 7.8 to 5.6 and in 14 (29.2%) non‐responders from 8.2 to 7.7. Pain reduction correlated with improvement of physical function. Pain disability, depression score, mood and exercise endurance improved, particularly in responders. Gastrointestinal complaints increased, central nervous system‐related complaints were reduced. Efficacy and safety of morphine in NTAS were demonstrated in this randomized‐controlled trial. Pretreatment failure was the indication for trying morphine treatment; predictive factors for responsiveness could not be identified.

Chronifizierungsausmaß von Schmerzerkrankungen

ZusammenfassungHintergrund: Die Beschreibung von Schmerzsyndromen ist durch eine Diagnose allein nicht ausreichend gewährleistet; erst die Angabe der Krankheitsschwere ermöglicht sowohl die Indikation der entsprechenden Behandlung als auch eine Vergleichbarkeit von Fällen. Patienten und Methode: In einer multizentrischen Studie wurde bei 542 Patienten das aus der Mainzer Arbeitsgruppe um Gerbershagen 1986 vorgestellte Stadienmodell der Chronifizierung ermittelt und in Abhängigkeit von Patienten- und Diagnosemerkmalen sowie im Hinblick auf seine parametrischen Eigenschaften analysiert. Ergebnisse und Diskussionen: Die Ergebnisse der Untersuchung bestätigen die gute Validität des Verfahrens im Hinblick auf seine Unabhängigkeit von schmerzspezifischen Parametern. Es besteht theoriegemäß eine gute Übereinstimmung zum Ausmaß der emotionalen Befindlichkeit (Depression), zur subjektiven Beeinträchtigung und zum Ausmaß der Arbeitsunfähigkeit. Die Ergebnisse zeigen auch Ansätze für Verbesserungsmöglichkeiten. Einige der berücksichtigten Kriterien sind vermutlich überflüssig, während der zusätzliche Einbezug des subjektiven Beeinträchtigungserlebens notwendig erscheint. Ob ein übergreifendes Graduierungsmodell für verschiedene Schmerzerkrankungen überhaupt valide sein kann, muss eine weitergehende Analyse zeigen.AbstractIntroduction: Chronic pain is an individually variable experience, incorporating physical, psychological and social dimensions. Chronic pain occurs in a broad spectrum of severity; therefore, a grading procedure is of crucial importance in clinical research and in epidemiologic studies.The Mainz Pain Staging System is an interview-administered, multi-dimensional measure of chronic pain severity. The system suggests grading chronic pain in terms of 4 axes: time (persistence), spreading of pain site, medication use, and health care utilization. The whole scale consist of 10 items. The resulting score is used to classify the pain problem in three stages (I, II, III). Analysing the broader validity and parametric properties of the staging system is the purpose of the present study. Methods: The staging system and psychosocial data were administered to 542 consecutive patients of different diagnoses who attended one of six pain clinics in the year 1995/96. In a time period of 3 months since first contact, treatment procedures were registered. Three months after first contact patients rated the effectiveness of treatment concerning reduction of pain intensity. Results: According to the criteria of the staging system 25% of the sample belonged to each stage I and stage III, whereas 50% were classified to stage II. As a measure of validity, chronic pain status demonstrated significant correlation with psychological impairment, disability and time off work, whereas there was no correlation to pain intensity and persistence of pain. Surprisingly we found no difference in amount and quality of treatment between patients who were graded as severe pain patients (stage III) and the other stages. Furthermore, effectiveness of treatment also did not differ between the three stages. We made several proposals for optimizing the staging system. Conclusion: Given the high prevalence of recurrent and chronic pain as well as the broadness of severity, an important issue on further research is identification of factors which influence the chronification process. For this purpose improved measures of graded classification of pain status are needed.

Effects of Two Guideline Implementation Strategies on Patient Outcomes in Primary Care : A Cluster Randomized Controlled Trial

Study Design. Cluster randomized controlled trial. Objective. To improve quality of care for patients with low back pain (LBP) a multifaceted general practitioner education alone and in combination with motivational counseling by practice nurses has been implemented in German general practices. We studied effects on functional capacity (main outcome), days in pain, physical activity, quality of life, or days of sick leave (secondary outcomes) compared with no intervention. Summary of Background Data. International research has lead to the development of the German LBP guideline for general practitioners. However, there is still doubt about the most effective implementation strategy. Although effects on process of care have been observed frequently, changes in patient outcomes are rarely seen. Methods. We recruited 1378 patients with LBP in 118 general practices, which were randomized to 1 of 3 study arms: a multifaceted guideline implementation (GI), GI plus training of practice nurses in motivational counseling (MC), and the postal dissemination of the guideline (controls, C). Data were collected (questionnaires and patient interviews) at baseline and after 6 and 12 months. Multilevel mixed effects modeling was used to adjust for clustering of data and potential confounders. Results. After 6 months, functional capacity was higher in the intervention groups with a cluster adjusted mean difference of 3.650 between the MC group and controls (95% CI = 0.320–6.979, P = 0.032) and 2.652 between the GI group and controls (95% CI = −0.704 to 6.007, P = 0.120). Intervention effects were more pronounced regarding days in pain per year with an average reduction of 16 (GI) to 17 days (MC) after 6 months (12 and 9 days after 12 months) compared with controls. Conclusion. Active implementation of the German LBP guideline results in slightly better outcomes during 6 months follow-up than its postal dissemination. Results are more distinct when practice nurses are trained in motivational counseling.

Acceptance and perceived barriers of implementing a guideline for managing low back in general practice

BackgroundImplementation of guidelines in clinical practice is difficult. In 2003, the German College of General Practitioners and Family Physicians (DEGAM) released an evidence-based guideline for the management of low back pain (LBP) in primary care. The objective of this study is to explore the acceptance of guideline content and perceived barriers to implementation.MethodsSeventy-two general practitioners (GPs) participating in quality circles within the framework of an educational intervention study for guideline implementation evaluated the LBP-guideline and its practicability with a standardised questionnaire. In addition, statements of group discussions were recorded using the metaplan technique and were incorporated in the discussion.ResultsMost GPs agree with the guideline content but believe that guideline stipulations are not congruent with patient wishes. Non-adherence to the guideline and contradictory information for patients by other professionals (e.g., GPs, orthopaedic surgeons, physiotherapists) are important barriers to guideline adherence. Almost half of the GPs have no access to recommended multimodal pain programs for patients with chronic LBP.ConclusionPromoting adherence to the LBP guideline requires more than enhancing knowledge about evidence-based management of LBP. Public education and an interdisciplinary consensus are important requirements for successful guideline implementation into daily practice. Guideline recommendations need to be adapted to the infrastructure of the health care system.Trial registrationBMBF Grant Nr. 01EM0113. FORIS (database for research projects in social science) Reg #: 20040116 [25].

Relevanz von Nervenblockaden bei der Diagnose und Therapie von Rückenschmerzen

Zusammenfassung. Mehr als 80% lumbaler wirbelsäulenbedingter Schmerzen sind unspezifisch und können nur mit größten Schwierigkeiten einer bestimmten Struktur zugeordnet werden. Als schmerzauslösende Gewebe kommen Bandscheiben, Zwischenwirbel- und Iliosakralgelenke, Muskulatur und Bänder infrage. Lediglich in maximal 7% sind die Schmerzen radikulär (4% durch Bandscheiben, 3% durch Stenosen bedingt). In 7–15% liegt die Schmerzursache im Bereich der Wirbelgelenke, in bis zu 15% im Bereich der Iliosakralgelenke (ISG). Obschon die überwältigende Mehrheit der Schmerzen keine eindeutige strukturelle Ursache hat, sind Infiltrationen und Nervenblockaden sehr beliebt und werden extrem häufig angewendet. Ihre Wirksamkeit wurde aber bisher bis auf epidurale Kortikosteroide bei radikulären Schmerzen in kontrollierten Studien nicht nachgewiesen. Epidural und epiradikulär applizierte Kortikosteroide scheinen bei radikulären Schmerzen zumindest kurzfristig wirksam zu sein, obwohl kontrollierte Studien zu kontroversen Ergebnissen kommen. Die Problematik liegt z. T. in der räumlich exakten Platzierung des Kortikoids an der betroffenen Wurzel. Dies ist bei der kaudalen Injektion kaum, bei der lumbalen epiduralen Injektion und bei periradikulären Injektionen sicher nur unter Röntgenkontrolle möglich.Abstract.Diagnostic nerve blocks: The popularity of neural blockade as a diagnostic tool in painful conditions, especially in the spine, is due to features like the unspecific character of spinal pain, the irrelevance of radiological findings and the purely subjective character of pain. It is said that apart from specific causes of pain and clear radicular involvement with obvious neurological deficits and corresponding findings of a prolapsed disc in MRI or CT pictures, a diagnosis of the anatomical cause of the pain can only be established if invasive tests are used [5]. These include zygapophyseal joint blocks, sacroiliacal joint blocks, disc stimulation and nerve root blocks. Under controlled conditions, it has been shown that among patients with chronic nonradicular low back pain, some 10–15% have zygapophyseal joint pain [58], some 15–20% have sacroiliacal joint pain [36, 59] and 40% have pain from internal disc disruption [60]. The diagnostic use of neural blockade rests on three premises. First, pathology causing pain is located in an exact peripheral location, and impulses from this site travel via a unique and consistent neural root. Second, injection of local aneasthetic totally abolishes sensory function of intended nerves and does not affect other nerves. Third, relief of pain after local anaesthetic block is attributable solely to block of the target afferent neural pathway. The validity of these assumptions is limited by complexities of anatomy, physiology, and psychology of pain perception and the effect of local anaesthetics on impulse conduction [28]. Facet joints: The prevalence of zygapophyseal joint pain among patients with low back pain seems to be between 15% and 40% [62], but apparently only 7% of patients have pure facet pain [8, 29]. Facet blockade is achieved either by injection of local anaesthetic into the joint space or around the medial branches of the posterior medial rami of the spinal nerves that innervate the joint. There are several problems with intraarticular facet injections, mainly failure to enter the joint capsule and rupture of the capsule during the injection [11]. There is no physiological means to test the adaequacy of medial nerve block, because the lower branches have no cutaneous innervation. Medial ramus blocks (for one joint two nerves have to be infiltrated) are as effective as intraarticular joint blocks [37]. Reproducibility of the test is not high, the specifity is only 65% [61]. For diagnosis of facet pain fluoroscopic control is always necessary as in the other diagnostic blocks. Sacroiliacal joint: Definitely the sacroiliacal joint can be the source of low back pain. Stimulation of the joint by injection in subjects without pain produces pain in the buttock, in the posterior thigh and the knee. There are many clinical tests which confirm the diagnosis, but the interrater reliability is moderate [53]. Intraarticular injection can be achieved in the lower part of the joint with fluoroscopic guidance only, but an accurate intraarticular injection, which is confirmed by contrast medium, even at this place is often difficult. It is not clear whether intraarticular spread is necessary to achieve efficacy. Discography: Two primary syndromes concerning the ventral compartment have been described: anular fissures of the disc and instability of the motion segment. In the syndrome of anular tear, leakage of nucleus pulposus material into the anulus fibrosus is considered to be the source of pain. The studies of Vaharanta [71] and Moneta [41] show a clear and significant correlation between disc pain and grade 3 fissures of the anulus fibrosus. intervertebral discs are difficult to anaesthetize. Intradiskal injections of local anaesthetics may succeed in relieving the patients pain, but such injections are liable to yield false negative results if the injected agent fails to adequately infiltrate the nerve endings in the outer anulus fibrosus that mediate the patients pain. In the majority of cases MRI provide adaequate information, but discography may be superior in early stages of anular tear and in clarifying the relation between imaging data and pain [71]. Selective spinal nerve injection: In patients with complicated radiculopathy, the contribution of root inflammation to pain may not be certain, or the level of pathology may be unclear. Diagnostic root blocks are indicated in the following situations: atypical topography of radicular pain, disc prolapses or central spinal stenosis at more than one level and monoradicular pain, lateral spinal stenosis, postnucleotomysyndrome. Injection of individual spinal nerves by paravertebral approach has to be used to elucidate the mechanism and source of pain in this unclear situations. The premise is that needle contact will identify the nerve that produces the patients characteristic pain and that local anaesthetic delivered to the pathogenic nerve will be uniquely analgesic. Often, this method is used for surgical planning, such as determining the site of foraminotomy. All diagnostic nerve root blocks have to be done under fluoroscopic guidance. Pain relief with blockade of a spinal nerve cannot distinguish between pathology of the proximal nerve in the intervertebral foramen or pain transmitted from distal sites by that nerve. Besides, the tissue injury in the nerves distribution and neuropathic pain (for instance as a result of root injury) likewise would be relieved by a proximal block of the nerve. Satisfactory needle placement could not be achieved in 10% of patients at L4, 15% at L5 and 30% at S1 [28]. The positive predictive value of indicated radiculopathy confirmed by surgery ranged between 87–100% [14, 22]. The negative predictive value is poorly studied, because few patients in the negative test group had surgery. Negative predictive values were 27% and 38% of the small number of patients operated on despite a negative test. Only one prospective study was published, which showed a positive predictive value of 95% and an untested negative predictive value [66]. Some studies repeatedly demonstrated that pain relief by nerve root block does not predict success by neuroablative procedures, neither by dorsal rhyzotomy nor by dorsal gangliectomy [46]. Therapeutic nerve blocks – facet joints: Intraarticular injection of steroids offer no greater benefit than injections of normal saline [8, 15] and long lasting success is lacking. In this case, a denervation of the medial branches can be considered. To date three randomized controlled studies of radiofrequency facet denervation have been published. One study [20] reported only modest outcomes and its results remained inconclusive, another study [72] with a double blind controlled design showed some effects in a small selected group of patients (adjusted odds ratio 4.8) 3, 6 and 12 months after treatment, concerning not only reduction of pain but alleviating functional disability also. The third study (34a) showed no effect 3 months after treatment. Discogenic pain: Intradiscal radiofrequency lesions, intradiscal injections of steroids and phenol have been advocated, but there are no well controlled studies. Just recently, intradiscal lesion and denervation of the anulus has been described with promising results, but a randomized controlled study is lacking up to now [31, 55]. Epidural Steroids: Steroids relieve pain by reducing inflammation and by blocking transmission of nociceptive C-fiber input. Koes et al. [33] reviewed the randomized trials of epidural steroids: To date, 15 trials have been performed to evaluate the efficacy, 11 of which showed method scores of 50 points (from 100) ore more. The trials showed inconsistent results of epidural injections. Of the 15 trials, 8 reported positive results and 7 others reported negative results. Consequently the efficacy of epidural steroid injections has not yet been established. The benefits of epidural steroid injections seem to be of short duration only. Future efficacy studies, which are clearly needed, should take into account the apparent methological shortcomings. Furthermore, it is unclear which patients benefit from these injections. In our hands the injection technique can be much improved by fluoroscopic guidance of the needle, with a prone position of the patient, and lateral injection at the relevant level and with a small volume (1–2 ml) and low dose of corticosteroid (20 mg triamcinolone in the case of a monoradicular pain, for example). In the case of epidural adhesions in postoperative radicular pain [50], the study of Heafner showed that the additional effect of hyaloronidase and hypertonic saline to steroids was mini

The use of pain drawings in screening for psychological involvement in complaints of low-back pain.

The pain drawings of 54 low-back-pain patients were examined to find out if it is possible to use them as a brief screening test in order to assess the psychological impairment of the patients. We were using the scoring system of Ransford et al, which we slightly changed, and chose as a criterion variable the ERMSS (Erweiterte Revidierte Mehrdimensionale Schmerzskala) of Cziske. This test originates in the McGill Pain Questionnaire of Melzack and Torgerson; its scales describe four dimensions of pain perception: pain intensity, the sensory-discriminative dimension reflecting the somatic aspect of pain; the affective-motivational dimension, and the total number of words, both representing the psychological involvement of a pain patient. A correlation was found between pain drawing score and the sensory-discriminative dimension of pain perception, whereas there was no such correlation between drawing score and the affective dimension. These results indicate that the pain drawing score might not be a sufficiently valid instrument for assessing psychological disturbances in pain patients to allow it to be used for individual diagnosis without hesitation.